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Recalls get issued with reasonable frequency. The crazy part is that clinics have no way of identifying exposures (patients) or inventory impacted by recalls b

Recalls get issued with reasonable frequency. The crazy part is that clinics have no way of identifying exposures (patients) or inventory impacted by recalls because US hospitals do not capture unique device identifiers (UDIs) in electronic health records or their supply chain systems.

TechDebtDevin 2y ago
That seems crazy
- franktankbank 2y ago
  US health care is 1 needle of sanity in a haystack of crazy.
- pfisherman 2y ago
  It is. FDA requires manufactures to display UDIs in packaging (or devices themselves) in human and machine readable format. But hospital IT systems are not set up to capture this information and they have no compelling (i.e. financial) incentive to invest in the IT system upgrades and operational changes needed to capture this information. You would think better inventory management would be enough of a selling point, but apparently not. I am convinced that it will take government interventions - like CMS requiring UDIs on reimbursement forms - to get it done.
iancmceachern 2y ago
They do for implants
- pfisherman 2y ago
  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?
6SixTy 2y ago
Honestly depends on how tight of a ship a hospital is run. I've seen plenty of Hospital systems that have their own asset tags so they can manage preventative maintenance routines and separate tags for finding the damn things. Mostly because doing that allows them to build a paper trail. I've also seen a couple hospital systems trade some very common equipment like infusion pumps though I'm not privy to the finer details of that. 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.

TechDebtDevin 2y ago

That seems crazy

franktankbank 2y ago
US health care is 1 needle of sanity in a haystack of crazy.
pfisherman 2y ago
It is. FDA requires manufactures to display UDIs in packaging (or devices themselves) in human and machine readable format. But hospital IT systems are not set up to capture this information and they have no compelling (i.e. financial) incentive to invest in the IT system upgrades and operational changes needed to capture this information. You would think better inventory management would be enough of a selling point, but apparently not. I am convinced that it will take government interventions - like CMS requiring UDIs on reimbursement forms - to get it done.

iancmceachern 2y ago

They do for implants

pfisherman 2y ago
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?

6SixTy 2y ago

Honestly depends on how tight of a ship a hospital is run. I've seen plenty of Hospital systems that have their own asset tags so they can manage preventative maintenance routines and separate tags for finding the damn things. Mostly because doing that allows them to build a paper trail. I've also seen a couple hospital systems trade some very common equipment like infusion pumps though I'm not privy to the finer details of that. 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.