Senate Committee Weighs-in on FDA Review of Duodendscopes

On Wednesday, Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member, Sen. Patty Murray (D-WA) released a new report: “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients.” According to the press release, the report is the result of a yearlong investigation by Sen. Murray’s staff into the cause of and response to outbreaks of antibiotic resistant infections linked to medical devices called duodenoscopes at hospitals nationwide. The report concludes that manufacturers were aware of design defects and problems without notifying the FDA, and hospitals were delinquent in notifying the FDA of subsequent patient adverse events. Further, the FDA then failed to both properly review these issues and notify the public in an effective and efficient manner.

The report recommends:

• Congress require unique device identifiers (UDIs) to be included in insurance claims and fully fund a National Medical Device Evaluation System to ensure that the FDA is able to effectively monitor the safety of medical devices on the market, rather than relying on adverse event reporting.
• FDA quickly evaluate the design of closed-channel duodenoscopes and implement a phased recall to fix or modify the devices if necessary.
• FDA update its guidance to clarify when manufacturers are required to seek 510(k) clearance when medical devices are modified, and that Congress clarify FDA’s authority to consider a 510(k) application incomplete in the absence of sufficient data to demonstrate a medical device can be safely cleaned and reused.
• FDA implement new draft guidance to more quickly disseminate information to health care providers when the agency becomes aware of information that patient safety might be compromised by a medical device; and
• Compliance by hospitals with adverse event reporting related to medical devices be made a Condition of Participation in Medicare.

To be clear, there are no action and changes at this time. This is simply a report from a ranking member of a Senate committee with a set of recommendations. However, ACG will continue to update membership if any hearings or legislation come to fruition as a result of this report.

What is the most cost-effective cleaning strategy for CRE resistance strains?

ACG encourage its members to read the American Journal of Gastroenterology’s recently published paper looking at cost-effective CRE prevention strategies:

Cost Utility of Competing Strategies to Prevent Endoscopic Transmission of Carbapenem-Resistant Enterobacteriaceae

Or listen to the podcast:

Christopher Almario, MD, MSHPM, co-author of a recent article examining the cost-effectiveness of various approaches for preventing transmission of carbapenem resistant Enterobacteriaceae (CRE) through ERCP endoscopes, discusses the genesis of the study and the finding that newly issued FDA recommendations for endoscope reprocessing were the most cost-effective compared to the other approaches studied. Which CRE Prevention Strategy for ERCP Endoscopes Is Most Cost-Effective?: Learn More From Dr. Christopher Almario on the Latest AJG Podcast

Whitfield Knapple, MD, Chair

ACG National Affairs Committee