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.

 

Phenelle Segal, RN, CIC, FAPIC

Phenelle Segal, RN, CIC, FAPIC, is the founder and president of Infection Control Consulting Services LLC (ICCS). Phenelle has more than 30 years' experience providing customized comprehensive infection control and prevention services to healthcare facilities nationwide. Her services focus on assisting hospitals, ambulatory surgery centers, dental office and oral surgery practices, doctor's offices, nursing homes and other organizations with implementing and maintaining an infection control program that: complies with The Joint Commission, AAAHC, Centers for Medicaid and Medicare Services (CMS) and other regulatory agencies; respond to situations of noncompliance; and improve the processes for reducing risk.