March 21, 2016
Eighteen Years Too Late: FDA Finally Heeds Public Citizen's Call, Moves to Ban Powdered Latex Surgical Gloves -- and all Powdered Medical Gloves
Statement of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group
Note: Public Citizen petitioned the U.S. Food and Drug Administration (FDA) in 1998 to ban powdered surgical latex gloves. The agency denied the petition, but Public Citizen petitioned again in 2011, calling for all powdered medical gloves to be banned.
The fact that it took the FDA 18 years to propose banning powdered surgical gloves from the market highlights how recklessly negligent the agency is. There is absolutely no new scientific information today that we didn’t have in 1998 about the dangers posed by cornstarch powder and by latex when used in surgical and patient examination gloves.
Alternatives to powdered medical gloves have existed for decades. Even in 1998, a quarter of all surgical gloves were powder-free. So the FDA could have taken action when Public Citizen first called for it. Instead, powdered medical gloves are still widely used today.
The idea behind the use of powder on gloves is to make it easier for medical workers to slip them on. But ease of use is not worth the risks: Cornstarch can get into surgical wounds and cause inflammation and infection, among other problems in surgical patients. When used on latex gloves, latex can adhere to the cornstarch and can cause serious allergic reactions such as asthma and anaphylactic shock when medical personnel inhale the latex-containing powder.
The FDA had the legal authority to ban these gloves in 1998. The agency should have used that authority to protect hundreds of thousands of hospital workers who have been exposed to the powder. 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.
When a medical product, drug or, in this case device, has unique serious risks but no unique benefit, it should be banned. The FDA’s statement that “we … only take this action when we feel it’s necessary to protect the public health” ignores overwhelming evidence going back almost two decades about the necessity to do so.