Durbin, Blumenthal Release GAO Report Recommending Expansion Of FDA’s Personnel And Authority To Oversee Medical Device Recalls

Durbin, Blumenthal Release GAO Report Recommending Expansion Of FDA's Personnel And Authority To Oversee Medical Device Recalls

Durbin and Blumenthal requested the report in December 2023 after reporting uncovered Philips Respironics' failure to recall faulty machines despite the company's knowledge that patients could be harmed by the medical devices

WASHINGTON - U.S. Senate Democratic Whip Dick Durbin (D-IL) and U.S. Senator Richard Blumenthal (D-CT) today released the Government Accountability Office's (GAO) newly-completed report on the Food and Drug Administration's (FDA) oversight of medical device recalls. In December 2023, Durbin and Blumenthal requested the report from GAO following the Pittsburgh Post-Gazette's and ProPublica's reporting on Philips Respironics' failure to submit timely and comprehensive adverse event reports, or recall faulty CPAP machines for more than a decade, despite the company's knowledge that patients could be experiencing severe health consequences from using the medical devices.

The report, which is entitled "Medical Device Recalls: HHS and FDA Should Address Limitations In Oversight of Recall Process," lays out how FDA's lack of legal authority jeopardizes patients' safety. GAO reports that "FDA does not have the legal authority to require the manufacturer to implement FDA's recommendations." For example, there have been instances in which the agency wanted a medical device manufacturer to inform patients about a recall, but the manufacturer believed communicating with the providers about the recalled device was sufficient. This issue leaves some patients with medical devices-including implanted ones-uninformed and at risk of significant health consequences.

Further, the report underscored the damaging impact of insufficient FDA staffing. GAO reports that FDA has insufficient staff to oversee medical device recalls, forcing FDA to forgo critical recall activities like conducting in-person recall audit checks. Despite these shortages, the Department of Health and Human Services (HHS) fired 3,500 FDA workers earlier this year, including personnel who worked to oversee medical devices.

"This report sounds the alarm on the shortcomings of how our government handles medical device recalls, detailing the harms caused by drastic staffing cuts to HHS and how weak enforcement authority has made it even more difficult for FDA to carry out critical oversight activities," said Durbin. "Now that we have a blueprint for improving medical device recall procedures, we must act. That begins with implementing GAO's recommendations and passing my legislation, the Medical Device Recall Improvement Act, to streamline communication between device manufacturers, FDA, hospitals, health care professionals, and patients about the medical devices that Americans rely on. HHS and FDA also must take GAO's recommendations to heart and implement them right away."

"GAO's report makes clear: FDA needs additional resources and staff to adequately protect Americans from unsafe medical devices. After FDA left patients vulnerable to defective Philips Respironics ventilators, I am glad GAO heeded our call for a thorough review into how these faulty devices reached consumers. Current and future staffing cuts at FDA will only further undermine the agency's ability to protect people from unnecessary harm. GAO's report must inform an effective response that protects the public and bolsters FDA's oversight," said Blumenthal.

Main takeaways from GAO's report include:

1. Insufficient Staffing at FDA. Even before HHS fired 3,500 FDA employees earlier this year, the agency did not have sufficient staff to conduct necessary medical device recall oversight activities. As a result, FDA will often forgo reviewing manufacturer Recall Status Reports or conducting in-person recall audit checks. FDA currently does not have sufficient resources or staffing to efficiently process the volume of medical device recalls, which is more than three times higher than the number of pharmaceutical recalls.
2. 1. In the report, GAO recommends that HHS develop a new workforce strategy to support efforts to conduct oversight on medical device recalls.
3. Lack of Legal Authority. FDA does not have the legal authority to require manufacturers to implement FDA's recommendations during a medical device recall. For instance, some manufacturers believed that communicating about a recall with only health care providers, and not directly reaching out to patients, was sufficient. This lack of authority puts patients at risk because they may not have received the proper details about a recall of their medical device.
4. 1. In the report, GAO recommends that HHS work with FDA to assess additional legislative authorities to oversee medical device recalls.

A copy of the final report can be found here.

Addressing some of the concerns laid out in GAO's report, Durbin reintroduced the Medical Device Recall Improvement Act earlier this week. The legislation would require FDA to establish an electronic format for medical device recall notifications to streamline communication between device manufacturers, FDA, hospitals, and health care professionals. It also would require manufacturers to include in recall notices information about how the recall could affect patients with medical devices and further instructs hospitals and health care professionals to share that information with patients.

FDA oversees the regulation of almost 200,000 medical devices in the U.S., from contact lenses and contraceptive devices to prosthetics and pacemakers. According to the American Medical Association, more than 32 million Americans have an implanted medical device, and countless others use them throughout their lives. These devices improve and save lives. However, medical devices that are recalled for safety issues or manufacturing defects can cause severe harm to patients.

Medical device manufacturers communicate recall information to FDA and health care professionals through letter and email. This extends the amount of time it takes FDA to review recall information, determine a recall classification, and communicate the recall to the public. It also extends the amount of time it takes hospital coordinators to track and pull recalled medical devices from inventories. As a result, patients are often the last informed about a recall-if ever. According to Consumer Reports, most Americans are not aware of recalls for their products, including medical devices.

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