February 22, 2000

**Notice to Users and Manufacturers of Medical Devices**

**Regarding Possible Leap Year Date-Related Problems with Medical
Devices**

Based on worldwide experience, FDA is not aware of any deaths or serious
injuries resulting from the Y2K problem and medical devices during the
rollover into the Year 2000. Every facet of the healthcare sector
contributed to this outstanding outcome.

With the approach of February 29, you should be prepared for the
possibility of date-related problems associated with the leap year
rollover. Because date-related problems could occur on or after February
29, 2000, we remind you to review your contingency plans and heighten
your level of vigilance for possible problems during this time. You can
check the Y2K (including leap year) status of computer-controlled
devices by consulting FDA\'s Federal Y2K Biomedical Equipment
Clearinghouse (Y2K Clearinghouse) at
[www.fda.gov/cdrh/yr2000/year2000.html](http://www.fda.gov/cdrh/yr2000/year2000.html).
In addition, the Rx2000 Solutions Institute lists products with reported
leap year problems on their web site at
[www.rx2000.org](http://www.rx2000.org/).

**Reporting Adverse Events**

Despite careful preparations, unexpected date-related problems could
occur on or after February 29, 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). For other reportable events, you should report to
FDA\'s MedWatch program as follows:

**Mandatory Reports**

For any device-related death or serious injury, user facilities are
required to report deaths to both FDA and the device manufacturer and
serious injuries to the manufacturer only. Manufacturers are required to
report to the FDA deaths, serious injuries, and malfunctions that could
cause death or serious injury if they recurred. Please report these
problems through procedures 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 serious injury and would not if it recurred but did cause
unexpected performance of the device. This would include device
malfunctions that could cause death or serious injury if the problem
recurred. Again, please 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.
Voluntary reports may be submitted as follows:

> By telephone, to 1-800-FDA-1088
>
> By FAX, send Form 3500 to 1-800-FDA-0178
>
> 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>

**Status of Federal Y2K Biomedical Equipment Clearinghouse**

The Y2K Clearinghouse is a database established to provide healthcare
facilities and device users with information on the Y2K compliance
status of biomedical equipment. The Clearinghouse contains information
or manufacturer web-site links for Y2K non-compliant products, and
information on specific product models that are Y2K compliant. After
February 29, 2000, we will continue to make the Y2K Clearinghouse
available on the World Wide Web; however, we will no longer update the
information contained there. The existing links to manufacturer\'s web
sites, which have been provided to FDA, will continue to be listed, but
some device manufacturers may in the future remove Y2K product status
information from their linked web sites. If Y2K information for a
specific product is not available through the Y2K Clearinghouse, users
should contact the device manufacturer directly.

Sincerely yours,

> David W. Feigal, Jr., MD, MPH
>
> Director
>
> Center for Devices and Radiological Health