The FDA's failure to ban latex gloves or the use of cornstarch in their manufacturing process "demonstrates astonishingly reckless and inexcusable disregard for the health and safety of patients and healthcare workers," says Public Citizen Health Research Group.
In a letter to the federal agency Monday, the advocacy group said that because the U.S. Food and Drug Administration has refused to take action on this and several similar petitions over the last 13 years, "untold numbers of preventable serious injuries have continued to occur to both patients and healthcare workers exposed to these extremely dangerous products."
An FDA spokeswoman declined comment.
In the group's letter, Public Citizen director Sidney Wolfe, MD and deputy director, and Michael Carome, MD accused the agency of acting "in the interests of cornstarch-powdered and latex glove manufacturers," who have opposed the ban, rather than "in the interests of public health." Although they are more expensive, non-latex products are now in use at many healthcare systems including Johns Hopkins in Baltimore, Kaiser Permanente, Legacy Healthcare in the Northwest and Geisinger Medical Center in Pennsylvania Alternatives, the letter says.
Serious problems with the latex products containing cornstarch may occur in both the clinicians who use them as well as their patients. When providers don and remove the gloves, the cornstarch powder can become aerosolized to cause allergic reactions in patients.
The powder also can be deposited in tissue of patients during surgery. When that happens, it can promote wound infections, delay healing, cause granuloma formation or intestinal obstruction, pelvic pain, and infertility secondary to peritoneal adhesions, as well as several other adverse events, Public Citizen says.