Where interoperability can kill

November 7, 2022 9:08 PM

Examples of Medical Device Misconnections (FDA) Patients may require dozens of different devices at once. [...] Because these connectors are easy to use and may be compatible with different medical devices, users can mistakenly connect unrelated systems to one another.
posted by meowzilla (29 comments total)

Yeeowch. Those examples were tough to read. The universality of the Luer-lock connector definitely seems like an issue. It's really good at what it does but the nonspecificity clearly is a problem. Seems like you could design some sort of plastic cuffs that fit around the connector that preserve the functionality of the Luer-lock, but only allow it to mate with a connector with a complementary cuff. Glad the FDA has identified the problem and is prioritizing solutions.
posted by biogeo at 10:14 PM on November 7, 2022 [2 favorites]

To be fair, Foley catheter erroneously connected to NG tube is a feature of the Stillsuit (and fully endorsed by Bear Grylls).
posted by a non e mouse at 10:26 PM on November 7, 2022 [6 favorites]

Fascinating and terrifying.

Almost all are "High" risk of patient harm. Roughly 75% of these cases died. Most common cause of death seems to be air embolism, which can occur with only a couple seconds of wrong connection. Second most was perhaps fluid in lungs. Some mis-connections were by family members trying to be helpful – tragic.

Recommendations included to manufacturers to make these mis-connections impossible, to label things, to create routines of checking, policies to reduce staff fatigue, and to educate patient families. It's such a complex picture. I'd imagine that, even if manufacturers begin to change things (itself a big challenge), previous equipment will be around for a long time.

This appears to be an excellent educational tool, and is certainly memorable.
posted by lookoutbelow at 10:54 PM on November 7, 2022

Cool, another thing to worry about the next time I'm in a hospital.
posted by wakannai at 2:55 AM on November 8, 2022 [9 favorites]

Some mis-connections were by family members trying to be helpful – tragic

I think they buried the lede with that one, just like the buried the lede with the other example of the nurse making a mistake while on a double-shift.

There are so many things that family members end up doing because summoning a nurse to the room can be a 40 minute wait. Did the patient roll over for the tenth time today and momentarily cause the IV line to kink setting off an alarm on the dispenser/pump? You can either hit the call button and wait for a nurse to come in and press the "clear alarm" button on the IV pump to cease the beeping, or you can just hit that button yourself. The same scenario plays out with dozens of similar "annoyances" that are too urgent/recurring to bother waiting for the nurse and it's a wonder that this sort of tragic mistake doesn't happen more often.

Incompatible connectors will save lives, but so will additional nurses on staff.
posted by RonButNotStupid at 4:35 AM on November 8, 2022 [27 favorites]

Incompatible connectors will save lives, but so will additional nurses on staff.

"The Boeing company did a study about 25 years ago that indicated that as the world began to fly more - as the worldwide airline fleets increased - if we didn't decrease the accident rate, we would soon get to a point where the
absolute number of accidents was going to become untenable. They predicted into the future we would reach a point where we would lose an airliner a week around the world.

You probably know in healthcare right now, including hospital and health care acquired conditions and errors, 200,000 lives are lost in this country alone every year. That's 20 jumbo jets a week crashing with no survivors.

I can tell you in my domain, if that were to happen, what our reaction would be. About the second or third day we would do what we did on september 11, 2001: there'd be a nationwide ground stop. Fleets would be grounded, airlines would shut down, airports would close. No one would push off at the gate until we'd solve the problems. There'd be a Presidential commission, Congressional hearings, the NTSB would investigate. There'd be a joint government-industry task force similar to what we have had as the Commercial Aviation Safety Team since the mid 90s.

Why? Because airline accidents are relatively rare, they involve many people at once, they're dramatic, they're noteworthy... they're newsworthy. We have achieved what we always must achieve in any democracy: prompt action, public awareness, and the political will to change.

What would it take, what is it taking, in your domain? Where the the deaths are one or two at a time more or less hidden from view, thought of by some - perhaps by many- as an unavoidable consequence of care? What if we changed our point of view, as many of you no doubt already have. What if we began to think of these
deaths not as unavoidable, and thought of them instead as inexcusable?"

posted by mhoye at 6:03 AM on November 8, 2022 [27 favorites]

I've done a little bit of sailing over the years, and have become fascinated by the functional design of maritime markers. (This is relevant I promise, stick with me.) Markers are often in the form of buoys to denote channels of deep water, hazards, etc. The thing that has always struck me about them, is that each particular type has several layers of redundancy. They will be a specific color, also a distinct shape, likely will make some sort of noise, and sometimes will light up or flash. This makes it VERY difficult to mistake one for the other, in a wide variety of conditions.

Here we come back to the topic at hand: WHY IS IT EVEN POSSIBLE TO CONNECT A TRACH TUBE TO AN IV LINE?!?!

I am amazed that these connectors don't have text labels, distinct colors, distinct shapes, and some sort of physical incompatibility between different lines.

I am extremely surprised (and horrified frankly) that it is physically possible to attack an oxygen line to an IV. One connector should be round and the other square. Right? am I off base here?
posted by TheCoug at 6:38 AM on November 8, 2022 [9 favorites]

Commodity components lead to entirely too many unmarked connectors - many of them disposable and needed for different types of connections - that can be reassembled into all sorts of physically compatible but ENTIRELY WRONG ways. Some of this might be able to be reduced by some industry standard markings, but I feel like that might introduce new risks.
posted by rmd1023 at 6:40 AM on November 8, 2022

My paranoid theory is that it's hard to get licensing for a new connector, so there aren't as many types of connector as there might be.

rmd1023's theory is also plausible.
posted by Nancy Lebovitz at 6:42 AM on November 8, 2022

There's enough manufacturing shortages in healthcare supplies. We were short of salt water (ahem, saline) for a year. Making each IV a different color won't help. It's staffing and patient severity. People are sicker and alive each year, alive with things that would have been their cause of death previously.
(That said I've never seen a trach that could be interchanged with anything else, the diameter is vastly different.)
posted by cobaltnine at 7:19 AM on November 8, 2022

My paranoid theory is that it's hard to get licensing for a new connector, so there aren't as many types of connector as there might be.

I work in the medical electronics industry, and believe me we have no problem ramming some bizarro connector through FDA. Our company also makes OEM tubeset products and conversations with those folks leads me to believe that the more specialized a tube product is the more they like it because it let's them have better customer lock-in
posted by Dr. Twist at 7:48 AM on November 8, 2022 [4 favorites]

>We were short of salt water (ahem, saline) for a year.

It's not like we didn't have manufacturing capacity available to make saline, it's just insanely expensive to meet FDA cGMP requirements. If we could accept EU standards we wouldn't have that problem.

Changing connectors will pose many challenges but manufacturing will be the least of them.

> I am extremely surprised (and horrified frankly) that it is physically possible to attack an oxygen line to an IV.

It more or less isn't possible, the connectors are very different shapes and sizes, but human ingenuity should not be underestimated.
posted by Easy problem of consciousness at 7:55 AM on November 8, 2022 [1 favorite]

Trach tubes have an inflatable cuff to allow an airtight seal to protect the patient's lungs if they're anesthetized/can't protect their airway (ie whatever is causing them to need intubation in the 1st place).

I'll second staffing as the real issue here.

I work in a different industry, and while engineering solutions to many problems are the most reliable (well documented and intensively researched by osha among others in the us and worldwide), healthcare has too many constantly changing, highly specific scenarios with zebras to spice things up, that well-trained, well-supported, well-rested staff are yhe solution to more problems than are addressed in this article.

Leuer locks and engineering problems are easier to research and document than the death by a thousand cuts that is understaffing.

Let's believe the health care workers leaving the field in droves (and unionizing!!) that staffing is a massive issue.
posted by esoteric things at 7:58 AM on November 8, 2022 [7 favorites]

Ok just figured out how to do it. You push the luer lock mechanism back from the iv tip, then you can jam the remaining portion of the iv tubing end into the oxygen tubing intake, just takes a little extra force. Must be what the family did... I don't think I could reverse the connection to blow oxygen into iv tubing without misusing at least two extra connectors
posted by Easy problem of consciousness at 8:03 AM on November 8, 2022

I am extremely surprised (and horrified frankly) that it is physically possible to attack an oxygen line to an IV.

I once filled my car's gas tank with diesel, something that required a heady mixture of ignorance, ingenuity, exhaustion, and persistent effort to accomplish. The sheer incompatibility of a typical diesel nozzle with a typical gasoline tank opening at least means far fewer people stumble into that particular brand of foolishness than might otherwise. For stuff that's not as mild and "POTENTIAL FOR HARM: LOW" as having to call a mechanic on a Sunday night to pump out your tank, seems like a good idea to not settle merely for idiot-proof and aim for more active and redundant countermeasures, yeah.
posted by cortex at 8:40 AM on November 8, 2022 [7 favorites]

cortex, are you the reason there's no self-service gas pumps in Oregon?
posted by biogeo at 9:03 AM on November 8, 2022 [11 favorites]

The oxygen tubing / IV port misconnection is a little hard to make out in the image they show reconstructing the mistake, but it looks like there may be tape involved. The narrative of the failure for that one indicates that the error was committed by a staff member at the end of a double shift, so understaffing is clearly a major contributing factor there. However, if the staff member jury-rigged a connection with tape, that also has to be a training issue compounded by the overwork issue; the incompatibility of the connectors should have been a clear sign that something was wrong. And if people are going to try jury-rigging incompatible connectors together with tape, no connector redesign is going to fix that problem. I agree with others: while design choices unambiguously guiding users to the right actions is good, the most important change is to ensure that patients are being treated by well-rested, well-trained, and readily-available staff, which is something our medical system is currently failing at badly.
posted by biogeo at 9:21 AM on November 8, 2022 [2 favorites]

This is why it's absolutely terrifying to be paralyzed and using a cuffed trach so you can't talk! I had to stop people from doing stupid things that might have harmed me with my facial expressions alone.

Whenever I have to direct someone to connect two things together without being able to watch them do it, I label the two pieces with colored tape. Much easier to direct someone to "plug the yellow cable into the yellow charger" than have someone guess which battery charger I'm talking about.
posted by Soliloquy at 9:22 AM on November 8, 2022 [11 favorites]

One person I know had to stop a nurse's aide from putting his g-tube feeding pump on his trach.
posted by Soliloquy at 9:34 AM on November 8, 2022 [3 favorites]

You often see "Maraíonn Tuirse Tiredness Kills" signs on Irish motorways. It bemuses me that there are strict regulations about Rest in the transport business for pilots and freight drivers while it is still routine in healthcare that professionals are on shift for more than eight hours and still expected to make instant life-critical decisions. Wes Ely, ICU consultant in Nashville, in his book Every Deep-drawn Breath is implicitly arguing that US health-care would be more fit for purpose if money was diverted from tech to salary: carers rather than monitors.
posted by BobTheScientist at 10:07 AM on November 8, 2022 [6 favorites]

cortex, are you the reason there's no self-service gas pumps in Oregon?

It's definitely worth contextualizing this story that I was southbound from Vancouver, BC when this happened, yeah.
posted by cortex at 10:25 AM on November 8, 2022 [4 favorites]

I spent an interesting afternoon in a hundred-year-old chem lab once

1) looking for the pressure tank top/attachment/valve for a particular gas

2) finding, deep in the closets, tops that predated the vital idea of having them be gas-specific.

AFAIK the tanks haven’t changed and we *could* have used them. Tricky for the medical instance - how do you improve safety without making working equipment obsolete? I guess you make universal-to-new-port bits that get stuck on once.
posted by clew at 10:34 AM on November 8, 2022

cortex: "I once filled my car's gas tank with diesel"

One of my college buddies did this. We still tease him about it.

The bigger picture here is that this medical device interoperability problem has a solution here in the good ol' US of A. We just make healthcare so goddamn expensive that getting your IV and catheter lines mixed is a rich person's problem! The rest of us proles, we just die of entirely preventable causes at home.
posted by caution live frogs at 10:37 AM on November 8, 2022 [1 favorite]

And if people are going to try jury-rigging incompatible connectors together with tape, no connector redesign is going to fix that problem.

Never underestimate the persistence and ingenuity of someone desperate to get everything wrapped up so they can go home to bed.
posted by RonButNotStupid at 12:48 PM on November 8, 2022 [4 favorites]

I've fried a few components by mixing up interoperable connectors on electric bicycles. (Yes, usually when tired and in a hurry.) The notion that the same thing can and does happen with medical equipment is terrifying.
posted by sibilatorix at 1:04 PM on November 8, 2022 [1 favorite]

This reminded me of a case where where an operating theatre's gas pipes were mislabelled, leading to a bungle that went undetected during installation work and as a result

"[witness] told an inquest there was no chance of a newborn surviving a rare gas mix-up at a Sydney hospital after he was administered nitrous oxide instead of oxygen for nearly an hour"
posted by chariot pulled by cassowaries at 1:09 PM on November 8, 2022

on shift for more than eight hours

At my hospital we call eight hour shifts "princess shifts" because only working for eight hours is a luxury.
posted by jesourie at 1:39 PM on November 8, 2022 [5 favorites]

I once filled my car's gas tank with diesel, something that required a heady mixture of ignorance, ingenuity, exhaustion, and persistent effort to accomplish. The sheer incompatibility of a typical diesel nozzle with a typical gasoline tank opening at least means far fewer people stumble into that particular brand of foolishness than might otherwise.
On the other hand, filling a diesel-powered vehicle with petrol is laughably easy, as I discovered in the wee hours of the morning on a lonely highway nowhere near anything.

This is a rare situation where people are both the problem (too few, too tired for safety) and the solution. Making connectors different won't solve the problem of human ingenuity and stubbornness.
posted by dg at 5:53 PM on November 8, 2022

Medical devices have a surprising, fairly recent history of dysfunction: bad surgical mesh; improperly sterilized and hard to sterilize colonoscopy instruments; deteriorating and dangerous polyurethane in CPAPs; leaky silicone bag breast implants and textured implants that cause cancer; hip and knee replacements that wear out rapidly or develop pathogenic biofilms; pacemaker recalls; and in the old days there were terrible quality control problems with the Dalkon Shield and other IUDs.
posted by jamjam at 5:58 PM on November 8, 2022