Conference outlines possible, all-too-ugly, Y2K scenarios
Conference outlines possible, all-too-ugly, Y2K scenarios
By DON LONG
Healthcare InfoTech Managing Editor
NASHVILLE Come 12:01 a.m., year 2000, it is very unlikely that pacemakers will shut down. And, overall, the large majority of medical devices will probably keep on working as they were designed.
But that doesn’t mean the first few minutes, days or even months of the coming year won’t be filled with multiple ugly and very expensive scenarios for healthcare, according to several experts speaking last week at a conference on Y2K issues sponsored by the Rx2000 Solutions Institute (Minneapolis, Minnesota).
Rx2000 is perhaps best known for the warning it issued last year concerning the early failure of two medical devices, a problem that the FDA verified and credited the group with identifying. The institute is a nonprofit group focused on gathering as much information as possible about the Y2K problem in healthcare and helping the industry prepare for its ramifications, according to its executive director, Joel Ackerman.
In his opening remarks, Ackerman told about 100 attendees that the large majority of medical devices would continue working properly and that the primary impact of Y2K effects on instruments will be mostly just some "confusion." But he didn’t rule out the possibility of major breakdowns throughout U.S. healthcare. Those concerns were echoed by other speakers, including Joseph Broseker, Y2K coordinator for the Health Care Financing Administration (HCFA; Baltimore, Maryland); Gayle Finch, IT director for HCFA and the U.S. Department of Health and Human Services; Jim Hutchinson, director of biomedical electronics at Vanderbilt University Medical Center (Nashville); and Michael Barsness, product compliance manager for Medtronic (Minneapolis, Minnesota).
Clearly, the message being delivered by this group was mixed, but necessarily so, Ackerman said "because we don’t really know what the size of the problem is. Nobody does."
Thus, all of the speakers urged contingency planning as the best protection against major adverse impact on patient health, massive impairment of health care administration, and the natural fallout of expensive litigation.
These problems, the conference speakers said, probably won't come directly from the failure of medical devices. Rather, they will result from the complex interconnection of systems making up U.S. healthcare.
Following are just some of the effects described at the conference improbable if we prepare for them, all-too-probable if we don't.
• Reallocation of budgets. As next Jan. 1 nears, health care facilities will be forced to shift funds to the Y2K compliance effort, a reallocation that will result in putting off capital purchases, delaying new programming and services and generally skewing budgets away from necessary updates and improvements. Reaching compliance has already resulted in expensive upgrades of IT systems, according to Ackerman, with those upgrades often including unnecessary features.
• Programmer burnout. Ackerman noted that while health care is the largest industry in the U.S., it is the least prepared for Y2K, and that most computer programmers working to correct the problem won't be able to get the job done on time. "They are getting burned out, and come Jan. 1, they are going to want to be on a beach as far away from the problem as possible," he said.
• Media scrutiny and public backlash. "You don’t want 60 Minutes’ on your doorstep on Jan. 2," one speaker warned the group. But healthcare organizations that fail to guarantee patient safety are guaranteed that kind of media attention - and the subsequent loss of public confidence. Overall, several speakers described the likelihood of "technological backlash" by the public as a strong possibility, and a growing survivalist movement as a current reality.
• Hoarding. Survivalists already have begun the hoarding of general supplies. And the hoarding of pharmaceuticals and other medical supplies by the public, patients and even providers already has been reported in the media and is likely to become intense in the final months of 1999. Related possibilities will be the difficulty of obtaining repair parts for devices, with the parts that are available susceptible to price gouging. Another possibility, mentioned during a conference panel session, is the use of recycled micro chips that may or may not be Y2K-compliant.
• Legal liability. The wake of Y2K is likely to bring massive litigation, and liability pitfalls abound. Medtronic’s Barsness warned against clinicians and hospitals doing their own testing of cardiovascular devices in particular, advising that such testing was complex and best done by the manufacturer. Rx2000’s legal expert, Gary Setterberg, JD, also warned that testing by other than the manufacturer would result in "off-loading" liability onto the health organization if it does its own testing.
Additionally, he advised against over-simplifying the process of determining device compliance, saying this had to be a continuous process. A single manufacturer’s letter stating Y2K compliance was simply "date stamping," and, in court, might not fulfill a legal level for due diligence.
Setterberg noted that current liability and malpractice insurance policies do not cover Y2K failures and that such insurance is not forthcoming. "You might be able to get $100 million worth of coverage," he said, "but it will cost you $70 million. What kind of deal is that?"
In perhaps the most interesting portion of the conference, two attorneys argued the case of a hypothetical Y2K failure and its disastrous consequences. In the suit, the estate of a woman who had died was suing "Chicago Hope" when that hospital could not supply her the daily medication she needed to stay alive. The medication had spoiled in a refrigerator that had lost power during a brown-out the result of a city system Y2K failure and the hospital could not find the medication elsewhere. The plaintiff’s attorney accused Chicago Hope of massive negligence in failing to supply an effective source of back-up power.
A lawsuit such as this is not entirely improbable, according to Laurene West, RN, another conference speaker on whose situation this scenario was loosely based. West told the attendees that she requires daily medication to treat a brain tumor. Without it she would, in two days, be seriously ill "and dead in three days," she said.
Perhaps the most sobering note of the conference came from Frank Reilly, a senior consultant to the U.S. Senate Y2K Committee. Reilly warned that government officials can’t be relied on to fend off a Y2K bug that could jeopardize the lives of 29 million Americans with chronic illnesses.
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