3 ms·

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

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/part-801/subpart-B https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H... What is your source?

yardstick 2y ago
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?
- iancmceachern 2y ago
  True, but most hospital systems and caregivers track them (not digitally but in the paper records) It's not true to say they are never captured.
  - LgWoodenBadger 2y ago
    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?
    - iancmceachern 2y ago
      They are, this commenter just works for a system that is sub standard and doesn't. Most do.
  - _zoltan_ 2y ago
    that's basically nothing then. 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.
    - iancmceachern 2y ago
      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." https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2774431 https://jamanetwork.com/journals/jamainternalmedicine/fullar...
pfisherman 2y ago
Manufactures are required to have UDIs on the label. FDA does not regulate the practice of medicine. Thus they cannot compel hospitals to record UDIs in electronic health records and they do not. 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/article-abstract/2808236 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.
- iancmceachern 2y ago
  The key here is "within electronic health records" 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)
  - pfisherman 2y ago
    It all ends up in the EHR, which is a legal document and considered THE source of truth about a patient’s care. Without seeing you hospital IT system I can guess with pretty high certainty that you are getting manufacturer info and model number, and very sparse coverage off lot number. 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.

yardstick 2y ago

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?

iancmceachern 2y ago
True, but most hospital systems and caregivers track them (not digitally but in the paper records) It's not true to say they are never captured.
- LgWoodenBadger 2y ago
  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?
  - iancmceachern 2y ago
    They are, this commenter just works for a system that is sub standard and doesn't. Most do.
- _zoltan_ 2y ago
  that's basically nothing then. 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.
  - iancmceachern 2y ago
    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." https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2774431 https://jamanetwork.com/journals/jamainternalmedicine/fullar...

pfisherman 2y ago

Manufactures are required to have UDIs on the label. FDA does not regulate the practice of medicine. Thus they cannot compel hospitals to record UDIs in electronic health records and they do not. 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/article-abstract/2808236 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.

iancmceachern 2y ago
The key here is "within electronic health records" 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)
- pfisherman 2y ago
  It all ends up in the EHR, which is a legal document and considered THE source of truth about a patient’s care. Without seeing you hospital IT system I can guess with pretty high certainty that you are getting manufacturer info and model number, and very sparse coverage off lot number. 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.