Devices

FDA Bans Powdered Gloves

For only the second time in almost 35 years, FDA has banned a medical device. This time it was powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove. Three Stinson Leonard Street attorneys write in an online blog post that the ban applies to products already in commercial distribution and already sold to ultimate users. The medical devices must be removed from the market by the agency rule’s 1/18 effective date.

FDA says it reviewed currently available information and concluded that the unreasonable and substantial risk of using the products outweighed their public health benefit. Risks cited by the agency included: healthcare worker and patient sensitization to natural rubber latex allergens, surgical complication related to peritoneal adhesions, severe airway inflammation, hypersensitivity reactions, allergic reactions, conjunctivitis, dyspnea, and granuloma. FDA said the benefits from the gloves were nominal and that disparity with the risks and the availability of non-powdered alternatives that provide similar protection met the standard necessary to justify the ban, the lawyers said.

The ban does not cover (1) powder used in the manufacturing process for non-powdered gloves, although the agency said that finished non-powdered gloves should include no more than trace amounts of residual powder; or (2) powder intended for use in or on other medical devices, such as condoms. Manufacturers will still be able to export existing inventory of powdered gloves to foreign countries if they comply with those countries’ law and if they are authorized to be marketed by the appropriate regulatory agencies of those countries.

The agency banned prosthetic hair fibers in 1983.

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

Read more

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