FDA warning: Computer glitches may happen now

The U.S. Food and Drug Administration (FDA) is warning hospitals, emergency medical services, and health care practitioners that computer glitches similar to the much-feared Y2K problem already are affecting some medical devices.

In a recent notice, the FDA cautioned that 15 instruments from seven manufacturers of medical devices would not work correctly after Dec. 31, 1998. The FDA has worked with all seven manufacturers of these 15 devices to investigate the problem, and manufacturers of two of the devices have verified that some aspects of the problems can happen. But the remaining manufacturers have reported that the other devices should have experienced no difficulty in the transition from 1998 to 1999. Some of those products, however, may have problems next year moving from 1999 to 2000.

The good news is that the two products with verified problems will work properly in direct use, so there should be no immediate threat to patient safety. The problems relate to the ability of the device to display, print, or store the correct time and date of the device’s operation. The FDA cautions that while these types of failure do not present an immediate risk to the patient, they do present a potential for confusion and incorrect records.

Defibrillator prints out set clock’

One of the products is the Hewlett-Packard 43100A/43200A external defibrillator. The device will defibrillate properly but will print out "set clock" rather than the month, day, hour, and minute on the paper event record. On trying to reset the clock, the cathode-ray tube will display a 1985 date.

The manufacturer advises it should be reset to 1998 (not 1999), after which the unit will work properly for the year 1999 (because the event record does not print the year, only the month, day, etc.). At the end of 1999, it will need to be reset again, from 1998 to the year 2000, after which it should work properly. A total of 39,000 of these defibrillators were sold worldwide between 1985 and 1992.

End of millennium confuses patient monitor

The second product, Invivo Research’s Millennia 3500 multiparameter patient monitor, has a potential New Year’s Eve problem for every year including 1998-1999. For products manufactured before December 1998, if the display clock is tested or reset as the year turns over, then the display and internal clocks become asynchronous until the product is powered down and restarted. The display clock and paper record then can show different times and dates.

The manufacturer advises the problem will not occur if you did not test or reset the clock on Dec. 31-Jan. 1. Invivo has a software upgrade to fix the problem, which it makes available to Invivo customers. This system has been sold since June 1996 and more than 2,000 are installed worldwide.

Because these "year 1999" problems exist in two products, there may be other devices with similar but unidentified problems. Hospitals and other health care facilities should be aware that these types of problems may occur, the FDA says. Providers should be alert to the date display, printing of date or device permanent records, and date recording features of medical devices after Jan. 1, 1999. Hospitals and health care facilities also should be alert for other possible date-related problems that may manifest in unexpected ways, the FDA says.