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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 elect

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
    " 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. Congress should authorize the infrastructure to create a national and publicly accessible registry that uses the UDI for tracking postmarket medical outcomes and safety." https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2774431 https://jamanetwork.com/journals/jamainternalmedicine/fullar...

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
  " 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. Congress should authorize the infrastructure to create a national and publicly accessible registry that uses the UDI for tracking postmarket medical outcomes and safety." https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2774431 https://jamanetwork.com/journals/jamainternalmedicine/fullar...