Multiply number of noncompliant items by 5

Estimates on products’ Y2K compliance were off

The number of medical products that are not year 2000 (Y2K) compliant is almost five times what was previously believed, according to Joel C. Willemssen, director of the Civil Agencies Inform-ation Systems Accounting and Information Management Division of the Washington, DC-based General Accounting Office (GAO). Willemssen recently testified before the Senate’s Special Committee on the Year 2000 Technology Problem.

As of June 1, the Federal Y2K Biomedical Equipment Clearinghouse listed 427 manufacturers referring users to their Web sites. When GAO officials studied the manufacturers’ sites, they determined about 4,445 medical products, or 12.5%, are considered noncompliant by the manufacturer, he said.

That number is almost five times the number of individual noncompliant products (897) that manufacturers reported to the federal clearinghouse, he said. Noncompliant products reported by manufacturers on their Web sites include a bedside monitor and laboratory information systems, according to Willemssen. In many cases, the manufacturer provides solutions to correct the problem, such as software upgrades and manual calculations, he said.

And that’s not all of the bad news, according to Willemssen. Several hospital engineers have tested their own biomedical equipment. "Several of these engineers informed us that their testing identified some noncompliant equipment that the manufacturers had previously certified as compliant," he said. The equipment found to be noncompliant had display problems and were not critical care/life support equipment. They included a cardiac catheterization unit, a pulse oximeter, medical imaging equipment, and ultrasound equipment, Willemssen added.

In response, the Food and Drug Administration (FDA) plans to review manufacturers’ test results supporting their compliance certifications for a sample of critical devices. The FDA has developed a list of about 70 such devices. To view a list of the devices, go to Web page: www.fda.gov/cdrh/yr 2000/cdrh/phrds/phrds.html. By putting a device on the list, the FDA is not implying that all devices of this type are not Y2K-compliant. Also, if they aren’t compliant, the devices wouldn’t necessarily pose a significant risk to patients.

Instead, FDA officials emphasize that these devices could pose a risk to patients if they aren’t Y2K compliant. The list of critical devices includes the following, listed with section number in Title 21 of the Code of Federal Regulations where the device type is described:

• gas machine for anesthesia or analgesia, 868.5160;

• infusion pump, 880.5725;

• laparoscopic insufflator, 884.1730.

This list can help same-day surgery facilities prioritize devices that should be assessed and brought into compliance.

According to Willemssen, health care providers have been slow to respond. Fewer than one-third of the hospitals responding to the Washington, DC-based Office of the Inspector General stated their biomedical equipment was currently compliant, and only 6% of the hospitals responding to a survey from the Chicago-based American Hospital Association stated their biomedical equipment was compliant, he said.

(Editor’s note: The FDA clearinghouse can be found on the Web at http://www.fda.gov/cdrh/yr2000/ year2000.html.)