The FDA’s complaint-tracking system for medical devices allowed Philips to obscure when it knew about dangerous CPAPs. New reporting shows the regulatory lapses extend to many devices and companies.

In 2021, after Philips Respironics sold millions of defective medical devices to those who struggle to breathe, the federal agency charged with protecting the health of the American public swept in.

The Food and Drug Administration accused the global powerhouse of a succession of mistakes — casting aside test results and health risks — long after the company discovered an industrial foam embedded in its breathing machines could break down and send tiny particles and fumes into the lungs of patients.

The FDA maintains that it acted as soon as it learned of the safety concerns in April 2021, just weeks before Philips launched one of the largest recalls of its kind.

  • givesomefucks@lemmy.world
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    9 months ago

    FDA and most government regulatory agencies are intentionally and habitually underfunded

    Because pretty much all Republicans and a disappointing amount of Democrats both take the political donations of lobbyists who want as little regulation as possible.

    When the agencies fail because of chronic underfunding, those politicians use it as an excuse to cut funding even more.

    Because some voters are dumb enough to believe that could somehow help.