FDA warns of confusion with purple bracelets or wristbands for do not resuscitate status

Aug. 20, 2021

The U.S. Food and Drug Administration (FDA) issued a letter about potential confusion and the possibility of inappropriate medical treatment based on the purple color of wristbands designated for “do not resuscitate” status because a device manufacturer gave patients purple bands to be worn as an identifier of an implanted device.

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 and they encourage following AHA recommendations and reserve 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.

The FDA has issued a recommendation to manufacturers to be aware of the 2008 AHA color recommendations for patient hospital wristbands. 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.

FDA release

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