Computers Plug and Play - Hospitals Plug and Pray

Medical mix-ups are common and deadly, but the FDA won't allow changes.

Simple, avoidable mistakes can be fatal in the high-tech world of modern hospitals.  The New York Times reports:

Thirty-five weeks pregnant, Robin Rodgers was vomiting and losing weight, so her doctor hospitalized her and ordered that she be fed through a tube until the birth of her daughter.

But in a mistake that stemmed from years of lax federal oversight of medical devices, 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.  [emphasis added]

The human blood system isn't designed to have food injected into it.  Although it probably wouldn't do all that much harm to inject food into a tube carrying urine out of the body, having food injected into her bloodstream killed Mrs. Rodgers.

Many hospital patients are hooked to clusters of clear plastic tubes carrying away their urine, putting food in the stomach, giving air to the lungs, sampling blood or putting drugs in the bloodstream.  These tubes all look alike, so it's easy to get them mixed up.  Nobody knows how many people are killed through this sort of error because such mistakes are rarely reported.

Various standards groups have been arguing since 1996 that the tubes ought at least to be made in different sizes or colors so that hospital staff would be less likely to make mistakes.  These proposals have been stalled by the medical industry and by quirks in the FDA regulations.

FDA regulations require that a new device be approved if the manufacturer can prove that it works exactly in the same way as the old one.  It doesn't matter if the old device has been shown to be unsafe, the fact that it was approved sets the standard for new devices.  Mimicking something existing is no big deal, so many different companies offer the same standard tubes.

If a manufacturer wants to make significant improvements, the approval process starts over from the beginning which adds enormously to development cost and risk.  This makes manufacturers reluctant to make improvements.

The FDA is reassessing its approval process and is considering creating a list of dangerous devices which should not be used as models for future devices, but their rules stand for the moment.

Mark E. Brager, a spokesman for AdvaMed [a California trade association of medical device manufacturers], said the agency's current device approval process "has an excellent safety record, facilitates medical innovation and has served patients well for more than 30 years." The organization fears that "proposed changes could, if implemented the wrong way, result in delaying patient access to improved medical technology."

Mr. Brager didn't bother to point out that the practice of approving devices which are modeled after existing devices retards innovation and helps keep other companies from competing with established manufacturers via new ideas.  Competition, after all, might drive down prices.

Neither the aviation industry nor the nuclear power industry tolerate situations where tubes carrying incompatible substances such as blood and food or oil and gasoline could be interconnected at all, but none of the main players in the medical industry seem to care - progress has been minimal since the issue was raised seriously in 1996.

It's Not Just Medical Tubes

To be fair, the computer industry, which is supposedly the poster child for market-driven innovation, hasn't always gotten it right either.  People who remember computers of 20 years ago will recall that the keyboard plugged in via a 1/2" round connector and there were no mice or networks.  There was only the keyboard and the power cord and you couldn't possibly get them mixed up.

When mice came along, they were treated as serial devices like printers and plugged into rectangular connectors on serial cards, again there was no possibility of plugging them in wrong.  When networks came along, the network cable always plugged into a unique connector too.

Once it was decided that all computers needed mice, the main computer board was rejiggered to have the keyboard and mouse connect directly via two little round PS-2 connectors.  They were identical in that it was physically possible to plug the keyboard into the mouse hole and vice versa, which usually wouldn't work if not damage the electronics.

Manfuacturers color-colded the connections, which helped, but isn't a complete solution when you're trying to snake cables through a dimly-lit jungle behind your desk.

The computer people finally got it right - USB keyboards and mice can plug into identical connectors and the computer figures out which is which while network, power, and the monitor have their own unique connectors.  We're finally back to where we were decades ago.

Unfortunately, medical folk can't do that - they can't redesign the blood system so that it can handle food, for example.  The medical device people will have to solve the problem the old-fashioned way and specify different sized, shaped, and colored connectors for each incompatible type of tube.

The fact that they're having difficulty doesn't necessarily mean that they're incompetent - it took the computer people a while to get their connections right - but the fact that there's been essentially no progress for 20 years shows that the players have managed to insulate themselves from accountability.

