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Good morning! The hearing will come to order.

The purpose of this morning’s hearing is to examine the preparations of the Department of Veterans Affairs (VA) and the Food and Drug Administration (FDA) for year 2000 (Y2K) compliance of medical devices used for the health care of veterans. The basic question we want to answer is, "Can veterans be confident that the VA’s medical equipment will work right on January 1, 2000?" The answer to this very serious question is the same for the general public as for veterans.

This is the subcommittee’s third hearing on Y2K issues. The last hearing was one year ago on September 25, 1997, also with GAO, VA and FDA witnesses. I first publicly raised the medical equipment Y2K compliance issue at that hearing and this hearing is to follow up on the specific issue and review progress.

As one of the largest health care systems in the country and the largest federal system, the VA is one of the largest users of medical equipment – about $3 billion worth at 711 facilities. Obviously, the VA uses much of the same medical equipment for treating veterans that other public and private hospitals, clinics and doctor’s offices use for treating every American.

This Subcommittee has been concerned for more than a year about the Y2K questions relating to the VA’s medical equipment. Because of our concern, in July 1997 I asked the General Accounting Office to do a careful study of the VA’s health care delivery systems and Y2K. I asked GAO to include the Food and Drug Administration in the study because the FDA regulates the manufacturers of medical devices, including those used by the VA. Today I am releasing that report, the "Year 2000 Computing Crisis, Compliance Status of Many Biomedical Equipment Items Still Unknown".

The title of this important report tells us what it has found. With only 464 days left until January 1, 2000, I find this information profoundly unsettling. We are running out of time to identify the medical equipment manufacturers who have produced equipment that has Y2K problems and get the critical equipment fixed or get it out of service. Some of these manufacturers are out of business. This is a very complex picture because of the large number of and many kinds of medical devices in use.

We are confronted with a major public safety issue. It can’t be left to chance or the hope that everybody will do the right thing. Of the thousands and thousands of medical devices out there, it only takes one critical non-compliant device to cause injury or perhaps even death. We can’t tell veterans and the public, "Don’t worry, you or your family can sue." The VA’s and the FDA’s jobs are to ensure safe health care for veterans and the public. We don’t want to know if they’re going to do it, we want to know how and when. Nothing less is acceptable. The objective should be coming as close to 100 percent certainty on critical medical equipment compliance as is humanly possible.

This morning’s witnesses will be our distinguished Senate colleague, Senator Charles Grassley, and representatives of the GAO, the VA, the FDA and the Health Industry Manufacturers Association. I appreciate their cooperation and willingness to testify on this serious topic, they are all here voluntarily, and I welcome them.

CLOSING STATEMENT

The House schedule today is very crowded, so some members of the Subcommittee could not be here today, and much media attention is focused on another committee.

But this hearing has raised a matter that should be of concern to every American. On January 1, 2000, people will get sick or hurt, just as they do every other day and they will need medical treatment.

The FDA’s effort on Y2K compliance of medical equipment appears to be finally coming together at what amounts to the eleventh hour. I just hope and pray that the database work can be done in time, and that if it can’t, adequate contingency plans will be in place.

The VA’s health care system, by contrast, now seems to a leader on Y2K for health care providers and I know that VA will cooperate with the FDA and share its information with everyone to the greatest extent possible.

The medical equipment manufacturers have their work cut out for them too. They are in the best position to know or find out what’s Y2K compliant and what’s not. The manufacturers have a public responsibility as well as a legal obligation to have safe products for heath care and to disclose if any products may become unsafe on January 1, 2000. These manufacturers have put so many wonderful, lifesaving devices on the market, that I cannot believe they would not live up to their responsibilities and obligations. But if they do not, I support listing those manufacturers not disclosing the Y2K status of their products on the FDA’s website for the whole world to see. Further, the federal government should stop doing business with them if possible.

Finally, there is still time for another hearing or two, and no matter what the November elections bring, the Subcommittee will continue to monitor the Y2K situation very closely next year.