US FDA Says Most Medical Devices Safe From Y2K Bug

Updated 1:35 AM ET August 25, 1999WASHINGTON (Reuters) -

Medical devices that could be susceptible to the so-called Y2K bug are expected to work properly if health care providers and consumers follow manufacturers' instructions, the U.S. Food and Drug Administration said Tuesday.

The FDA has required makers of date-sensitive devices sold in the United States to provide hospitals, other health facilities and consumers with upgrades or instructions on how to keep the products from failing when year 2000 arrives.

If the products cannot be fixed in time, the agency has required that device makers inform customers to stop using them when the new year approaches.

"FDA sees no indication of widespread problems which will place patients at risk as long as the solutions now offered by manufacturers are implemented," the FDA said in a statement.

The year 2000, or Y2K, problem could arise because many older computers record dates using only the last two digits of the year. If left uncorrected, such systems could treat 2000 as 1900, generating errors or systems crashes.

The FDA said only a small percentage of medical devices could suffer Y2K troubles. Of the 13,500 U.S. medical device manufacturers, only about 2,000 make products that might be controlled by computers, and most of those products are not date-sensitive, the FDA said.

"The vast majority of computer-controlled medical devices used and marketed in the United States will not be significantly affected by the Y2K date problem," the FDA said.

Devices that could be affected by the Y2K problem are used primarily in hospitals and laboratories, the FDA said. Those devices include some ultrasound systems, kidney dialysis machines, blood-product devices and planning systems for radiation therapy, the agency said.

Makers of some potentially high-risk products have agreed to undergo an FDA review of their Y2K readiness. The FDA said it plans to release those results in October.

The agency said there was no reason to worry about home medical devices or implantable devices such as heart pacemakers or defibrillators because they do not depend on the current date to operate properly. Glucose monitors, which measure diabetics' blood sugar levels, could be affected, however.

The FDA has listed medical devices that could face Y2K failures on its Web site at www.fda.gov/cdrh/yr2000.html. ========================================== End

Ray

-- Ray (ray@totacc.com), August 25, 1999