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In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said.

“Use of this device may cause serious injuries or death,” an FDA notice about the recall said.

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.

In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

When it comes to medical devices, recalls can include not only “removals,” in which the device is removed from where it is used or sold, but also “corrections,” which address the problem in the field — for instance, by repairing, adjusting, relabeling, or inspecting a device.

“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”

Though the FDA and federal regulations call these actions recalls, they might be described more aptly as “non-recalls.” And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.
 

Safeguarding the Public

Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?

There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.

In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.

Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.

Where recalled devices have already been implanted, “removal” doesn’t necessarily mean removing them from patients’ bodies. “When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place,” the FDA website says.

The FDA allowed the recalled MitraClip devices to remain in use “because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm’s recall strategy was appropriate and adequate,” Harrison said.

The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.

Abbott, the maker of MitraClip, said the device has been proven safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” company spokesperson Brent Tippen said.

Speaking of the MitraClip recalls, Redberg said, “So hard to imagine these are effective actions in protecting patients.”

In 2021, for Medtronic’s StealthStation S7 cranial software, the company and the FDA sent a different message.

StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it’s meant to show the location of the surgical instruments.

In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in “life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.”

The FDA website explained what Medtronic was doing about it.

“The recalling firm will provide a warning and instructional placard to be applied to impacted systems,” the website said. “Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring,” it advised doctors.

In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company’s primary concern, and certain issues “can be safely and effectively remedied with a correction on site.”

Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.

“But, I mean, then you could ask, ‘Well, why don’t they just disable the view [of the brain] that’s bugged?’” Everson said. “Why would they give you the option of looking at an inaccurate one?”

“That’s kind of a strange solution,” he said.

The FDA lists the 2021 recall as still open, explaining “not all products have been corrected or removed.”

That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.

In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they “had almost no speech for two days,” according to a Medtronic report. In the report, Medtronic said there was “insufficient information to determine the relationship of the software to the reported issue.”

In a February 2024 case, after brain surgery, an MRI found that the operation “missed the tumor” and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.

In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.

“Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed,” Medtronic’s Winkels told KFF Health News in a July email. “While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions.”

In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of “destruction of the impeller blades,” which could cause “low flow” and “embolization of the fractured impeller material,” an entry on the FDA website said.

“Clinicians are cautioned to position the Impella system carefully in patients,” the FDA website said, among other instructions.

The updated instructions “provide technical guidance to mitigate the risk of rare complications,” Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events “related to product design or manufacturing,” Carbain said.

Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.

The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.

In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.

During the summer of 2023, the FDA noted that “alternative treatments are limited” and said the devices could continue to be used.

But, in May, the FDA changed its stance. The agency advised health care facilities to “transition away from these devices and seek alternatives, if possible.”

“These recommendations are based on our continued concerns” that the manufacturer “has not sufficiently addressed the problems and risks with these recalled devices.”

Getinge sent KFF Health News written answers from Elin Frostehav, the company’s president of Acute Care Therapies.

“There is no question that we would have liked to have solved these issues in full much earlier,” she said.

As a result of the FDA’s May action, the company “immediately paused proactive marketing” of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.

“We are working with the agency to finalize remediation and product update solutions,” Frostehav said.
 

‘Known Possible Complications’

Abbott’s MitraClip system includes tiny clips implanted in the heart’s mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.

Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.

The 2016 MitraClip recall described cases in which “the user was unable to separate the implantable Clip from the delivery system.”

In a news release at the time, Abbott said it had “received a small number of reports” in which that happened.

Those cases “resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem,” the FDA said in a 2016 notice. “There was one patient death in these cases as a result of severe comorbidities following surgery.”

Years later, something similar happened.

In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn’t separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system “had to be cut down in order to detach the clip.”

The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.

The patient “coded” the next day and died from an aortic bleed, the report said.

In the report to the FDA, the manufacturer blamed “case-specific circumstances.”

“Cardiac arrest, hemorrhage and death are listed” in the device instructions “as known possible complications associated with mitraclip procedures,” the company said. “There is no indication of a product issue with respect to manufacture, design or labeling.”

The third MitraClip recall, initiated in September 2022, cited an “increase in clip locking malfunctions.”

Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip “remains within the anticipated risk levels,” the company told customers.

As with the two earlier recalls, the third advised doctors to follow the device’s instructions. But the 2022 recall identified a contributing factor: the way the device was made.

“Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components,” the company said in a 2022 letter to customers.

“Abbott is working on producing new lots with updated manufacturing processing and raw material,” the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.

Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.

“There is no evidence that death was related to the device but it was likely related to the procedure,” Abbott wrote.

Now, almost two years later, the 2022 recall remains open, according to the FDA website, and “not all products have been corrected or removed.”

KFF Health News data editor Holly K. Hacker contributed to this report.
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said.

“Use of this device may cause serious injuries or death,” an FDA notice about the recall said.

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.

In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

When it comes to medical devices, recalls can include not only “removals,” in which the device is removed from where it is used or sold, but also “corrections,” which address the problem in the field — for instance, by repairing, adjusting, relabeling, or inspecting a device.

“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”

Though the FDA and federal regulations call these actions recalls, they might be described more aptly as “non-recalls.” And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.
 

Safeguarding the Public

Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?

There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.

In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.

Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.

Where recalled devices have already been implanted, “removal” doesn’t necessarily mean removing them from patients’ bodies. “When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place,” the FDA website says.

The FDA allowed the recalled MitraClip devices to remain in use “because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm’s recall strategy was appropriate and adequate,” Harrison said.

The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.

Abbott, the maker of MitraClip, said the device has been proven safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” company spokesperson Brent Tippen said.

Speaking of the MitraClip recalls, Redberg said, “So hard to imagine these are effective actions in protecting patients.”

In 2021, for Medtronic’s StealthStation S7 cranial software, the company and the FDA sent a different message.

StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it’s meant to show the location of the surgical instruments.

In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in “life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.”

The FDA website explained what Medtronic was doing about it.

“The recalling firm will provide a warning and instructional placard to be applied to impacted systems,” the website said. “Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring,” it advised doctors.

In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company’s primary concern, and certain issues “can be safely and effectively remedied with a correction on site.”

Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.

“But, I mean, then you could ask, ‘Well, why don’t they just disable the view [of the brain] that’s bugged?’” Everson said. “Why would they give you the option of looking at an inaccurate one?”

“That’s kind of a strange solution,” he said.

The FDA lists the 2021 recall as still open, explaining “not all products have been corrected or removed.”

That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.

In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they “had almost no speech for two days,” according to a Medtronic report. In the report, Medtronic said there was “insufficient information to determine the relationship of the software to the reported issue.”

In a February 2024 case, after brain surgery, an MRI found that the operation “missed the tumor” and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.

In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.

“Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed,” Medtronic’s Winkels told KFF Health News in a July email. “While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions.”

In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of “destruction of the impeller blades,” which could cause “low flow” and “embolization of the fractured impeller material,” an entry on the FDA website said.

“Clinicians are cautioned to position the Impella system carefully in patients,” the FDA website said, among other instructions.

The updated instructions “provide technical guidance to mitigate the risk of rare complications,” Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events “related to product design or manufacturing,” Carbain said.

Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.

The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.

In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.

During the summer of 2023, the FDA noted that “alternative treatments are limited” and said the devices could continue to be used.

But, in May, the FDA changed its stance. The agency advised health care facilities to “transition away from these devices and seek alternatives, if possible.”

“These recommendations are based on our continued concerns” that the manufacturer “has not sufficiently addressed the problems and risks with these recalled devices.”

Getinge sent KFF Health News written answers from Elin Frostehav, the company’s president of Acute Care Therapies.

“There is no question that we would have liked to have solved these issues in full much earlier,” she said.

As a result of the FDA’s May action, the company “immediately paused proactive marketing” of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.

“We are working with the agency to finalize remediation and product update solutions,” Frostehav said.
 

‘Known Possible Complications’

Abbott’s MitraClip system includes tiny clips implanted in the heart’s mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.

Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.

The 2016 MitraClip recall described cases in which “the user was unable to separate the implantable Clip from the delivery system.”

In a news release at the time, Abbott said it had “received a small number of reports” in which that happened.

Those cases “resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem,” the FDA said in a 2016 notice. “There was one patient death in these cases as a result of severe comorbidities following surgery.”

Years later, something similar happened.

In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn’t separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system “had to be cut down in order to detach the clip.”

The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.

The patient “coded” the next day and died from an aortic bleed, the report said.

In the report to the FDA, the manufacturer blamed “case-specific circumstances.”

“Cardiac arrest, hemorrhage and death are listed” in the device instructions “as known possible complications associated with mitraclip procedures,” the company said. “There is no indication of a product issue with respect to manufacture, design or labeling.”

The third MitraClip recall, initiated in September 2022, cited an “increase in clip locking malfunctions.”

Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip “remains within the anticipated risk levels,” the company told customers.

As with the two earlier recalls, the third advised doctors to follow the device’s instructions. But the 2022 recall identified a contributing factor: the way the device was made.

“Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components,” the company said in a 2022 letter to customers.

“Abbott is working on producing new lots with updated manufacturing processing and raw material,” the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.

Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.

“There is no evidence that death was related to the device but it was likely related to the procedure,” Abbott wrote.

Now, almost two years later, the 2022 recall remains open, according to the FDA website, and “not all products have been corrected or removed.”

KFF Health News data editor Holly K. Hacker contributed to this report.
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said.

“Use of this device may cause serious injuries or death,” an FDA notice about the recall said.

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.

In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

When it comes to medical devices, recalls can include not only “removals,” in which the device is removed from where it is used or sold, but also “corrections,” which address the problem in the field — for instance, by repairing, adjusting, relabeling, or inspecting a device.

“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”

Though the FDA and federal regulations call these actions recalls, they might be described more aptly as “non-recalls.” And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.
 

Safeguarding the Public

Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?

There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.

In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.

Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.

Where recalled devices have already been implanted, “removal” doesn’t necessarily mean removing them from patients’ bodies. “When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place,” the FDA website says.

The FDA allowed the recalled MitraClip devices to remain in use “because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm’s recall strategy was appropriate and adequate,” Harrison said.

The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.

Abbott, the maker of MitraClip, said the device has been proven safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” company spokesperson Brent Tippen said.

Speaking of the MitraClip recalls, Redberg said, “So hard to imagine these are effective actions in protecting patients.”

In 2021, for Medtronic’s StealthStation S7 cranial software, the company and the FDA sent a different message.

StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it’s meant to show the location of the surgical instruments.

In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in “life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.”

The FDA website explained what Medtronic was doing about it.

“The recalling firm will provide a warning and instructional placard to be applied to impacted systems,” the website said. “Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring,” it advised doctors.

In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company’s primary concern, and certain issues “can be safely and effectively remedied with a correction on site.”

Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.

“But, I mean, then you could ask, ‘Well, why don’t they just disable the view [of the brain] that’s bugged?’” Everson said. “Why would they give you the option of looking at an inaccurate one?”

“That’s kind of a strange solution,” he said.

The FDA lists the 2021 recall as still open, explaining “not all products have been corrected or removed.”

That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.

In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they “had almost no speech for two days,” according to a Medtronic report. In the report, Medtronic said there was “insufficient information to determine the relationship of the software to the reported issue.”

In a February 2024 case, after brain surgery, an MRI found that the operation “missed the tumor” and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.

In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.

“Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed,” Medtronic’s Winkels told KFF Health News in a July email. “While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions.”

In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of “destruction of the impeller blades,” which could cause “low flow” and “embolization of the fractured impeller material,” an entry on the FDA website said.

“Clinicians are cautioned to position the Impella system carefully in patients,” the FDA website said, among other instructions.

The updated instructions “provide technical guidance to mitigate the risk of rare complications,” Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events “related to product design or manufacturing,” Carbain said.

Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.

The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.

In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.

During the summer of 2023, the FDA noted that “alternative treatments are limited” and said the devices could continue to be used.

But, in May, the FDA changed its stance. The agency advised health care facilities to “transition away from these devices and seek alternatives, if possible.”

“These recommendations are based on our continued concerns” that the manufacturer “has not sufficiently addressed the problems and risks with these recalled devices.”

Getinge sent KFF Health News written answers from Elin Frostehav, the company’s president of Acute Care Therapies.

“There is no question that we would have liked to have solved these issues in full much earlier,” she said.

As a result of the FDA’s May action, the company “immediately paused proactive marketing” of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.

“We are working with the agency to finalize remediation and product update solutions,” Frostehav said.
 

‘Known Possible Complications’

Abbott’s MitraClip system includes tiny clips implanted in the heart’s mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.

Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.

The 2016 MitraClip recall described cases in which “the user was unable to separate the implantable Clip from the delivery system.”

In a news release at the time, Abbott said it had “received a small number of reports” in which that happened.

Those cases “resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem,” the FDA said in a 2016 notice. “There was one patient death in these cases as a result of severe comorbidities following surgery.”

Years later, something similar happened.

In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn’t separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system “had to be cut down in order to detach the clip.”

The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.

The patient “coded” the next day and died from an aortic bleed, the report said.

In the report to the FDA, the manufacturer blamed “case-specific circumstances.”

“Cardiac arrest, hemorrhage and death are listed” in the device instructions “as known possible complications associated with mitraclip procedures,” the company said. “There is no indication of a product issue with respect to manufacture, design or labeling.”

The third MitraClip recall, initiated in September 2022, cited an “increase in clip locking malfunctions.”

Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip “remains within the anticipated risk levels,” the company told customers.

As with the two earlier recalls, the third advised doctors to follow the device’s instructions. But the 2022 recall identified a contributing factor: the way the device was made.

“Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components,” the company said in a 2022 letter to customers.

“Abbott is working on producing new lots with updated manufacturing processing and raw material,” the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.

Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.

“There is no evidence that death was related to the device but it was likely related to the procedure,” Abbott wrote.

Now, almost two years later, the 2022 recall remains open, according to the FDA website, and “not all products have been corrected or removed.”

KFF Health News data editor Holly K. Hacker contributed to this report.
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

The American Board of Internal Medicine (ABIM) has revoked certification for two physicians known for leading an organization that promotes ivermectin as a treatment for COVID-19.

Pierre Kory, MD, is no longer certified in critical care medicine, pulmonary disease, and internal medicine, according to the ABIM website. Paul Ellis Marik, MD, is no longer certified in critical care medicine or internal medicine. 

Dr. Marik is the chief scientific officer and Dr. Kory is president emeritus of the Front Line COVID-19 Critical Care Alliance, a group they founded in March 2020. The FLCCC gained notoriety during the height of the pandemic for advocating ivermectin as a treatment for COVID. It now espouses regimens of supplements to treat “vaccine injury” and also offers treatments for Lyme disease.

