Infection risk from reprocessed duodenoscopes is low, but the goal is zero

 

BOSTON – Once attributed to human error, the outbreaks of infection from persistent contamination of reprocessed duodenoscopes have eluded an easy fix, according to three experts addressing the problem at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. This session is part of the AGA Center for GI Innovation and Technology’s ongoing efforts to convene stakeholders, including endoscope manufacturers and the Food and Drug Administration, and to collaborate on a solution to ensure zero device-transmitted infections.

Since the problem first was recognized, changes in device design and cleaning protocols have produced a fivefold reduction in the risk of infection.

“The risk is now very low and well beneath the benefits provided by endoscopy, but we will not settle for anything less than complete resolution of the problem,” said David R. Lichtenstein, MD, the director of the endoscopy program at Boston University. Leading off a program that outlined the problem and possible solutions, Dr. Lichtenstein said, “We need to make this a historical issue.”

After scrutiny by the many stakeholders, including the manufacturers, gastroenterologists, and regulatory agencies, the elevator mechanism has remained one focus of concern. The difficulty of cleaning this mechanism was recognized in the earliest devices, but redesigns to permit these channels to be flushed did not resolve the problem completely. In the AGA Tech Summit session, there was general consensus that even dedicated reprocessing technicians fully adherent to current protocols cannot reliably completely clean the currently available duodenoscopes in every case.

“In most instances, it is not the technician at fault and it is extremely difficult to get a flexible scope clean after a messy procedure,” explained Cori Ofstead, MSPH, an epidemiologist and president of Ofstead & Associates. In one study she conducted in endoscopes reprocessed using best practice recommendations, microbial presence could still be detected.

Although risk of contamination increases with repeated use of scopes, with damaged scopes, and after scopes have been used in procedures generating relatively high amounts of debris, Ms. Ofstead said, “If you look, you will find contamination.” While she emphasized the importance of developing incentives that reward quality over efficiency when attempting to reduce human error in duodenoscope reprocessing, she, like Dr. Lichtenstein, believes new strategies are needed to achieve zero tolerance for infection risk.

“Disinfection simply may not be enough,” Ms. Ofstead said. “The solution is likely to be something else, such as single-use scopes or sterilization.” Explaining how processes of sterilization and disinfection differ, David Weber, MD, MPH, professor of epidemiology, University of North Carolina School of Medicine, Chapel Hill, outlined the relative advantages and disadvantages of current options. Dr. Weber, who has been involved in numerous studies regarding duodenoscope decontamination, emphasized that that rigorous cleaning of biological debris is a central tenet of any solution, but he outlined evidence that the current standard of high level disinfection (HLD) has not been sufficient to bring the infection risk to zero.

 

“There is no simple answer, because every solution so far has introduced some challenges,” Dr. Lichtenstein observed. Listing some examples, he noted that autoclaving results in damage to endoscopes since they are heat labile; that some proposed sterilization techniques may be limited by sterilants that can’t penetrate biofilm formation into deeper layers that harbor viable bacteria and are associated with a risk of toxicity to technicians or patients; and that disposable endoscopes or elevator mechanisms may involve unacceptable costs or operating characteristics. However, he is convinced there is a solution.

“The problem is being addressed from different angles, and I think we will find the solution within several years. This may involve a series of additional incremental improvements, but I think no one with a stake in this issue will sit comfortably until it is no longer a problem,” Dr. Lichtenstein said.

In the discussion that followed the formal presentations, it was generally acknowledged that the ultimate solution remains unclear even though incremental progress is being made. In fact, there have been no major outbreaks in the United States in the last year following the attention given to this issue, which is likely to have promoted more diligence in disinfection, according to Dr. Lichtenstein.

“Disposable endoscopes or disposable parts on endoscopes that facilitate cleaning may be coming, but I think the best current step is a standardized method of testing scopes after cleaning to verify that disinfection has been achieved,” Dr. Lichtenstein said.

 

Other solutions, including new sterilization techniques may also emerge, but there was general consensus that the human factor will always be important even if the best solution proves to be a disposable endoscope. Dr. Weber said, “You can still place a disposable scope on a contaminated surface. The human factor is always important.”

Michael L. Kochman, MD, the Wilmott Professor of Medicine and director of the Center for Endoscopic Innovation, Research and Training at the University of Pennsylvania, Philadelphia, and past chair of the AGA Center for GI Innovation and Technology, added, “AGA will build on the relationships that we have with the manufacturers of the endoscopes along with companies developing other novel approaches to reprocessing, as well as the FDA and CDC, to further the discussion. Ultimately, we hope to see the availability of devices that are effective and reliably clean so that we do not have to be concerned about patient-to-patient transmission of infection.”
 

