Ensure your healthcare organization has removed all powdered gloves (powdered surgeon’s gloves, powdered patient exam gloves and absorbable powder for lubricating surgeon’s gloves) from the facility. As of January 18, 2017 these gloves have been banned by the FDA.
On December 19, 2016, the FDA published a final rule banning powdered gloves (powdered surgeon’s gloves, powdered patient exam gloves and absorbable powder for lubricating surgeon’s gloves) based on the unreasonable and substantial risk of illness or injury to patients and healthcare providers exposed to the powdered gloves and that the risk cannot be corrected or eliminated by labeling or a change in labeling.
The effective date of this rule applies to devices already in commercial distribution and those already sold to the ultimate user as well as to devices that would be sold or distributed in the future. ALL powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s gloves must be removed from the market upon as of January 18, 2017. Section 501(g) of the FD&C Act (21 U.S.C. 351(g)) deems a device to be adulterated if it is a banned device.
According to the FDA, the use of powder on medical gloves presents numerous risks to patients and health care workers. These devices are associated with an extensive list of potentially serious adverse events, including severe airway inflammation, hypersensitivity reactions, allergic reactions (including asthma), lung inflammation and damage or post-surgical bands of fibrous scar tissue that form between internal organs and tissues (adhesions). These adverse events have been attributed to the use of glove powder with all types of gloves. In addition, aerosolized glove powder can carry proteins that may cause respiratory allergic reactions
The FDA states, “The state of the art of both surgeon’s and patient examination gloves includes non-powdered alternatives that provide similar performance as the various powdered glove types do. That is, there are many non-powdered gloves available that have the same level of protection, dexterity, and performance. Thus based on a careful evaluation of the risks and benefits of powdered gloves and the risks and benefits of the current state of the art, which includes readily available alternatives that carry not of the risks posed by powdered gloves, DA has determined that the standard to ban powdered gloves has been met, and that it is appropriate to issue this ban.”
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