Section 516 of the Federal Food, Drug, and Cosmetic Act (FDCA) grants FDA the authority to ban, by regulation, any device the agency finds to present “an unreasonable and substantial risk of illness or injury” when that risk cannot be “corrected or eliminated by labeling or [a] change in labeling.” 21 U.S.C. § 360f.
Powder, most typically cornstarch, is a commonly used lubricant in surgeons’ gloves and patient evaluation gloves. According to the proposed regulation, FDA has had longstanding concerns with powdered gloves. The agency was aware that “glove powder could cause inflammation and granulomas, and that aerosolized glove powder on natural rubber latex (NRL) gloves can carry allergenic proteins that have the potential to cause respiratory allergic reactions” as early as 1997, when it considered banning powdered gloves. Ultimately, the agency determined that no effective and widely available alternative existed at the time for glove lubrication.
After receiving several citizen petitions on the issue, FDA published a request for comments on the use of powdered gloves, specifically requesting comments on the risks and benefits of powdered gloves, 76 Fed. Reg. 6684 (Feb. 7, 2011), and published a draft guidance recommending warnings on powdered gloves.
As described in detail in the proposed regulation, FDA no longer believes that a warning on the product labeling would correct or eliminate the risks. The agency has concluded “that the risks posed by powdered gloves, including healthcare worker and patient sensitization to NRL allergens, surgical complications related to peritoneal adhesions, and other adverse health events not necessarily related to surgery, such as inflammatory responses to glove powder, outweigh the benefits that these devices pose to patients.” FDA also reviewed the available commercial information on sources for medical gloves, relative numbers and types of gloves and the costs of different glove types and concluded that “both industry and glove users appear to be shifting away from the use of powdered gloves, which has led to an increase in the manufacturing and usage of alternative non-powdered gloves” and that “powdered gloves now lag behind the state of the art.” According to the proposed regulation, the current state of the art includes numerous non-powdered latex and synthetic gloves that are “readily available and that do not carry the risks posed by powdered gloves” and that are as easily donned as powdered gloves. In sum, the agency concluded that the benefits provided by powdered gloves are so minimal that they do not outweigh the risk of injury or illness.
The proposed regulation, if finalized, will amend the classification regulations for powdered surgeons’ gloves, 21 C.F.R. § 878.4460, powdered patient examination gloves, 21 C.F.R. § 880.6250, and absorbable powder for lubricating a surgeons’ glove, 21 C.F.R. § 878.4480, to make clear that the regulations apply only to non-powdered gloves and will add the powdered versions of each glove type to the listing of banned devices in 21 C.F.R. Part 895. The ban would apply to powdered gloves currently being used in the marketplace, making them adulterated and subject to enforcement action under the FDCA. 21 U.S.C. § 351(g).
Other regulatory authorities and healthcare systems have either banned or restricted the use of glove powder, and professional organizations — including the National Institute for Occupational Safety and Health, the American College of Surgeons and the American Nurses Association — have issued statements discouraging the use of powdered gloves.
This historic announcement from FDA comes amidst calls for bans from a number of patient groups concerned about the safety of medical devices such as aversive conditioning devices, power morcellators, certain birth control implants and metal-on-metal hip implants. So far, FDA has not concluded there is sufficient scientific evidence of harm outweighing the clinical utility of any of these products, but the agency has acknowledged in several cases that it is considering whether to take further action in response to safety concerns. Until today, FDA’s banning a previously approved product may have seemed a remote possibility. The proposed powdered-glove action suggests that banning may be the regulatory tool of choice where the balance of harm versus utility is overwhelming and market forces have not resulted in the product’s removal.
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