FDA Public Health Notification:
Important Information about Y2K and Medical Devices

December 13, 1999

(You are encouraged to copy and distribute this information)

To: Hospital/Healthcare Facility Administrators
      Risk Managers
      Biomedical/Clinical Engineers

As the new year approaches, I want to remind you about key points concerning computer-controlled medical devices and the Year 2000. This letter will discuss:

• Contingency planning, equipment assessment, and equipment remediation;
• Reporting Y2K adverse events;
• Acquiring medical devices after January 1, 2000; and
• Getting information about date-related device problems.

Contingency Planning, Equipment Assessment and Equipment Remediation

If your facility does not already have a Y2K contingency plan, you should develop one immediately. Because the time available to develop and test plans is extremely short, facilities that have not completed contingency plans should focus on their most critical operations and systems. The following resources are available to assist with contingency planning:

Health Care Financing Administration: http://www.hcfa.gov
Department of Veterans Affairs: http://www.va.gov
American Hospital Association: http://www.aha.org

It is very important that you assess the Y2K status of all computer-controlled biomedical equipment in your inventory and take action to remedy or remove from service any devices that could present a risk to patients due to an identified Y2K problem. You can find information from device manufacturers regarding the Y2K status of their products by consulting FDA's Federal Year 2000 Biomedical Equipment Clearinghouse at:

http://www.fda.gov/cdrh/yr2000/year2000.html

You should also assess any computer systems that contain patient records and other significant data, and any internally developed systems involving the interconnection of devices from different manufacturers.

Reporting Y2K Adverse Events

Despite careful preparation, unexpected date-related problems could occur after January 1, 2000. If you become aware of a medical device Y2K problem that appears to have serious implications for patient safety, please report it immediately to FDA at our Emergency Operations Center. The FDA Emergency Operations Center may be reached at 301-443-1240 or via the FDA information hotline at 1-888-INFO-FDA (1-888-463-6332). We request that you fulfill your normal adverse event reporting responsibilities immediately upon learning of a reportable event, rather than taking advantage of the longer timeframes provided for in Part 803. Reporting requirements and procedures are summarized below.

• Mandatory Reports
   
  You are required to report deaths to both FDA and the manufacturer; injuries are reported to the manufacturer only. Please report these problems through procedures already established by your facility, and be sure to identify the report as a Y2K problem, using the following special codes on the FDA Form 3500A, in addition to other appropriate codes:
   
  • MedWatch Device Problem Codes, Block F10
    2581 - Date-related problem, Y2K
    2582 - Date-related problem, not Y2K
     
    
  • MedWatch Conclusion Codes, Block H6
    90 - Date-related problem, Y2K
    91 - Date-related problem, not Y2K
     
• Voluntary Reports
   
  We recommend that you report any date-related problem that did not cause death or injury, but may have been related to unexpected performance of the device. This would include device malfunctions that could cause death or serious injury if the problem recurred. Again, be sure to identify your report as a Y2K problem. We also encourage you to report any contradiction between your observation of device performance and the performance described by the manufacturer of the device. Voluntary reports may be submitted as follows:
   
  • By telephone, to 1-800-FDA-1088
    By mail, send Form 3500 to:
         MedWatch
         Food and Drug Administration, HF-2
         5600 Fishers Lane
         Rockville, MD 20857-9787
    Electronically, at:
         http://www.fda.gov/medwatch/index.html

Acquiring Medical Devices after January 1, 2000

After January 1, 2000, medical device manufacturers may continue to market devices with non-significant Y2K problems, if these are fully disclosed and present no risk to patients. This would include devices whose date-related operations are not fully compliant with the strict definition of Y2K compliance used by FDA, however, these devices may continue to be distributed and should be safe for use according to the instructions. We expect that very few manufacturers will choose this course, deciding instead to market fully Y2K-compliant devices.

Any new medical device you acquire after January 1, 2000 should be either Y2K compliant or should have product labeling that prominently discloses the existence of the Y2K problem and provides instructions for the safe use of the device.

If you should decide to acquire a computer-controlled medical device that was originally marketed before January 1, 2000, you should determine the compliance status of that particular device. The FDA's Federal Y2K Biomedical Equipment Clearinghouse (http://www.fda.gov/cdrh/yr2000/year2000.html) provides information on the Y2K status of many medical devices.

Getting More Information

To alert healthcare facilities, physicians, and consumers to current news about computer-controlled medical device problems, CDRH has established a special link on its web site (see web site above). FDA will use this web site to provide rapid notification of unexpected Y2K device problems that could present a serious risk to patients. We invite you to browse this site for current news and updates.

You may receive Y2K and other device-related information by subscribing to our electronic mailing list. We will be using this mailing list to provide the healthcare community with rapid notification of unexpected Y2K problems with medical devices. To subscribe, visit the following web page:
http://service.govdelivery.com/service/subscribe.html?code=USFDACDRH_10

Updated Decmeber 13, 1999