The Food and Drug Administration rarely uses its authority to pull dangerous medical devices off the market and is so poorly staffed that it’s sometimes unable to make sure companies are taking critical steps to protect patients during health emergencies, according to a new report by the Government Accountability Office.
The inquiry by the congressional watchdog was requested nearly two years ago by top members of the Senate in the wake of an investigation about the 2021 recall of breathing machines that threatened the health of millions of Americans.
ProPublica and the Pittsburgh Post-Gazette revealed that the FDA had received hundreds of complaints over many years about the machines and never ordered a recall. Philips Respironics eventually recalled the devices, which were fitted with an industrial foam that could break down and release toxic material into the lungs of patients, including the elderly, veterans and infants.
Philips had fielded thousands more complaints before initiating a recall and didn’t notify FDA, the news organizations found. Customers who relied on the continuous positive airway pressure, or CPAP, machines and other devices reported respiratory illnesses, kidney and liver conditions, and cancer.
In 2023, U.S. Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., urged the GAO to investigate the agency’s practices amid one of the most tumultuous medical device recalls in recent history.
In a statement, Durbin called the GAO report “long overdue,” saying it details “the harms caused by drastic staffing cuts” and “how weakened enforcement authority has made it even more difficult for FDA to carry out critical oversight activities.”
The probe, which began last year, found the FDA doesn’t use its authority to force manufacturers to pull defective devices from the market. The agency has been empowered under federal law for decades to take such action, but it has only done so four times, the last in 1992.
In the vast number of cases, device makers voluntarily initiated recalls — about 900 in each of the past five years, the GAO said.
Even when companies start the process, FDA staff — which has weathered significant cuts under the Trump administration — can’t always properly ensure that there are no delays or missteps in removing defective devices and communicating with consumers, the report said.
The agency currently regulates more than 190,000 medical devices in the United States, an increase of about 15,000 since 2016, according to the GAO.
“FDA needs additional resources and staff to adequately protect Americans from unsafe medical devices,” Blumenthal said in a statement. “Current and future staffing cuts at FDA will only further undermine the agency’s ability to protect people from unnecessary harm.”
The investigation by ProPublica and the Post-Gazette found some patients didn’t learn about the 2021 recall of their breathing machines for months or years and continued to use them even as company tests showed that foam in the machines were releasing dangerous compounds.
The FDA has received more than 500 reports of deaths associated with the devices since 2021, according to the agency’s last update.
Dr. Rita Redberg, a cardiologist and expert on medical device safety, called the FDA’s recall notification system “primitive by today’s standards” and said improvements have been badly needed for years.
“I mean, recall notices are still faxed because the FDA lacks a modern comprehensive data infrastructure for recalls,” she said. “It’s really shocking.”
One former FDA official said he fears the agency’s handling of recalls could become less efficient in the wake of recent staffing cuts. FDA employees told the GAO they often can’t carry out basic tasks, such as reading status reports submitted by companies while recalls are underway. Those reports detail how many people have been notified about defective devices, the number of products fixed and the estimated time frame to complete the recall.
“I would be worried that the circumstances at FDA are now even worse than portrayed in the report,” said Dr. Peter Lurie, a former FDA associate commissioner who left the agency in 2017.
In response to the GAO’s findings, the Department of Health and Human Services, which oversees the FDA, said it would assess the need for additional staff and greater legislative authority to better manage recalls. The FDA previously defended its handling of the Philips recall, saying it acted as soon as it learned of safety concerns.
Philips, which manufactured the devices at two plants outside Pittsburgh, has said the original foam caused “no appreciable harm” to patients. Last year, the company reached an agreement with the Justice Department, promising to hire an independent safety monitor and undergo regular facility inspections.
The company also agreed to pay more than $1 billion to settle lawsuits filed by thousands of people who say they were injured by the devices. Under the terms of the settlement, Philips did not admit fault or liability.
This week, Durbin and Rep. Jan Schakowsky, D-Ill., introduced legislation that would require the FDA to address some of the GAO’s most pressing concerns.
The bill, among other things, would require the FDA to establish an electronic format for recall alerts so that critical information can more easily be shared between companies, the FDA, hospitals and doctors.
“Millions of Americans rely on a medical device to stay healthy,” Durbin said. “But if their medical device is recalled, patients have the right to know as soon as possible so that they can understand the risks.”
