A number of readers emailed me a link to this New York Times article: “U.S. Inaction Lets Look-Alike Tubes Kill Patients.” The headline emphasizes the lack of governmental oversight, but I'd rather talk about the poor system design that allows deadly errors to occur.
The article describes an error where food was mistakenly injected into her veins:
… the hospital mixed up the tubes. Instead of snaking a tube through Ms. Rodgers's nose and into her stomach, the nurse instead coupled the liquid-food bag to a tube that entered a vein.
Putting such food directly into the bloodstream is like pouring concrete down a drain. Ms. Rodgers was soon in agony.
So is this a one time fluke? It seems not:
Their deaths were among hundreds of deaths or serious injuries that researchers have traced to tube mix-ups. But no one knows the real toll, because this kind of mistake, like medication errors in general, is rarely reported. A 2006 survey of hospitals found that 16 percent had experienced a feeding tube mix-up.
Why are errors rarely reported? That's a topic for a different post. I think the question here is why there's such a risk of systemic mixup.
Hospitalized patients often have an array of clear plastic tubing sticking out of their bodies to deliver or extract medicine, nutrition, fluids, gases or blood to veins, arteries, stomachs, skin, lungs or bladders.
Much of the tubing is interchangeable, and with nurses connecting and disconnecting dozens each day, mix-ups happen — sometimes with deadly consequences.
Interchangeable, identical looking clear tubing – that's a mistake just waiting to happen, isn't it?
I saw, last week, a presentation about a chemical factory that had made huge strides in improving worker safety. One of the risk factors the engineers identified is that the pipes through the factory were all gray — somebody's idea of aesthetics. But, in an emergency, not having pipes clearly labeled could be deadly.
So if this is fixable in a chemical factory, why not in our hospitals?
It's not a new idea that there are systemic risks. Again, from the article:
Experts and standards groups have advocated since 1996 that tubes for different functions be made incompatible — just as different nozzles at gas stations prevent drivers from using the wrong fuel.
But action has been delayed by resistance from the medical-device industry and an approval process at the Food and Drug Administration that can discourage safety-related changes.
It's often said that it takes 19 years for a change to make its way from idea to widespread implementation in healthcare. So we have a few more years left on that clock…
If it's far too easy to mistake a food line for an intravenous line, can't we fix that today? Isn't there an opportunity for simple labeling and visual controls? Do we really need to let the FDA get in the way of this? I'm asking a question I don't completely know the answer to  — what do the clinical readers have to say?
One paragraph in the article that I agree strongly with is this:
“Nurses should not have to work in an environment where it is even possible to make that kind of mistake,” said Nancy Pratt, a senior vice president at Sharp HealthCare in San Diego who is a vocal advocate for changing the system. “The nuclear power and airline industries would never tolerate a situation where a simple misconnection could lead to a death.”
So when a systemic mistake occurs (one that's predictable), what happens? Often, a person gets blamed — and the article brings up the case of a nurse, Julie Thao, who was convicted after a fatal error (and I blogged about it a number of times over the fast few years).
The article talks a lot about failed legislative attempts and failed regulatory efforts — so my question (and there may be a good answer) is why hospitals don't each individually fix this tomorrow?? If we can't change the equipment, how can we change the process to avoid the error? Does the FDA really get in the way?
It's a shame we have this dynamic:
“The regulators have been waiting for the manufacturers to come up with a solution,” Ms. Pratt said, “and the manufacturers won't spend the money to design and produce something different until the regulators force them to. And now the international standards organization is taking forever to get the whole world onto the same page.”
Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association, agreed, “These things are hard to change when you have to get so many different organizations to act in concert.”
I guess that makes it much more complicated than a chemical factory, which is also regulated? People are dying, unnecessarily, during this delay. How can we avoid this suffering?
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I heard a story about a facility that does Electro-Chemical Milling having a burst pipe. The engineering who finally rallied the crew to start shutting *all* the valves had been an officer on a nuclear submarine earlier in his career. A few weeks after the incident when I visited the piping had been painted different colors and each valve had a very clear placard indicating what it’s used for. Simple error proofing steps.
I’m surprised that even the FDA could stand in the way of a simple color change in the tubing, but bureaucracies are easily underestimated.
Mark,
We don’t see the problem as a system and we don’t solve it as a system. The knowledge and advice to address it has been available for years. Chapter 10 of Out of the Crisis (W.E. Deming) shows us the way. I especially like the remarks quoted by William Ouchi on page 307.
Mike
Thanks, Mike – here is a link to that page of Out of the Crisis in Google Books (if this works….)