Ivermectin was proven to not be of use in treating COVID. Studies purporting to show a benefit were later linked to errors, and some were found to have been based on potentially fraudulent research.

The ABIM declined to comment when asked by this news organization about its action. Its website indicates that “revoked” indicates “loss of certification due to disciplinary action for which ABIM has determined that the conduct underlying the sanction does not warrant a defined pathway for restoration of certification at the time of disciplinary sanction.”

In a statement emailed to this news organization, Dr. Kory and Dr. Marik said, “we believe this decision represents a dangerous shift away from the foundation principles of medical discourse and scientific debate that have historically been the bedrock of medical education associations.”

The FLCCC said in the statement that it, along with Dr. Kory and Dr. Marik, are “evaluating options to challenge these decisions.”

Dr. Kory and Dr. Marik said they were notified in May 2022 that they were facing a potential ABIM disciplinary action. An ABIM committee recommended the revocation in July 2023, saying the two men were spreading “false or inaccurate medical information,” according to FLCCC. Dr. Kory and Dr. Marik lost an appeal. 

In a 2023 statement, Dr. Kory and Dr. Marik called the ABIM action an “attack on freedom of speech.”

“This isn’t a free speech question,” said Arthur L. Caplan, PhD, the Drs. William F. and Virginia Connolly Mitty Professor of Bioethics at NYU Grossman School of Medicine’s Department of Population Health, New York City. “You do have the right to free speech, but you don’t have the right to practice outside of the standard of care boundaries,” he told this news organization.

The ABIM action “is the field standing up and saying, ‘These are the limits of what you can do,’” said Dr. Caplan. It means the profession is rejecting those “who are involved in things that harm patients or delay them getting accepted treatments,” he said. Caplan noted that a disciplinary action had been a long time in coming — 3 years since the first battles over ivermectin. 

Wendy Parmet, JD, Matthews Distinguished University Professor of Law at Northeastern University School of Public Policy and Urban Affairs, Boston, said that misinformation spread by physicians is especially harmful because it comes with an air of credibility.

“We certainly want people to be able to dissent,” Ms. Parmet told this news organization. To engender trust, any sanctions by a professional board should be done in a deliberative process with a strong evidentiary base, she said. 

“You want to leave sufficient room for discourse and discussion within the profession, and you don’t want the board to enforce a narrow, rigid orthodoxy,” she said. But in cases where people are “peddling information that is way outside the consensus” or are “profiting off of it, for the profession to take no action, that is, I think, detrimental also to the trust in the profession,” she said.

She was not surprised that Dr. Kory and Dr. Marik would fight to retain certification. “Board certification is an important, very worthwhile thing to have,” she said. “Losing it is not trivial.”

Dr. Kory, who is licensed in California, New York, and Wisconsin, “does not require this certification for his independent practice but is evaluating next steps with attorneys,” according to the statement from FLCCC.

Dr. Marik, whose Virginia medical license expired in 2022, “is no longer treating patients and has dedicated his time and efforts to the FLCCC Alliance,” the statement said.

Dr. Caplan served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position) and is a contributing author and advisor for this news organization. Ms. Parmet reports no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

The American Board of Internal Medicine (ABIM) has revoked certification for two physicians known for leading an organization that promotes ivermectin as a treatment for COVID-19.

Pierre Kory, MD, is no longer certified in critical care medicine, pulmonary disease, and internal medicine, according to the ABIM website. Paul Ellis Marik, MD, is no longer certified in critical care medicine or internal medicine. 

Dr. Marik is the chief scientific officer and Dr. Kory is president emeritus of the Front Line COVID-19 Critical Care Alliance, a group they founded in March 2020. The FLCCC gained notoriety during the height of the pandemic for advocating ivermectin as a treatment for COVID. It now espouses regimens of supplements to treat “vaccine injury” and also offers treatments for Lyme disease.

Ivermectin was proven to not be of use in treating COVID. Studies purporting to show a benefit were later linked to errors, and some were found to have been based on potentially fraudulent research.

The ABIM declined to comment when asked by this news organization about its action. Its website indicates that “revoked” indicates “loss of certification due to disciplinary action for which ABIM has determined that the conduct underlying the sanction does not warrant a defined pathway for restoration of certification at the time of disciplinary sanction.”

In a statement emailed to this news organization, Dr. Kory and Dr. Marik said, “we believe this decision represents a dangerous shift away from the foundation principles of medical discourse and scientific debate that have historically been the bedrock of medical education associations.”

The FLCCC said in the statement that it, along with Dr. Kory and Dr. Marik, are “evaluating options to challenge these decisions.”

Dr. Kory and Dr. Marik said they were notified in May 2022 that they were facing a potential ABIM disciplinary action. An ABIM committee recommended the revocation in July 2023, saying the two men were spreading “false or inaccurate medical information,” according to FLCCC. Dr. Kory and Dr. Marik lost an appeal. 

In a 2023 statement, Dr. Kory and Dr. Marik called the ABIM action an “attack on freedom of speech.”

“This isn’t a free speech question,” said Arthur L. Caplan, PhD, the Drs. William F. and Virginia Connolly Mitty Professor of Bioethics at NYU Grossman School of Medicine’s Department of Population Health, New York City. “You do have the right to free speech, but you don’t have the right to practice outside of the standard of care boundaries,” he told this news organization.

The ABIM action “is the field standing up and saying, ‘These are the limits of what you can do,’” said Dr. Caplan. It means the profession is rejecting those “who are involved in things that harm patients or delay them getting accepted treatments,” he said. Caplan noted that a disciplinary action had been a long time in coming — 3 years since the first battles over ivermectin. 

Wendy Parmet, JD, Matthews Distinguished University Professor of Law at Northeastern University School of Public Policy and Urban Affairs, Boston, said that misinformation spread by physicians is especially harmful because it comes with an air of credibility.

“We certainly want people to be able to dissent,” Ms. Parmet told this news organization. To engender trust, any sanctions by a professional board should be done in a deliberative process with a strong evidentiary base, she said. 

“You want to leave sufficient room for discourse and discussion within the profession, and you don’t want the board to enforce a narrow, rigid orthodoxy,” she said. But in cases where people are “peddling information that is way outside the consensus” or are “profiting off of it, for the profession to take no action, that is, I think, detrimental also to the trust in the profession,” she said.

She was not surprised that Dr. Kory and Dr. Marik would fight to retain certification. “Board certification is an important, very worthwhile thing to have,” she said. “Losing it is not trivial.”

Dr. Kory, who is licensed in California, New York, and Wisconsin, “does not require this certification for his independent practice but is evaluating next steps with attorneys,” according to the statement from FLCCC.

Dr. Marik, whose Virginia medical license expired in 2022, “is no longer treating patients and has dedicated his time and efforts to the FLCCC Alliance,” the statement said.

Dr. Caplan served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position) and is a contributing author and advisor for this news organization. Ms. Parmet reports no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

The American Board of Internal Medicine (ABIM) has revoked certification for two physicians known for leading an organization that promotes ivermectin as a treatment for COVID-19.

Pierre Kory, MD, is no longer certified in critical care medicine, pulmonary disease, and internal medicine, according to the ABIM website. Paul Ellis Marik, MD, is no longer certified in critical care medicine or internal medicine. 

Dr. Marik is the chief scientific officer and Dr. Kory is president emeritus of the Front Line COVID-19 Critical Care Alliance, a group they founded in March 2020. The FLCCC gained notoriety during the height of the pandemic for advocating ivermectin as a treatment for COVID. It now espouses regimens of supplements to treat “vaccine injury” and also offers treatments for Lyme disease.

Ivermectin was proven to not be of use in treating COVID. Studies purporting to show a benefit were later linked to errors, and some were found to have been based on potentially fraudulent research.

The ABIM declined to comment when asked by this news organization about its action. Its website indicates that “revoked” indicates “loss of certification due to disciplinary action for which ABIM has determined that the conduct underlying the sanction does not warrant a defined pathway for restoration of certification at the time of disciplinary sanction.”

In a statement emailed to this news organization, Dr. Kory and Dr. Marik said, “we believe this decision represents a dangerous shift away from the foundation principles of medical discourse and scientific debate that have historically been the bedrock of medical education associations.”

The FLCCC said in the statement that it, along with Dr. Kory and Dr. Marik, are “evaluating options to challenge these decisions.”

Dr. Kory and Dr. Marik said they were notified in May 2022 that they were facing a potential ABIM disciplinary action. An ABIM committee recommended the revocation in July 2023, saying the two men were spreading “false or inaccurate medical information,” according to FLCCC. Dr. Kory and Dr. Marik lost an appeal. 

In a 2023 statement, Dr. Kory and Dr. Marik called the ABIM action an “attack on freedom of speech.”

“This isn’t a free speech question,” said Arthur L. Caplan, PhD, the Drs. William F. and Virginia Connolly Mitty Professor of Bioethics at NYU Grossman School of Medicine’s Department of Population Health, New York City. “You do have the right to free speech, but you don’t have the right to practice outside of the standard of care boundaries,” he told this news organization.

The ABIM action “is the field standing up and saying, ‘These are the limits of what you can do,’” said Dr. Caplan. It means the profession is rejecting those “who are involved in things that harm patients or delay them getting accepted treatments,” he said. Caplan noted that a disciplinary action had been a long time in coming — 3 years since the first battles over ivermectin. 

Wendy Parmet, JD, Matthews Distinguished University Professor of Law at Northeastern University School of Public Policy and Urban Affairs, Boston, said that misinformation spread by physicians is especially harmful because it comes with an air of credibility.

“We certainly want people to be able to dissent,” Ms. Parmet told this news organization. To engender trust, any sanctions by a professional board should be done in a deliberative process with a strong evidentiary base, she said. 

“You want to leave sufficient room for discourse and discussion within the profession, and you don’t want the board to enforce a narrow, rigid orthodoxy,” she said. But in cases where people are “peddling information that is way outside the consensus” or are “profiting off of it, for the profession to take no action, that is, I think, detrimental also to the trust in the profession,” she said.

She was not surprised that Dr. Kory and Dr. Marik would fight to retain certification. “Board certification is an important, very worthwhile thing to have,” she said. “Losing it is not trivial.”

Dr. Kory, who is licensed in California, New York, and Wisconsin, “does not require this certification for his independent practice but is evaluating next steps with attorneys,” according to the statement from FLCCC.

Dr. Marik, whose Virginia medical license expired in 2022, “is no longer treating patients and has dedicated his time and efforts to the FLCCC Alliance,” the statement said.

Dr. Caplan served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position) and is a contributing author and advisor for this news organization. Ms. Parmet reports no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

The Heritage Foundation sponsored and developed Project 2025 for the explicit, stated purpose of building a conservative victory through policy, personnel, and training with a 180-day game plan after a sympathetic new President of the United States takes office. To date, Project 2025 has not been formally endorsed by any presidential campaign.

More than 100 conservative organizations are said to be participating. More than 400 conservative scholars and experts have collaborated in authorship of the mandate’s 40 chapters. Chapter 14 of the “Mandate for Leadership” is an exhaustive proposed overhaul of the Department of Health and Human Services (HHS), one of the major existing arms of the executive branch of the US government. 

The mandate’s sweeping recommendations, if implemented, would impact the lives of all Americans and all healthcare workers, as outlined in the following excerpts. 
 

Healthcare-Related Excerpts From Project 2025

• “From the moment of conception, every human being possesses inherent dignity and worth, and our humanity does not depend on our age, stage of development, race, or abilities. The Secretary must ensure that all HHS programs and activities are rooted in a deep respect for innocent human life from day one until natural death: Abortion and euthanasia are not health care.”
• “Unfortunately, family policies and programs under President Biden’s HHS are fraught with agenda items focusing on ‘LGBTQ+ equity,’ subsidizing single motherhood, disincentivizing work, and penalizing marriage. These policies should be repealed and replaced by policies that support the formation of stable, married, nuclear families.”
• “The next Administration should guard against the regulatory capture of our public health agencies by pharmaceutical companies, insurers, hospital conglomerates, and related economic interests that these agencies are meant to regulate. We must erect robust firewalls to mitigate these obvious financial conflicts of interest.”
• “All National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration regulators should be entirely free from private biopharmaceutical funding. In this realm, ‘public–private partnerships’ is a euphemism for agency capture, a thin veneer for corporatism. Funding for agencies and individual government researchers must come directly from the government with robust congressional oversight.”
• “The CDC [Centers for Disease Control and Prevention] operates several programs related to vaccine safety including the Vaccine Adverse Event Reporting System (VAERS); Vaccine Safety Datalink (VSD); and Clinical Immunization Safety Assessment (CISA) Project. Those functions and their associated funding should be transferred to the FDA [Food and Drug Administration], which is responsible for post-market surveillance and evaluation of all other drugs and biological products.”
• “Because liberal states have now become sanctuaries for abortion tourism, HHS should use every available tool, including the cutting of funds, to ensure that every state reports exactly how many abortions take place within its borders, at what gestational age of the child, for what reason, the mother’s state of residence, and by what method. It should also ensure that statistics are separated by category: spontaneous miscarriage; treatments that incidentally result in the death of a child (such as chemotherapy); stillbirths; and induced abortion. In addition, CDC should require monitoring and reporting for complications due to abortion and every instance of children being born alive after an abortion.”
• “The CDC should immediately end its collection of data on gender identity, which legitimizes the unscientific notion that men can become women (and vice versa) and encourages the phenomenon of ever-multiplying subjective identities.”
• “A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a ‘new’ laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlaboratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories without the current regulatory burdens.”
• “[FDA should] Reverse its approval of chemical abortion drugs because the politicized approval process was illegal from the start. The FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women.”
• “[FDA should] Stop promoting or approving mail-order abortions in violation of long-standing federal laws that prohibit the mailing and interstate carriage of abortion drugs.”
• “[HHS should] Promptly restore the ethics advisory committee to oversee abortion-derived fetal tissue research, and Congress should prohibit such research altogether.”
• “[HHS should] End intramural research projects using tissue from aborted children within the NIH, which should end its human embryonic stem cell registry.”
• “Under Francis Collins, NIH became so focused on the #MeToo movement that it refused to sponsor scientific conferences unless there were a certain number of women panelists, which violates federal civil rights law against sex discrimination. This quota practice should be ended, and the NIH Office of Equity, Diversity, and Inclusion, which pushes such unlawful actions, should be abolished.”
• “Make Medicare Advantage [MA] the default enrollment option.”
• “[Legislation reforming legacy (non-MA) Medicare should] Repeal harmful health policies enacted under the Obama and Biden Administrations such as the Medicare Shared Savings Program and Inflation Reduction Act.”
• “…the next Administration should] Add work requirements and match Medicaid benefits to beneficiary needs. Because Medicaid serves a broad and diverse group of individuals, it should be flexible enough to accommodate different designs for different groups.”
• “The No Surprises Act should scrap the dispute resolution process in favor of a truth-in-advertising approach that will protect consumers and free doctors, insurers, and arbiters from confused and conflicting standards for resolving disputes that the disputing parties can best resolve themselves.”
• “Prohibit abortion travel funding. Providing funding for abortions increases the number of abortions and violates the conscience and religious freedom rights of Americans who object to subsidizing the taking of life.”
• “Prohibit Planned Parenthood from receiving Medicaid funds. During the 2020–2021 reporting period, Planned Parenthood performed more than 383,000 abortions.”
• “Protect faith-based grant recipients from religious liberty violations and maintain a biblically based, social science–reinforced definition of marriage and family. Social science reports that assess the objective outcomes for children raised in homes aside from a heterosexual, intact marriage are clear.”
• “Allocate funding to strategy programs promoting father involvement or terminate parental rights quickly.”
• “Eliminate the Head Start program.”
• “Support palliative care. Physician-assisted suicide (PAS) is legal in 10 states and the District of Columbia. Legalizing PAS is a grave mistake that endangers the weak and vulnerable, corrupts the practice of medicine and the doctor–patient relationship, compromises the family and intergenerational commitments, and betrays human dignity and equality before the law.”
• “Eliminate men’s preventive services from the women’s preventive services mandate. In December 2021, HRSA [Health Resources and Services Administration] updated its women’s preventive services guidelines to include male condoms.”
• “Prioritize funding for home-based childcare, not universal day care.”
• “ The Office of the Secretary should eliminate the HHS Reproductive Healthcare Access Task Force and install a pro-life task force to ensure that all of the department’s divisions seek to use their authority to promote the life and health of women and their unborn children.”
• “The ASH [Assistant Secretary for Health] and SG [Surgeon General] positions should be combined into one four-star position with the rank, responsibilities, and authority of the ASH retained but with the title of Surgeon General.”
• “OCR [Office for Civil Rights] should withdraw its Health Insurance Portability and Accountability Act (HIPAA) guidance on abortion.”

