Single-use endoscopy: Here to stay?

Single-use endoscopes are becoming increasingly common, and economic and regulatory factors are driving growth and innovation in this field. Those were some of the messages presented at a session on innovations in endoscope devices at the 2022 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“We’ve seen a shift in the need for more disposable technologies to support overall environmental parameters,” Brian Sanders, director of market development for GI at Ambu, explained during his presentation. “The more complicated these designs became, the more challenging they became to clean.”

Mr. Sanders highlighted some of the advantages of single-use scopes. There are no repair costs, and fewer storage and supply costs. They are more convenient since there is no need to wait for a scope to be cleaned. And the Food and Drug Administration has supported moving to single-use duodenoscopes. He also surmised that consumers might prefer single-use endoscopes since the risk of infection is likely to be lower than with reusable endoscopes.

Still, it can be difficult to get a full understanding of the costs of reusable versus single-use devices. Costs may be spread out across departments within a facility, and can include capital costs, repairs, reprocessing, consumables, and opportunity costs that occur due to delays. “[Many] categories are not transparent because they are hosted with cross-lateral budgets throughout the facility, so this is a messy web,” said Mr. Sanders.

Furthermore, findings from a meta-analysis of bronchoscopes indicate a 15.2% contamination rate, and an infection rate attributable to reusable bronchoscopes of 2.8%, with an average treatment cost of $11,788.

“When you consider all of the drivers we’re seeing in the endoscope arena, it’s our strong belief that, within the next 10 years, most endoscopes being utilized in medical practice will turn to single use,” Mr. Sanders continued.

During the Q&A period following the presentation, the discussion turned to the environmental impact of single-use devices. “We do a lot of endoscopies. If we start moving into single-use gastroscopes and colonoscopes, how do we process them? Can we recycle them?” asked panel moderator Sushovan Guha, MD, PhD, professor of medicine at McGovern Medical School and codirector of the Center for Interventional Gastroenterology at UTHealth Science Center, Houston.

The question drew a response from panelist Katie Eckerline, EUS group manager at Boston Scientific. She noted that the water and chemicals used in reprocessing the company’s EXALT single-use duodenoscope device are important, as is the requirement for personal protective equipment. “[T]here’s an underappreciated environmental impact that comes along with scope reprocessing because it’s not happening directly in the rooms, and this is often overlooked,” replied Ms. Eckerline.

She noted that Boston Scientific has taken steps to make EXALT duodenoscopes recyclable. The company sends used scopes to a third-party company that autoclaves them and separates the plastic from the electronics and metals. The electronics and metals can be repurposed for nonmedical use, and the plastic is recycled.

However, while Boston Scientific offers this recycling option for free, and hospital administrators and physicians often bring up the issue of environmental impact during negotiations, “only about 25% or 30% of the customers who are using EXALT choose to implement [recycling],” Ms. Eckerline explained.

Sanders noted that the FDA updated its guidance on April 4, encouraging transition to duodenoscopes that are fully disposable or have disposable components. The revision was based on new interim information from postmarketing surveillance studies, which showed that duodenoscopes with a removable component to facilitate cleaning had a contamination rate of 0.5%, compared with rates as high as 6% in older models. “It’s really almost forcing our hand at this point to move to some type of disposable option,” said Mr. Sanders.

Dr. Guha has consulted for Medtronic.

Single-use endoscopes are becoming increasingly common, and economic and regulatory factors are driving growth and innovation in this field. Those were some of the messages presented at a session on innovations in endoscope devices at the 2022 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“We’ve seen a shift in the need for more disposable technologies to support overall environmental parameters,” Brian Sanders, director of market development for GI at Ambu, explained during his presentation. “The more complicated these designs became, the more challenging they became to clean.”

Mr. Sanders highlighted some of the advantages of single-use scopes. There are no repair costs, and fewer storage and supply costs. They are more convenient since there is no need to wait for a scope to be cleaned. And the Food and Drug Administration has supported moving to single-use duodenoscopes. He also surmised that consumers might prefer single-use endoscopes since the risk of infection is likely to be lower than with reusable endoscopes.

Still, it can be difficult to get a full understanding of the costs of reusable versus single-use devices. Costs may be spread out across departments within a facility, and can include capital costs, repairs, reprocessing, consumables, and opportunity costs that occur due to delays. “[Many] categories are not transparent because they are hosted with cross-lateral budgets throughout the facility, so this is a messy web,” said Mr. Sanders.

Furthermore, findings from a meta-analysis of bronchoscopes indicate a 15.2% contamination rate, and an infection rate attributable to reusable bronchoscopes of 2.8%, with an average treatment cost of $11,788.

“When you consider all of the drivers we’re seeing in the endoscope arena, it’s our strong belief that, within the next 10 years, most endoscopes being utilized in medical practice will turn to single use,” Mr. Sanders continued.

