12/16/16

FDA Finalizes Ban on Powdered Surgeon Gloves, Citing Potential for 'Substantial Risks'


By on 12:31 PM

The U.S. Food & Drug Administration (FDA) has announced it is finalizing its ban on powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove.

The reason: FDA concluded these products "present unreasonable and substantial risk to healthcare providers, patients and other individuals."

FDA noted that powdered gloves are "very dangerous" for a few reasons:
  • They are associated with potentially serious adverse events, including severe airway inflammation, hypersensitivity reactions, allergic reactions, lung inflammation and damage or post-surgical bands of fibrous scar tissue that form between internal organs and tissues. 
  • Aerosolized glove powder can carry proteins that may cause respiratory allergic reactions.

FDA concluded that a transition to non-powdered alternatives should provide similar protection, dexterity and performance that powdered gloves do, without the risks associated with powder. 

This is only the second instance of an FDA ban of a device. The first was prosthetic hair fibers in 1983.

 

2 comments:

  1. As an OR nurse who had to completely leave the OR for several years because of the severe airway issues, I applaud this decision! I just wish it had come 18 years ago! My employer at the time refused to even admit that this was an issue...

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  2. Dianna, thank you for sharing your personal struggle with this issue. I am sorry that it interfered with your career choice at the time.

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