FDA issues early alert for Baxter's Spectrum infusion pump | Hacker News Reader

FDA issues early alert for Baxter's Spectrum infusion pump

medicaldevice-network.com

39 pointsiancmceachern46 comments

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.

That seems crazy

US health care is 1 needle of sanity in a haystack of crazy.

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.

They do for implants

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.

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

They do, its required by law.

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H...

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...

What is your source?

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?

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.

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?

They are, this commenter just works for a system that is sub standard and doesn't. Most do.

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.

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:

https://jamanetwork.com/journals/jamainternalmedicine/fullar...

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/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.

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)

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.

" 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/fullar...

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.

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://nestcc.org/nestcc-udi-playbook/

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!

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.

That's not what it's for!

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.

> I would never do such a thing, why are you?

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.

Not a constructive comment, but I'm gonna say it anyway: this conversation is perfectly frustrating to watch. Thank you both.

Yes, but this is a specific use case. In your parent comment you asked me why I don't just go do that. I said that would be illegal (because I'm not a researcher). You assume everyone is a researcher? You assume that all medical systems operate like research institutions? You assume that because your research institution is providing sub standard care by loosing and not tracking vital patient data that is needed for their quality of care that every other caregiver does the same?

The world of Healthcare is far far bigger than research....

> 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?

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

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.

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

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.

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.

The problem with the devices (missing screws) leads to uncontrolled fluid amounts in IV pumps... which is dangerous.

How is this HN-related though? How did it even get on the front page?

> Please don't complain that a submission is inappropriate. If a story is spam or off-topic, flag it.

(https://news.ycombinator.com/newsguidelines.html)

A lot of us here work on medical devices. Besides that, it's just interesting to see how technology directly affects people.

Presumably someone thought it was something that 1- met the standards for submission and 2- they wanted to discuss.

Dang has a post about submission standards if you're curious. Did you have a specific reason why it shouldn't be here? I've seen articles about everything from beluga whales to jelly beans posted, not everything needs to be about an emerging framework or IPO.

Reply on news.ycombinator.com