Low staffing at the FDA has prevented the agency from adequately overseeing the more than 190,000 devices under its purview, according to a Dec. 12 report from ProPublica and the Pittsburgh Post-Gazette.
The findings come from a Government Accountability Office report obtained by the outlets in the course of their investigation into the FDA’s failure to recall tainted breathing machines. The GAO report said the FDA relies almost entirely on manufacturers to voluntarily initiate recalls, about 900 per year, and lacks the staffing needed to monitor them effectively. FDA staff told the GAO they often can’t read status reports or track how many patients have been notified.
The GAO investigation followed ProPublica and the Post-Gazette’s earlier reporting on Philips’ Respironics breathing machines, which were recalled in 2021 after long delays, despite hundreds of complaints about toxic foam exposure. The FDA did not issue a mandatory recall. Since then, more than 500 related deaths have been reported.
Public health experts said the FDA’s recall system is outdated and opaque, relying on faxed alerts and lacking real-time infrastructure. HHS said it would consider staffing and legislative fixes. A bill introduced this week would require electronic alert systems and faster coordination among the FDA, hospitals and manufacturers.
