FDA ban on powdered medical gloves now in effect
Patient Safety Monitor, April 1, 2017
This is an excerpt from a member only article. To read the article in its entirety, please login or subscribe to Patient Safety Monitor.
The Food and Drug Administration’s (FDA) ban on powdered medical gloves went into effect on January 18. It’s now forbidden to use, advertise, and market powdered surgeon's gloves, patient examination gloves, and absorbable powder for surgeon's gloves at medical clinics and hospitals.
The Joint Commission also announced that all accredited programs are expected to comply with the FDA’s ban. Joint Commission surveyors will now issue citations on the ban under LD 04.01.01 element of performance (EP) 2.
Powders have been used to lubricate gloves for easy removal for more than 100 years. But since the 1930s alone, the type of powder used on medical gloves has been changed three times due to various medical risks. The powder currently used in medical gloves came under fire in 1997 when an FDA report found that it could cause severe airway and wound inflammation, granulomas, and post-surgical adhesions in the tissue between internal organs. Furthermore, aerosolized glove powder on natural rubber latex (NRL) gloves can carry allergens that can spark a respiratory allergic reaction in a patient or wearer.
“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 FDA’s Center for Devices and Radiological Health, in a press release. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”
The current ban was published in March 2016 and was the result of three citizen petitions sent to the FDA between 2008 and 2011. That said, the FDA was certain of the harmful effects of powdered gloves back in 1997, but it chose not to ban them due to a lack of alternatives. The most common lubrication alternative at the time was chlorination, which was known to damage gloves’ material. The agency believed a ban at that time would cause a medical glove shortage or promote the use of unsafe alternatives.
This is an excerpt from a member only article. To read the article in its entirety, please login or subscribe to Patient Safety Monitor.
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