The US Food and Drug Administration (FDA) has issued its final rule banning the use of powdered surgical gloves, powdered patient examination gloves, and absorbable powder for lubricating surgical gloves. Noting that these products present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling or a change in labeling, the FDA has banned them, effective January 18, 2017.
“This ban is about protecting patients and healthcare professionals from a danger they might not even be aware of,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”
Powdered gloves are associated with an extensive list of potentially serious adverse events, the FDA reports, including severe airway inflammation, hypersensitivity reactions, allergic reactions including asthma, lung inflammation and damage, and post-surgical bands of fibrous scar tissue that form between internal organs and tissues (adhesions). Also, aerosolized glove powder can carry proteins that may cause respiratory allergic reactions.
The FDA additionally states that nonpowdered gloves provide similar protection, dexterity, and performance without the risks. Also, the FDA says, the economic and shortage impact of the ban on the healthcare industry likely will be minimal. As a result, the FDA concludes, a transition to nonpowdered gloves should not result in any detriment to public health. In fact, the FDA expects the reduction in adverse effects associated with powdered gloves to yield a maximum total annual net benefit of $26.8 million to $31.8 million.
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