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FDA issues early alert for Baxter's Spectrum infusion pump

pfisherman

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.

iancmceachern

They do for implants

pfisherman

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.

jampekka

> 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?

iancmceachern

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?

iancmceachern

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.

fragmede

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

TechDebtDevin

That seems crazy

pfisherman

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.

franktankbank

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

slowmovintarget

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

BurnGpuBurn

[flagged]

kelnos

> Please don't complain about tangential annoyances—e.g. article or website formats, name collisions, or back-button breakage. They're too common to be interesting.

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

dylan604

There should be a special place in hell for devs that do this. Trying to rank it in dev hell for ad tech/tracking devs and user hostile JS devs, and I think they are just two ballrooms on the same floor

sidewndr46

I wish I had been on the committee when this change the browser API was proposed. I would obviously gotten kicked out for asking "just what the hell do you think people are going to do with this?". But at least I'd be somewhat infamous for asking the question when seemingly no one else was willing to.

the_sleaze_

I used it once for an SPA doing highly dynamic user surveys, users really wanted the back button to push them one question back, and depending on the path through the question graph back wasn't always "back".

varikin

Equating a frustrating anti-pattern of websites with medical equipment failure is extremely disingenuous. An infusion pump failure can harm a person, and according to the article, has seriously injured at least on person. Hijacking the back button isn't going to physically harm someone.

TheRealPomax

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

null

[deleted]

kelnos

> 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)

HeyLaughingBoy

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

moate

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.