Believe it or not, simple powdered gloves could endanger someone's life. The Food and Drug Administration is seeking to put a nationwide ban on the use of this type of gloves as it is associated with several health risks.
A press release published by the FDA narrated the reasons why they have decided to propose the ban. "This ban is about protecting patients and health care professionals from a danger they might not even be aware of," Dr. Jeffrey Shuren, head of the FDA's Center for Devices and Radiological Health, said in a statement. "We take bans very seriously and only take this action when we feel it's necessary to protect the public health."
The press release stated that the use of the powdered gloves poses illness or injury risk to those individuals who are exposed to such, including health care providers and patients. These risks cannot be corrected through new or updated labeling.
The said ban is applicable to powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove.
According to the FDA, the banning standard is not applicable to powdered radiographic protection gloves, non-powdered surgeon gloves, and non-powdered patient examination gloves. These, however, will be labelled as Class I medical devices. Meaning to say, together with this ban comes the proposal to amend classification regulations in order to provide clarifications.
Furthermore, the press release stated that the ban will not, in any way, affect the performance of medical experts and will not likely have an impact on medical practice in general.
The proposed ban came after thorough study and research by the FDA. "In making the determination that these products are dangerous and present an unreasonable and substantial risk, the FDA considered all available evidence, which included a thorough review of the available scientific literature and comments received on a February 2011 Federal Register Notice. In addition, given the critical role medical gloves play in protecting patients and health care providers, the FDA also conducted an economic analysis that showed a powdered glove ban would not cause a glove shortage and the economic impact of a ban would not be significant," the press release stated.
Meanwhile, the proposed rule is available online at www.regulations.gov for public comment for 90 days.
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