Healthcare has fallen far behind in correcting millennium-date problems with medical devices, and patients will suffer unless manufacturers step up disclosures about their products, a coalition of provider groups said last week.
The coalition, led by the Department of Veterans Affairs, called on the nation's medical equipment manufacturers to tell customers and the public how prepared their products are to handle dates past Dec. 31, 1999.
That's when the trouble starts for date-related programming unable to recognize the year 2000 and beyond.
With 18 months left and tens of thousands of medical devices in use, the sheer number of manufacturers and products "makes it impossible for any entity to do the testing," said Kenneth Kizer, M.D., the VA's undersecretary for health. "We must rely on the manufacturer."
But in nearly a year of concerted efforts to contact more than 1,600 medical equipment makers, the VA has found too many of them either mum or mumbling about the millennium status of their products.
According to the VA, nearly a third of the manufacturers of devices used by the agency could not be reached, wouldn't respond or said they no longer service their product and therefore would not address the year-2000 problem (See chart).
The coalition, called the National Patient Safety Partnership, wants device manufacturers to make information about their products available to customers and the public no later than Jan. 31, 1999. The information should include advice and assistance to understand risks and the level of year-2000 compliance, the coalition said.
It also called for the establishment of a national clearinghouse for information on problems with medical devices used in hospitals and homes. The information should be accessible to the public and the healthcare industry, the coalition said. But asked who would run the clearinghouse, Kizer said only that it's "a topic of ongoing discussion."
Members of the group also have yet to address the database's operation or funding, added Don Nielsen, M.D., senior vice president for quality leadership with the American Hospital Association, a coalition member.
Other members include the American Medical Association, the American Nurses Association, the Association of American Medical Colleges and the Joint Commission on Accreditation of Healthcare Organizations.
The healthcare industry depends on electronic medical devices controlled by microprocessors with embedded programs governing dates and times.
But because references to years are often kept as the last two digits of a date in the 1900s, medical devices could stop calculating dates, compute them inaccurately or even shut down, said Paul Schyve, M.D., senior vice president of the JCAHO.
Hooked up to patients, the devices could determine a wrong dose of radiation or compile serial tests out of sequence, leading to misdiagnosis based on a faulty trend analysis, Schyve said. Or a device such as an infusion pump might no longer be internally prompted about essential maintenance and recalibration of settings, he said.
"We believe this problem is 100% preventable," Kizer said. "No patient should suffer from this."
The dangers to patients aren't limited to hospital or clinic settings, Nielsen said. Patients treated at home for acute or chronic problems may rely on something as small as an insulin pump supplied by a physician's office. That's why a clearinghouse should make information available to consumers, he said.
Several national databases on the millennium status of medical devices have sprung up during the past year, including a service for hospitals offered by a for-profit AHA subsidiary in partnership with the Connecticut Hospital Association (June 1, p. 42).
Nielsen said that service does customized investigations of specific device inventories for individual hospitals, while the envisioned national clearinghouse would be more of a repository of information for the industry and the public.
Kizer said the VA's unsatisfactory experience with manufacturers justifies the extra pressure. If the VA, the largest health system in the nation, cannot get the answers, "what is a small hospital in Texas going to do?"
"Facilities have to know, and they have to know early enough to make decisions," Kizer said. For example, the VA has hundreds of defibrillators that cost $10,000 each but are not being supported by the manufacturer because they are obsolete, he said.