United States of America. The Food and Drug Administration has issued a guidance for industry entitled “Guidance on FDA’s Expectations of Medical Device Manufacturers Concerning the Year 2000 Date Problem”.
Many medical devices employ or incorporate computer systems or microprocessor controls as aspects of their design. Some of these computer systems and software applications, including embedded microprocessors, may experience problems in processing dates or date-related data due to their use of two digits to represent the year. The problems may be manifested on or after 1 January 2000 when the year 2000 is represented as “00” and the computer system or software cannot differentiate 1900 from 2000. Other date-related problems may occur, such as the failure to accurately address leap years (e.g. there will be a 29 February 2000) or the use of certain dates (e.g. 9 September 1999 - 9/9/99) as “flags” for specific computer actions.
During 1996, the FDA reviewed the types of devices for which problems or potential risks to patients might arise due to the Year 2000 date problem. This review did not identify many devices for which the use of a date is critical to the function of the device or for which incorrect date representation could have an adverse impact on patient safety. However, the FDA is providing information regarding how manufacturers may meet regulatory requirements of the FDA in addressing computer date representation problems.
The full text is available on request.
Reference: Federal Register 63(121): 34436-34442 (1998).