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AAST Update on Industry Standards

Posted by AAST Coordinator on Feb 28, 2017 9:57:29 AM

Banned Devices; Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove

A Rule by the Food and Drug Administration on 12/19/2016

On Jan 18th, 2017 the FDA’s final rule on using powdered surgeon gloves, powdered patient examination gloves and absorbable powered for lubrication a surgeon’s glove went into effect.  The FDA concluded that the risks posed by powdered gloves, including health care worker and patient sensitization to natural rubber latex allergens, inflammatory responses to glove powder is unreasonable and substantial.   The FDA has determined that the risk of powdered gloves cannot be corrected or eliminated by labeling or change in labeling.  The FDA also has determined that a transition to alternative gloves should not result in any detriment to public health.

Banning powdered glove products is not expected to impose any costs to society, but is expected to reduce the number of adverse events associated with using powdered gloves; adverse events that impose costs for the public health system. The FDA estimates maximum total annual net benefits to range between $26.8 million and $31.8 million.

This ban does apply to powdered gloves currently being use in the marketplace. In response to the recent ban of powdered gloves the Joint Commission will now evaluate organizations for compliance. 

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Topics: Sleep Technology Trends, Events, Sleep Medicine