August 18, 2021 – The U.S. Food and Drug Administration (FDA) this week sent a letter to medical device manufacturers asking them to follow AHA recommended standards and only use purple-colored bracelets or wristbands for DNR status.
The agency said it has had reports of manufacturers giving purple bracelets or wristbands to patients to identify they have an implanted device.
The FDA said it is concerned that it wanted to avoid “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.”
Premarket submission is not needed to change the color of a device identification patient bracelet or wristband.
In 2008, the AHA asked all U.S. hospitals to consider standardizing the color of their patient hospital wristbands as an improved safety measure. The agency recommended that manufacturers review and be aware of the following AHA color recommendations for patient hospital wristbands:
- 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 said it 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. At this time, the FDA is not aware of reports of patient harm related to the color of device identification patient bracelets or wristbands.