FDA Warns Implant Device Makers Not To Use Purple Wristbands To Identify Implant Patients

Federal regulators are warning medical device manufacturers not to use purple wristbands or bracelets to alert medical staff that a patient has a particular implant, since that color is reserved to identify patients who do not want to be resuscitated, and use of the color may lead to confusion by medical providers.

A letter to medical device manufacturers was sent by the FDA last week, following a recent complaint indicating an unidentified medical device manufacturer was giving out purple wristbands to patients who had received a particular device. The letter urges device manufacturers not use the color purple, red or yellow to denote the presence of implants, since those colors are reserved for other uses.

Specific color coded hospital wristbands were standardized by the American Hospital Association (AHA) in 2008, which set the color purple to denote a patient’s “Do Not Resuscitate” (DNR) status. It also set the color red to denote a patient with allergies and the color yellow to identify patients who had a high risk of falling.

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However, the agency received a complaint recently that a medical device manufacturer was providing device identification bracelets which were also purple to denote the presence of their implant, which the agency warns could cause confusion for hospital staff who may mistake the wristband as a DNR status. To date, the FDA has no reports of any incidents linked to the bracelets being confused.

“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,” the letter states. “We encourage following AHA recommendations and reserve the use of purple bracelets or wristbands only for DNR status.”

The FDA recommends following the 2008 AHA recommendations for patients and using purple bracelets or wristbands only for DNR status. The agency also recommended manufactures be aware that a premarket submission is not needed to change the color of device identification patient bracelets or wristbands.

Manufacturers with questions can contact the Center for Devices and Radiological Health’s Division of Industry Communication and Education (DICE) at DICE@FDA.HHS.GOV, or by calling 800-638-2041, or 301-796-7100.

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