In one of the most disturbing reports to date on the Year 2000 problem, the General Accounting Office has concluded that the millennium bug poses a potential threat to patients using biomedical devices, such as pacemakers.
"I would encourage users of biomedical devices to check up on the status of their equipment," said Helen Lew, assistant director of the GAO's accounting and managment division, and a principal author of the report. "There is a risk to patient safety because we haven't heard from all of the manufacturers."
Some biomedical equipment -- such as magnetic image resonance systems, cardiac defibrillators, and pacemakers -- might rely on computers or embedded computer chips for calibration or day-to-day operation.
The controlling software may be susceptible to the Y2K bug if the equipment relies on any type of date or time calculation.
"Veterans and the general public should have confidence that on January 1, 2000, those devices with date-sensitive functions are going to work right," said Representative Terry Everett (R-Alabama), who requested the GAO report.
The report was the focus of a 24 September hearing by the House Veterans' Affairs Oversight and Investigations Committee, which Everett chairs.
The report praised the Veterans Health Administration's progress in implementing a Y2K strategy but was distressed by the medical industry's failure to disclose information crucial to helping hospitals root out vulnerable equipment.
As of 29 July, the administration had received information on biomedical equipment from 73 percent of the nation's 1,409 manufacturers. Forty-seven percent of the suppliers reported that their products were not susceptible to the millennium bug.
The Food and Drug Administration also mailed a survey to 16,000 medical equipment suppliers. Only 12 percent responded.
Jose Garcia, clinical engineer at the San Francisco VA Medical Center expressed concern about the low rate of compliance. He said the hospital was busily assessing the problem.
"We're hoping that we don't have to inform patients," said Garcia. "To scare them at this time would be inappropriate."
The head of the VHA's technology division downplayed the risks to patient safety posed by Y2K errors in patient records. However, he warned that date screwups could wreak havoc if physicians and nurses fail to pay close attention to critical patient data, such as blood-sugar levels.
"It can be worked around provided that everybody gets busy," said David Hall, embedded systems specialist with the Cara Corporation. "But I don't see people in every hospital doing the job."
The General Accounting Office raised a red flag on other more potentially harmful risks.
For instance, one manufacturer reported that an error in a device used to deliver radiation treatment could generate an incorrect dosage. The VHA identified three facilities using the equipment and plans to replace it.
To ensure equipment safety, the GAO recommended creating an independent service to verify test results submitted by manufacturers. However, the Department of Health and Human Services said it had neither the resources nor the time to do that.
VHA officials are reluctant to perform their own tests for fear that they'd be exposing themselves to legal liability if the equipment subsequently failed.
In its most recent quarterly report to the Office of Management and Budget, the VHA estimated the cost of replacing or repairing buggy medical equipment at US$40 million. They expect the figure to rise as more manufacturers disclose their progress on battling the bug.
Finally, the GAO endorsed the VHA's plan to make compliance information available to the public on the Web. Although the information isn't online yet, the FDA currently publishes a database on the Year 2000 status of biomedical devices used in the United States.
