August 16, 2021
Dear Medical Device Manufacturers:
The U.S. Food and Drug Administration (FDA) is aware of potential confusion and the possibility of inappropriate medical treatment based on the color of the bracelet or wristband provided by a device manufacturer and given to patients to be worn as an identifier of an implanted device. These are also called device identification patient bracelets or wristbands. The FDA became aware of the concern through information submitted in a recent complaint.
In 2008, the American Hospital Association (AHA) asked all U.S. hospitals to consider standardizing the color of their patient hospital wristbands as an improved safety measure, with these specific meanings:
- Purple to denote a patient's "Do Not Resuscitate" (DNR) status
- Red to denote a patient’s “Allergy”
- Yellow to denote that a patient is a “Fall Risk”
The FDA is aware that purple hospital wristbands are given to patients in many health care settings to denote DNR status. The FDA is also aware other purple wristbands may have different meanings. We encourage following AHA recommendations andreserve the use of purple bracelets or wristbands only for DNR status.
At this time, the FDA is not aware of reports of patient harm related to the color of device identification patient bracelets or wristbands.
Recommendations for Manufacturers
- Be aware of the 2008 AHA color recommendations for patient hospital wristbands.
- Use purple bracelets or wristbands only for DNR status.
- Be aware that a premarket submission is not needed to change the color of a device identification patient bracelet or wristband.
FDA Actions
The FDA is notifying medical device manufacturers who provide device identification patient bracelets or wristbands and working to ensure that all device manufacturers are aware of this issue.
The FDA appreciates your attention to this matter. If you have questions, contact the Center for Devices and Radiological Health's Division of Industry Communication and Education (DICE) at [email protected], 800-638-2041, or 301-796-7100.
Sincerely,
William H. Maisel, M.D., M.P.H.
Director, Office of Product Evaluation and Quality
Center for Devices and Radiological Health
