Regulators in the US have moved to ban most powdered gloves because they pose a health risk to health professionals and patients, and new or updated labeling would not be enough to reduce the risk.
The Food and Drug Administration (FDA) note in their announcement this week that:
“The proposed ban applies to powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove.”
Dr. Jeffrey Shuren, director for Devices and Radiological Health at the FDA, says the purpose of the ban is to protect patients and health professionals from risks they may not even be aware of.
The FDA say they considered all the available evidence before proposing the ban. They reviewed all the available scientific literature and comments they received following a Federal Register Notice they posted in February 2011.
Powder in the form of cornstarch is sometimes added to gloves to make them easier for doctors, nurses and other health care professionals to put on and take off. But, note the FDA, there are several reasons why powdered gloves pose health risks.
One reason is that in natural rubber latex gloves, the aerosolized glove powder can carry proteins that can lead to respiratory allergic reactions. This is not the case, though, with synthetic (non-rubber) powdered gloves.
However, while synthetic powdered gloves do not present risk of allergic reaction due to the proteins that can adhere to the powder, the use of powder in itself is linked to a long list of potentially serious side effects, note the FDA.
These potentially serious side effects – which include severe airway inflammation, wound inflammation and post-surgical adhesions – have been attributed to the use of glove powder in all types of gloves.
Post-surgical adhesions are bands of scar tissue that form between internal organ and tissues.
The FDA say the purpose of the ban is to remove the products from the marketplace completely, as these risks “cannot be corrected through new or updated labeling.”
The federal authority also carried out an economic analysis that concluded a ban on powdered gloves would not lead to a glove shortage and would have no economic impact. It would not affect medical practice, because many non-powdered options are available, they note.
The ban does not apply to powdered radiographic protection gloves. The FDA note they are “not aware of any powdered radiographic protection gloves that are currently on the market.”
Public Citizen, the consumer watchdog group, say the ban is 18 years too late. In a statement, Dr. Sidney Wolfe, a senior adviser with the group, says they first petitioned the FDA in 1998 to ban powdered surgical latex gloves.
“The agency denied the petition,” says Dr. Wolfe, “but Public Citizen petitioned again in 2011, calling for all powdered medical gloves to be banned.”
He says there is no new evidence today that was not available in 1998 about the dangers posed by cornstarch powder and latex in surgical and patient examination gloves. Dr. Wolfe concludes:
“Had the FDA initiated the process of banning powdered medical gloves in 1998 instead of 18 years later, hundreds of thousands of health workers and patients would have been spared preventable, often life-threatening adverse reactions.”
The proposed rule will be available for public view and comment on the regulations website for 90 days.
In January 2015, Medical News Today learned of a study that suggests doctors can safely use clean, boxed gloves rather than the more expensive sterile gloves for minor surgical procedures. The researchers note that this could save practices $1.05 per pair of gloves, without increasing infection rates.