Yes they do (I work in the industry)
It's required by law. Many implants have things in them they don't want put into cremation for example.
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H...
What is your source?
It's required by law. Many implants have things in them they don't want put into cremation for example.
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H...
What is your source?
Source: I have published articles, organized symposia, and lobbied the US federal government about this subject.
Here is a relevant article (not one of mine :)
https://jamanetwork.com/journals/jamainternalmedicine/articl...
> At present, UDIs are not routinely or comprehensively captured, integrated as structured data within patients’ electronic health records, or available for clinicians, patients, and others to use.
Many of these things are tracked via taking the sticker off the device and putting it in the paper records.
Just because it isn't electronically tracked doesn't mean it's not tracked at all.
It needs to be tracked for recalls. It's (too) common for implants and things to be recalled, etc. They need to k ow who has what to do so.
As I said before, electronic health records are just a part of the picture.
(Edited to respond to your child comment)
If that's happening in your hospital system (loosing patient data when it enters the EHR) that's a problem you need to fix. It's not an indication that everyone has that same (major) issue. Your facility is not providing the standard of care expected and therefore patients will be harmed and your system will be sued (rightfully) as a result)
The problem is that this is not enough to unambiguously resolve the identity of devices across databases, or even within the same database at different time points.
For example, mapping between model number and UDI is often one to many. Model numbers might be omitted or mutated across databases and time. Manufacturer and device names are most definitely mutated. Overall it is a nightmare of an entity resolution problem.
https://jamanetwork.com/journals/jamainternalmedicine/fullar...
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...