Dr. Lundberg is Editor in Chief, Cancer Commons, and has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The Heritage Foundation sponsored and developed Project 2025 for the explicit, stated purpose of building a conservative victory through policy, personnel, and training with a 180-day game plan after a sympathetic new President of the United States takes office. To date, Project 2025 has not been formally endorsed by any presidential campaign.

More than 100 conservative organizations are said to be participating. More than 400 conservative scholars and experts have collaborated in authorship of the mandate’s 40 chapters. Chapter 14 of the “Mandate for Leadership” is an exhaustive proposed overhaul of the Department of Health and Human Services (HHS), one of the major existing arms of the executive branch of the US government. 

The mandate’s sweeping recommendations, if implemented, would impact the lives of all Americans and all healthcare workers, as outlined in the following excerpts. 
 

Healthcare-Related Excerpts From Project 2025

• “From the moment of conception, every human being possesses inherent dignity and worth, and our humanity does not depend on our age, stage of development, race, or abilities. The Secretary must ensure that all HHS programs and activities are rooted in a deep respect for innocent human life from day one until natural death: Abortion and euthanasia are not health care.”
• “Unfortunately, family policies and programs under President Biden’s HHS are fraught with agenda items focusing on ‘LGBTQ+ equity,’ subsidizing single motherhood, disincentivizing work, and penalizing marriage. These policies should be repealed and replaced by policies that support the formation of stable, married, nuclear families.”
• “The next Administration should guard against the regulatory capture of our public health agencies by pharmaceutical companies, insurers, hospital conglomerates, and related economic interests that these agencies are meant to regulate. We must erect robust firewalls to mitigate these obvious financial conflicts of interest.”
• “All National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration regulators should be entirely free from private biopharmaceutical funding. In this realm, ‘public–private partnerships’ is a euphemism for agency capture, a thin veneer for corporatism. Funding for agencies and individual government researchers must come directly from the government with robust congressional oversight.”
• “The CDC [Centers for Disease Control and Prevention] operates several programs related to vaccine safety including the Vaccine Adverse Event Reporting System (VAERS); Vaccine Safety Datalink (VSD); and Clinical Immunization Safety Assessment (CISA) Project. Those functions and their associated funding should be transferred to the FDA [Food and Drug Administration], which is responsible for post-market surveillance and evaluation of all other drugs and biological products.”
• “Because liberal states have now become sanctuaries for abortion tourism, HHS should use every available tool, including the cutting of funds, to ensure that every state reports exactly how many abortions take place within its borders, at what gestational age of the child, for what reason, the mother’s state of residence, and by what method. It should also ensure that statistics are separated by category: spontaneous miscarriage; treatments that incidentally result in the death of a child (such as chemotherapy); stillbirths; and induced abortion. In addition, CDC should require monitoring and reporting for complications due to abortion and every instance of children being born alive after an abortion.”
• “The CDC should immediately end its collection of data on gender identity, which legitimizes the unscientific notion that men can become women (and vice versa) and encourages the phenomenon of ever-multiplying subjective identities.”
• “A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a ‘new’ laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlaboratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories without the current regulatory burdens.”
• “[FDA should] Reverse its approval of chemical abortion drugs because the politicized approval process was illegal from the start. The FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women.”
• “[FDA should] Stop promoting or approving mail-order abortions in violation of long-standing federal laws that prohibit the mailing and interstate carriage of abortion drugs.”
• “[HHS should] Promptly restore the ethics advisory committee to oversee abortion-derived fetal tissue research, and Congress should prohibit such research altogether.”
• “[HHS should] End intramural research projects using tissue from aborted children within the NIH, which should end its human embryonic stem cell registry.”
• “Under Francis Collins, NIH became so focused on the #MeToo movement that it refused to sponsor scientific conferences unless there were a certain number of women panelists, which violates federal civil rights law against sex discrimination. This quota practice should be ended, and the NIH Office of Equity, Diversity, and Inclusion, which pushes such unlawful actions, should be abolished.”
• “Make Medicare Advantage [MA] the default enrollment option.”
• “[Legislation reforming legacy (non-MA) Medicare should] Repeal harmful health policies enacted under the Obama and Biden Administrations such as the Medicare Shared Savings Program and Inflation Reduction Act.”
• “…the next Administration should] Add work requirements and match Medicaid benefits to beneficiary needs. Because Medicaid serves a broad and diverse group of individuals, it should be flexible enough to accommodate different designs for different groups.”
• “The No Surprises Act should scrap the dispute resolution process in favor of a truth-in-advertising approach that will protect consumers and free doctors, insurers, and arbiters from confused and conflicting standards for resolving disputes that the disputing parties can best resolve themselves.”
• “Prohibit abortion travel funding. Providing funding for abortions increases the number of abortions and violates the conscience and religious freedom rights of Americans who object to subsidizing the taking of life.”
• “Prohibit Planned Parenthood from receiving Medicaid funds. During the 2020–2021 reporting period, Planned Parenthood performed more than 383,000 abortions.”
• “Protect faith-based grant recipients from religious liberty violations and maintain a biblically based, social science–reinforced definition of marriage and family. Social science reports that assess the objective outcomes for children raised in homes aside from a heterosexual, intact marriage are clear.”
• “Allocate funding to strategy programs promoting father involvement or terminate parental rights quickly.”
• “Eliminate the Head Start program.”
• “Support palliative care. Physician-assisted suicide (PAS) is legal in 10 states and the District of Columbia. Legalizing PAS is a grave mistake that endangers the weak and vulnerable, corrupts the practice of medicine and the doctor–patient relationship, compromises the family and intergenerational commitments, and betrays human dignity and equality before the law.”
• “Eliminate men’s preventive services from the women’s preventive services mandate. In December 2021, HRSA [Health Resources and Services Administration] updated its women’s preventive services guidelines to include male condoms.”
• “Prioritize funding for home-based childcare, not universal day care.”
• “ The Office of the Secretary should eliminate the HHS Reproductive Healthcare Access Task Force and install a pro-life task force to ensure that all of the department’s divisions seek to use their authority to promote the life and health of women and their unborn children.”
• “The ASH [Assistant Secretary for Health] and SG [Surgeon General] positions should be combined into one four-star position with the rank, responsibilities, and authority of the ASH retained but with the title of Surgeon General.”
• “OCR [Office for Civil Rights] should withdraw its Health Insurance Portability and Accountability Act (HIPAA) guidance on abortion.”

Dr. Lundberg is Editor in Chief, Cancer Commons, and has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The Heritage Foundation sponsored and developed Project 2025 for the explicit, stated purpose of building a conservative victory through policy, personnel, and training with a 180-day game plan after a sympathetic new President of the United States takes office. To date, Project 2025 has not been formally endorsed by any presidential campaign.

More than 100 conservative organizations are said to be participating. More than 400 conservative scholars and experts have collaborated in authorship of the mandate’s 40 chapters. Chapter 14 of the “Mandate for Leadership” is an exhaustive proposed overhaul of the Department of Health and Human Services (HHS), one of the major existing arms of the executive branch of the US government. 

The mandate’s sweeping recommendations, if implemented, would impact the lives of all Americans and all healthcare workers, as outlined in the following excerpts. 
 

Healthcare-Related Excerpts From Project 2025

• “From the moment of conception, every human being possesses inherent dignity and worth, and our humanity does not depend on our age, stage of development, race, or abilities. The Secretary must ensure that all HHS programs and activities are rooted in a deep respect for innocent human life from day one until natural death: Abortion and euthanasia are not health care.”
• “Unfortunately, family policies and programs under President Biden’s HHS are fraught with agenda items focusing on ‘LGBTQ+ equity,’ subsidizing single motherhood, disincentivizing work, and penalizing marriage. These policies should be repealed and replaced by policies that support the formation of stable, married, nuclear families.”
• “The next Administration should guard against the regulatory capture of our public health agencies by pharmaceutical companies, insurers, hospital conglomerates, and related economic interests that these agencies are meant to regulate. We must erect robust firewalls to mitigate these obvious financial conflicts of interest.”
• “All National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration regulators should be entirely free from private biopharmaceutical funding. In this realm, ‘public–private partnerships’ is a euphemism for agency capture, a thin veneer for corporatism. Funding for agencies and individual government researchers must come directly from the government with robust congressional oversight.”
• “The CDC [Centers for Disease Control and Prevention] operates several programs related to vaccine safety including the Vaccine Adverse Event Reporting System (VAERS); Vaccine Safety Datalink (VSD); and Clinical Immunization Safety Assessment (CISA) Project. Those functions and their associated funding should be transferred to the FDA [Food and Drug Administration], which is responsible for post-market surveillance and evaluation of all other drugs and biological products.”
• “Because liberal states have now become sanctuaries for abortion tourism, HHS should use every available tool, including the cutting of funds, to ensure that every state reports exactly how many abortions take place within its borders, at what gestational age of the child, for what reason, the mother’s state of residence, and by what method. It should also ensure that statistics are separated by category: spontaneous miscarriage; treatments that incidentally result in the death of a child (such as chemotherapy); stillbirths; and induced abortion. In addition, CDC should require monitoring and reporting for complications due to abortion and every instance of children being born alive after an abortion.”
• “The CDC should immediately end its collection of data on gender identity, which legitimizes the unscientific notion that men can become women (and vice versa) and encourages the phenomenon of ever-multiplying subjective identities.”
• “A test developed by a lab in accordance with the protocols developed by another lab (non-commercial sharing) currently constitutes a ‘new’ laboratory-developed test because the lab in which it will be used is different from the initial developing lab. To encourage interlaboratory collaboration and discourage duplicative test creation (and associated regulatory and logistical burdens), the FDA should introduce mechanisms through which laboratory-developed tests can easily be shared with other laboratories without the current regulatory burdens.”
• “[FDA should] Reverse its approval of chemical abortion drugs because the politicized approval process was illegal from the start. The FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women.”
• “[FDA should] Stop promoting or approving mail-order abortions in violation of long-standing federal laws that prohibit the mailing and interstate carriage of abortion drugs.”
• “[HHS should] Promptly restore the ethics advisory committee to oversee abortion-derived fetal tissue research, and Congress should prohibit such research altogether.”
• “[HHS should] End intramural research projects using tissue from aborted children within the NIH, which should end its human embryonic stem cell registry.”
• “Under Francis Collins, NIH became so focused on the #MeToo movement that it refused to sponsor scientific conferences unless there were a certain number of women panelists, which violates federal civil rights law against sex discrimination. This quota practice should be ended, and the NIH Office of Equity, Diversity, and Inclusion, which pushes such unlawful actions, should be abolished.”
• “Make Medicare Advantage [MA] the default enrollment option.”
• “[Legislation reforming legacy (non-MA) Medicare should] Repeal harmful health policies enacted under the Obama and Biden Administrations such as the Medicare Shared Savings Program and Inflation Reduction Act.”
• “…the next Administration should] Add work requirements and match Medicaid benefits to beneficiary needs. Because Medicaid serves a broad and diverse group of individuals, it should be flexible enough to accommodate different designs for different groups.”
• “The No Surprises Act should scrap the dispute resolution process in favor of a truth-in-advertising approach that will protect consumers and free doctors, insurers, and arbiters from confused and conflicting standards for resolving disputes that the disputing parties can best resolve themselves.”
• “Prohibit abortion travel funding. Providing funding for abortions increases the number of abortions and violates the conscience and religious freedom rights of Americans who object to subsidizing the taking of life.”
• “Prohibit Planned Parenthood from receiving Medicaid funds. During the 2020–2021 reporting period, Planned Parenthood performed more than 383,000 abortions.”
• “Protect faith-based grant recipients from religious liberty violations and maintain a biblically based, social science–reinforced definition of marriage and family. Social science reports that assess the objective outcomes for children raised in homes aside from a heterosexual, intact marriage are clear.”
• “Allocate funding to strategy programs promoting father involvement or terminate parental rights quickly.”
• “Eliminate the Head Start program.”
• “Support palliative care. Physician-assisted suicide (PAS) is legal in 10 states and the District of Columbia. Legalizing PAS is a grave mistake that endangers the weak and vulnerable, corrupts the practice of medicine and the doctor–patient relationship, compromises the family and intergenerational commitments, and betrays human dignity and equality before the law.”
• “Eliminate men’s preventive services from the women’s preventive services mandate. In December 2021, HRSA [Health Resources and Services Administration] updated its women’s preventive services guidelines to include male condoms.”
• “Prioritize funding for home-based childcare, not universal day care.”
• “ The Office of the Secretary should eliminate the HHS Reproductive Healthcare Access Task Force and install a pro-life task force to ensure that all of the department’s divisions seek to use their authority to promote the life and health of women and their unborn children.”
• “The ASH [Assistant Secretary for Health] and SG [Surgeon General] positions should be combined into one four-star position with the rank, responsibilities, and authority of the ASH retained but with the title of Surgeon General.”
• “OCR [Office for Civil Rights] should withdraw its Health Insurance Portability and Accountability Act (HIPAA) guidance on abortion.”

