Here are five takeaways:
1. Between 2012 and 2015, 250 patients in 25 incidents worldwide suffered from an illiness as a result of antibiotic-resistant infections linked to the use of closed-channel duodenoscopes, according to the Senate Health, Education, Labor and Pensions Committee report.
2. The report found that the outbreak was much broader than previously indicated, and that the FDA’s current reliance on self-reporting for device safety may have slowed the agency’s response.
3. Rajesh N. Keswani, MD, an interventional gastroenterologist at Northwestern Medicine in Chicago, explained there is minimal postmarket monitoring of device safety despite the potential for harm from new devices. Moreover, small modifications to device designs are not assessed with the same rigor as new devices.
4. The Senate report called for steps to improve tracking of adverse events for all medical devices in the United States, including adding unique device identifiers to insurance claims.
5. The FDA has already phased in requirements that high-risk and implanted devices bear UDIs, and will require UDIs for moderate-risk devices starting this fall. Bipartisan support exists in the House and Senate to add UDIs in the next update of standardized medical claim forms.
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