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December 30, 1998
New Year May Affect Medical Devices
By The Associated Press
WASHINGTON (AP) -- The government is warning hospitals, emergency personnel and health care practitioners that so-called Year 2000 computer problems could affect two medical products a year early.
A Food and Drug Administration's advisory issued Tuesday said the potential problems do not pose any immediate health threat, but could create confusion and incorrect records.
The problems involve switching from the year 1998 to 1999, affecting the ability of the products to display, print or store the correct time and date of when they are in use, the FDA said.
One product, Hewlett-Packard's 43100A/43200A external defibrillator, will defibrillate properly but will print out ''set clock'' rather than the month, day, hour and minute that it is in use.
The manufacturer advises that the clock be reset to 1998 -- not 1999-- after which it will work properly for the year 1999. At the end of 1999, it will have to be reset again -- from 1998 to 2000. Approximately 39,000 of these defibrillators were sold worldwide between 1985 and 1992, the FDA said.
The second product is Invivo Research Inc.'s Millennia 3500 multiparameter patient monitor. To avoid a clock problem, the manufacturer advises health care personnel to neither test nor reset the devices on Dec. 31 or Jan. 1. The company also has software to fix the problem. More than 2,000 of these devices have been installed worldwide since June of 1996.
The FDA has been working with seven manufacturers of 15 various medical devices to investigate whether they will work in the year 2000. So far, only Invivo Research and Hewlett-Packard have verified that some problems with their clocks could occur.
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