Close window | View original article
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.
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.