FDA News

FDA encourages innovative duodenoscope designs, reprocessing procedures

In its ongoing effort to limit potential disease transmission due to difficult-to-clean devices, the FDA is recommending a transition to duodenoscopes with innovative designs and is encouraging the development of new methods to clean the scopes, according to recent safety communication.

In August, the FDA recommended a transition to duodenoscopes with disposable components. In this updated communication, the agency is recommending that hospitals and other endoscopy centers transition away from fixed endcap duodenoscopes to ones with newer features that “facilitate or eliminate the need for reprocessing.”

“We continue to work with manufacturers to increase the supply of disposable cap duodenoscopes and the development of other new and innovative device designs that will further minimize or eliminate the risk of patient infection,” the safety communication said. “We continue to address challenges with current reprocessing methods and support expanding the types of validated methods available to reprocess duodenoscopes.”

In addition to its recommendation to use scopes with disposable components, the FDA suggested that hospitals take additional steps to ensure proper handling and reprocessing of scopes. That includes recommendations to institute quality control programs, supplemental reprocessing measures and routine inspection procedures.

The FDA has already cleared three duodenoscopes with disable components, but they have also asked scope manufacturers to develop innovative approaches for the whole processing of decontaminating the scopes and making them ready to reintroduce for use in endoscopic retrograde cholangiopancreatography. Although better decontamination methods exist, like gas sterilization, their limited availability means that even more sterilization technologies are needed, the FDA said.

“We have also recently announced two challenges for new, innovative sterilization methods,” the agency said in the safety communication. “These challenges are intended to advance the science of sterilization with the goal of developing sterilization technologies that are compatible with a variety of medical devices; those advancements may be applied to reusable medical devices like duodenoscopes.”

As the transition to new duodenoscopes progresses, the FDA advised patients that the risk for infection due to inadequately reprocessed scopes is relatively low and not to cancel any planned procedure without discussing the benefits and risks with their health care provider.

“ERCP procedures performed with duodenoscopes are often life-saving and the benefits continue to outweigh the risks for appropriately selected patients,” the agency said. “The continued availability of duodenoscopes to perform these procedures remains a critical public health need.”

Reference: FDA.gov

In its ongoing effort to limit potential disease transmission due to difficult-to-clean devices, the FDA is recommending a transition to duodenoscopes with innovative designs and is encouraging the development of new methods to clean the scopes, according to recent safety communication.

In August, the FDA recommended a transition to duodenoscopes with disposable components. In this updated communication, the agency is recommending that hospitals and other endoscopy centers transition away from fixed endcap duodenoscopes to ones with newer features that “facilitate or eliminate the need for reprocessing.”

“We continue to work with manufacturers to increase the supply of disposable cap duodenoscopes and the development of other new and innovative device designs that will further minimize or eliminate the risk of patient infection,” the safety communication said. “We continue to address challenges with current reprocessing methods and support expanding the types of validated methods available to reprocess duodenoscopes.”

In addition to its recommendation to use scopes with disposable components, the FDA suggested that hospitals take additional steps to ensure proper handling and reprocessing of scopes. That includes recommendations to institute quality control programs, supplemental reprocessing measures and routine inspection procedures.

The FDA has already cleared three duodenoscopes with disable components, but they have also asked scope manufacturers to develop innovative approaches for the whole processing of decontaminating the scopes and making them ready to reintroduce for use in endoscopic retrograde cholangiopancreatography. Although better decontamination methods exist, like gas sterilization, their limited availability means that even more sterilization technologies are needed, the FDA said.

“We have also recently announced two challenges for new, innovative sterilization methods,” the agency said in the safety communication. “These challenges are intended to advance the science of sterilization with the goal of developing sterilization technologies that are compatible with a variety of medical devices; those advancements may be applied to reusable medical devices like duodenoscopes.”

As the transition to new duodenoscopes progresses, the FDA advised patients that the risk for infection due to inadequately reprocessed scopes is relatively low and not to cancel any planned procedure without discussing the benefits and risks with their health care provider.

“ERCP procedures performed with duodenoscopes are often life-saving and the benefits continue to outweigh the risks for appropriately selected patients,” the agency said. “The continued availability of duodenoscopes to perform these procedures remains a critical public health need.”

Reference: FDA.gov