FDA in a safety statement released Thursday advised health care facilities and manufacturers to transition to duodenoscopes with disposable endcap components to help reduce the spread of infection between patients.
Scopes help physicians inspect the digestive tract, respiratory system, and other areas of the body without resorting to surgery. However, the devices also can be a vector for infection. To clean scopes, which contain sensitive equipment such as lights and cameras, health care providers must use disinfectants and carefully brush and wash the products.
But some pathogens make it through the cleaning process. FDA in 2013 learned about a potential link between multi-drug resistant bacteria and scopes—even those that were properly sterilized and disinfected based on the instructions from manufacturers. According to FDA, as many as 350 patients at 41 medical facilities across the globe were infected by or exposed to contaminated gastrointestinal scopes between 2010 and 2015. As of January 2017, contaminated scopes had killed at least 35 patients in the United States since 2013.
FDA in 2013 started to collaborate with duodenoscope manufacturers Fujifilm, Olympus, and Pentax to address contamination risks. In 2015, the agency ordered the companies to conduct post-market surveillance studies to assess whether health care professionals can properly clean and disinfect duodenoscopes. FDA also ordered the companies to evaluate whether hospital professionals are adequately trained to follow reprocessing instructions.
FDA recommends that providers, manufacturers switch to duodenoscopes with disposable parts
FDA in the safety statement issued Thursday advised health care facilities and duodenoscope manufacturers to transition to duodenoscopes with disposable endcap components to help reduce the spread of infection between patients. FDA made the recommendation based on post-market surveillance, which revealed providers struggle to disinfect non-disposable scopes.
FDA in the announcement said the cleaning instructions for duodenoscopes without disposable components might be too complicated for providers to fully complete. The agency said results from the post-market studies "suggest that users frequently had difficulty understanding and following manufacturers' [instructions] and as a result, were not able to successfully complete reprocessing."
According to FDA, removable and disposable endcaps will allow health care providers to clean parts of the duodenoscopes that usually are inaccessible because of their current metal caps. FDA said it has approved two duodenoscopes with disposable endcaps, one made by Pentax Medical and one by Fujifilm.
FDA also said it will continue efforts to improve cleaning instructions for the scopes. In addition, FDA said it is:
- Requesting that manufacturers list "real-world contamination rates" on labels for duodenoscopes with no disposable endcap components;
- Requesting that manufacturers develop improved cleaning methods; and
- Requiring post-market surveillance studies by manufacturers of duodenoscopes with disposable endcap components.
The agency said it will hold an advisory committee meeting before January 2020 to discuss the effectiveness of current efforts intended to reduce contamination from duodenoscopes.
Jeff Shuren, director of FDA's Center for Devices and Radiological Health, said the agency does not plan to recall conventional duodenoscopes at this time because doing so could result in a shortage of the scopes. "We recognize that an immediate transition away from conventional duodenoscopes to the newer, innovative models will take time due to cost and market availability," he said, adding, "We encourage health care facilities purchasing new duodenoscopes to begin developing a transition plan and work to replace their conventional duodenoscopes with newer models."
William Maisel, director of the Office of Product Evaluation and Quality in FDA's Center for Devices and Radiological Health, said FDA is confident that introducing more duodenoscopes with disposable endcaps will reduce infection.
However, Shuren emphasized that the risk of a patient being infected by a contaminated conventional duodenoscope is low, meaning patients "should not cancel or delay any planned procedure without first discussing the benefits and risks with a health care professional" (Rabin, New York Times, 8/29; Gever, MedPage Today, 8/29; Mulero, Regulatory Focus, 8/30; FDA release, 8/29).