Sen. Patty Murray (D-WA), lead Democrat on the Senate’s health committee, has released a report (PDF) on carbapenem-resistant Enterobacteriaceae (CRE) outbreaks associated with contaminated duodenoscopes. The report
includes recommendations to provide a clear and timely path for reporting new infections that stem from medical devices. At the request of Sen. Murray’s staff, IDSA’s Public Health Committee provided feedback on the initial recommendations and subsequent bill.
The legislation would require the Food and Drug Administration (FDA) to publish a list of reusable devices that would need to provide proposed cleaning instructions as part of a 510(k) pre-market submission process. Manufacturers of the devices on this list would also need to provide FDA with validation data showing that proposed cleaning instructions are effective. IDSA and several other organizations formally supported the bill, which the Senate health committee is considering as part of its biomedical innovations effort. The legislation was later approved by the committee, and committee leaders anticipate that it will move to the floor of the Senate later this year with other bills approved as a biomedical innovations package.