Y2K: don't leave it to its own devices.

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."

Although the FDA database is voluntary and the information on it is only as reliable as the manufacturer that provides it, it is probably the best clearinghouse available for Y2K information related to biomedical devices and equipment. The URL of the database is http://www.fda.gov/cdrh/yr2000.html.

There are other potentially useful Web sites:

"Billy the Biomedical Bot" is a specialized search engine for biomedical Y2K compliance information. It searches all sites, including manufacturers', providing compliance information on biomedical equipment. Billy's URL is http://hilary.hypermart.net/cgi-bin/search.cgi.

The Medical Devices Bureau of Health Canada's Therapeutic Products Programme has a database of manufacturer-supplied Y2K compliance data on the Web at http://www.hc-sc.gc.ca/hpb-dgps/therapeut/index.html. Even in distant Australia, a useful biomedical equipment database is maintained at http://www. y2k.gov.au/biomed.

Duke University has a downloadable database of over 300 biomedical devices and their Y2K compliance status based on independent testing at www2.mc.duke.edu/depts/clineng/y2result.htm.

A good, general Y2K biomedical equipment site with links to other sites is known as M.E.L.'S Place and can be found at http://www.invisionet.com/bioywk.htm.

What may be the best overall Y2K site on the Internet specifically for healthcare providers is the one produced by Rx2000 Solutions Institute, which bills itself as an independent, nonprofit, member-supported organization helping ensure survival of healthcare organizations into the next millennium. This site's URL is http://www.rx2000.org.

Many of these sites greet visitors with ticking countdown clocks, and as these make only too clear, Y2K looms nearer with every passing day. This is no time to panic - the fixes could be easy and the problems could fall short of life-threatening. Or, if a device is Y2K-compliant or has no chips, there may be no problem at all. The point is not to just sit back and see what happens. That could get you into deep trouble, and your patients into worse trouble. Take time - lots of time - to check it out and make sure.

AAHSA Resource

The American Association of Homes and Services for the Aging (AAHSA) has an agreement with Allied Healthcare Association Services to help AAHSA members identify medical devices that might be affected by the Y2K problem. The resource is an Internet-based tool called Security Third Millennium (or SIIIM), which automatically checks a particular device against Y2K testing information supplied by its manufacturer. The Web site can be found at http://www.siiim.com.

David Patterson is a contributing editor to Nursing Homes/Long Term Care Management.