That law only says the devices have to have unique IDs.
It doesn’t say anywhere (from my quick skim) that those unique IDs need to be recorded against/associated with patient records when they are implanted.
Sounds like they're effectively not-captured. Or are you saying that hospitals et al will look through their entire library of paper records to find contact info for a specific device to communicate recall information?
I've worked at several large medical device implant makers.
I've been in many many surgeries to implant them.
Often even the manufacturers have records of who has what implant.
I'm arguing because I know it to be a personal fact after working for Abott, J&J, etc.
It's a fact. They track them. I'm sure some don't, but they should.
Edited to add:
"Numerous private device registries use the UDI to monitor long-term outcomes for breast implants, cardiac pacemakers, implantable defibrillators, and other devices. However, participating physicians may not be able to view each other’s submissions, and nonparticipating physicians cannot view submissions. The data are proprietary and not publicly available."
It doesn’t say anywhere (from my quick skim) that those unique IDs need to be recorded against/associated with patient records when they are implanted.
Or have I misread?