The FDA Bans Powdered Gloves

by  Christine Woolstenhulme, QMC QCC CMCS CPC CMRS
Jan 20th, 2017

As of December 19, 2016, the FDA published a final rule banning powdered gloves due to substantial risk of illness or injury when exposed to powdered gloves. The FDA stated “The risks to both patients and health care providers when internal body tissue is exposed to the powder include severe airway inflammation and hypersensitivity reactions. Powder particles may also trigger the body's immune response, causing tissue to form around the particles (granulomas) or scar tissue formation (adhesion's) which can lead to surgical complications.”

This ban prohibits any current, future sales or manufacturing.

There has only been one ban on a medical device since June 1983, the ban was on Prosthetic Hair Fibers. The FDA states, “This device presented a substantial deception to patients or users about the benefits of the device. The prosthetic hair fibers did not stimulate hair growth nor conceal baldness, but could actually cause serious infections, illness, and injuries from their implantation.”

There is currently a proposal for banning the use of electrical stimulation devices (ESD). This proposal was introduced  April 22, 2016. 

The FDA points out there are patients being exposed to these devices that have intellectual or developmental disabilities that make it difficult to communicate to give consent or tell if they are in pain.   The FDA reports “A number of significant psychological and physical risks associated with the use of these devices, including depression, anxiety, worsening of self-injury behaviors and symptoms of post traumatic stress disorder, pain, burns, and tissue damage. In addition, there is a risk of errant shocks from a device malfunction. As these risks cannot be eliminated through new or updated labeling, banning the product is necessary to protect public health.”  The FDA is open to comments and has extended the closing date. To comment on the proposed Ban on electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior submit your comments here FDA Comments on ESD Ban.