The U.S. Food and Drug Administration announced Monday, March 21, its proposal to ban the use of powdered medical gloves in the country.
The said ban includes powdered patient examination gloves, powdered surgical gloves and absorbable powder used for lubricating a surgeon's glove.
"This ban is about protecting patients and health care professionals from a danger they might not even be aware of," says FDA's Center for Devices and Radiological Health director Dr. Jeffrey Shuren.
Suren says that the agency considers bans as something very serious and that it only raises actions when there is a really a need to safeguard the public.
What's In A Powdered Glove?
Some gloves contain powder to help the user wear and remove the gloves more easily. While it is beneficial in that sense, the FDA says it poses different health hazards. For one, materials that have been converted into fine spray for powder applied to natural rubber latex gloves contain proteins that may possibly trigger respiratory allergies.
Such possibility does not apply for synthetic powdered gloves, but these products are associated with a number of serious adverse effects such as wound inflammation and severe respiratory tract inflammation. These effects have been linked with all glove types that contain glove powder.
Although the use of powdered medical gloves has shown a decreasing trend of use over the years, it still poses risks for injury or illness to medical staff, patients and exposed individuals. These threats cannot be corrected by updated labeling and for this; the FDA has decided to propose a ban for these products. If the proposal would push through, all powdered medical gloves in the market would be lifted.
How Did The FDA Decide On The Ban?
The FDA studied all existing evidences, literature and comments in the February 2011 Federal Register Notice.
The agency also analyzed the economic impacts of banning powdered medical gloves and found that there would be no shortage issues or significant impacts to the economy.
The medical field will most likely not feel heavy changes if the ban push through. This is because there are many available types of gloves aside from the ones that use powder.
Other Glove Use Amendments
Exception to the proposal is powdered radiographic protection gloves, which the FDA thinks is not currently available in the market.
If the proposal will take effect, the FDA would also like to make some amendments on the classifications of gloves to ensure that non-powdered gloves are not included and that these types of gloves should remain as Class I medical devices.
The public may soon comment on the proposed ban for 90 days via www.regulations.gov.