FDA Proposes Ban On Powdered Surgical Gloves

The Washington Post: The FDA, For Only The Second Time Ever, Wants To Ban A Medical Device. Here’s Why.
Powdered medical gloves — the kind used in surgery or to examine patients — would be ordered off the market under a new proposal by the Food and Drug Administration. That would put the gloves in an exclusive club — only one other device has been banned by the agency: prosthetic hair fibers in 1983. When an already approved device turns out to pose higher-than-expected risks, the agency usually tries to correct the problem by adding a warning to the label or changing how the device is used. But in the case of the gloves — and the hair fibers — the FDA concluded that no labeling fixes would do the trick. (McGinley, 3/21)

The Associated Press: FDA Moves To Ban Most Powdered Surgical Gloves
Federal health officials are moving to ban most surgical gloves made with powder, a feature designed to make them easier to wear, but which actually poses health risks to patients and health professionals. The Food and Drug Administration said Monday that the powder added to some latex gloves can cause breathing problems, wound inflammation, and scar tissue on internal organs when used during surgery. The agency proposed the ban Monday in a federal filing. (Perrone, 3/21)

NBC News: Food And Drug Administration Proposes Banning Powdered Surgical Gloves
The Food and Drug Administration proposed banning powdered surgical gloves Monday, saying the powder can carry dangerous allergens into the air. The FDA has been warning about the gloves for nearly 20 years. Powder makes the gloves easier to take on and off and absorbs sweat — but it can get into the air and even into surgical openings. (Fox, 3/21)

In other FDA news —

Modern Healthcare: MitraClip Recall Shines Spotlight On Surgeon Training, Testing Concerns
Abbott's recent recall of its new $30,000 heart valve repair device called the MitraClip led to an intensive educational campaign to retrain surgeons in proper implantation techniques. The speedy action will likely prevent thousands of injuries. But the voluntary action has also renewed concerns by patient safety advocates that some new devices are being thrown on the market without sufficient clinical testing or adequate training.The rapid response by Abbott and the Food and Drug Administration comes at a time when quality and safety researchers are increasingly concerned about the cascade of new medical devices and equipment being introduced into day-to-day practice. (Rubenfire and Rice, 3/21)

The Associated Press: FDA Approves New Injection To Combat Anthrax
Federal health officials have approved a new injectable drug to treat patients who have been exposed to the deadly toxin anthrax. The Food and Drug Administration said it approved Anthim on Friday to treat inhalation anthrax, which can cause serious injury and death. The condition occurs when anthrax bacterial spores are inhaled. (3/21)

CQ Healthbeat: Medicine Man Tackles Food Challenges At FDA
Before joining the Food and Drug Administration as a deputy commissioner in February 2015, Robert Califf, a cardiologist by training, spent most of his career running a clinical trial institute at Duke University. His expertise in clinical research was considered good preparation to lead an agency where those trials are ultimately analyzed as evidence in drug and device approvals. But with his elevation to FDA commissioner last month, he added a few new areas to his portfolio, including the agency’s $1 billion food safety mission. And while that area is outside of Califf’s traditional expertise, in a March 16 interview with CQ he described the many parallels he sees between food safety and the regulation of medical products. (Siddons, 3/21)