Page 307
Mark,
Value Stream thinking with the customer as the focus – this isn’t new or revolutionary. In healthcare, we seem to be too busy looking for the next “great” solution to reign down from on high instead of solving the right problems, right now, with the right people, and for the right reasons – because the solution will improve safety, quality and efficacy of care for the patients and their care givers
The problem appears to be a lack of focus, will and ownership; not a problem of an issue that is too difficult to solve.
Well said, Shana!
The problem is that changes are not born out of industry, but rather through bureaucracy. There is a market need for this type of error proofing and the government apparently seems content to stand in the way of consumer safety and satisfaction of a job well done, i.e., not killing the patient over a mistake.
If the regulation on the types of devices used to couple liquids to patients were lifted and/or eased for the purposes of market regulation, the deaths would approach zero by the end of the next reporting cycle.
At the level of the actual devices in question, the answer seems obvious to us all: poka yoke solutions abound, real ones that fit Dr. Shingo’s criteria (hope I’ve got these right!): cheap, 100% inspection, providing immediate feedback. The world of connectors is loaded with them.
So, it is clear that lack of an obvious solution at the level of the device isn’t the root cause, however frustrating that may be to the “just do it” lean thinkers in the crowd. Here’s a place where medicine and manufacturing diverge to some extent. It doesn’t mean lean doesn’t work. We just have to do real problem solving and not always expect to apply familiar tools. Some problems are social at root, not technical.
Is it bureaucratic impediment to improvement and change in medical devices? The legal protection provided by regulatory approval of a device? Without some kind of protection, where would this story be? Let’s say (just for example) that these were accelerator pedals…
An important consideration is who loses in these scenarios and who would pay for a poka yoke solution, with all the costs of device testing and approval, however cheap it may be at the level of manufacturing. They aren’t the same people and the system of payment and liability in healthcare isolates them, one from the other. A really good, succinct (and disturbing, from this layman’s perspective) cut into this comes in the May 7, 2009 podcast from AHRQ WebM&M Perspectives, interview with William B. Weeks, MD, MBA. (available from iTunes store, podcasts: ‘AHRQ WebM&M Perspectives’, or from their website: http://webmm.ahrq.gov/ ).
Steve Spear also has a really good interview in this series with the same date – listen to them both if you download the wrong one by mistake! The whole series is a “must listen” for followers of this blog, if I may be so bold, whether the are specifically interested in healthcare lean (we all should be!) or not.
You are right. We can’t just let this continued failure persist. Unfortunately management practices fail to adopt good ideas for decades frequently. But we have to find ways to improve this, everywhere hopefully, but at least for life threatening failures.
I don’t think the answers are simple tools. I think it is the change in attitude that is most important. Adopting simple problem solving, mistake proofing, process improvement, pdsa… is really not hard. Getting people to be willing to do those things seems to be hard – given how many organizations don’t.
One root cause solution is to apply a straightforward pokayoke approach in the product/process design phase.
Each tube should be a different diameter, different color, and possibly even a different shape (why do all tubes have to be round?). An alternative to different shape is to add different textures to the outside of the tube.
One design goal should be to engage the operator on multiple levels — not just with visual work instructions and warning sign reminders, which can be ignored.
The physical appearance and tactile feel of the tubes can be differentiated to engage all the operator’s senses, and make it impossible to make a mistake.
Imagine a darkened ICU room where the tubes are being changed without much ambient light. The differently-shaped tubes with added texture make it possible for the operator to change feeding bags or other IV drips with their eyes closed.
Too often, design pokayokes make it difficult for the operator to do their job, adding extra steps, self-checks, and obstacles. Design pokayokes should make it easier to do the job, but impossible to make a mistake.
Most Nurses work long hours and there are usually about 5 nurses per one patient within 24 hour period. A lot of times they have trouble keeping track of given medications,. There definitely needs to be some kind of regulations to protect people. Medical industry is so bureaucratic and so barred in paperwork that it might take years for any type of legislation to pass in senate. We actually make laser marking machines that could potentially mark even a single tablet in order to keep track. Tablets, medications, surgical equipment, etc. could be marked with a 2D Matrix in order to keep track of medications. Especially during shift change. Thanks for a great article.
Maybe this error proofing (color coding) would have helped?
http://mmpp.wikispaces.com/ColorSafeIVLines
Poka yoke devices as solutions here are so obvious and available that there simply MUST be another “why” (root cause) that prevents their deployment. I think we need to dig deeper into the social/financial/regulatory issues surrounding errors associated with regulated medical devices if we want to really understand this situation.
http://www.colorsafeivlines.com
The medical errors resulting in death to infants similarly occurs in neonatal intensive care units. There is a company named NeoChild that just got a patent on incompatible and color-coded infant feeding tubes to reduce these types of medical errors and save babies’ lives. visit http://www.neochild.com to find out more or order samples.