When a customer plugged the keyboard into the mouse hole and the computer wouldn't work, at a minimum, the manufacturer had to pay the cost of a call to the 800 number and if something fried, had to replace the unit.  This cost money, so they had an incentive to fix the problem as rapidly as possible.

The FDA has no incentive to change their rules any time soon because the bureaucrats are never even criticized when their rules lead to deaths.  They've got a study going, but it's taken almost 20 years and they aren't close to being able to keep tubes apart.  Like most agencies, the FDA is punished for major failures by being forced to suffer a massive budget increase.

The trial lawyers can't touch the tube manufacturers - all the tubes come with warning leaflets which tell hospital staff not to put food in the blood stream.  When utterly fatigued health care staff foul up, the hospitals can prove that they've trained them over and over not to do that, no liability there.

The situation is likely to persist for quite some time because none of the players have any reason to fix the problem.  Until Obamacare kicks in and fixes all these problems, then, you'd best be very alert whenever anyone injects anything into a tube that's connected to you.  You're the only one who really cares.

Will Offensicht is a staff writer for and an internationally published author by a different name.  Read other articles by Will Offensicht or other articles on Bureaucracy.
Reader Comments
"You're the only one who really cares."

Absent any real market competition - which does not exist in health care, energy, aviation, etc - that sentence is the crux of the matter. YOU are the only one that cares about what you buy. The vendor couldn't care less. With real market competition, the vendors start to care.
August 30, 2010 8:35 AM

Reuters says mistakes are quite common in hospitals. PAY ATTENTION!

(Reuters) - Harmful errors and accidents remain common in U.S. hospitals despite a decade of efforts to improve patient safety, a study found.

According to the study, published in the New England Journal of Medicine, the number of patients experiencing hospital acquired infections, medication errors, complications from diagnostic techniques or treatments, and other such "harms" did not change between 2002 and 2007.

Medical complications, some of which are preventable, can prove costly. The U.S. Office of the Inspector General released a report recently estimating that complications contribute to 180,000 patient deaths per year and overall, cost Medicare up to $4.4 billion annually.

A team led by Christopher Landrigan, at Brigham and Women's Hospital in Boston, looked at 2,300 patient admission records from 10 randomly selected hospitals in North Carolina.

They found 588 incidents of patient harm resulting from medical procedures, medications or other causes, with two-thirds of these complications considered preventable by researchers at the hospitals themselves.

"These harms are still very common, and there's no evidence that they're improving," said Landrigan.

"The problem is that the methods that have been best proven to improve care have not been implemented across the nation."

These methods include computerizing patient records and drug prescription orders, limiting the number of consecutive hours that residents and nurses work, and using checklists for surgical procedures, among others.

Another method is using a standardized checklist developed by Johns Hopkins to reduce bloodstream infections, with Landrigan noting that hospitals in Michigan that have used the list have kept the number of infections to nearly zero over three years.

The study found that hospital-acquired infections were one of the most common complications, but the types of harm done to patients varied widely and included falls, unintended injury during surgery, low blood pressure and low blood sugar.

Close to 85 percent were treatable and temporary, but 3 percent were permanent, 8.5 percent were deemed life-threatening, and 2.4 percent "caused or contributed to a patient's death."

While some patient care specialists said advances had been made simply by increasing hospital awareness of patient safety over the last ten years, others said more needed to be done -- and that a "cultural shift" in hospitals and other care centers was needed.

"In order to change the way we do things, we have to work effectively as teams, and to become a good team is difficult in healthcare because that's not how it's set up, that's not how we train our doctors," said Lucian Leape, a health policy analyst at Harvard University and adviser for the recent study.

But he added that patients also needed to become more pro-active, by doing things such as asking doctors to make sure they'd washed their hands or talking with doctors about drug interactions.

"Some patients are uncomfortable doing that, but asking a doctor to double check something isn't insulting them, it's just recognizing that mistakes can be made," he said.


November 25, 2010 10:16 AM

NY Times says that patient safety has not improved in a decade.

Efforts to make hospitals safer for patients are falling short, researchers report in the first large study in a decade to analyze harm from medical care and to track it over time.

The study, conducted from 2002 to 2007 in 10 North Carolina hospitals, found that harm to patients was common and that the number of incidents did not decrease over time. The most common problems were complications from procedures or drugs and hospital-acquired infections.

