A complete failure of the QMS.

I know the FDA wants/needs to keep Philips around to manage the recall, and like... people with CPAPs need them, but I really wish they would just terminate all of Philips' licenses/approvals/clearances right now. I hope the DOJ has bigger penalties to lay down.

FDA's post market surveillance relies on manufacturers to be sufficiently honest. Philips sat on thousands of reports for over a decade. This is simply unacceptable. For the FDA to be able to say with a straight face that their post market surveillance has value, they need stronger assurances that manufactures will play by the rules, and I feel that means really making an example of Philips here.

I've worked in medical devices before, and I am quite aware of how easily QMS and SOP can diffuse responsibility. It's so easy as a line worker/line manager/middle manager to shrug and go "well, I did my role as prescribed by QMS and SOP - it's not my problem that we're sitting on 10k medical device reports that we should be notifying the FDA about". And that's a huge problem.

Obviously upper management has the most blame here, but no one involved is blameless. The QMS has some boilerplate about how everyone is responsible for quality. If that's true, then everyone involved is also responsible in some part.

I know terminating all of Philips' licenses for like 5 years or something will basically make a lot of people jobless. But like 500 people died because some assholes decided to go for the $$$, and everyone else involved let it happen. That's not an acceptable corporate standard.