THE YEAR 2000: FDA's Absolute Last Word (for the moment . . .)

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI August 1998 Column

Issues of liability and cost allocation add more rings to the Y2K circus.

In 1894, during the dedication ceremony of the Ryerson Laboratory at the University of Chicago, the distinguished physicist Albert Abraham Michelson delivered a pronouncement that has become one of the classic examples of shortsightedness: "The more important fundamental laws and facts of physical science have all been discovered, and these are now so firmly established that the possibility of their ever being supplanted in consequence of new discoveries is exceedingly remote . . . . Our future discoveries must be looked for in the sixth place of decimals."

Today, the second part of Michelson's statement sounds as quaint as the first, with "the sixth place of decimals" barely skimming the surface of modern science's bottomless computational depths. How ironic, then, that at the end of the 20^th century, the fly in the technological ointment is a largely unanticipated "problem" that hinges on the recognition of two simple digits—the final "00" of the date in the year 2000.

The possibility that—without corrective action—a certain percentage of computers or software embedded in devices could malfunction following the last New Year's Eve parties of the millennium has resulted in widespread alarm and engendered an entire short-term industry of doomsayers, symposia organizers, consultants, and code writers. One analyst has published a survey estimating the cost to the United States alone at approximately $520 billion, of which more than 30% has allegedly already been spent on remediation. Advertisements for firms offering "Y2K solutions" tend to combine images of imminence and destruction: a ground-level shot of racehorses thundering toward the viewer or a time bomb labeled "January 1, 2000," its fuse lit and burning.

At FDA, concern that devices or software with year 2000 problems could pose a risk to health has led to the recent issuance of a draft guidance document (available at http://www.fda.gov/cdrh/yr2000/year2000.html), regarding which the agency is currently soliciting comments and suggestions from the public. In this issue of MD&DI, author Jeffrey K. Shapiro reviews FDA's current position on the responsibilities of medical device manufacturers to evaluate, correct, and report date-related problems in their products. A practicing attorney, Shapiro also discusses the product liability implications of a company's response to year 2000 problems, and addresses the potentially convoluted matter of who should pay for repairs.

The one indisputable fact is that the clock is ticking, and FDA is doing its part to emphasize the implacability of a deadline that cannot be extended. At the top of CDRH's Web page titled "Year 2000 Impact on Biomedical Equipment," a running counter registers the time remaining until the fateful double-zero will manifest itself. When I printed this page from my PC, on July 20, there was a glitch in the line that appeared, which read "1 year, 5 months, 14 days, 7 hours, 35 minutes, 55 secon." I tried again, but the last two characters—the "ds" of "seconds"—were still missing. As time flies, marches, or hobbles on, it's almost comforting to know that genuine year-1998 problems, those relics of a dying century, are still around.

Jon Katz

[email protected]

Copyright ©1998 Medical Device & Diagnostic Industry