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No they don’t. I helped lead a failed effort to implement UDI capture at a major academic research hospital. To date only Duke and Mercy health systems have i

No they don’t. I helped lead a failed effort to implement UDI capture at a major academic research hospital. To date only Duke and Mercy health systems have implemented UDI capture in a limited capacity. 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.

fragmede 2y ago
I'm being told breast implants have serial numbers, but I'd readily believe that other kinds of implants don't.
- iancmceachern 2y ago
  They do, its required by law. 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...
iancmceachern 2y ago
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.
iancmceachern 2y ago
What you are talking about is different. 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.
- pfisherman 2y ago
  UDI information is not captured at the point of care. Like if you try to go into EPIC at a hospital and query encounters or implantations by UDI it will not return anything. 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. https://pmc.ncbi.nlm.nih.gov/articles/PMC9872505/ https://pmc.ncbi.nlm.nih.gov/articles/PMC9872505/ https://nestcc.org/nestcc-udi-playbook/ https://nestcc.org/nestcc-udi-playbook/
  - iancmceachern 2y ago
    Yes but these are different things. 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!
    - pfisherman 2y ago
      Which barcode are you scanning? Are you sure it the right one? Which field is the data from the barcode scan going into? What data is actually deposited into the field? 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.
jampekka 2y ago
> The big problem is that implementation requires significant up front capital investment and operational changes; for nebulous / speculative ROI in terms of dollars. This sounds like something like one field in a database?
- Muromec 2y ago
  The actual difficilut problems are never technical ones. It's also probably not one field and not in one database, but something like a federated system. Everything eventually becomes this
  - jampekka 2y ago
    One field in a database is of course a bit of a caricature, but it does seem like a good example of how dysfunctional the medical software system field is. A single installation of these things can cost literally a billion dollars, yet such straightforward (seeming) things can't be implemented. It's not apples to apples, but that whole Linux kernel is estimated to be "worth" around a single EPIC installation is just bonkers.
    - Muromec 2y ago
      Well, I work in a bank, so the actual one field in the database is still half a year of a job for the reasons that are well intended, but the results are pretty hilarious
- organsnyder 2y ago
  The hard part isn't creating the column—it's modifying all of the workflows (or "careflows", as a hospital system I used to work for called them) to make sure they're reliably populated.

fragmede 2y ago

I'm being told breast implants have serial numbers, but I'd readily believe that other kinds of implants don't.

iancmceachern 2y ago
They do, its required by law. 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...

iancmceachern 2y ago

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.

iancmceachern 2y ago

What you are talking about is different. 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.

pfisherman 2y ago
UDI information is not captured at the point of care. Like if you try to go into EPIC at a hospital and query encounters or implantations by UDI it will not return anything. 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. https://pmc.ncbi.nlm.nih.gov/articles/PMC9872505/ https://pmc.ncbi.nlm.nih.gov/articles/PMC9872505/ https://nestcc.org/nestcc-udi-playbook/ https://nestcc.org/nestcc-udi-playbook/
- iancmceachern 2y ago
  Yes but these are different things. 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!
  - pfisherman 2y ago
    Which barcode are you scanning? Are you sure it the right one? Which field is the data from the barcode scan going into? What data is actually deposited into the field? 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.

jampekka 2y ago

> The big problem is that implementation requires significant up front capital investment and operational changes; for nebulous / speculative ROI in terms of dollars. This sounds like something like one field in a database?

Muromec 2y ago
The actual difficilut problems are never technical ones. It's also probably not one field and not in one database, but something like a federated system. Everything eventually becomes this
- jampekka 2y ago
  One field in a database is of course a bit of a caricature, but it does seem like a good example of how dysfunctional the medical software system field is. A single installation of these things can cost literally a billion dollars, yet such straightforward (seeming) things can't be implemented. It's not apples to apples, but that whole Linux kernel is estimated to be "worth" around a single EPIC installation is just bonkers.
  - Muromec 2y ago
    Well, I work in a bank, so the actual one field in the database is still half a year of a job for the reasons that are well intended, but the results are pretty hilarious
organsnyder 2y ago
The hard part isn't creating the column—it's modifying all of the workflows (or "careflows", as a hospital system I used to work for called them) to make sure they're reliably populated.