Dr. Lundberg is Editor in Chief, Cancer Commons, and has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

My husband Scott and I were flying back to Washington state with our two kids, who were about 1 and 4. We had been in Florida for a family vacation, and we were near the end of the flight, with both kids passed out on top of me.

Suddenly, there was some scuffling and a lot of movement from the flight attendants. The announcement came: “Are there any healthcare providers on board?” My husband and I are both nurses. We looked at each other, and we looked at our sleeping kids. Should we say anything?

One of the stewardesses walked by looking very flustered. My husband was in the aisle seat, so he leaned out and told her that we were nurses. Her eyes got all big, and she said: “Oh yeah, come on up.”

She was looking at both of us. I said, “I think he’s got it.” I assumed it wasn’t that big of a deal. Plus — kids sleeping on top of me.

Scott went up to the front of the plane. But a few minutes later, the stewardess came back and said: “You need to help.” I was holding my 1-year-old son, so I handed her my kid. She sat down with him, and I boogied up to the front of the plane.

I got to the first-class stewards’ area where the restrooms are and the cabinets with all the food and drinks. I could see an older man on the ground on his back. He was unconscious and bleeding profusely from his scalp.

When I saw the bleeding, my first reaction was we need to apply pressure. I asked for a towel. There were no towels. A blanket? Anything to help absorb the blood? Nope. They had nothing. I was given a pair of gloves that were much too big and a fistful of cocktail napkins.

It was such a small space there wasn’t any way to be next to the man. So, I kind of squatted over the top of him to reach behind his head. I got a stack of napkins on there and held pressure as hard as I could with the tips of my fingers on one hand.

I’m a postanesthesia care unit nurse, so my next thought was to check his pupils and make sure he had a good airway by doing a jaw thrust and a chin lift. I noticed there was blood in his mouth. His breathing was in short gusts. I was trying to do all that with my free hand without crushing him with my body.

Scott had made some ice packs, so I applied those as well, which helped to constrict the bleeding. Then he checked the plane’s medical kit to try to get an intravenous (IV) started. It wasn’t easy. The IV start kit was very different from what you would normally use. And at the same time, the plane had started to descend for landing, so we were on an angle. But he tried.

We asked about what had happened. The steward team said the man had fallen and hit his head on one of the stainless steel cabinets. He seemed to be in his 70s or 80s, a tall, solid guy.

His wife was sitting nearby — pretty calm and stoic given the circumstances. We asked her about his medical history, trying to get a feel for why he might be unconscious. He was still totally out. She told us he had diabetes. He was on a blood pressure medication and also a blood thinner.

The plane kept going down. I was in a really awkward position, squatting and holding myself up against the cabinets. I just kept talking to the man, trying to get him to wake up. “Can you hear me? Everything’s okay. You hit your head.”

Someone brought us an oxygen tank. I looked for the mask. And realized it wasn’t a mask. It was a plastic bag. I set it on the patient’s face, and it felt like I was suffocating him. So, I tried to do it blowby to just increase the oxygen in the air near his face.

At one point, his breathing was agonal for a few minutes, which really concerned me. My fear was that he was going to stop breathing. I rubbed his chest and kind of said: “Hey, let’s not do that!”

I would have felt a lot better about resuscitating him with an actual oxygen mask rather than a plastic bag.

The amount of blood definitely looked alarming. I couldn’t tell how much he was actively bleeding. But it was a lot. He wasn’t turning gray though, so that was a good sign.

Finally, he started coming to and opening his eyes. I introduced myself and asked him: “Do you know where you are? Do you know what’s going on?” Trying to see if he was oriented at all.

Eventually, he was able to talk to me, so I kept asking questions: “Are you guys on vacation? Where are you headed? Where are you staying?”

He told me they were going to visit his granddaughter, and he was able to talk about that. He didn’t try to get up, which I was glad about, because that would’ve been really challenging to navigate.

I could tell he was embarrassed about what had happened. I’ve helped a lot of older gentlemen after falling down, and their egos are often bruised. They don’t want to be in a position of needing help.

Finally, the plane landed. There was blood absolutely everywhere. The ice packs had melted, and the water had mixed with the pool of blood. It was such a mess.

The pilots had called the airport ahead to let them know we needed medical services. So, the first responding team came on right away. They stabilized the man with a board, put the neck brace on him, and did all the stuff you do for a patient after a fall.

I gave them a report — that’s just my style. But it didn’t seem like they needed a lot of information at that point.

I was finally able to talk to the man’s wife who was clearly terrified. I gave her a hug and told her he would be all right. She thanked us.

The emergency team didn’t seem to have anything to help staunch the bleeding either because the rolling gurney left puddles of blood all down the gangway, causing a significant biohazard problem.

They let one person leave who had a connecting flight, but everyone else had to get off from the rear of the plane and walk across the tarmac.

When we finally got back to our seats, the stewardess was still sitting with our kids. They were both totally chill, watching some show, apparently very well behaved. Our daughter asked us what was going on, and I said: “Oh, somebody got hurt at the front of the plane.” She’s so used to hearing that we work with sick people that it didn’t faze her at all.

As we left, we got a lot of thank-yous from people who had been sitting up front and saw what happened.

When we got home, there was still blood on my shoes. I remember looking at them and thinking: Disinfect or throw away? I disinfected them. They were still a good pair of shoes.

A few days later, we got an email from the airline with a voucher, expressing their gratitude for our help. That was nice and unexpected.

I responded with a suggestion: How about having some protocols for medical events on airplanes? Pilots go through checklists for almost everything they do. Why wouldn’t they have something like that for medical responses?

I also asked how the man and his wife were doing. But they couldn’t disclose that information.

It was certainly strange being out of my element, helping a patient in that tiny little space; I’m used to working in a recovery room where you have literally everything you need within arm’s reach — the Ambu bag, suction, and bandages. And with airway management, there’s usually more than one person in the room to assist. If there’s a problem, a whole bunch of people show up around the bed so fast.

I’m definitely thinking about field medicine a lot more. Wondering what I would do in certain situations. While debriefing with my mom (an advanced registered nurse practitioner), she pointed out that we should have asked passengers for sanitary pads or diapers to stabilize the bleeding instead of the cocktail napkins. Brilliant idea! I didn’t think of it in the moment. But I’m keeping that little tip tucked in my back pocket for any future bleeding-in-the-wild scenarios.

Audra Podruzny, MSN, RN, CPAN, lives in Washington state and is currently attending the Washington State University Doctor of Nursing Practice Family Nurse Practitioner program.

A version of this article first appeared on Medscape.com.

My husband Scott and I were flying back to Washington state with our two kids, who were about 1 and 4. We had been in Florida for a family vacation, and we were near the end of the flight, with both kids passed out on top of me.

Suddenly, there was some scuffling and a lot of movement from the flight attendants. The announcement came: “Are there any healthcare providers on board?” My husband and I are both nurses. We looked at each other, and we looked at our sleeping kids. Should we say anything?

One of the stewardesses walked by looking very flustered. My husband was in the aisle seat, so he leaned out and told her that we were nurses. Her eyes got all big, and she said: “Oh yeah, come on up.”

She was looking at both of us. I said, “I think he’s got it.” I assumed it wasn’t that big of a deal. Plus — kids sleeping on top of me.

Scott went up to the front of the plane. But a few minutes later, the stewardess came back and said: “You need to help.” I was holding my 1-year-old son, so I handed her my kid. She sat down with him, and I boogied up to the front of the plane.

I got to the first-class stewards’ area where the restrooms are and the cabinets with all the food and drinks. I could see an older man on the ground on his back. He was unconscious and bleeding profusely from his scalp.

When I saw the bleeding, my first reaction was we need to apply pressure. I asked for a towel. There were no towels. A blanket? Anything to help absorb the blood? Nope. They had nothing. I was given a pair of gloves that were much too big and a fistful of cocktail napkins.

It was such a small space there wasn’t any way to be next to the man. So, I kind of squatted over the top of him to reach behind his head. I got a stack of napkins on there and held pressure as hard as I could with the tips of my fingers on one hand.

I’m a postanesthesia care unit nurse, so my next thought was to check his pupils and make sure he had a good airway by doing a jaw thrust and a chin lift. I noticed there was blood in his mouth. His breathing was in short gusts. I was trying to do all that with my free hand without crushing him with my body.

Scott had made some ice packs, so I applied those as well, which helped to constrict the bleeding. Then he checked the plane’s medical kit to try to get an intravenous (IV) started. It wasn’t easy. The IV start kit was very different from what you would normally use. And at the same time, the plane had started to descend for landing, so we were on an angle. But he tried.

We asked about what had happened. The steward team said the man had fallen and hit his head on one of the stainless steel cabinets. He seemed to be in his 70s or 80s, a tall, solid guy.

His wife was sitting nearby — pretty calm and stoic given the circumstances. We asked her about his medical history, trying to get a feel for why he might be unconscious. He was still totally out. She told us he had diabetes. He was on a blood pressure medication and also a blood thinner.

The plane kept going down. I was in a really awkward position, squatting and holding myself up against the cabinets. I just kept talking to the man, trying to get him to wake up. “Can you hear me? Everything’s okay. You hit your head.”

Someone brought us an oxygen tank. I looked for the mask. And realized it wasn’t a mask. It was a plastic bag. I set it on the patient’s face, and it felt like I was suffocating him. So, I tried to do it blowby to just increase the oxygen in the air near his face.

At one point, his breathing was agonal for a few minutes, which really concerned me. My fear was that he was going to stop breathing. I rubbed his chest and kind of said: “Hey, let’s not do that!”

I would have felt a lot better about resuscitating him with an actual oxygen mask rather than a plastic bag.

The amount of blood definitely looked alarming. I couldn’t tell how much he was actively bleeding. But it was a lot. He wasn’t turning gray though, so that was a good sign.

Finally, he started coming to and opening his eyes. I introduced myself and asked him: “Do you know where you are? Do you know what’s going on?” Trying to see if he was oriented at all.

Eventually, he was able to talk to me, so I kept asking questions: “Are you guys on vacation? Where are you headed? Where are you staying?”

He told me they were going to visit his granddaughter, and he was able to talk about that. He didn’t try to get up, which I was glad about, because that would’ve been really challenging to navigate.

I could tell he was embarrassed about what had happened. I’ve helped a lot of older gentlemen after falling down, and their egos are often bruised. They don’t want to be in a position of needing help.

Finally, the plane landed. There was blood absolutely everywhere. The ice packs had melted, and the water had mixed with the pool of blood. It was such a mess.

The pilots had called the airport ahead to let them know we needed medical services. So, the first responding team came on right away. They stabilized the man with a board, put the neck brace on him, and did all the stuff you do for a patient after a fall.

I gave them a report — that’s just my style. But it didn’t seem like they needed a lot of information at that point.

I was finally able to talk to the man’s wife who was clearly terrified. I gave her a hug and told her he would be all right. She thanked us.

The emergency team didn’t seem to have anything to help staunch the bleeding either because the rolling gurney left puddles of blood all down the gangway, causing a significant biohazard problem.

They let one person leave who had a connecting flight, but everyone else had to get off from the rear of the plane and walk across the tarmac.

When we finally got back to our seats, the stewardess was still sitting with our kids. They were both totally chill, watching some show, apparently very well behaved. Our daughter asked us what was going on, and I said: “Oh, somebody got hurt at the front of the plane.” She’s so used to hearing that we work with sick people that it didn’t faze her at all.

As we left, we got a lot of thank-yous from people who had been sitting up front and saw what happened.

When we got home, there was still blood on my shoes. I remember looking at them and thinking: Disinfect or throw away? I disinfected them. They were still a good pair of shoes.

A few days later, we got an email from the airline with a voucher, expressing their gratitude for our help. That was nice and unexpected.

I responded with a suggestion: How about having some protocols for medical events on airplanes? Pilots go through checklists for almost everything they do. Why wouldn’t they have something like that for medical responses?

I also asked how the man and his wife were doing. But they couldn’t disclose that information.

It was certainly strange being out of my element, helping a patient in that tiny little space; I’m used to working in a recovery room where you have literally everything you need within arm’s reach — the Ambu bag, suction, and bandages. And with airway management, there’s usually more than one person in the room to assist. If there’s a problem, a whole bunch of people show up around the bed so fast.

I’m definitely thinking about field medicine a lot more. Wondering what I would do in certain situations. While debriefing with my mom (an advanced registered nurse practitioner), she pointed out that we should have asked passengers for sanitary pads or diapers to stabilize the bleeding instead of the cocktail napkins. Brilliant idea! I didn’t think of it in the moment. But I’m keeping that little tip tucked in my back pocket for any future bleeding-in-the-wild scenarios.

Audra Podruzny, MSN, RN, CPAN, lives in Washington state and is currently attending the Washington State University Doctor of Nursing Practice Family Nurse Practitioner program.

A version of this article first appeared on Medscape.com.

My husband Scott and I were flying back to Washington state with our two kids, who were about 1 and 4. We had been in Florida for a family vacation, and we were near the end of the flight, with both kids passed out on top of me.

Suddenly, there was some scuffling and a lot of movement from the flight attendants. The announcement came: “Are there any healthcare providers on board?” My husband and I are both nurses. We looked at each other, and we looked at our sleeping kids. Should we say anything?

One of the stewardesses walked by looking very flustered. My husband was in the aisle seat, so he leaned out and told her that we were nurses. Her eyes got all big, and she said: “Oh yeah, come on up.”

She was looking at both of us. I said, “I think he’s got it.” I assumed it wasn’t that big of a deal. Plus — kids sleeping on top of me.

Scott went up to the front of the plane. But a few minutes later, the stewardess came back and said: “You need to help.” I was holding my 1-year-old son, so I handed her my kid. She sat down with him, and I boogied up to the front of the plane.

I got to the first-class stewards’ area where the restrooms are and the cabinets with all the food and drinks. I could see an older man on the ground on his back. He was unconscious and bleeding profusely from his scalp.

When I saw the bleeding, my first reaction was we need to apply pressure. I asked for a towel. There were no towels. A blanket? Anything to help absorb the blood? Nope. They had nothing. I was given a pair of gloves that were much too big and a fistful of cocktail napkins.

