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Y2K bug hits medical devices

January 12, 1999
Web posted at: 1:25 p.m. EDT (1325 GMT)

by Barb Cole-Gomolski
@2000
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    (IDG) -- Health care providers are accusing medical device makers of leaving them in a potential lurch come year 2000 by failing to give them sufficient warning that their equipment could fail to function.

    The U.S. Food and Drug Administration issued a warning in the last days of 1998 that more than a dozen medical devices might not be able to accommodate the transition from Dec. 31, 1998, to Jan. 1, 1999. The devices include monitors, defibrillators and electrocardiogram recorders.

    Some manufacturers are ominously quiet.

    "We've got political posturing going on here," said Cassandra Junker, co-founder of Rx2000 Solutions Institute, a Minneapolis-based organization that acts as a clearinghouse for year 2000 information on medical devices and software. Messages from Rx2000 members citing date problems with the medical devices that were published on the organization's Web site prompted the FDA warning.

    Junker said some device manufacturers had been very frank about the problem, warning customers months ago. Others weren't.

    Long-term effect

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    Industry observers noted that the problem doesn't put patients at risk, because it doesn't interfere with the operation of the equipment. However, it could cause problems down the road. "Going forward, a lot of companies are looking to integrate medical devices with an electronic patient record," said Chris Pavik, an analyst at Aberdeen Group Inc., a research firm in Boston. "If the dates from these devices are incorrect, that could cause problems."

    According to the FDA, some manufacturers -- including Hewlett-Packard Co. and Invivo Corp. -- verified the date problem. The agency is still investigating whether other manufacturers' products have the problem and whether or not the makers will offer a fix.

    Cole-Gomolski is a Computerworld senior editor. Her E-mail address is barb_cole@cw.com.


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