Y2K: don't leave it to its own devices - Computer Quarterly Update

Nursing Homes, March, 1999 by David Patterson

No matter where you look in the healthcare industry there are fears and concerns about the millennium bug. Y2K warnings are everywhere and, if we are to judge by the breadth and depth of expert opinion, for good reason. We can hope that the most dire of the Y2K predictions turn out to be overreaction, but far too much is at stake to risk leaving it to chance. Nowhere is that more true than when it comes to medical devices.

According to a fact sheet issued by the Department of Health and Human Services last December 31: "Medical devices and scientific laboratory equipment may experience problems beginning January 1, 2000, if the computer systems, software applications or embedded chips used in these devices and equipment contain two-digit fields for year representation."

The wide diversity of products manufactured - everything from monitoring equipment and medical information systems to sophisticated lab instruments and pacemakers - results in an equally wide variety of potential Y2K problems. Couple that with the number of manufacturers (1,935 biomedical equipment companies had, as of press time, been identified by the federal government as being susceptible to the Y2K problem), and the complexity of addressing the situation becomes staggering.

It starts with a simple problem: Anything with a chip in it could be date-dependent. It's one thing if the electronic coffee machine in the staff lounge fails to start dripping on January 1, and quite another when you're talking about a life-supporting or life-sustaining piece of equipment.

One recent report tells of a facility team that decided to test a new ventilator. They set the unit's clock/calendar to 11:00 p.m. on December 31, 1999, and turned it on. When the unit reached 12:00 a.m., January 1, 2000, it failed. They called the manufacturer, which instructed them to shut down the unit, remove a cover and change an internal switch. That did the trick, and the ventilator worked just fine.

So what's the problem, if the manufacturer had a simple solution to recommend? Look at it this way - if it had really been midnight January 1, 2000, would there have been anyone to answer the vendor's phone? Would the facility even have been able to get a functioning line, for that matter? And, oh yes, what about the patients whose ventilators had failed?

Devices with embedded chips require attention. Two such devices common to the nursing home environment are intravenous drips/infusion pumps and pacemakers. Infusion pumps in intravenous drips are calibrated to deliver correct drug and fluid dosage. However, they become inaccurate over time and require recalibration every three months. An embedded chip registers when the last calibration took place and compares it with the current date in its internal time clock. If no calibration has taken place, the pump might issue an alert and shut down. Similarly, when information from a pacemaker is downloaded, the device resets itself. If the computer receiving the data records faulty times for shock deliveries from the pacemaker, data can be misinterpreted and lead to seriously misguided action.

If you haven't already considered or addressed this situation thoroughly, there is still time to act. Start with an aggressive assessment of every piece of medicaid - and for that matter nonmedical - equipment in the facility to determine whether it could pose a Y2K risk. Then look for help.

These days, the Internet is the best place to begin the search for assistance, so if you don't have a link, get one now. Tens of thousands of Web sites offer information on Y2K problems and, of course, thousands address healthcare-related issues.

Perhaps the most valuable Web site is the one established by the U.S. Food and Drug Administration (FDA), working with the Department of Veterans' Affairs to provide information on the Y2K status of medical devices. Originally, the site was intended only for federal agencies that use and purchase medical devices and laboratory equipment. However, realizing that the private sector had the same need for reliable information, the FDA enlarged the role of the Web site.

In January 1998, Kevin Thurm, deputy secretary of the Department of Health and Human Services, asked bio-medical equipment manufacturers to submit details on the Y2K compliance status of all their products that could be in use on January 1, 2000. Manufacturers were asked to respond in one of three ways: (1) a certification that none of their products is affected by date-related problems, (2) provision of a list of products that have been identified as having date-related problems, for posting in a database maintained on the FDA Web site, or (3) a Web site address (URL) link to a Web page maintained by the manufacturer, where specific Y2K product information is posted.

The FDA database was slow to get off the ground, in large part because manufacturers feared that the information they disclosed would be used against them in lawsuits. In response, on October 19 President Clinton signed into law an act prohibiting statements manufacturers make about their products and Y2K problems from being used against them in court. The opportunity to apply for that protection expired in December, but already by November Alan H. Magazine, president of the Health Industry Manufacturers Association (HIMA), was announcing that all of its more than 800 member-manufacturers of medical devices, diagnostic products and medical information systems were "... fully compliant with the FDA's Y2K information program."