Suren says that the agency considers bans as something very serious and that it only raises actions when there is a really a need to safeguard the public.
Advertisement
The powder has been linked to airway inflammation, wound inflammation and post-surgical adhesions, which are bands of scar tissue that form between organs and tissues.
“This ban is about protecting patients and health care professionals from a danger they might not even be aware of”, said Dr. Jeffrey Shuren, head of the FDA’s medical device center.
The proposed ban would apply to all powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder used to lubricate surgeon’s gloves, though it would exclude powdered radiographic protection gloves.
For more than a century, various types of powder have been used make it easier for users to take gloves on and off. According to FDA, cornstarch is now the most common powdered lubricant used for medical gloves. For one, materials that have been converted into fine spray for powder applied to natural rubber latex gloves contain proteins that may possibly trigger respiratory allergies.
These threats can not be corrected by updated labeling and for this; the FDA has made a decision to propose a ban for these products.
Such a ban would not create a shortage and the economic impact would be insignificant, the FDA determined after reviewing the scientific literature and analyzing comments on a 2011 notice indicating the agency’s concerns.
How Did The FDA Decide On The Ban?
The ban is only the second medical supply banned by the government.
Non-powdered gloves used in surgeries and examinations will not be affected by this proposal. In that report, the agency stated that it had received numerous requests to ban glove powder due to health issues, such as an increase in the number of infections that could be tied to the powder. Therefore, the FDA is also proposing amendments to their classification regulations to clarify that they apply only to non-powdered gloves. If the ban is finalized, powdered gloves would be removed from the market completely.
Advertisement
The proposal is available online for public comment for 90 days.
