Devices

FDA Says Purple Wristbands, Bracelets Only for DNR

FDA says it is aware of potential confusion and the possibility of inappropriate medical treatment based on the color of the bracelet or wristband provided by a medical device manufacturer and given to patients to be worn as an identifier of an implanted device. An online notice says in 2008 the American Hospital Association (AHA) asked all hospitals to consider standardizing the color of patient wristbands so that purple would denote “Do Not Resuscitate (DNR)” status, red would denote a patient’s “Allergy,” and yellow would denote that a patient is a “Fall Risk.”

“FDA is aware that purple hospital wristbands are given to patients in many healthcare settings to denote DNR status,” the notice says. “FDA is also aware other purple wristbands may have different meanings. We encourage following AHA recommendations and reserve the use of purple bracelets or wristbands only for DNR status.”

The notice says the agency is not aware of reports of patient harm related to the color of device identification patient bracelets or wristbands.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome