The Food and Drug Administration (FDA) has faced criticism for its insufficient action in removing hazardous medical devices from the market, as revealed in a recent report by the Government Accountability Office (GAO). This investigation was prompted by U.S. Senators after the 2021 recall of Philips Respironics breathing machines, which contained industrial foam that could degrade and release toxic substances into users' lungs, affecting vulnerable populations such as the elderly, veterans, and infants.

Despite receiving numerous complaints over the years, the FDA did not initiate a recall until Philips Respironics acted on its own, with users of the continuous positive airway pressure (CPAP) machines reporting various health issues, including respiratory illnesses and cancer. Senators Dick Durbin and Richard Blumenthal called for the GAO investigation due to concerns about the FDA's handling of medical device recalls, with Durbin describing the report as “long overdue” and highlighting the negative impact of staffing cuts on the agency's oversight capabilities.

The GAO's findings indicate that the FDA has rarely exercised its legal authority to compel manufacturers to withdraw defective devices, having done so only four times since 1992. Most recalls are initiated voluntarily by manufacturers, with approximately 900 occurring annually in recent years. However, the FDA's ability to manage these recalls has been significantly hindered by staffing reductions, particularly during the Trump administration. Currently, the agency oversees over 190,000 medical devices, a number that has increased by 15,000 since 2016. Blumenthal emphasized the need for more resources to effectively protect public health from unsafe medical devices.

The report also noted that some patients were unaware of the 2021 recall for extended periods, continuing to use the devices despite known health risks. Since 2021, the FDA has recorded over 500 reports of deaths linked to these devices. Dr. Rita Redberg, a cardiologist, criticized the FDA's outdated recall notification system, which relies on fax communications due to a lack of modern data infrastructure.

Concerns regarding the FDA's efficiency in managing recalls have been echoed by former officials, who worry that recent staffing cuts may exacerbate existing issues. In response to the GAO's findings, the Department of Health and Human Services stated it would evaluate the need for additional personnel and legislative authority to enhance recall management.

Philips, the manufacturer of the devices, has claimed that the original foam did not cause significant harm to patients. The company has reached a settlement with the Justice Department, agreeing to hire an independent safety monitor and pay over $1 billion to settle lawsuits from affected individuals, without admitting fault. In light of the GAO's report, Durbin and Representative Jan Schakowsky have introduced legislation aimed at addressing the FDA's shortcomings, including the establishment of an electronic format for recall alerts to improve communication among stakeholders. Durbin emphasized the importance of timely information for patients relying on medical devices for their health.