 

 

BOSTON – Once attributed to human error, the outbreaks of infection from persistent contamination of reprocessed duodenoscopes have eluded an easy fix, according to three experts addressing the problem at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. This session is part of the AGA Center for GI Innovation and Technology’s ongoing efforts to convene stakeholders, including endoscope manufacturers and the Food and Drug Administration, and to collaborate on a solution to ensure zero device-transmitted infections.

Since the problem first was recognized, changes in device design and cleaning protocols have produced a fivefold reduction in the risk of infection.

“The risk is now very low and well beneath the benefits provided by endoscopy, but we will not settle for anything less than complete resolution of the problem,” said David R. Lichtenstein, MD, the director of the endoscopy program at Boston University. Leading off a program that outlined the problem and possible solutions, Dr. Lichtenstein said, “We need to make this a historical issue.”

After scrutiny by the many stakeholders, including the manufacturers, gastroenterologists, and regulatory agencies, the elevator mechanism has remained one focus of concern. The difficulty of cleaning this mechanism was recognized in the earliest devices, but redesigns to permit these channels to be flushed did not resolve the problem completely. In the AGA Tech Summit session, there was general consensus that even dedicated reprocessing technicians fully adherent to current protocols cannot reliably completely clean the currently available duodenoscopes in every case.

“In most instances, it is not the technician at fault and it is extremely difficult to get a flexible scope clean after a messy procedure,” explained Cori Ofstead, MSPH, an epidemiologist and president of Ofstead & Associates. In one study she conducted in endoscopes reprocessed using best practice recommendations, microbial presence could still be detected.

Although risk of contamination increases with repeated use of scopes, with damaged scopes, and after scopes have been used in procedures generating relatively high amounts of debris, Ms. Ofstead said, “If you look, you will find contamination.” While she emphasized the importance of developing incentives that reward quality over efficiency when attempting to reduce human error in duodenoscope reprocessing, she, like Dr. Lichtenstein, believes new strategies are needed to achieve zero tolerance for infection risk.

“Disinfection simply may not be enough,” Ms. Ofstead said. “The solution is likely to be something else, such as single-use scopes or sterilization.” Explaining how processes of sterilization and disinfection differ, David Weber, MD, MPH, professor of epidemiology, University of North Carolina School of Medicine, Chapel Hill, outlined the relative advantages and disadvantages of current options. Dr. Weber, who has been involved in numerous studies regarding duodenoscope decontamination, emphasized that that rigorous cleaning of biological debris is a central tenet of any solution, but he outlined evidence that the current standard of high level disinfection (HLD) has not been sufficient to bring the infection risk to zero.

 

“There is no simple answer, because every solution so far has introduced some challenges,” Dr. Lichtenstein observed. Listing some examples, he noted that autoclaving results in damage to endoscopes since they are heat labile; that some proposed sterilization techniques may be limited by sterilants that can’t penetrate biofilm formation into deeper layers that harbor viable bacteria and are associated with a risk of toxicity to technicians or patients; and that disposable endoscopes or elevator mechanisms may involve unacceptable costs or operating characteristics. However, he is convinced there is a solution.

“The problem is being addressed from different angles, and I think we will find the solution within several years. This may involve a series of additional incremental improvements, but I think no one with a stake in this issue will sit comfortably until it is no longer a problem,” Dr. Lichtenstein said.

In the discussion that followed the formal presentations, it was generally acknowledged that the ultimate solution remains unclear even though incremental progress is being made. In fact, there have been no major outbreaks in the United States in the last year following the attention given to this issue, which is likely to have promoted more diligence in disinfection, according to Dr. Lichtenstein.

“Disposable endoscopes or disposable parts on endoscopes that facilitate cleaning may be coming, but I think the best current step is a standardized method of testing scopes after cleaning to verify that disinfection has been achieved,” Dr. Lichtenstein said.

 

Other solutions, including new sterilization techniques may also emerge, but there was general consensus that the human factor will always be important even if the best solution proves to be a disposable endoscope. Dr. Weber said, “You can still place a disposable scope on a contaminated surface. The human factor is always important.”

Michael L. Kochman, MD, the Wilmott Professor of Medicine and director of the Center for Endoscopic Innovation, Research and Training at the University of Pennsylvania, Philadelphia, and past chair of the AGA Center for GI Innovation and Technology, added, “AGA will build on the relationships that we have with the manufacturers of the endoscopes along with companies developing other novel approaches to reprocessing, as well as the FDA and CDC, to further the discussion. Ultimately, we hope to see the availability of devices that are effective and reliably clean so that we do not have to be concerned about patient-to-patient transmission of infection.”
 

