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.
Or have I misread?
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?
if there is a recall good luck sorting through all the paper records, especially over a large time period.
I don't know why you argue when you know your argument is very weak at best.
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."
https://jamanetwork.com/journals/jamainternalmedicine/fullar...