It was such a small space there wasn’t any way to be next to the man. So, I kind of squatted over the top of him to reach behind his head. I got a stack of napkins on there and held pressure as hard as I could with the tips of my fingers on one hand.

I’m a postanesthesia care unit nurse, so my next thought was to check his pupils and make sure he had a good airway by doing a jaw thrust and a chin lift. I noticed there was blood in his mouth. His breathing was in short gusts. I was trying to do all that with my free hand without crushing him with my body.

Scott had made some ice packs, so I applied those as well, which helped to constrict the bleeding. Then he checked the plane’s medical kit to try to get an intravenous (IV) started. It wasn’t easy. The IV start kit was very different from what you would normally use. And at the same time, the plane had started to descend for landing, so we were on an angle. But he tried.

We asked about what had happened. The steward team said the man had fallen and hit his head on one of the stainless steel cabinets. He seemed to be in his 70s or 80s, a tall, solid guy.

His wife was sitting nearby — pretty calm and stoic given the circumstances. We asked her about his medical history, trying to get a feel for why he might be unconscious. He was still totally out. She told us he had diabetes. He was on a blood pressure medication and also a blood thinner.

The plane kept going down. I was in a really awkward position, squatting and holding myself up against the cabinets. I just kept talking to the man, trying to get him to wake up. “Can you hear me? Everything’s okay. You hit your head.”

Someone brought us an oxygen tank. I looked for the mask. And realized it wasn’t a mask. It was a plastic bag. I set it on the patient’s face, and it felt like I was suffocating him. So, I tried to do it blowby to just increase the oxygen in the air near his face.

At one point, his breathing was agonal for a few minutes, which really concerned me. My fear was that he was going to stop breathing. I rubbed his chest and kind of said: “Hey, let’s not do that!”

I would have felt a lot better about resuscitating him with an actual oxygen mask rather than a plastic bag.

The amount of blood definitely looked alarming. I couldn’t tell how much he was actively bleeding. But it was a lot. He wasn’t turning gray though, so that was a good sign.

Finally, he started coming to and opening his eyes. I introduced myself and asked him: “Do you know where you are? Do you know what’s going on?” Trying to see if he was oriented at all.

Eventually, he was able to talk to me, so I kept asking questions: “Are you guys on vacation? Where are you headed? Where are you staying?”

He told me they were going to visit his granddaughter, and he was able to talk about that. He didn’t try to get up, which I was glad about, because that would’ve been really challenging to navigate.

I could tell he was embarrassed about what had happened. I’ve helped a lot of older gentlemen after falling down, and their egos are often bruised. They don’t want to be in a position of needing help.

Finally, the plane landed. There was blood absolutely everywhere. The ice packs had melted, and the water had mixed with the pool of blood. It was such a mess.

The pilots had called the airport ahead to let them know we needed medical services. So, the first responding team came on right away. They stabilized the man with a board, put the neck brace on him, and did all the stuff you do for a patient after a fall.

I gave them a report — that’s just my style. But it didn’t seem like they needed a lot of information at that point.

I was finally able to talk to the man’s wife who was clearly terrified. I gave her a hug and told her he would be all right. She thanked us.

The emergency team didn’t seem to have anything to help staunch the bleeding either because the rolling gurney left puddles of blood all down the gangway, causing a significant biohazard problem.

They let one person leave who had a connecting flight, but everyone else had to get off from the rear of the plane and walk across the tarmac.

When we finally got back to our seats, the stewardess was still sitting with our kids. They were both totally chill, watching some show, apparently very well behaved. Our daughter asked us what was going on, and I said: “Oh, somebody got hurt at the front of the plane.” She’s so used to hearing that we work with sick people that it didn’t faze her at all.

As we left, we got a lot of thank-yous from people who had been sitting up front and saw what happened.

When we got home, there was still blood on my shoes. I remember looking at them and thinking: Disinfect or throw away? I disinfected them. They were still a good pair of shoes.

A few days later, we got an email from the airline with a voucher, expressing their gratitude for our help. That was nice and unexpected.

I responded with a suggestion: How about having some protocols for medical events on airplanes? Pilots go through checklists for almost everything they do. Why wouldn’t they have something like that for medical responses?

I also asked how the man and his wife were doing. But they couldn’t disclose that information.

It was certainly strange being out of my element, helping a patient in that tiny little space; I’m used to working in a recovery room where you have literally everything you need within arm’s reach — the Ambu bag, suction, and bandages. And with airway management, there’s usually more than one person in the room to assist. If there’s a problem, a whole bunch of people show up around the bed so fast.

I’m definitely thinking about field medicine a lot more. Wondering what I would do in certain situations. While debriefing with my mom (an advanced registered nurse practitioner), she pointed out that we should have asked passengers for sanitary pads or diapers to stabilize the bleeding instead of the cocktail napkins. Brilliant idea! I didn’t think of it in the moment. But I’m keeping that little tip tucked in my back pocket for any future bleeding-in-the-wild scenarios.

Audra Podruzny, MSN, RN, CPAN, lives in Washington state and is currently attending the Washington State University Doctor of Nursing Practice Family Nurse Practitioner program.

A version of this article first appeared on Medscape.com.

Only one third of pediatric patients were correctly triaged at emergency departments (EDs) in a northern California health care system, according to a multicenter retrospective study published in JAMA Pediatrics. Researchers also identified gender, age, race, ethnicity, and comorbidity disparities in those who were undertriaged.

The researchers found that only 34.1% of visits were correctly triaged while 58.5% were overtriaged and 7.4% were undertriaged. The findings were based on analysis of more than 1 million pediatric emergency visits over a 5-year period that used the Emergency Severity Index (ESI) version 4 for triage.

“The ESI had poor sensitivity in identifying a critically ill pediatric patient, and undertriage occurred in 1 in 14 children,” wrote Dana R. Sax, MD, a senior emergency physician at The Permanente Medical Group in northern California, and her colleagues.

Disparities in Emergency Care

The results underscore the need for more work to address disparities in emergency care, wrote Warren D. Frankenberger, PhD, RN, a nurse scientist at Children’s Hospital of Philadelphia, and two colleagues in an accompanying editorial.

“Decisions in triage can have significant downstream effects on subsequent care during the ED visit,” they wrote in their editorial. “Given that the triage process in most instances is fully executed by nurses, nurse researchers are in a key position to evaluate these and other covariates to influence further improvements in triage.” They suggested that use of clinical decision support tools and artificial intelligence (AI) may improve the triage process, albeit with the caveat that AI often relies on models with pre-existing historical bias that may perpetuate structural inequalities.
 

Study Methodology

The researchers analyzed 1,016,816 pediatric visits at 21 emergency departments in Kaiser Permanente Northern California between January 2016 and December 2020. The patients were an average 7 years old, and 47% were female. The researchers excluded visits that lacked ESI data or had incomplete ED time variables as well as those with patients who left against medical advice, were not seen, or were transferred from another ED.

The study relied on novel definitions of ESI undertriage and overtriage developed through a modified Delphi process by a team of four emergency physicians, one pediatric emergency physician, two emergency nurses, and one pediatric ICU physician. The definition involved comparing ESI levels to the clinical outcomes and resource use.

Resources included laboratory analysis, electrocardiography, radiography, CT, MRI, diagnostic ultrasonography (not point of care), angiography, IV fluids, and IV, intramuscular, or nebulized medications. Resources did not include “oral medications, tetanus immunizations, point-of-care testing, history and physical examination, saline or heparin lock, prescription refills, simple wound care, crutches, splints, and slings.”

Level 1 events were those requiring time-sensitive, critical intervention, including high-risk sepsis. Level 2 events included most level 1 events that occurred after the first hour (except operating room admission or hospital transfer) as well as respiratory therapy, toxicology consult, lumbar puncture, suicidality as chief concern, at least 2 doses of albuterol or continuous albuterol nebulization, a skeletal survey x-ray order, and medical social work consult with an ED length of stay of at least 2 hours. Level 3 events included IV mediation order, any CT order, OR admission or hospital transfer after one hour, or any pediatric hospitalist consult.
 

Analyzing the ED Visits

Overtriaged cases were ESI level 1 or 2 cases in which fewer than 2 resources were used; level 3 cases where fewer than 2 resources were used and no level 1 or 2 events occurred; and level 4 cases where no resources were used.

Undertriaged cases were defined as the following:

• ESI level 5 cases where any resource was used and any level 1, 2, or 3 events occurred.
• Level 4 cases where more than 1 resource was used and any level 1, 2, or 3 events occurred.
• Level 3 cases where any level 1 event occurred, more than one level 2 event occurred, or any level 2 event occurred and more than one additional ED resource type was used.
• Level 2 cases where any level 1 event occurred.

About half the visits (51%) were assigned ESI 3, which was the category with the highest proportion of mistriage. After adjusting for study facility and triage vital signs, the researchers found that children age 6 and older were more likely to be undertriaged than those younger than 6, particularly those age 15 and older (relative risk [RR], 1.36).

Undertriage was also modestly more likely with male patients (female patients’ RR, 0.93), patients with comorbidities (RR, 1.11-1.2), patients who arrived by ambulance (RR, 1.04), and patients who were Asian (RR, 1.10), Black (RR, 1.05), or Hispanic (RR, 1.04). Undertriage became gradually less likely with each additional year in the study period, with an RR of 0.89 in 2019 and 2020.

Among the study’s limitations were use of ESI version 4, instead of the currently used 5, and the omission of common procedures from the outcome definition that “may systematically bias the analysis toward overtriage,” the editorial noted. The authors also did not include pain as a variable in the analysis, which can often indicate patient acuity.

Further, this study was unable to include covariates identified in other research that may influence clinical decision-making, such as “the presenting illness or injury, children with complex medical needs, and language proficiency,” Dr. Frankenberger and colleagues wrote. “Furthermore, environmental stressors, such as ED volume and crowding, can influence how a nurse prioritizes care and may increase bias in decision-making and/or increase practice variability.”

The study was funded by the Kaiser Permanente Northern California (KPNC) Community Health program. One author had consulting payments from CSL Behring and Abbott Point-of-Care, and six of the authors have received grant funding from the KPNC Community Health program. The editorial authors reported no conflicts of interest.

Only one third of pediatric patients were correctly triaged at emergency departments (EDs) in a northern California health care system, according to a multicenter retrospective study published in JAMA Pediatrics. Researchers also identified gender, age, race, ethnicity, and comorbidity disparities in those who were undertriaged.

The researchers found that only 34.1% of visits were correctly triaged while 58.5% were overtriaged and 7.4% were undertriaged. The findings were based on analysis of more than 1 million pediatric emergency visits over a 5-year period that used the Emergency Severity Index (ESI) version 4 for triage.

“The ESI had poor sensitivity in identifying a critically ill pediatric patient, and undertriage occurred in 1 in 14 children,” wrote Dana R. Sax, MD, a senior emergency physician at The Permanente Medical Group in northern California, and her colleagues.

Disparities in Emergency Care

The results underscore the need for more work to address disparities in emergency care, wrote Warren D. Frankenberger, PhD, RN, a nurse scientist at Children’s Hospital of Philadelphia, and two colleagues in an accompanying editorial.

“Decisions in triage can have significant downstream effects on subsequent care during the ED visit,” they wrote in their editorial. “Given that the triage process in most instances is fully executed by nurses, nurse researchers are in a key position to evaluate these and other covariates to influence further improvements in triage.” They suggested that use of clinical decision support tools and artificial intelligence (AI) may improve the triage process, albeit with the caveat that AI often relies on models with pre-existing historical bias that may perpetuate structural inequalities.
 

Study Methodology

The researchers analyzed 1,016,816 pediatric visits at 21 emergency departments in Kaiser Permanente Northern California between January 2016 and December 2020. The patients were an average 7 years old, and 47% were female. The researchers excluded visits that lacked ESI data or had incomplete ED time variables as well as those with patients who left against medical advice, were not seen, or were transferred from another ED.

The study relied on novel definitions of ESI undertriage and overtriage developed through a modified Delphi process by a team of four emergency physicians, one pediatric emergency physician, two emergency nurses, and one pediatric ICU physician. The definition involved comparing ESI levels to the clinical outcomes and resource use.

Resources included laboratory analysis, electrocardiography, radiography, CT, MRI, diagnostic ultrasonography (not point of care), angiography, IV fluids, and IV, intramuscular, or nebulized medications. Resources did not include “oral medications, tetanus immunizations, point-of-care testing, history and physical examination, saline or heparin lock, prescription refills, simple wound care, crutches, splints, and slings.”

Level 1 events were those requiring time-sensitive, critical intervention, including high-risk sepsis. Level 2 events included most level 1 events that occurred after the first hour (except operating room admission or hospital transfer) as well as respiratory therapy, toxicology consult, lumbar puncture, suicidality as chief concern, at least 2 doses of albuterol or continuous albuterol nebulization, a skeletal survey x-ray order, and medical social work consult with an ED length of stay of at least 2 hours. Level 3 events included IV mediation order, any CT order, OR admission or hospital transfer after one hour, or any pediatric hospitalist consult.
 

Analyzing the ED Visits

Overtriaged cases were ESI level 1 or 2 cases in which fewer than 2 resources were used; level 3 cases where fewer than 2 resources were used and no level 1 or 2 events occurred; and level 4 cases where no resources were used.

Undertriaged cases were defined as the following:

• ESI level 5 cases where any resource was used and any level 1, 2, or 3 events occurred.
• Level 4 cases where more than 1 resource was used and any level 1, 2, or 3 events occurred.
• Level 3 cases where any level 1 event occurred, more than one level 2 event occurred, or any level 2 event occurred and more than one additional ED resource type was used.
• Level 2 cases where any level 1 event occurred.

About half the visits (51%) were assigned ESI 3, which was the category with the highest proportion of mistriage. After adjusting for study facility and triage vital signs, the researchers found that children age 6 and older were more likely to be undertriaged than those younger than 6, particularly those age 15 and older (relative risk [RR], 1.36).

Undertriage was also modestly more likely with male patients (female patients’ RR, 0.93), patients with comorbidities (RR, 1.11-1.2), patients who arrived by ambulance (RR, 1.04), and patients who were Asian (RR, 1.10), Black (RR, 1.05), or Hispanic (RR, 1.04). Undertriage became gradually less likely with each additional year in the study period, with an RR of 0.89 in 2019 and 2020.

Among the study’s limitations were use of ESI version 4, instead of the currently used 5, and the omission of common procedures from the outcome definition that “may systematically bias the analysis toward overtriage,” the editorial noted. The authors also did not include pain as a variable in the analysis, which can often indicate patient acuity.

