GAO official criticizes FDA Y2K information-gathering

Billing disruptions in Medicare are likely to be slight, but patient care problems stemming from malfunctioning medical equipment could be a major problem on Jan. 1, 2000, witnesses told a joint hearing of two House Commerce subcommittees.

One witness, Joel Willemssen of the General Accounting Office in Washington, DC, warned that available information on year 2000 (Y2K) readiness throughout the health care sector — including providers, insurers, manufacturers and suppliers — "indicates much work remains in renovating, testing, and implementing compliant systems." Willemssen criticized the Food and Drug Administration (FDA), which is responsible for ensuring that medical equipment does not malfunction when the year 2000 begins.

While FDA did request information from equipment manufacturers on potential Y2K problems and posted the information on a Web site, "it was not detailed enough to be useful," Willemssen testified. "Specifically, FDA’s list of compliant equipment lacked information relating to the particular make and model of the equipment."

Even more serious, said Willemssen, FDA did not require device makers to submit test results certifying compliance. When three hospitals sent engineers to independently verify certification claims, Willemssen testified, "several of these engineers informed us that their testing identified some noncompliant equipment that the manufacturer has previously certified as compliant." Among those items was a cardiac catheterization unit, a pulse oximeter and medical imaging equipment.

The FDA and representatives of the medical device industry declined to send witnesses to the hearing, members of the subcommittee said.