Monday, 19 December 2016

It's Final: FDA Bans Powdered Gloves in Surgery, Medicine

The US Food and Drug Administration (FDA) has finalized a rule banning the use of
powdered gloves in medicine because they pose dangers to human health.
The ban, first proposed in March 2016, will further propel efforts already underway
to phase out the use of prepowdered surgeons' gloves, powdered exam gloves, and
absorbable powder for lubricating surgeons' gloves. Professional societies have
advocated for a ban, and many large health systems have already either restricted
or completely ended the use of such products, as have a majority of individual
clinicians.
"While medical gloves play a significant role in protecting patients, healthcare
providers, and other individuals in close proximity, powdered gloves are very
dangerous for a variety of reasons," the FDA said in a statement.
Powder used within all types of gloves has been associated with many potentially
serious adverse events, including severe airway inflammation, hypersensitivity
reactions, allergic reactions (including asthma), lung inflammation and damage,
granulomas, and peritoneal adhesions.
Respiratory allergic reactions can also result from proteins in aerosolized glove
powder, the FDA notes.
According to the agency, nonpowdered alternatives to both surgeons' and patient
examination gloves are available that provide similar protection, dexterity, and
performance but without any of the risks associated with powdered gloves. "Thus, a
transition to alternatives in the marketplace should not result in any detriment to
public health."
Most device removals from the US market are initiated by manufacturers, not the
FDA. In fact, this is only the second time the FDA has ever done so. The first was the
removal of prosthetic hair fibers in 1983. The FDA has now proposed one other ban,
on the use of electrical stimulation devices to treat self-injurious or aggressive
behavior.
Source : Medscape

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