Tuesday, May 29, 2012
There is an article at The Economist on a problem exacerbated, if not
caused, by government regulation of medicine. "Medical
Devices: A Ticking Time Bomb" begins with the following statement of the
A man with one clock knows what time it is, goes the old saw, a man with two is never sure. Imagine the confusion, then, experienced by a doctor with dozens. Julian Goldman is an anaesthetist at Massachusetts General Hospital in Boston. Like many modern health care facilities, it has become increasingly digitised and networked, with hundreds of high-tech medical devices feeding data to a centralised electronic medical record (EMR), which acts as both a permanent repository for health information and a system that can be accessed instantly by doctors to assist with clinical decisions.The article then describes how one physician encountered a timing glitch that could have led to a potentially life-threatening error on his part. The discovery caused the physician to ask how many other such errors there were.
Of over 1,700 devices checked, only 3% were found to be accurate to within three seconds. One in five were off by more than 30 minutes; one ultrasound machine was running 42 years (and some minutes) early. The average error was a staggering 24 minutes.This seems like a good news/bad news situation. With the adoption of so many new, life-saving technologies in recent years, problems are bound to come up when doctors attempt to integrate computerized equipment -- especially when some of it is older -- into centralized computer networks, right?
Perhaps, but a relatively straightforward solution to this problem has existed for decades. It is interesting to see that our omniscient government regulators have both failed to see to it that it has been implemented and will surely make fixing the problem much more difficult than it has to be now that its seriousness is coming to light:
The rub is that few of today's assorted medical devices (or wall clocks for that matter) can tap an NTP server. Regulators like America's Food and Drug Administration have never insisted that medical-device manufacturers include this feature. Adding it now would mean rewriting software, retesting devices and resubmitting them for approval. This, too, carries considerable costs.I wonder how many device manufacturers have omitted or failed to add this feature to avoid having to jump through expensive and time-consuming FDA hoops, and whether this form of "encouragement" will result in some devices being pulled from the market altogether because they will have been rendered unprofitable.
Still, they may be ones the industry will have to bear. In the United States, the Department of Health has proposed new "meaningful use" rules that would require EMR systems to include NTP technology starting from 2014. If you find yourself in need of a procedure before then, you might want to ask your surgeons to synchronise their watches and device clocks before they get cracking. [explanatory link for Network Time Protocol added]