Further, this study was unable to include covariates identified in other research that may influence clinical decision-making, such as “the presenting illness or injury, children with complex medical needs, and language proficiency,” Dr. Frankenberger and colleagues wrote. “Furthermore, environmental stressors, such as ED volume and crowding, can influence how a nurse prioritizes care and may increase bias in decision-making and/or increase practice variability.”

The study was funded by the Kaiser Permanente Northern California (KPNC) Community Health program. One author had consulting payments from CSL Behring and Abbott Point-of-Care, and six of the authors have received grant funding from the KPNC Community Health program. The editorial authors reported no conflicts of interest.

Only one third of pediatric patients were correctly triaged at emergency departments (EDs) in a northern California health care system, according to a multicenter retrospective study published in JAMA Pediatrics. Researchers also identified gender, age, race, ethnicity, and comorbidity disparities in those who were undertriaged.

The researchers found that only 34.1% of visits were correctly triaged while 58.5% were overtriaged and 7.4% were undertriaged. The findings were based on analysis of more than 1 million pediatric emergency visits over a 5-year period that used the Emergency Severity Index (ESI) version 4 for triage.

“The ESI had poor sensitivity in identifying a critically ill pediatric patient, and undertriage occurred in 1 in 14 children,” wrote Dana R. Sax, MD, a senior emergency physician at The Permanente Medical Group in northern California, and her colleagues.

Disparities in Emergency Care

The results underscore the need for more work to address disparities in emergency care, wrote Warren D. Frankenberger, PhD, RN, a nurse scientist at Children’s Hospital of Philadelphia, and two colleagues in an accompanying editorial.

“Decisions in triage can have significant downstream effects on subsequent care during the ED visit,” they wrote in their editorial. “Given that the triage process in most instances is fully executed by nurses, nurse researchers are in a key position to evaluate these and other covariates to influence further improvements in triage.” They suggested that use of clinical decision support tools and artificial intelligence (AI) may improve the triage process, albeit with the caveat that AI often relies on models with pre-existing historical bias that may perpetuate structural inequalities.
 

Study Methodology

The researchers analyzed 1,016,816 pediatric visits at 21 emergency departments in Kaiser Permanente Northern California between January 2016 and December 2020. The patients were an average 7 years old, and 47% were female. The researchers excluded visits that lacked ESI data or had incomplete ED time variables as well as those with patients who left against medical advice, were not seen, or were transferred from another ED.

The study relied on novel definitions of ESI undertriage and overtriage developed through a modified Delphi process by a team of four emergency physicians, one pediatric emergency physician, two emergency nurses, and one pediatric ICU physician. The definition involved comparing ESI levels to the clinical outcomes and resource use.

Resources included laboratory analysis, electrocardiography, radiography, CT, MRI, diagnostic ultrasonography (not point of care), angiography, IV fluids, and IV, intramuscular, or nebulized medications. Resources did not include “oral medications, tetanus immunizations, point-of-care testing, history and physical examination, saline or heparin lock, prescription refills, simple wound care, crutches, splints, and slings.”

Level 1 events were those requiring time-sensitive, critical intervention, including high-risk sepsis. Level 2 events included most level 1 events that occurred after the first hour (except operating room admission or hospital transfer) as well as respiratory therapy, toxicology consult, lumbar puncture, suicidality as chief concern, at least 2 doses of albuterol or continuous albuterol nebulization, a skeletal survey x-ray order, and medical social work consult with an ED length of stay of at least 2 hours. Level 3 events included IV mediation order, any CT order, OR admission or hospital transfer after one hour, or any pediatric hospitalist consult.
 

Analyzing the ED Visits

Overtriaged cases were ESI level 1 or 2 cases in which fewer than 2 resources were used; level 3 cases where fewer than 2 resources were used and no level 1 or 2 events occurred; and level 4 cases where no resources were used.

Undertriaged cases were defined as the following:

• ESI level 5 cases where any resource was used and any level 1, 2, or 3 events occurred.
• Level 4 cases where more than 1 resource was used and any level 1, 2, or 3 events occurred.
• Level 3 cases where any level 1 event occurred, more than one level 2 event occurred, or any level 2 event occurred and more than one additional ED resource type was used.
• Level 2 cases where any level 1 event occurred.

About half the visits (51%) were assigned ESI 3, which was the category with the highest proportion of mistriage. After adjusting for study facility and triage vital signs, the researchers found that children age 6 and older were more likely to be undertriaged than those younger than 6, particularly those age 15 and older (relative risk [RR], 1.36).

Undertriage was also modestly more likely with male patients (female patients’ RR, 0.93), patients with comorbidities (RR, 1.11-1.2), patients who arrived by ambulance (RR, 1.04), and patients who were Asian (RR, 1.10), Black (RR, 1.05), or Hispanic (RR, 1.04). Undertriage became gradually less likely with each additional year in the study period, with an RR of 0.89 in 2019 and 2020.

Among the study’s limitations were use of ESI version 4, instead of the currently used 5, and the omission of common procedures from the outcome definition that “may systematically bias the analysis toward overtriage,” the editorial noted. The authors also did not include pain as a variable in the analysis, which can often indicate patient acuity.

Further, this study was unable to include covariates identified in other research that may influence clinical decision-making, such as “the presenting illness or injury, children with complex medical needs, and language proficiency,” Dr. Frankenberger and colleagues wrote. “Furthermore, environmental stressors, such as ED volume and crowding, can influence how a nurse prioritizes care and may increase bias in decision-making and/or increase practice variability.”

The study was funded by the Kaiser Permanente Northern California (KPNC) Community Health program. One author had consulting payments from CSL Behring and Abbott Point-of-Care, and six of the authors have received grant funding from the KPNC Community Health program. The editorial authors reported no conflicts of interest.

In a case that spotlights the importance of comprehensive financial controls in medical offices, a leading New York City emergency medicine physician stands accused of using his business credit card to steal nearly $1.5 million from his clinical practice and spend it on cash advances, personal travel, lavish pet services, and more.

Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”

Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.

Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.

The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.

“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.

SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.

Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
 

Size of Alleged Theft Is ‘Very Unusual’

David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”

William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).

Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).

The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
 

Even Small Medical Offices Can Act to Prevent Fraud

What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”

Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”

One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
 

A version of this article first appeared on Medscape.com.

In a case that spotlights the importance of comprehensive financial controls in medical offices, a leading New York City emergency medicine physician stands accused of using his business credit card to steal nearly $1.5 million from his clinical practice and spend it on cash advances, personal travel, lavish pet services, and more.

Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”

Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.

Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.

The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.

“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.

SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.

Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
 

Size of Alleged Theft Is ‘Very Unusual’

David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”

William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).

Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).

The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
 

Even Small Medical Offices Can Act to Prevent Fraud

What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”

Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”

One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
 

A version of this article first appeared on Medscape.com.

In a case that spotlights the importance of comprehensive financial controls in medical offices, a leading New York City emergency medicine physician stands accused of using his business credit card to steal nearly $1.5 million from his clinical practice and spend it on cash advances, personal travel, lavish pet services, and more.

Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”

Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.

Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.

The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.

“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.

SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.

Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
 

Size of Alleged Theft Is ‘Very Unusual’

David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”

William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).

Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).

The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
 

Even Small Medical Offices Can Act to Prevent Fraud

What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”

Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”

One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
 

A version of this article first appeared on Medscape.com.

The drones are coming.

Starting in September, if someone in Clemmons, North Carolina, calls 911 to report a cardiac arrest, the first responder on the scene may be a drone carrying an automated external defibrillator, or AED.

“The idea is for the drone to get there several minutes before first responders,” such as an emergency medical technician or an ambulance, said Daniel Crews, a spokesperson for the sheriff’s office in Forsyth County, where Clemmons is located. The sheriff’s office is partnering on the project with local emergency services, the Clinical Research Institute at Duke University, and the drone consulting firm Hovecon. “The ultimate goal is to save lives and improve life expectancy for someone experiencing a cardiac episode,” Mr. Crews said.

The Forsyth County program is one of a growing number of efforts by public safety and healthcare organizations across the country to use drones to speed up lifesaving treatment in situations in which every second counts.

More than 356,000 people have a cardiac arrest outside of a hospital setting every year in the United States, according to the American Heart Association. Most people are at home when it happens, and about 90% die because they don’t get immediate help from first responders or bystanders. Every minute that passes without medical intervention decreases the odds of survival by 10%.

“We’ve never been able to move the needle for cardiac arrest in private settings, and this technology could meet that need,” said Monique Anderson Starks, MD, a cardiologist and associate professor of medicine at Duke University. Dr. Starks is leading pilot studies in Forsyth County and James City County, Virginia, to test whether drone AED delivery can improve treatment response times. The work is funded by a 4-year grant from the American Heart Association.

A 2017 study found it takes an emergency medical services unit 7 minutes, on average, to arrive on the scene following a 911 call, though response times vary considerably by region, and rural wait times can be much longer. Dr. Starks said she believes the drone-delivered AEDs in the pilot study could reduce the time to treatment by 4 minutes compared with first responders.

Unlike a heart attack, which occurs when blood flow to the heart is blocked, a cardiac arrest happens when a heart malfunction causes it to stop beating, typically because of an arrhythmia or an electrical problem. Eighty percent of cardiac arrests start as heart attacks. The only way to get the heart restarted is with CPR and a defibrillator.

In Forsyth County, a drone pilot from the sheriff’s department will listen in on 911 calls. If there’s a suspected cardiac arrest, the pilot can dispatch the drone even before emergency medical services are contacted. The drone, which weighs 22 pounds and can travel 60 mph, will fly to the location and hover 125 feet in the air before lowering an AED to the ground on a winch. The AED provides simple verbal instructions; the 911 dispatcher on the phone can also help a bystander use the AED.

Eventually there will be six drone bases in Forsyth and James City counties, Dr. Starks said.

While the technology is promising and research has often found that drones arrive faster than first responders, there’s little conclusive evidence that drones improve health outcomes.

A Swedish study published in The Lancet in 2023 compared the response times between drones and ambulances for suspected cardiac arrest in 58 deployments in an area of about 200,000 people. It found that drones beat the ambulance to the scene two thirds of the time, by a median of 3 minutes and 14 seconds.

In the United States, most programs are just getting started, and they are exploring the use of drones to also provide remedies for drug overdoses and major trauma or potential drowning rescues.

In Florida, Tampa General Hospital, Manatee County, and Archer First Response Systems, or AFRS, began a program in May to deliver AEDs, a tourniquet, and Narcan, a nasal spray that can reverse an opioid overdose. The program initially covers a 7-square-mile area, and EMS dispatchers deploy the drones, which are monitored by drone pilots.

There were nearly 108,000 drug overdose deaths in the United States in 2022, according to the National Institute on Drug Abuse.

As of early July, the Tampa program hadn’t yet deployed any drones, said Gordon Folkes, the founder and chief executive of AFRS, which develops and deploys emergency drone logistics systems. One request in June to send a drone to an overdose couldn’t be fulfilled because of a violent thunderstorm, Mr. Folkes said. In the testing area, which covers about 7,000 residents, Mr. Folkes estimates that 10-15 drones might be deployed each year.

“The bread and butter for these systems is suburban areas” like Manatee County that are well-populated and where the drones have the advantage of being able to avoid traffic congestion, Mr. Folkes said.

There are other uses for drones in medical emergencies. The New York Police Department plans to drop emergency flotation devices to struggling swimmers at local beaches. In Chula Vista, California, a police drone was able to pinpoint the location of a burning car, and then officers pulled the driver out, said Sgt. Tony Molina.

Rescue personnel have used drones to locate people who wander away from nursing homes, said James Augustine, a spokesperson for the American College of Emergency Physicians who is the medical director for the International Association of Fire Chiefs.

In the United States, one hurdle for drone programs is that the Federal Aviation Administration typically requires that drones be operated within the operators’ visual line of sight. In May, when Congress passed the FAA reauthorization bill, it gave the FAA 4 months to issue a notice of proposed rule-making on drone operations beyond the visual line of sight.

“The FAA is focused on developing standard rules to make [Beyond Visual Line of Sight] operations routine, scalable, and economically viable,” said Rick Breitenfeldt, an FAA spokesperson.

Some civil liberties groups are concerned that the FAA’s new rules may not provide enough protection from drone cameras for people on the ground.

Jay Stanley, a senior policy analyst at the American Civil Liberties Union, acknowledged the benefits of using drones in emergency situations but said there are issues that need to be addressed.

“The concern is that the FAA is going to significantly loosen the reins of drones without any significant privacy protections,” he said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

The drones are coming.

Starting in September, if someone in Clemmons, North Carolina, calls 911 to report a cardiac arrest, the first responder on the scene may be a drone carrying an automated external defibrillator, or AED.

“The idea is for the drone to get there several minutes before first responders,” such as an emergency medical technician or an ambulance, said Daniel Crews, a spokesperson for the sheriff’s office in Forsyth County, where Clemmons is located. The sheriff’s office is partnering on the project with local emergency services, the Clinical Research Institute at Duke University, and the drone consulting firm Hovecon. “The ultimate goal is to save lives and improve life expectancy for someone experiencing a cardiac episode,” Mr. Crews said.

The Forsyth County program is one of a growing number of efforts by public safety and healthcare organizations across the country to use drones to speed up lifesaving treatment in situations in which every second counts.

More than 356,000 people have a cardiac arrest outside of a hospital setting every year in the United States, according to the American Heart Association. Most people are at home when it happens, and about 90% die because they don’t get immediate help from first responders or bystanders. Every minute that passes without medical intervention decreases the odds of survival by 10%.

“We’ve never been able to move the needle for cardiac arrest in private settings, and this technology could meet that need,” said Monique Anderson Starks, MD, a cardiologist and associate professor of medicine at Duke University. Dr. Starks is leading pilot studies in Forsyth County and James City County, Virginia, to test whether drone AED delivery can improve treatment response times. The work is funded by a 4-year grant from the American Heart Association.

A 2017 study found it takes an emergency medical services unit 7 minutes, on average, to arrive on the scene following a 911 call, though response times vary considerably by region, and rural wait times can be much longer. Dr. Starks said she believes the drone-delivered AEDs in the pilot study could reduce the time to treatment by 4 minutes compared with first responders.

Unlike a heart attack, which occurs when blood flow to the heart is blocked, a cardiac arrest happens when a heart malfunction causes it to stop beating, typically because of an arrhythmia or an electrical problem. Eighty percent of cardiac arrests start as heart attacks. The only way to get the heart restarted is with CPR and a defibrillator.

