Posternak Blankstein & Lund LLP is now Arent Fox. Read the press release

Purple Means DNR: FDA Issues Letter to Medical Device Manufacturers on Color-Coded Wristbands

Hospitals have long used color-coded wristbands as a patient safety initiative. Recently, the FDA issued a letter to medical device manufacturers to caution them against using colors for device identification wristbands that could create confusion for clinicians and result in inappropriate medical treatment.

What Does Red Mean, Again?

If you look around a healthcare facility, you may notice that certain patients are wearing wristbands of various colors. One color might denote that a patient has an allergy, for example, while another might denote that a patient is a fall risk. And, critically, a third color may denote a patient’s “Do Not Resuscitate” (DNR) status.

Recognizing the risks associated with wristband color schemes varying from facility to facility, the American Hospital Association (AHA) issued a statement in September 2008 asking that all U.S. hospitals adhere to standardized colors for alert wristbands:

  • Red for patient allergies
  • Yellow for a fall risk
  • Purple for DNR patient preferences

AHA’s statement came on the heels of color-coding mix-ups such as one incident in Pennsylvania, where clinicians almost failed to resuscitate a patient who had erroneously received a yellow wristband—the nurse who placed the wristband also worked at a nearby hospital where yellow meant “restricted extremity,” but at the hospital in question that same color signified DNR.

FDA’s Caution to Medical Device Industry

On August 16, 2021, FDA issued a letter to caution medical device manufacturers about causing similar confusion.

Certain device manufacturers provide color-coded wristbands to patients that are meant to identify an implanted device. Per FDA, a recently submitted complaint brought to the agency’s attention the risk of confusion between the color of these device identification wristbands and the standardized hospital wristbands.

To avoid confusion and the risk of inappropriate medical treatment, FDA recommends as follows:

  • “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.”

While FDA specified that it is not currently aware of reports of patient harm due to a mix-up between the color of a device identification wristband and a hospital-issued wristband, device manufacturers should nonetheless take care in this area and adhere to the agency’s recommendations above.

If you are interested in more information about medical device regulations, requirements, and pertinent recommendations from FDA, please contact Arent Fox’s FDA Practice Group.


Continue Reading