 

 

BOSTON – Once attributed to human error, the outbreaks of infection from persistent contamination of reprocessed duodenoscopes have eluded an easy fix, according to three experts addressing the problem at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. This session is part of the AGA Center for GI Innovation and Technology’s ongoing efforts to convene stakeholders, including endoscope manufacturers and the Food and Drug Administration, and to collaborate on a solution to ensure zero device-transmitted infections.

Since the problem first was recognized, changes in device design and cleaning protocols have produced a fivefold reduction in the risk of infection.

“The risk is now very low and well beneath the benefits provided by endoscopy, but we will not settle for anything less than complete resolution of the problem,” said David R. Lichtenstein, MD, the director of the endoscopy program at Boston University. Leading off a program that outlined the problem and possible solutions, Dr. Lichtenstein said, “We need to make this a historical issue.”

After scrutiny by the many stakeholders, including the manufacturers, gastroenterologists, and regulatory agencies, the elevator mechanism has remained one focus of concern. The difficulty of cleaning this mechanism was recognized in the earliest devices, but redesigns to permit these channels to be flushed did not resolve the problem completely. In the AGA Tech Summit session, there was general consensus that even dedicated reprocessing technicians fully adherent to current protocols cannot reliably completely clean the currently available duodenoscopes in every case.

“In most instances, it is not the technician at fault and it is extremely difficult to get a flexible scope clean after a messy procedure,” explained Cori Ofstead, MSPH, an epidemiologist and president of Ofstead & Associates. In one study she conducted in endoscopes reprocessed using best practice recommendations, microbial presence could still be detected.

Although risk of contamination increases with repeated use of scopes, with damaged scopes, and after scopes have been used in procedures generating relatively high amounts of debris, Ms. Ofstead said, “If you look, you will find contamination.” While she emphasized the importance of developing incentives that reward quality over efficiency when attempting to reduce human error in duodenoscope reprocessing, she, like Dr. Lichtenstein, believes new strategies are needed to achieve zero tolerance for infection risk.

“Disinfection simply may not be enough,” Ms. Ofstead said. “The solution is likely to be something else, such as single-use scopes or sterilization.” Explaining how processes of sterilization and disinfection differ, David Weber, MD, MPH, professor of epidemiology, University of North Carolina School of Medicine, Chapel Hill, outlined the relative advantages and disadvantages of current options. Dr. Weber, who has been involved in numerous studies regarding duodenoscope decontamination, emphasized that that rigorous cleaning of biological debris is a central tenet of any solution, but he outlined evidence that the current standard of high level disinfection (HLD) has not been sufficient to bring the infection risk to zero.

 

“There is no simple answer, because every solution so far has introduced some challenges,” Dr. Lichtenstein observed. Listing some examples, he noted that autoclaving results in damage to endoscopes since they are heat labile; that some proposed sterilization techniques may be limited by sterilants that can’t penetrate biofilm formation into deeper layers that harbor viable bacteria and are associated with a risk of toxicity to technicians or patients; and that disposable endoscopes or elevator mechanisms may involve unacceptable costs or operating characteristics. However, he is convinced there is a solution.

“The problem is being addressed from different angles, and I think we will find the solution within several years. This may involve a series of additional incremental improvements, but I think no one with a stake in this issue will sit comfortably until it is no longer a problem,” Dr. Lichtenstein said.

In the discussion that followed the formal presentations, it was generally acknowledged that the ultimate solution remains unclear even though incremental progress is being made. In fact, there have been no major outbreaks in the United States in the last year following the attention given to this issue, which is likely to have promoted more diligence in disinfection, according to Dr. Lichtenstein.

“Disposable endoscopes or disposable parts on endoscopes that facilitate cleaning may be coming, but I think the best current step is a standardized method of testing scopes after cleaning to verify that disinfection has been achieved,” Dr. Lichtenstein said.

 

Other solutions, including new sterilization techniques may also emerge, but there was general consensus that the human factor will always be important even if the best solution proves to be a disposable endoscope. Dr. Weber said, “You can still place a disposable scope on a contaminated surface. The human factor is always important.”

Michael L. Kochman, MD, the Wilmott Professor of Medicine and director of the Center for Endoscopic Innovation, Research and Training at the University of Pennsylvania, Philadelphia, and past chair of the AGA Center for GI Innovation and Technology, added, “AGA will build on the relationships that we have with the manufacturers of the endoscopes along with companies developing other novel approaches to reprocessing, as well as the FDA and CDC, to further the discussion. Ultimately, we hope to see the availability of devices that are effective and reliably clean so that we do not have to be concerned about patient-to-patient transmission of infection.”