To: John Mansfield who wrote (246 ) 3/18/1998 6:20:00 PM From: Judge Respond to of 618
FDA Website Provides Year 2000 Information on Computerized Biomedical Equipment The Federal Government has established a World Wide Web site to provide information on the "Year 2000" status of medical devices and scientific laboratory equipment (biomedical equipment). There is a chance some of these products will experience problems associated with the use of date information on January 1, 2000 if the computer systems, software applications or imbedded chips used in these devices and equipment contain two-digit fields for representation of the year. In such a circumstance, the software program will not be able to distinguish the year 2000 from the year 1900. When the device needs to calculate a date to work, this can potentially lead to the product failing to function as expected. Analysis of the year 2000 problem shows the most likely errors will result in printed test results that are incorrectly dated or self evidently wrong but some may more directly put patients at risk. The website, administered by the U.S. Food and Drug Administration for the government's Chief Information Officers Council Subcommittee on the Year 2000, is intended to give product users in healthcare facilities and research laboratories and other interested parties one comprehensive resource for information about the "Year 2000 compliance" of biomedical equipment. "Year 2000 compliance" means that the product accurately processes and stores date and time data during, from, into and between the 20th and 21st centuries, and the years 1999 and 2000. (Processing and storing data may include calculating, comparing, displaying, recording and sequencing operations involving date and time data, including correct processing of leap year data.) To be Year 2000 compliant, products must function as intended or expected, regardless of the date. Should they not be corrected in time, Year 2000 date problems potentially could pose serious health and safety consequences. A medical device function which depends on a calculation involving a date and which is performed incorrectly as a result of a date problem could lead to a risk to the patient. One example is a product used for planning the delivery of radiation treatment using an radioactive isotope as the radiation source. An error in the calculation of the radiation source strength on the day the therapy is to be delivered could result in an incorrect treatment and have adverse consequences for the patient. While the website was originally planned to aid the several agencies in the Federal Government that use and purchase medical devices and laboratory equipment, it was quickly realized that the private sector has the same needs for this information. Manufacturers will benefit too, as they can refer inquiries to the website instead of answering them repeatedly. Deputy Secretary Kevin Thurm of the Department of Health and Human Services, in a letter on January 21, 1998, asked biomedical equipment manufacturers to provide information on the Year 2000 compliance status of their products. The information received from manufacturers will be made available on the World Wide Web page maintained by FDA. The website will contain information only for those products identified by their manufacturer as not being "Year 2000 compliant." The website is located at: fda.gov .