Clinics get a little dicey, since they often do not have the same resources at their disposal that hospitals do, but you are unlikely to find anything much more advanced than an ECG in there.
The problems are pretty much getting the device to cooperate with the EHR (which is hard enough already) and attaching that information consistently to every patient (even John Does that paramedics drag in). And between those two, I can't really see equipment realistically being attached to every patient in a way that's consistent enough for a court to use as evidence. There's way too much room for nurses to just screw up between all of their different responsibilities.
The big problem is that implementation requires significant up front capital investment and operational changes; for nebulous / speculative ROI in terms of dollars. So organizational incentives are just not there.
Ultimately this is the type of problem that will require government intervention to solve. And that intervention will require the creation of incentives for organizations to implement UDI capture - similar to how it took an act of congress (Obamacare) to incentivize healthcare systems to adopt electronic health care records and protocols for communicating / sharing health care information.
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H...
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 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...
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...
UDIs of devices are typically tracked in the patients medical records.
What you are talking about is a central database with all of it. Yes, that would be good, but it doesn't mean that each patients UDIs of devices implanted or used isn't tracked (or supposed to be) within their medical records.
I think that maybe you are having trouble believing that such simple and basic information is omitted from medical records. Like it is obvious from the perspective of anyone who touches data that we should be capturing this info. But I can assure that we are not.
Here is some reading material about the issue.
It's in your chart, not epic. There are stickers that come with the devices that they put on the charts. In digital hospitals it's a barcode that gets scanned.
I personally know of many situations in which they were and are recorded. They may not be everywhere, but they are most places.
I'm in the hospital now by chance, they're doing it!
I invite you to do the exercise of tracking implant data of a case you observe (i.e. you have the MRN and first hand knowledge) through your clinic / hospital IT system. I think you might be surprised.
Anyway, these details like training clinicians to scan the right barcode, checking integrity, routing the right info into the right fields, etc are what I was referring to when I mentioned up front expenditures on IT and operations.
HIPPA exists so this can't happen. You (not the patient or their caregiver) should absolutely have no access, no right to access, and no need to access the personal medical details of a person.
I would never do such a thing, why are you?
Pragmatically, it exists. If Boston Scientific has an issue with a lead in one of their neurostimulators, they need to know who needs surgury to replace it and who doesn't.
These processes exist, you just don't know about them because you are focused on it from a data mining perspective, not a caregivers or patients perspective.
LOL! Because I wrote a research proposal that was approved, got an IRB, and worked with a team of clinical staff to execute the study. That’s generally what goes on at major academic research hospitals.
> If Boston Scientific has an issue with a lead in one of their neurostimulators, they need to know who needs surgury to replace it and who doesn't.
This is an assumption you are making that is not valid. Please do yourself a favor and look at some of the links that I have posted in this thread. What I am telling you is not a secret. Many people have been writing and talking about for many years.
The world of Healthcare is far far bigger than research....
This sounds like something like one field in a database?
Everything eventually becomes this
It's not apples to apples, but that whole Linux kernel is estimated to be "worth" around a single EPIC installation is just bonkers.