Beat The Clock
Beat The Clock
Trust but verify. The General Accounting Office wants the Food and Drug Administration and the Veterans Health Administration to verify year 2000 readiness claims by medical device manufacturers. But both agencies are wary of GAO's advice.
Neither thinks it has the regulatory authority to review manufacturers' year 2000 test results or the technical resources to verify the test data. But GAO keeps pressing the issue. In May, FDA said it would at least consider its options for reviewing manufacturers' claims of readiness for critical-care and life-support equipment.
Joel C. Willemssen, GAO director of civilian information systems, recently answered questions about the 2000 readiness of biomedical equipment in his testimony before a joint House subcommittee. The title of Willemssen's testimony''Much Biomedical Equipment Status Information Available, Yet Concerns Remain''plainly describes the current state of affairs.
Statistical picture. FDA, with VHA participation, keeps a 2000 database of biomedical equipment information, available on the Web at www.fda.gov/cdrh/yr2000/year2000.html. More than 4,000 biomedical equipment manufacturers had submitted their data to the FDA for inclusion in the database by May.
About 60 percent of the manufacturers reported no date-dependent hardware, software or firmware that could affect accuracy or ability to operate after Jan. 1, 2000. Twenty-one percent of manufacturers with date-dependent equipment said everything was 2000-ready.
About 8 percent of the manufacturers who reported data dependencies said any problems likely would be minor ones that physicians and nurses could handle.
Of greater concern are monitoring devices that use dates to record biomedical readings of, say, a patient's blood sugar levels. If the physician or clinician did not pay close attention, a diagnosis or treatment decision could be made based on a misreading, Willemssen said.
Clinical concerns. Erroneous dates recorded and used in biomedical calculations pose another problem if undetected. Of concern are devices for calculating isotope doses in radiations, hemodialysis systems, therapeutic blood plasma exchange systems, magnetic resonance imaging systems and X-ray machines.
Unfortunately, only a small percentage of health care providers have consulted FDA's biomedical equipment database, according to several surveys. No one responding to a survey from the inspector general of the Health and Human Services Department was even aware of FDA's biomedical readiness database, Willemssen testified.
By Florence Olsen