|Y2K: Not Just a Technical Issue|
Medical Device & Diagnostic Industry
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An MD&DI August 1998 Column
"The biggest problem we've seen in making medical devices year 2000 compliant is that some manufacturers are not facing the issue in a timely manner," says Jeffrey K. Shapiro, an associate specializing in medical device law at the Hogan & Hartson law firm in Washington, DC. Shapiro wrote this month's story on who should cover the costs of fixing year 2000 problems. "There's no cause for panic," he notes, "but time is running out."
His impression appears to be borne out by FDA's experience with collecting data from manufacturers for its Web site. FDA has been encouraging companies to make their year 2000 status available to the agency and the public by posting data on a designated Web site. This past January, FDA sent letters to 16,000 companies, including all registered medical device manufacturers, asking them to participate. As of June, FDA reported that only 10% had responded, and most of those were companies saying that they did not have a year 2000 problem. One FDA official told Shapiro he believes that a major reason for this low response rate is that most manufacturers with year 2000 problems are still in the assessment stage and have not even begun working toward a solution.
Jeffrey Shapiro urges readers to tackle Y2K glitches now.
Interestingly, the so-called year 2000 problem could actually start affecting devices as early as next year. "Computer software program designs have other flaws in addition to their using two digits, such as 00, to represent a year. In some programs, the programmers used a date such as 9/9/99 as a flag to trigger certain computer actions." Unfortunately, it is unknown what exactly will happen when these flags are activated. "But we could start to see medical devices fail as early as next year.
"Another problem is that the year 2000 is a leap year, which is very unusual," Shapiro says. "Generally, years ending in 00 are not leap yearsbut there's a little-known exception for years ending in 00 and evenly divisible by 400, which includes the year 2000. Some programmers likely didn't realize that fact when writing their software, so this is another flaw that will need to be fixed, because after February 28, 2000, some devices will record data one day ahead of the actual calendar day.
"We should bear in mind that the machines that process or manufacture medical devices also rely heavily on software. Medical device manufacturers have a regulatory obligation under the quality system regulation to make certain that the equipment used to manufacture their devices can continue to function properly after the turn of the century."
In his conversations with clients and other medical device manufacturers, Shapiro says there seems to be a tendency to think of year 2000 device problems as a technical challenge for programmers to handle. "While that's true to a degree," says Shapiro, "one of the main reasons why I wrote this article is to remind everyone that it's also very much a managerial and regulatory issue for device companies. There are FDA regulatory and product liability concerns at stake. FDA has said that if a device may harm a patient as a result of a year 2000 problem, the manufacturer has a compliance obligation to fix it. Also, if patients are injured, I have little doubt that the personal injury lawyers will start pursuing product liability lawsuits in a big way."
In addition to his role in the food and drug law practice group at Hogan & Hartson, Shapiro also works with the law firm's year 2000 team, which studies this issue across a range of industries, and Shapiro notes that medical device companies appear to be a little behind their counterparts in other industries in terms of addressing this challenge. "While it's really a minority of devices that could injure patients because of a year 2000 glitch, unless vigilance is practiced, patients could get hurt."