Public Citizen Seeks US Ban of Latex Surgical, Exam Gloves
The organization submitted a similar petition that FDA denied in 1999, but Public Citizen says the reasons cited for the denial are no longer valid and many glove manufacturers support a ban.
Public Citizen on April 25 submitted another petition asking the Food and Drug Administration to ban surgical and patient examination gloves with cornstarch powder on them. This petition also asks FDA to ban all natural latex surgical and patient examination gloves. The petition says these actions are necessary "because of the serious threat posed by these products to patients and healthcare workers and the ready availability of widely used safer alternatives (i.e., powder-free synthetic gloves)."
The petition is signed by Dr. Michael Carome, deputy director of the Public Citizen Health Research Group, and Dr. Sidney Wolfe, director of that group. Thirty-seven references are listed, including journal articles and comments in FDA regulatory dockets.
FDA gave three reasons for denying Public Citizen's previous petition in 1999, including an estimated $64 million increase in annual costs to health care facilities. But now Public Citizen says all three rationales are no longer valid, and its new petition says many glove manufacturers now support a ban. It also suggests "many incidents of allergic reactions secondary to latex gloves," including powder-free latex gloves, go unreported and are not captured by FDA's Manufacturer and User Facility Device Experience (MAUDE) database.
This petition is addressed to Dr. Margaret Hamburg, FDA commissioner, and Jeffrey Shuren, M.D., JD, director of FDA's Center for Devices and Radiological Health. "Given the serious threat posed by these products," it says, "it is not reasonable for FDA to rely upon the marketplace as the mechanism for removing them from use in the healthcare system.
"We also note that FDA has proposed placing a warning on the packaging of powdered latex gloves.," it continues. "Such an action is grossly inadequate for dealing with this problem and likely would have little to no impact on this serious problem which is already widely recognized throughout the medical profession. Furthermore, the warning would not be visible to most users of gloves in the healthcare setting. Such a proposal would be laughable if the problem were not so serious for patients and healthcare providers alike."