Conversation

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.

https://www.propublica.org/article/fda-defective-device-recalls-gao-report