Medical technology companies are feeling the heat from hospitals demanding answers about whether their medical equipment will withstand the upcoming millennium moment of truth.
Under mounting pressure from customers, the Department of Veterans Affairs and the Food and Drug Administration, equipment suppliers say that they are working on the problem. But many claim that sorting through all the technical variables to make a compliance determination takes time. Unfortunately, time is quickly running out, critics say.
In testimony on behalf of the Health Industry Manufacturers Association before a testy congressional committee last month, Ramin Mojdeh acknowledged the medical device industry's concern about the problem while defending its plodding progress.
Mojdeh, director of research and development at Indianapolis-based Guidant Corp., emphasized that the technical challenges are significant, given the ubiquity of software and microprocessors in medical products today. Manpower crunches compound the problem at many companies, he told the panel. He added that nearly 80% of the 18,000 medical device companies registered with the FDA have fewer than 50 employees.
"For the majority of cases . . . solutions to the year-2000 problem developed by one company likely will not be applicable to, or feasible for, others," Mojdeh testified, adding that the "problem cannot be resolved with an easy, one-size-fits-all solution."
Thankfully, some of the worst fears have been allayed.
For example, the year 2000 is a nonproblem for all of the implantable devices made by Medtronic, the world's largest supplier of pacemakers and implantable defibrillators.
"Most of our implantable devices weren't date sensitive in the first place," says Dick Reid, a spokesman for the Minneapolis-based company.
It's a different story for some desktop equipment used by doctors to program pacemakers and also some Medtronic products used to manage blood transfusions. But Medtronic has developed software and hardware fixes that are free to customers with extended warranties and available at cost to others.
For the panoply of other medical suppliers, it seems to be a matter of time before they produce answers.
A quick scan of the Food and Drug Administration's year-2000 Web site (http: www.fda.gov/cdrh/yr2000/year2000.html) is not reassuring.
First, there's the ominous electronic clock that greets visitors with a second-by-second countdown to the millennium calendar switchover.
Then comes the spotty listing of companies that have reported that their products will be OK or that a fix is available to make them compliant. You don't have to be an electrical engineer to know that mattresses, rubber gloves and orthopedic implants won't be affected by the millennium bug. But companies that make such simple products as those dominate the FDA listing so far.
For many of those with more sophisticated and potentially troublesome gizmos, it's still hurry up and wait.
Varian Associates makes radiation therapy equipment for cancer treatment and was a recent finalist for the coveted Malcolm Baldrige quality award. But a visit to the Palo Alto, Calif.-based company's Web site (www.varian.com) yields mixed results when it comes to the year-2000 status of its medical equipment. The company's latest linear accelerator is A-OK, but many of Varian's treatment-planning software products, for instance, still fall in the category of "to be determined." Varian representatives were not available for comment at deadline for this story.
