89 days to have a hand in an FDA decision

For the next 89 days, the U.S. Food and Drug Administration will accept public comment on a proposed ban on the use of powdered medical gloves. Afterward, it will review the new information and make a final decision.

According to a report by Newsweek.com, on Monday the FDA issued the proposal, saying “the substance on the latex—meant to make it easier for surgeons and physicians to apply them for exams and other procedures—can cause serious harm, both to patients and health care providers.”

The ban would eliminate powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove from the entire medical industry.

“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” said Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, in a press statement. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”

The background behind the proposal, according to regulations.gov: two citizen petitions highlight the adverse health effects that can result from powdered glove use, including allergic reactions, irritation, and foreign body reactions resulting in inflammation, granulomas, and adhesions of peritoneal tissue after surgery, as well as glove powder’s ability to serve as a carrier of endotoxin.

Read more at: http://www.newsweek.com/fda-moves-ban-powdered-medical-gloves-439157

Share your comment with the FDA at: https://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0027-0001

One thought on “89 days to have a hand in an FDA decision

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s