As a result of the Y2K problem, equipment may operate abnormally or may quit functioning altogether. For example, an X-ray machine may erroneously compute the patient's age and deliver too high or too low a dose of radiation therapy or a computerized office system may erase all data held in memory. Even when the computer chip identified in a device is found to be compliant, dangerous problems could result if the device communicates with a non-compliant computer through telemetry to provide mathematical calculations.

The Food and Drug Administration (FDA) has been calling upon medical device manufacturers to voluntarily identify those devices which they have determined to be compliant, those that have been determined to be non-compliant, and those that have yet to be fully tested. While the FDA has issued several letters explaining to the approximately 13,000 identified medical device manufacturers that, as part of their continuing obligation to ensure that their products are safe and effective, they must provide this information, only about 12 percent had responded as of the July 1998 deadline according to a critical Government Accounting Office (GAO) report issued in September 1998. This report and other reports focusing upon Y2K issues involving the health care industry are found at http://www.gao.gov/y2kr.htm.

While several Y2K-related, health care class action lawsuits have now been filed, they have only focused upon the damages incurred in remediating (upgrading or replacing) purportedly non-compliant medical software that was sold to doctors and hospitals as being Y2K compliant. The more frightening suits for the health care industry, however, will involve patient injury and wrongful death suits. Plaintiffs' attorneys may ask juries to hold hospitals, software companies, attending doctors, medical device manufacturers, and equipment suppliers responsible for patient injuries. Their claims will be that many of these defendants breached their fiduciary duties owed to patients to use reasonable care in locating and correcting dangers associated with Y2K problems. Such patient dangers are not imaginary. Even with the limited responses provided to the FDA by the medical device manufacturing industry, among the already identified, non-compliant devices are: defibrillator monitors; cardiology monitors; off-line analysis of ECG data; electrocardiograph; bone densitometry; noninvasive blood pressure machines; vital signs monitors; radiation diagnostic and therapy; conversion of pacemaker telemetry data; conversion and transmission of medical images; anesthesia equipment; and other laboratory equipment.

Beyond the problems health care providers face in determining which devices and equipment may be noncompliant, there is also the very real threat that payments will be delayed because many government systems have yet to be remediated. The Department of Health and Human Services and the Health Care Financing Administration (HCFA), which administers the Medicare program, recently received an "F" for their progress in resolving Y2K problems. Providers in Texas and around the country who participate in Medicaid likewise face Y2K problems. A November 1998 GAO report entitled, "Year 2000 Computing Crisis: Readiness of State Automated Systems to Support Federal Welfare Programs," found at the GAO link provided above, paints a particularly dismal picture: overall, only about one-third of the systems in the 49 states that responded are reported to be currently compliant.

- by Michael E. Clark, J.D., LL.M. in Taxation, candidate for LL.M. in Health Law

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©2006 Texas Medical Center

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