In Forsyth County, a drone pilot from the sheriff’s department will listen in on 911 calls. If there’s a suspected cardiac arrest, the pilot can dispatch the drone even before emergency medical services are contacted. The drone, which weighs 22 pounds and can travel 60 mph, will fly to the location and hover 125 feet in the air before lowering an AED to the ground on a winch. The AED provides simple verbal instructions; the 911 dispatcher on the phone can also help a bystander use the AED.

Eventually there will be six drone bases in Forsyth and James City counties, Dr. Starks said.

While the technology is promising and research has often found that drones arrive faster than first responders, there’s little conclusive evidence that drones improve health outcomes.

A Swedish study published in The Lancet in 2023 compared the response times between drones and ambulances for suspected cardiac arrest in 58 deployments in an area of about 200,000 people. It found that drones beat the ambulance to the scene two thirds of the time, by a median of 3 minutes and 14 seconds.

In the United States, most programs are just getting started, and they are exploring the use of drones to also provide remedies for drug overdoses and major trauma or potential drowning rescues.

In Florida, Tampa General Hospital, Manatee County, and Archer First Response Systems, or AFRS, began a program in May to deliver AEDs, a tourniquet, and Narcan, a nasal spray that can reverse an opioid overdose. The program initially covers a 7-square-mile area, and EMS dispatchers deploy the drones, which are monitored by drone pilots.

There were nearly 108,000 drug overdose deaths in the United States in 2022, according to the National Institute on Drug Abuse.

As of early July, the Tampa program hadn’t yet deployed any drones, said Gordon Folkes, the founder and chief executive of AFRS, which develops and deploys emergency drone logistics systems. One request in June to send a drone to an overdose couldn’t be fulfilled because of a violent thunderstorm, Mr. Folkes said. In the testing area, which covers about 7,000 residents, Mr. Folkes estimates that 10-15 drones might be deployed each year.

“The bread and butter for these systems is suburban areas” like Manatee County that are well-populated and where the drones have the advantage of being able to avoid traffic congestion, Mr. Folkes said.

There are other uses for drones in medical emergencies. The New York Police Department plans to drop emergency flotation devices to struggling swimmers at local beaches. In Chula Vista, California, a police drone was able to pinpoint the location of a burning car, and then officers pulled the driver out, said Sgt. Tony Molina.

Rescue personnel have used drones to locate people who wander away from nursing homes, said James Augustine, a spokesperson for the American College of Emergency Physicians who is the medical director for the International Association of Fire Chiefs.

In the United States, one hurdle for drone programs is that the Federal Aviation Administration typically requires that drones be operated within the operators’ visual line of sight. In May, when Congress passed the FAA reauthorization bill, it gave the FAA 4 months to issue a notice of proposed rule-making on drone operations beyond the visual line of sight.

“The FAA is focused on developing standard rules to make [Beyond Visual Line of Sight] operations routine, scalable, and economically viable,” said Rick Breitenfeldt, an FAA spokesperson.

Some civil liberties groups are concerned that the FAA’s new rules may not provide enough protection from drone cameras for people on the ground.

Jay Stanley, a senior policy analyst at the American Civil Liberties Union, acknowledged the benefits of using drones in emergency situations but said there are issues that need to be addressed.

“The concern is that the FAA is going to significantly loosen the reins of drones without any significant privacy protections,” he said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

The drones are coming.

Starting in September, if someone in Clemmons, North Carolina, calls 911 to report a cardiac arrest, the first responder on the scene may be a drone carrying an automated external defibrillator, or AED.

“The idea is for the drone to get there several minutes before first responders,” such as an emergency medical technician or an ambulance, said Daniel Crews, a spokesperson for the sheriff’s office in Forsyth County, where Clemmons is located. The sheriff’s office is partnering on the project with local emergency services, the Clinical Research Institute at Duke University, and the drone consulting firm Hovecon. “The ultimate goal is to save lives and improve life expectancy for someone experiencing a cardiac episode,” Mr. Crews said.

The Forsyth County program is one of a growing number of efforts by public safety and healthcare organizations across the country to use drones to speed up lifesaving treatment in situations in which every second counts.

More than 356,000 people have a cardiac arrest outside of a hospital setting every year in the United States, according to the American Heart Association. Most people are at home when it happens, and about 90% die because they don’t get immediate help from first responders or bystanders. Every minute that passes without medical intervention decreases the odds of survival by 10%.

“We’ve never been able to move the needle for cardiac arrest in private settings, and this technology could meet that need,” said Monique Anderson Starks, MD, a cardiologist and associate professor of medicine at Duke University. Dr. Starks is leading pilot studies in Forsyth County and James City County, Virginia, to test whether drone AED delivery can improve treatment response times. The work is funded by a 4-year grant from the American Heart Association.

A 2017 study found it takes an emergency medical services unit 7 minutes, on average, to arrive on the scene following a 911 call, though response times vary considerably by region, and rural wait times can be much longer. Dr. Starks said she believes the drone-delivered AEDs in the pilot study could reduce the time to treatment by 4 minutes compared with first responders.

Unlike a heart attack, which occurs when blood flow to the heart is blocked, a cardiac arrest happens when a heart malfunction causes it to stop beating, typically because of an arrhythmia or an electrical problem. Eighty percent of cardiac arrests start as heart attacks. The only way to get the heart restarted is with CPR and a defibrillator.

In Forsyth County, a drone pilot from the sheriff’s department will listen in on 911 calls. If there’s a suspected cardiac arrest, the pilot can dispatch the drone even before emergency medical services are contacted. The drone, which weighs 22 pounds and can travel 60 mph, will fly to the location and hover 125 feet in the air before lowering an AED to the ground on a winch. The AED provides simple verbal instructions; the 911 dispatcher on the phone can also help a bystander use the AED.

Eventually there will be six drone bases in Forsyth and James City counties, Dr. Starks said.

While the technology is promising and research has often found that drones arrive faster than first responders, there’s little conclusive evidence that drones improve health outcomes.

A Swedish study published in The Lancet in 2023 compared the response times between drones and ambulances for suspected cardiac arrest in 58 deployments in an area of about 200,000 people. It found that drones beat the ambulance to the scene two thirds of the time, by a median of 3 minutes and 14 seconds.

In the United States, most programs are just getting started, and they are exploring the use of drones to also provide remedies for drug overdoses and major trauma or potential drowning rescues.

In Florida, Tampa General Hospital, Manatee County, and Archer First Response Systems, or AFRS, began a program in May to deliver AEDs, a tourniquet, and Narcan, a nasal spray that can reverse an opioid overdose. The program initially covers a 7-square-mile area, and EMS dispatchers deploy the drones, which are monitored by drone pilots.

There were nearly 108,000 drug overdose deaths in the United States in 2022, according to the National Institute on Drug Abuse.

As of early July, the Tampa program hadn’t yet deployed any drones, said Gordon Folkes, the founder and chief executive of AFRS, which develops and deploys emergency drone logistics systems. One request in June to send a drone to an overdose couldn’t be fulfilled because of a violent thunderstorm, Mr. Folkes said. In the testing area, which covers about 7,000 residents, Mr. Folkes estimates that 10-15 drones might be deployed each year.

“The bread and butter for these systems is suburban areas” like Manatee County that are well-populated and where the drones have the advantage of being able to avoid traffic congestion, Mr. Folkes said.

There are other uses for drones in medical emergencies. The New York Police Department plans to drop emergency flotation devices to struggling swimmers at local beaches. In Chula Vista, California, a police drone was able to pinpoint the location of a burning car, and then officers pulled the driver out, said Sgt. Tony Molina.

Rescue personnel have used drones to locate people who wander away from nursing homes, said James Augustine, a spokesperson for the American College of Emergency Physicians who is the medical director for the International Association of Fire Chiefs.

In the United States, one hurdle for drone programs is that the Federal Aviation Administration typically requires that drones be operated within the operators’ visual line of sight. In May, when Congress passed the FAA reauthorization bill, it gave the FAA 4 months to issue a notice of proposed rule-making on drone operations beyond the visual line of sight.

“The FAA is focused on developing standard rules to make [Beyond Visual Line of Sight] operations routine, scalable, and economically viable,” said Rick Breitenfeldt, an FAA spokesperson.

Some civil liberties groups are concerned that the FAA’s new rules may not provide enough protection from drone cameras for people on the ground.

Jay Stanley, a senior policy analyst at the American Civil Liberties Union, acknowledged the benefits of using drones in emergency situations but said there are issues that need to be addressed.

“The concern is that the FAA is going to significantly loosen the reins of drones without any significant privacy protections,” he said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

There has been an “alarming” increase in mental health hospital admissions involving methamphetamine use, new research showed. Investigators found that between 2008 and 2020, such admissions increased by more than 10-fold.

“Overall, our results show an alarming increase in mental health disorder–related hospitalizations with concurrent methamphetamine use from 2008 to 2020,” wrote the investigators, led by Diensn Xing, Department of Medicine, Louisiana State University Health Sciences Center, Shreveport.

“These results are especially concerning because these hospitalizations outpace hospitalizations for methamphetamine use alone or mental health disorders alone,” they added.

The study was published online in Nature Mental Health .
 

Action Needed

Mental illness and methamphetamine use are both growing health problems. The investigators pointed out that methamphetamine use can cause serious harm to an individual’s mental, emotional, and social well-being and can significantly alter the brain.

They added that long-term methamphetamine users can exhibit “extreme anxiety, confusion, troubled sleep, mood changes, and aggressive behavior.” In addition, use of the drug can cause psychotic side effects such as paranoia, hallucinations, delusions, and suicidality.

The investigators noted that, to date, no studies have examined the combined effects of both diseases or characterized national trends over more than 10 years.

The researchers analyzed US mental health–related trends in methamphetamine users from 2008 to 2020. In particular, they wanted to characterize which demographic and geographic groups might be affected by both of these diseases because people with mental illness and co-occurring methamphetamine use are an “intersectional group” that is “doubly vulnerable to suicide and overdose death due to the synergistic effects of methamphetamine and mental health disorders.”

The investigators evaluated US trends in mental health disorder–related hospital admissions (MHD-HAs) and compared them with mental health admissions that involved concurrent methamphetamine use (MHD-HA-MUs) between 2008 and 2020.

Using data from the largest US inpatient care database, which encompasses more than 7 million hospital stays annually, they examined close to 4 million weighted hospital admissions and found more than a 10-fold increase in MHD-HA-MUs, compared with a 1.4-fold increase in MHD-HAs.

MHD-HA-MUs increased significantly among men (13-fold), non-Hispanic Black patients (39-fold), and those aged 41-64 years (16-fold). In the southern United States, MHD-HA-MUs increased 24-fold, larger than in any other region in the United States.

“Overall, the data suggest that there are synergistic effects with methamphetamine use and mental health disorder, highlighting this patient group’s unique needs, requiring distinct action,” the researchers wrote.

They proposed several interventions, including public education about substance use disorders, mental illness, and the effects of stigma. They also suggested decreasing criminal penalties for those with substance use disorders and improving healthcare delivery for this patient population.

This work was supported by the National Institutes of Health and an award from the National Institute of General Medical Sciences. The study authors declared no relevant financial relationships.

A version of this article first appeared on Medscape.com.

There has been an “alarming” increase in mental health hospital admissions involving methamphetamine use, new research showed. Investigators found that between 2008 and 2020, such admissions increased by more than 10-fold.

“Overall, our results show an alarming increase in mental health disorder–related hospitalizations with concurrent methamphetamine use from 2008 to 2020,” wrote the investigators, led by Diensn Xing, Department of Medicine, Louisiana State University Health Sciences Center, Shreveport.

“These results are especially concerning because these hospitalizations outpace hospitalizations for methamphetamine use alone or mental health disorders alone,” they added.

The study was published online in Nature Mental Health .
 

Action Needed

Mental illness and methamphetamine use are both growing health problems. The investigators pointed out that methamphetamine use can cause serious harm to an individual’s mental, emotional, and social well-being and can significantly alter the brain.

They added that long-term methamphetamine users can exhibit “extreme anxiety, confusion, troubled sleep, mood changes, and aggressive behavior.” In addition, use of the drug can cause psychotic side effects such as paranoia, hallucinations, delusions, and suicidality.

The investigators noted that, to date, no studies have examined the combined effects of both diseases or characterized national trends over more than 10 years.

The researchers analyzed US mental health–related trends in methamphetamine users from 2008 to 2020. In particular, they wanted to characterize which demographic and geographic groups might be affected by both of these diseases because people with mental illness and co-occurring methamphetamine use are an “intersectional group” that is “doubly vulnerable to suicide and overdose death due to the synergistic effects of methamphetamine and mental health disorders.”

The investigators evaluated US trends in mental health disorder–related hospital admissions (MHD-HAs) and compared them with mental health admissions that involved concurrent methamphetamine use (MHD-HA-MUs) between 2008 and 2020.

Using data from the largest US inpatient care database, which encompasses more than 7 million hospital stays annually, they examined close to 4 million weighted hospital admissions and found more than a 10-fold increase in MHD-HA-MUs, compared with a 1.4-fold increase in MHD-HAs.

MHD-HA-MUs increased significantly among men (13-fold), non-Hispanic Black patients (39-fold), and those aged 41-64 years (16-fold). In the southern United States, MHD-HA-MUs increased 24-fold, larger than in any other region in the United States.

“Overall, the data suggest that there are synergistic effects with methamphetamine use and mental health disorder, highlighting this patient group’s unique needs, requiring distinct action,” the researchers wrote.

They proposed several interventions, including public education about substance use disorders, mental illness, and the effects of stigma. They also suggested decreasing criminal penalties for those with substance use disorders and improving healthcare delivery for this patient population.

This work was supported by the National Institutes of Health and an award from the National Institute of General Medical Sciences. The study authors declared no relevant financial relationships.

A version of this article first appeared on Medscape.com.

There has been an “alarming” increase in mental health hospital admissions involving methamphetamine use, new research showed. Investigators found that between 2008 and 2020, such admissions increased by more than 10-fold.

“Overall, our results show an alarming increase in mental health disorder–related hospitalizations with concurrent methamphetamine use from 2008 to 2020,” wrote the investigators, led by Diensn Xing, Department of Medicine, Louisiana State University Health Sciences Center, Shreveport.

“These results are especially concerning because these hospitalizations outpace hospitalizations for methamphetamine use alone or mental health disorders alone,” they added.

The study was published online in Nature Mental Health .
 

Action Needed

Mental illness and methamphetamine use are both growing health problems. The investigators pointed out that methamphetamine use can cause serious harm to an individual’s mental, emotional, and social well-being and can significantly alter the brain.

They added that long-term methamphetamine users can exhibit “extreme anxiety, confusion, troubled sleep, mood changes, and aggressive behavior.” In addition, use of the drug can cause psychotic side effects such as paranoia, hallucinations, delusions, and suicidality.

