Leap Year May Cause Medical Device Failures

From the WebMD Archives

Feb. 24, 2000 (Washington) -- By Feb. 29, one would think that the potential for year 2000 computer-related problems would have largely diminished for medical devices, which made a relatively smooth transition into the next millennium. But think again. Although Feb. 29 rolls around every 4 years, Feb. 29, 2000, will only take place once, and unless medical device makers accounted for this seemingly obscure factor, their devices might still be prone to date-related computer problems, the FDA now says.

The problem is that a number of computer-run medical devices are unlikely to identify the year 2000 as a leap year because they were not programmed to divide blocks of 100 by increments of four, says Tom Shope, the FDA's leading expert on Y2K issues and medical devices. "It's basically still a year 2000 glitch," he tells WebMD.

But at the same time, he says, the mere potential for further Y2K-related problems does not mean that any further complications will crop up. The FDA already made this possible glitch clear while helping medical device makers prepare for the year 2000 transition, and although the potential for further problems still exists, these problems are likely to have very simple fixes, he tells WebMD.

The most common problems probably will be related to the devices' date displays and record-keeping capabilities, predicts Shope. But as with the transition to the year 2000 in January, the FDA does not expect any serious threat to patient care, Shope says.

Regardless of the magnitude, there will be a number of events reported, according to RX2000, a nonprofit institute that maintains a database on medical devices and Y2K compliance. That database presently has more than 400 medical devices that are also not leap year compliant, Joel Ackerman, executive director of RX2000, tells WebMD.

A lot of manufacturers were aware of these potential leap year-related problems long before the transition to the year 2000, Ackerman says. But either for economic reasons or because of simple oversight, these problems did not get fixed. "I guess in many cases, it didn't make sense to make changes for a one-day problem," he tells WebMD.

Devices on the RX2000 list range from infusion pumps to ultrasounds. There are no pacemakers, defibrillators, or other implanted devices. "We will never know the true extent of the problem," Ackerman says. But the majority of problems identified do appear to affect noncritical devices, and also appear to be largely "cosmetic."

Some of these products also are no longer made or supported, says Dianne Prenbible, a spokesperson for Agilent Healthcare Group Solutions, which has the largest number of products on the RX2000 list. And those that are, she tells WebMD, require a very simple fix.

So why did the FDA raise this issue? "Well, it's just a general reminder," Shope says. "We wanted folks to know that there could be a problem."