“It is unlikely that other regions of the country have fared better,” said Dr. Christopher P. Landrigan, the lead author of the study and an assistant professor at Harvard Medical School. The study is being published on Thursday in The New England Journal of Medicine.

It is one of the most rigorous efforts to collect data about patient safety since a landmark report in 1999 found that medical mistakes caused as many as 98,000 deaths and more than one million injuries a year in the United States. That report, by the Institute of Medicine, an independent group that advises the government on health matters, led to a national movement to reduce errors and make hospital stays less hazardous to patients’ health.

Among the preventable problems that Dr. Landrigan’s team identified were severe bleeding during an operation, serious breathing trouble caused by a procedure that was performed incorrectly, a fall that dislocated a patient’s hip and damaged a nerve, and vaginal cuts caused by a vacuum device used to help deliver a baby.

Dr. Landrigan’s team focused on North Carolina because its hospitals, compared with those in most states, have been more involved in programs to improve patient safety.

But instead of improvements, the researchers found a high rate of problems. About 18 percent of patients were harmed by medical care, some more than once, and 63.1 percent of the injuries were judged to be preventable. Most of the problems were temporary and treatable, but some were serious, and a few — 2.4 percent — caused or contributed to a patient’s death, the study found.

The findings were a disappointment but not a surprise, Dr. Landrigan said. Many of the problems were caused by the hospitals’ failure to use measures that had been proved to avert mistakes and to prevent infections from devices like urinary catheters, ventilators and lines inserted into veins and arteries.

“Until there is a more coordinated effort to implement those strategies proven beneficial, I think that progress in patient safety will be very slow,” he said.

An expert on hospital safety who was not associated with the study said the findings were a warning for the patient-safety movement. “We need to do more, and to do it more quickly,” said the expert, Dr. Robert M. Wachter, the chief of hospital medicine at the University of California, San Francisco.

A recent government report found similar results, saying that in October 2008, 13.5 percent of Medicare beneficiaries — 134,000 patients — experienced “adverse events” during hospital stays. The report said the extra treatment required as a result of the injuries could cost Medicare several billion dollars a year. And in 1.5 percent of the patients — 15,000 in the month studied — medical mistakes contributed to their deaths. That report, issued this month by the inspector general of the Department of Health and Human Services, was based on a sample of Medicare records from patients discharged from hospitals.

Dr. Landrigan’s study reviewed the records of 2,341 patients admitted to 10 hospitals — in both urban and rural areas and involving large and small medical centers. (The hospitals were not named.) The researchers used a “trigger tool,” a list of 54 red flags that indicated something could have gone wrong.

November 26, 2010 5:20 PM

Device makers say FDA is too tough.

Medical Treatment, Out of Reach
Medical device executives say regulation by the Food and Drug Administration has hurt the industry domestically.

It's government - they're probably merely incompetent. Both too lax and too severe at the same time.

Late last year, Biosensors International, a medical device company, shut down its operation in Southern California, which had once housed 90 people, including the company’s top executives and researchers.

The reason, executives say, was that it would take too long to get its new cardiac stent approved by the Food and Drug Administration.

“It’s available all over the world, including Mexico and Canada, but not in the United States,” said the chief executive, Jeffrey B. Jump, an American who runs the company from Switzerland. “We decided, let’s spend our money in China, Brazil, India, Europe.”

Medical device industry executives and investors are complaining vociferously these days that the industry’s competitive edge in the United States and overseas is being jeopardized by a heightened regulatory scrutiny.

The F.D.A., they and others say, appears to be reacting to criticism that its approvals for some products had been lax, leading to a spate of recalls of some unsafe medical devices, like implanted defibrillators and hip replacements.

Now, executives of device companies say the F.D.A. has gone too far in flexing its regulatory muscle, and they worry that a slower, tougher approval process in a weakened economy could chill investments and cripple innovation.

In addition, they say that American patients are being deprived of the latest technology because companies routinely seek approval for new devices in Europe first. For instance, heart valves that can be installed through a catheter instead of open-heart surgery have been available in Europe since 2007 but will not be available in the United States until late this year at the earliest.

February 10, 2011 7:26 PM
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