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Alarms in medical equipment

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Re: Alarms in medical equipment

#31

Post by HeyLaughingBoy »

thomasthorpe wrote: post #14
g15jv2dp wrote: post #7

What's not clear from this webpage is whether these are actually used anywhere. Are they? I couldn't tell.

Yes, well, some. To gain certification, often something customers require, medical devices must comply with standards such as ISO60601 (hardware) ISO62304 (software) and ISO13485 (process, quality management). The alarm waveforms described are within the scope of the hardware standard guidelines, sufficiently common that application notes such as this exist. https://www.ti.com/lit/pdf/slaaec3 [ti.com]

> often something customers require

A bit more than that. Certification is required in order to put your product on the market. Whether or not customers require it is irrelevant.

Re: Alarms in medical equipment

#32

Post by davidw »

HeyLaughingBoy wrote: post #30
davidw wrote: post #11

It gives me anxiety just looking at this. Add this to the list of things I don't want to work on.

On the producing or consuming side? FWIW, I found the article interesting as I'm starting a new Oxygenator project so I'm probably about to become even more familiar with IEC60601 :-(

I don't want to work on software where bugs might cost someone their life.

Re: Alarms in medical equipment

#34

Post by ler_ »

mschuster91 wrote: post #27
blackeyeblitzar wrote: post #13

I absolutely hate the poor design of medical equipment found in hospitals. The worst thing by far is the constant beeping and noises in the room, which totally disrupts rest and hurts recovery. It is SO obvious that this hurts patients (and visitors), that I cannot believe the entire medical industry (nurses, doctors, hospital administrators, equipment makers, insurance companies) have failed to do anything about it.…

It's a necessity, a side-product of not having anywhere near enough nurses, assistant staff and doctors in hospitals. They're juggling alarms constantly (which have to blare in a cacophony) and speed from one patient to the next. Ideally you'd have a 1:1 (or better!) assignment between a single patient to a single nurse in critical care, 1:3 for patients that can't move around on their own (and thus need more assista…

Thank you for bringing that up, understaffing affects everything and harms patients. No set of alarms will ever replace the benefit of having enough people working.

Re: Alarms in medical equipment

#35

Post by blackeyeblitzar »

atahanacar wrote: post #24
blackeyeblitzar wrote: post #13

I absolutely hate the poor design of medical equipment found in hospitals. The worst thing by far is the constant beeping and noises in the room, which totally disrupts rest and hurts recovery. It is SO obvious that this hurts patients (and visitors), that I cannot believe the entire medical industry (nurses, doctors, hospital administrators, equipment makers, insurance companies) have failed to do anything about it.…

>I’ve seen nurses make mistakes several times because the equipment is too confusing. Once, I had to page the nurse myself because the IV they thought they set up was not functioning and I was able to discern that from the screen on the IV machine (which said one particular drug was not active) but they had not noticed This doesn't sound like the equipment's fault.

Technically no, but watching them debug it and configure it made me think it’s too complicated. They basically had to figure out the right sequence of buttons to hit.

Re: Alarms in medical equipment

#36

Post by pjerem »

kelnos wrote: post #18
jandrese wrote: post #9

Earlier quoted context omitted.

False positives are definitely a problem. When you read industrial accident reports one extremely common theme is some sensor that was notifying the controller of the problem, but that sensor had a history of false positives so it was disregarded. Companies that don't take false positives seriously are inherently dangerous.

> Companies that don't take false positives seriously are inherently dangerous. Alarms with incessant false positives are inherently dangerous. Sure, there's some threshold of false positives, under which we should still expect people to investigate all alarms. But above that threshold, how can we continue to blame the people involved? The hardware is at fault.

I think GP was talking about the people who don’t try to reduce false positives (by actively searching for solutions to reduce them), not the ones ignoring them because they are used to.

Re: Alarms in medical equipment

#37

Post by graypegg »

HeyLaughingBoy wrote: post #29
graypegg wrote: post #25

Earlier quoted context omitted.

I wonder how much information any 1 medical device with an alert knows though. GPWS has the benefit of being part of 1 system, where (I think, no experience here) hospitals seem to treat equipment as singular items that do 1 thing or are meant for a specific area of responsibility in an operation. Like a vitals monitor might not know what the drug pump is doing. I could imagine ventilation? arrhyth-*C-chord*-ARRHYTHM…

That's really the problem many here are describing. 60601 mandates what alarms shall be active, but it spans a single device. If you have, e.g., 10 ventilators in a room that are alarming, you can't silence them all with a single button press.

I can kind of understand why it ended up that way. There's some benefit to just assuming, nothing works together. It's at least a consistent state of affairs. You can just wheel in any heart rate monitor, and you only need to understand that heart rate monitor.

But it seems like a space that's really ripe for improving. We have very reliable simple protocols you could hook these all into. Imagine it was law that every medical device had to emit the numbers it displays on something like an ODB2 port. Something that can be visually checked to be plugged in, be unplugged and replugged with no handshake, and handle daisy chaining so in the event the "network" breaks in two, or a device goes down, you still get information from the remaining network/it can reroute.

For such a highly regulated industry... you kind of wish they would regulate. I guess status quo is also a regulation.

Re: Alarms in medical equipment

#38

Post by blackeyeblitzar »

mschuster91 wrote: post #27
blackeyeblitzar wrote: post #13

I absolutely hate the poor design of medical equipment found in hospitals. The worst thing by far is the constant beeping and noises in the room, which totally disrupts rest and hurts recovery. It is SO obvious that this hurts patients (and visitors), that I cannot believe the entire medical industry (nurses, doctors, hospital administrators, equipment makers, insurance companies) have failed to do anything about it.…

It's a necessity, a side-product of not having anywhere near enough nurses, assistant staff and doctors in hospitals. They're juggling alarms constantly (which have to blare in a cacophony) and speed from one patient to the next. Ideally you'd have a 1:1 (or better!) assignment between a single patient to a single nurse in critical care, 1:3 for patients that can't move around on their own (and thus need more assista…

I don’t disagree but I’m not sure how to make the costs of healthcare work with those ratios

Re: Alarms in medical equipment

#40

Post by dmurray »

btach wrote: post #22
LorenPechtel wrote: post #4

And how about the fact that there are simply too many of them! I was once in the recovery room with my wife. For some reason the sensor was having a very hard time reading her pulse. The normal bips would frequently fail. Too many failures in a row and the alarm would start it's EEEEEE scream we've all seen from Hollywood. It would shut up as soon as it managed to pick up a beat. Hers was definitely not the only one…

Anecdote: At an ED I used to work at, our cardiac monitors got "upgraded" to another manufacturer. Silencing false alarms was a black hole of a game of whack-a-mole. You could never silence them all, another would just pop up to spite you. Anyway, one night, it was continuing to alarm and being ignored (with a glance occasionally to make sure). Except somebody was in v-tach and the person who noticed was a medic brin…

What would have happened if the medic didn't notice and the patient died? Would you have got the blame for ignoring it, or management for creating a situation where you had no choice but to ignore some alarms because of false positives, or the manufacturer, or would it have been swept under the rug as "the patient was having heart failure and unfortunately even our state-of-the-art medical care couldn't save him"?

All of those sound superficially plausible to me, although I have my ideas on which are more likely... Would you even do an, um, incident post mortem for something like that or would it just be a statistic?

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