During the Q&A period following the presentation, the discussion turned to the environmental impact of single-use devices. “We do a lot of endoscopies. If we start moving into single-use gastroscopes and colonoscopes, how do we process them? Can we recycle them?” asked panel moderator Sushovan Guha, MD, PhD, professor of medicine at McGovern Medical School and codirector of the Center for Interventional Gastroenterology at UTHealth Science Center, Houston.

The question drew a response from panelist Katie Eckerline, EUS group manager at Boston Scientific. She noted that the water and chemicals used in reprocessing the company’s EXALT single-use duodenoscope device are important, as is the requirement for personal protective equipment. “[T]here’s an underappreciated environmental impact that comes along with scope reprocessing because it’s not happening directly in the rooms, and this is often overlooked,” replied Ms. Eckerline.

She noted that Boston Scientific has taken steps to make EXALT duodenoscopes recyclable. The company sends used scopes to a third-party company that autoclaves them and separates the plastic from the electronics and metals. The electronics and metals can be repurposed for nonmedical use, and the plastic is recycled.

However, while Boston Scientific offers this recycling option for free, and hospital administrators and physicians often bring up the issue of environmental impact during negotiations, “only about 25% or 30% of the customers who are using EXALT choose to implement [recycling],” Ms. Eckerline explained.

Sanders noted that the FDA updated its guidance on April 4, encouraging transition to duodenoscopes that are fully disposable or have disposable components. The revision was based on new interim information from postmarketing surveillance studies, which showed that duodenoscopes with a removable component to facilitate cleaning had a contamination rate of 0.5%, compared with rates as high as 6% in older models. “It’s really almost forcing our hand at this point to move to some type of disposable option,” said Mr. Sanders.

Dr. Guha has consulted for Medtronic.

Single-use endoscopes are becoming increasingly common, and economic and regulatory factors are driving growth and innovation in this field. Those were some of the messages presented at a session on innovations in endoscope devices at the 2022 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“We’ve seen a shift in the need for more disposable technologies to support overall environmental parameters,” Brian Sanders, director of market development for GI at Ambu, explained during his presentation. “The more complicated these designs became, the more challenging they became to clean.”

Mr. Sanders highlighted some of the advantages of single-use scopes. There are no repair costs, and fewer storage and supply costs. They are more convenient since there is no need to wait for a scope to be cleaned. And the Food and Drug Administration has supported moving to single-use duodenoscopes. He also surmised that consumers might prefer single-use endoscopes since the risk of infection is likely to be lower than with reusable endoscopes.

Still, it can be difficult to get a full understanding of the costs of reusable versus single-use devices. Costs may be spread out across departments within a facility, and can include capital costs, repairs, reprocessing, consumables, and opportunity costs that occur due to delays. “[Many] categories are not transparent because they are hosted with cross-lateral budgets throughout the facility, so this is a messy web,” said Mr. Sanders.

Furthermore, findings from a meta-analysis of bronchoscopes indicate a 15.2% contamination rate, and an infection rate attributable to reusable bronchoscopes of 2.8%, with an average treatment cost of $11,788.

“When you consider all of the drivers we’re seeing in the endoscope arena, it’s our strong belief that, within the next 10 years, most endoscopes being utilized in medical practice will turn to single use,” Mr. Sanders continued.

During the Q&A period following the presentation, the discussion turned to the environmental impact of single-use devices. “We do a lot of endoscopies. If we start moving into single-use gastroscopes and colonoscopes, how do we process them? Can we recycle them?” asked panel moderator Sushovan Guha, MD, PhD, professor of medicine at McGovern Medical School and codirector of the Center for Interventional Gastroenterology at UTHealth Science Center, Houston.

The question drew a response from panelist Katie Eckerline, EUS group manager at Boston Scientific. She noted that the water and chemicals used in reprocessing the company’s EXALT single-use duodenoscope device are important, as is the requirement for personal protective equipment. “[T]here’s an underappreciated environmental impact that comes along with scope reprocessing because it’s not happening directly in the rooms, and this is often overlooked,” replied Ms. Eckerline.

She noted that Boston Scientific has taken steps to make EXALT duodenoscopes recyclable. The company sends used scopes to a third-party company that autoclaves them and separates the plastic from the electronics and metals. The electronics and metals can be repurposed for nonmedical use, and the plastic is recycled.

However, while Boston Scientific offers this recycling option for free, and hospital administrators and physicians often bring up the issue of environmental impact during negotiations, “only about 25% or 30% of the customers who are using EXALT choose to implement [recycling],” Ms. Eckerline explained.

Sanders noted that the FDA updated its guidance on April 4, encouraging transition to duodenoscopes that are fully disposable or have disposable components. The revision was based on new interim information from postmarketing surveillance studies, which showed that duodenoscopes with a removable component to facilitate cleaning had a contamination rate of 0.5%, compared with rates as high as 6% in older models. “It’s really almost forcing our hand at this point to move to some type of disposable option,” said Mr. Sanders.

Dr. Guha has consulted for Medtronic.