FDA proposes ban on powdered gloves in healthcare system

Ban proposed on the grounds of the ‘unreasonable and substantial risk of illness or injury the gloves pose to healthcare providers, patients and others who are exposed to them.’
Latex gloves
Image courtesy of Ambro from freedigitalphotos.net

Most powdered gloves may soon be barred from the US healthcare system.

The US’ Food and Drug Administration (FDA) has proposed the ban on the grounds of the ‘unreasonable and substantial risk of illness or injury the gloves pose to healthcare providers, patients and others who are exposed to them,’ reported Infection Control Today.

“This ban is about protecting patients and healthcare professionals from a danger they might not even be aware of,” said Jeffrey Shuren, MD, director of FDA’s centre for devices and radiological health.

According to the FDA, ‘aerosolised glove powder on natural rubber latex gloves, but not on synthetic powdered gloves, can carry proteins that may cause respiratory allergic reactions. Although powdered synthetic gloves do not present the risk of allergic reactions, these devices are associated with an extensive list of potentially serious adverse events, including severe airway inflammation, wound inflammation, and post-surgical adhesions, which are bands of fibrous scar tissue that form between internal organs and tissues. These side effects have been attributed to the use of glove powder with all types of gloves.’

The proposed ban would apply to powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove. However, the FDA has determined that the banning standard would not apply to powdered radiographic protection gloves.

Also, Infection Control Today noted that the FDA is ‘moving forward with the proposal’ due to these risks that cannot effectively be avoided through ‘new or updated labelling’. If finalised, the ban would ultimately remove powdered gloves from the marketplace.

www.infectioncontroltoday.com

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