Senate Report Labels FDA’s Device Safety Monitoring System as Inadequate

A Senate report that followed an investigation by Sen. Patty Murray’s (D-Wash.) office has found that the FDA’s regulatory system for monitoring the safety of devices failed to quickly identify and resolve the spread of antibiotic-resistant infections linked to duodenoscopes.

In September 2013, the FDA started investigating how closed-channel duodenoscopes could spread infection despite proper cleaning, but the agency did not alert the public of the risks for 17 months, says the report, issued by Murray, ranking member of the Senate HELP Committee.

Also, three duodenoscope manufacturers failed to meet regulatory requirements — Olympus submitted incomplete and misleading medical device reports, and Pentax and Fujifilm filed late and incomplete reports, the report says. In addition, several hospitals failed to send required adverse event forms.

“While responsibility for the slow response is shared among Olympus and the other device manufacturers, hospitals, and FDA, the investigation overall demonstrates that FDA’s device surveillance system is overly-reliant on device manufacturers and user facilities to make

quick and complete reporting of safety issues over their own competing priorities,” the report says.

The report calls for:

• The FDA to update its guidance to clarify at what point manufacturers are required to seek clearance when medical devices are modified, and Congress to clarify the 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;
• Congress to require unique device identifiers 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 device safety rather than relying on adverse event reporting;
• The FDA to quickly evaluate the design of closed-channel duodenoscopes and implement a phased recall to fix or modify the devices if necessary; and
• The FDA to more quickly disseminate information to healthcare providers when it becomes aware that patient safety might be compromised by a device.

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