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This warning from the NRC to the FDA indicates that the medical industry is especially vulnerable to the embedded chip problem.
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UNITED STATES NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS WASHINGTON, D.C. 20555
August 6, 1997
NRC INFORMATION NOTICE 97-61: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES LETTER, TO MEDICAL DEVICE MANUFACTURERS, ON THE YEAR 2000 PROBLEM
Addressees
All U.S. Nuclear Regulatory Commission medical licensees, veterinarians, and manufacturers/distributors of medical devices.
Purpose
The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice to inform licensees of a letter from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA), to medical device manufacturers, about the Year 2000 problem. It is expected that recipients will review this information for applicability to their facilities and consider actions, as appropriate, to avoid potential problems. However, suggestions contained in this information notice are not NRC requirements; therefore, no specific action nor written response is required.
Description of Circumstances
In a letter dated June 25, 1997, the FDA reminded medical device manufacturers that some computer systems and software applications currently used in medical devices, including embedded microprocessors, may experience problems as a result of the turn to the new century. In addition, the letter indicated that computer-controlled design, production, or quality control processes could be adversely affected.
Discussion
The FDA requires the manufacturers it regulates to investigate and correct problems with medical devices that present a significant risk to public health. To ensure the continued safety and effectiveness of medical devices, the FDA recommended that manufacturers take the following actions: (1) ensure that medical devices submitted for premarket approval can perform date recording and computations that will not be affected by the Year 2000 problem; (2) conduct hazard and safety analyses on currently manufactured devices to determine whether device performance could be affected by the Year 2000 problem, and, if so, take appropriate steps to correct production and help customers who have purchased such devices; and (3) check design, production, and quality control processes to ensure year 2000 compliance. This letter also applies to those manufacturers that use radioactive material in their medical devices.
If there are any questions about medical device manufacturers' responsibilities regarding the Year 2000 problem, contact the FDA's Center for Devices and Radiological Health, Division of Small Manufacturers Assistance, by phone, at 1-800-638-2041 or fax, at 301-443-8818. Also, an electronic copy of the letter is available on the FDA's World Wide Web home page at http://www.fda.gov/cdrh.
Related Generic Communications
NRC Information Notice 96-70, "Year 2000 Effect on Computer System Software," issued on December 24, 1996, addressed the Year 2000 problem and its applicability to NRC licensed programs.
This information notice requires no specific action nor written response. If you have any questions about the information in this notice, please contact the technical contact listed below or the appropriate regional office.
signed by
Donald A. Cool, Director Division of Industrial and Medical Nuclear SafetyOffice of Nuclear Material Safetyand Safeguards
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