The investigators noted that, to date, no studies have examined the combined effects of both diseases or characterized national trends over more than 10 years.

The researchers analyzed US mental health–related trends in methamphetamine users from 2008 to 2020. In particular, they wanted to characterize which demographic and geographic groups might be affected by both of these diseases because people with mental illness and co-occurring methamphetamine use are an “intersectional group” that is “doubly vulnerable to suicide and overdose death due to the synergistic effects of methamphetamine and mental health disorders.”

The investigators evaluated US trends in mental health disorder–related hospital admissions (MHD-HAs) and compared them with mental health admissions that involved concurrent methamphetamine use (MHD-HA-MUs) between 2008 and 2020.

Using data from the largest US inpatient care database, which encompasses more than 7 million hospital stays annually, they examined close to 4 million weighted hospital admissions and found more than a 10-fold increase in MHD-HA-MUs, compared with a 1.4-fold increase in MHD-HAs.

MHD-HA-MUs increased significantly among men (13-fold), non-Hispanic Black patients (39-fold), and those aged 41-64 years (16-fold). In the southern United States, MHD-HA-MUs increased 24-fold, larger than in any other region in the United States.

“Overall, the data suggest that there are synergistic effects with methamphetamine use and mental health disorder, highlighting this patient group’s unique needs, requiring distinct action,” the researchers wrote.

They proposed several interventions, including public education about substance use disorders, mental illness, and the effects of stigma. They also suggested decreasing criminal penalties for those with substance use disorders and improving healthcare delivery for this patient population.

This work was supported by the National Institutes of Health and an award from the National Institute of General Medical Sciences. The study authors declared no relevant financial relationships.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity. 

It doesn’t really matter what disease you are looking at — cancer, heart disease, dementia, drug abuse, psychiatric disorders. In every case, poverty is associated with worse disease. 

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. Wilson

JAMA

Dr. Wilson

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity. 

It doesn’t really matter what disease you are looking at — cancer, heart disease, dementia, drug abuse, psychiatric disorders. In every case, poverty is associated with worse disease. 

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. Wilson

JAMA

Dr. Wilson

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity. 

It doesn’t really matter what disease you are looking at — cancer, heart disease, dementia, drug abuse, psychiatric disorders. In every case, poverty is associated with worse disease. 

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. Wilson

JAMA

Dr. Wilson

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Ahmad Reza Djalali, an Iranian-Swedish physician specializing in disaster medicine, has begun a hunger strike after being sentenced to death in 2017.

Last year, Iran set a grim record, leading the world in executions. The country carried out at least 853 executions, which accounted for three quarters of the officially recorded executions worldwide. The Iranian government uses the death penalty to intimidate political opponents, especially since the women’s uprising in 2022, and to exert pressure on Western states in diplomatic standoffs.

Among the thousands of political prisoners currently on death row in Tehran’s notorious Evin prison is Dr. Djalali, a 52-year-old physician.

He emigrated to Sweden in 2009 and joined the Karolinska Institutet in Stockholm, Sweden. Over the years, he became one of Europe’s leading experts in disaster medicine. His work has been cited more than 700 times in medical literature, and he played a key role in establishing the emergency and disaster research center at the University of Piedmont.

In Italy, Denmark, and Sweden, Dr. Djalali helped hospitals and healthcare professionals in preparing for earthquakes, nuclear accidents, and terrorist attacks and designed several disaster medicine training programs.
 

‘Spreading Corruption’

Despite settling in Sweden with his family, Dr. Djalali never forgot his Iranian roots. His doctoral thesis was dedicated to the victims of the 2003 Bam earthquake in Iran, which killed 23,000 people. He expressed a desire to share his knowledge with his Iranian colleagues to help people. So when he was invited to participate in a 2016 conference at the University of Tehran, he accepted without hesitation.

Unfortunately, this decision had severe consequences. On April 25, 2016, as he was concluding his trip to Iran, the researcher was arrested by intelligence agents. After being held incommunicado for several days, he was officially accused of passing confidential information to Israeli intelligence services. According to his family, this accusation was baseless. They believed he was targeted for refusing to work for Iranian intelligence services in Europe.

On October 21, 2017, Dr. Djalali was sentenced to death for “spreading corruption on Earth,” a vague charge often used by Islamic courts against those who allegedly have challenged the regime. A few days later, a video of his “confessions” was broadcast on Iranian television. These confessions were coerced; Dr. Djalali later revealed that Iranian police had threatened to harm his mother in Iran and his family in Sweden.

Since then, Dr. Djalali and his loved ones have anxiously awaited the moment when the regime might carry out the sentence. Several times over the years, he has seemed on the verge of execution, only to receive a last-minute reprieve each time.

His imprisonment has taken a severe toll on his physical and mental health. He has reportedly lost 24 kg since his incarceration, and his family, who receive sporadic updates, suspect he has leukemia. Despite his deteriorating condition, the authorities have refused him access to a hematologist.
 

‘Forgotten’ in Exchange

The international medical community has rallied to secure Dr. Djalali’s release, but their efforts have so far been fruitless. The United Nations, the European Union, Amnesty International, several universities, and the World Medical Association have called for his release. In 2018, Sweden granted him citizenship in an attempt to increase pressure on Tehran, but Iranian law does not recognize dual citizenship.

On June 16, after nearly 7 years on death row, Dr. Djalali informed his family that he had begun a hunger strike. “It’s the only way to make my voice heard in the world,” he explained. “As a doctor, Ahmad Reza knows all too well that his fragile physical state makes a hunger strike potentially fatal, but he sees no other option. He suffers from cardiac arrhythmia, bradycardia, hypotension, chronic gastritis, anemia, and extreme weight loss following his two previous hunger strikes,” his wife told the press.

Aside from a potential (and unlikely) act of clemency by the Iranian authorities, Dr. Djalali’s best hope lies in a prisoner exchange. The Iranian government often imprisons foreign nationals to exchange them for Iranians detained in Western countries.

On June 15, Sweden agreed to release an Iranian dignitary serving a life sentence in exchange for the release of Swedish nationals detained in Iran. For a long time, Dr. Djalali’s family had hoped he would be included in this exchange.

However, to avoid jeopardizing the deal, the Swedish prime minister chose to accept the release of only two other Swedish nationals, leaving Dr. Djalali to his grim fate. “Mr Prime Minister, you have decided to abandon me at the enormous risk of being executed,” Dr. Djalali responded bitterly, knowing he could be hanged at any moment.
 

This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Ahmad Reza Djalali, an Iranian-Swedish physician specializing in disaster medicine, has begun a hunger strike after being sentenced to death in 2017.

Last year, Iran set a grim record, leading the world in executions. The country carried out at least 853 executions, which accounted for three quarters of the officially recorded executions worldwide. The Iranian government uses the death penalty to intimidate political opponents, especially since the women’s uprising in 2022, and to exert pressure on Western states in diplomatic standoffs.

Among the thousands of political prisoners currently on death row in Tehran’s notorious Evin prison is Dr. Djalali, a 52-year-old physician.

He emigrated to Sweden in 2009 and joined the Karolinska Institutet in Stockholm, Sweden. Over the years, he became one of Europe’s leading experts in disaster medicine. His work has been cited more than 700 times in medical literature, and he played a key role in establishing the emergency and disaster research center at the University of Piedmont.

In Italy, Denmark, and Sweden, Dr. Djalali helped hospitals and healthcare professionals in preparing for earthquakes, nuclear accidents, and terrorist attacks and designed several disaster medicine training programs.
 

‘Spreading Corruption’

Despite settling in Sweden with his family, Dr. Djalali never forgot his Iranian roots. His doctoral thesis was dedicated to the victims of the 2003 Bam earthquake in Iran, which killed 23,000 people. He expressed a desire to share his knowledge with his Iranian colleagues to help people. So when he was invited to participate in a 2016 conference at the University of Tehran, he accepted without hesitation.

Unfortunately, this decision had severe consequences. On April 25, 2016, as he was concluding his trip to Iran, the researcher was arrested by intelligence agents. After being held incommunicado for several days, he was officially accused of passing confidential information to Israeli intelligence services. According to his family, this accusation was baseless. They believed he was targeted for refusing to work for Iranian intelligence services in Europe.

On October 21, 2017, Dr. Djalali was sentenced to death for “spreading corruption on Earth,” a vague charge often used by Islamic courts against those who allegedly have challenged the regime. A few days later, a video of his “confessions” was broadcast on Iranian television. These confessions were coerced; Dr. Djalali later revealed that Iranian police had threatened to harm his mother in Iran and his family in Sweden.

Since then, Dr. Djalali and his loved ones have anxiously awaited the moment when the regime might carry out the sentence. Several times over the years, he has seemed on the verge of execution, only to receive a last-minute reprieve each time.

His imprisonment has taken a severe toll on his physical and mental health. He has reportedly lost 24 kg since his incarceration, and his family, who receive sporadic updates, suspect he has leukemia. Despite his deteriorating condition, the authorities have refused him access to a hematologist.
 

‘Forgotten’ in Exchange

The international medical community has rallied to secure Dr. Djalali’s release, but their efforts have so far been fruitless. The United Nations, the European Union, Amnesty International, several universities, and the World Medical Association have called for his release. In 2018, Sweden granted him citizenship in an attempt to increase pressure on Tehran, but Iranian law does not recognize dual citizenship.

On June 16, after nearly 7 years on death row, Dr. Djalali informed his family that he had begun a hunger strike. “It’s the only way to make my voice heard in the world,” he explained. “As a doctor, Ahmad Reza knows all too well that his fragile physical state makes a hunger strike potentially fatal, but he sees no other option. He suffers from cardiac arrhythmia, bradycardia, hypotension, chronic gastritis, anemia, and extreme weight loss following his two previous hunger strikes,” his wife told the press.

Aside from a potential (and unlikely) act of clemency by the Iranian authorities, Dr. Djalali’s best hope lies in a prisoner exchange. The Iranian government often imprisons foreign nationals to exchange them for Iranians detained in Western countries.

On June 15, Sweden agreed to release an Iranian dignitary serving a life sentence in exchange for the release of Swedish nationals detained in Iran. For a long time, Dr. Djalali’s family had hoped he would be included in this exchange.

However, to avoid jeopardizing the deal, the Swedish prime minister chose to accept the release of only two other Swedish nationals, leaving Dr. Djalali to his grim fate. “Mr Prime Minister, you have decided to abandon me at the enormous risk of being executed,” Dr. Djalali responded bitterly, knowing he could be hanged at any moment.
 

This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Ahmad Reza Djalali, an Iranian-Swedish physician specializing in disaster medicine, has begun a hunger strike after being sentenced to death in 2017.

Last year, Iran set a grim record, leading the world in executions. The country carried out at least 853 executions, which accounted for three quarters of the officially recorded executions worldwide. The Iranian government uses the death penalty to intimidate political opponents, especially since the women’s uprising in 2022, and to exert pressure on Western states in diplomatic standoffs.

Among the thousands of political prisoners currently on death row in Tehran’s notorious Evin prison is Dr. Djalali, a 52-year-old physician.

He emigrated to Sweden in 2009 and joined the Karolinska Institutet in Stockholm, Sweden. Over the years, he became one of Europe’s leading experts in disaster medicine. His work has been cited more than 700 times in medical literature, and he played a key role in establishing the emergency and disaster research center at the University of Piedmont.

In Italy, Denmark, and Sweden, Dr. Djalali helped hospitals and healthcare professionals in preparing for earthquakes, nuclear accidents, and terrorist attacks and designed several disaster medicine training programs.
 

‘Spreading Corruption’

Despite settling in Sweden with his family, Dr. Djalali never forgot his Iranian roots. His doctoral thesis was dedicated to the victims of the 2003 Bam earthquake in Iran, which killed 23,000 people. He expressed a desire to share his knowledge with his Iranian colleagues to help people. So when he was invited to participate in a 2016 conference at the University of Tehran, he accepted without hesitation.

Unfortunately, this decision had severe consequences. On April 25, 2016, as he was concluding his trip to Iran, the researcher was arrested by intelligence agents. After being held incommunicado for several days, he was officially accused of passing confidential information to Israeli intelligence services. According to his family, this accusation was baseless. They believed he was targeted for refusing to work for Iranian intelligence services in Europe.

On October 21, 2017, Dr. Djalali was sentenced to death for “spreading corruption on Earth,” a vague charge often used by Islamic courts against those who allegedly have challenged the regime. A few days later, a video of his “confessions” was broadcast on Iranian television. These confessions were coerced; Dr. Djalali later revealed that Iranian police had threatened to harm his mother in Iran and his family in Sweden.

Since then, Dr. Djalali and his loved ones have anxiously awaited the moment when the regime might carry out the sentence. Several times over the years, he has seemed on the verge of execution, only to receive a last-minute reprieve each time.

His imprisonment has taken a severe toll on his physical and mental health. He has reportedly lost 24 kg since his incarceration, and his family, who receive sporadic updates, suspect he has leukemia. Despite his deteriorating condition, the authorities have refused him access to a hematologist.
 

‘Forgotten’ in Exchange

The international medical community has rallied to secure Dr. Djalali’s release, but their efforts have so far been fruitless. The United Nations, the European Union, Amnesty International, several universities, and the World Medical Association have called for his release. In 2018, Sweden granted him citizenship in an attempt to increase pressure on Tehran, but Iranian law does not recognize dual citizenship.

On June 16, after nearly 7 years on death row, Dr. Djalali informed his family that he had begun a hunger strike. “It’s the only way to make my voice heard in the world,” he explained. “As a doctor, Ahmad Reza knows all too well that his fragile physical state makes a hunger strike potentially fatal, but he sees no other option. He suffers from cardiac arrhythmia, bradycardia, hypotension, chronic gastritis, anemia, and extreme weight loss following his two previous hunger strikes,” his wife told the press.

Aside from a potential (and unlikely) act of clemency by the Iranian authorities, Dr. Djalali’s best hope lies in a prisoner exchange. The Iranian government often imprisons foreign nationals to exchange them for Iranians detained in Western countries.

On June 15, Sweden agreed to release an Iranian dignitary serving a life sentence in exchange for the release of Swedish nationals detained in Iran. For a long time, Dr. Djalali’s family had hoped he would be included in this exchange.

However, to avoid jeopardizing the deal, the Swedish prime minister chose to accept the release of only two other Swedish nationals, leaving Dr. Djalali to his grim fate. “Mr Prime Minister, you have decided to abandon me at the enormous risk of being executed,” Dr. Djalali responded bitterly, knowing he could be hanged at any moment.
 

This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.