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.
For healthcare workers, proteins in the latex can cause allergic reactions, some of which are serious or even life threatening, including contact dermatitis, rhinitis, conjunctivitis and even more serious conditions such as asthma or anaphylactic shock, Wolfe and Carome wrote.
Nancy Foster, Vice President for Quality and Patient Safety Policy for the American Hospital Association, said in an interview Tuesday that "latex gloves and other products are an important part of the current methods we use to protect against transmission of infection." She adds that there seems to be a growing trend to use non-latex products within the industry, although they are more expensive.
She emphasizes, however, that the Centers for Disease Control and Prevention has not advised against the use of such products, although the agency follows the issue closely.
"There are potential risks for many of the things we do," Foster says. "We and most hospitals follow the guidance from the CDC, and if it were to release information suggesting that the risk of infection from cornstarch were significant enough that people should look for alternatives, that would be something hospitals would clearly pay attention to. But we're not at that stage yet."
The letter from Public Citizen detailed its review of the FDA's Manufacturer and User Facility Device Experience (MAUDE) database and found that since 2005, there have been nine reports of serious allergic reactions in healthcare workers and one patient exposed to powder-free latex-gloves.
They include seven cases of serious allergic skin reactions, one case of allergic rhinitis and conjunctivitis, one case of a serious allergic skin reaction with anaphylaxis and one patient who died from anaphylaxis during surgery.
The consumer advocacy group says that the FDA has proposed a requirement that manufacturers place a warning on powdered latex glove products, but says "such action is grossly inadequate for dealing with this problem and likely would have little to no impact" on a problem widely recognized throughout the medical profession.
The letter says that in the FDA's 1999 explanation of reasons why it would not impose a ban on latex gloves and cornstarch, it estimated the increased cost to the healthcare industry of $64 million per year to purchase alternative products. However, Wolfe and Carome said that because so many hospitals have already made the transition, there is a bigger market and costs have significantly dropped.
In an interview, Carome said that he believes "the FDA recognizes that this is a serious problem. But pressure from the rubber industry in the late 1990s played a role." And while the FDA did list reasons for not ordering a ban, "we think their arguments are flawed."
Gina Pugliese, Vice President of the Premier Healthcare Alliance Safety Institute, affiliated with Premier purchasing alliance, says that many hospitals continue using latex because many doctors and surgeons prefer it because of its tactile sensation for specific procedures.
But other hospitals "are phasing out latex" because of those issues. "Children's hospitals are the first ones to go latex-free, as has the Cleveland Clinic."
Cost, she says, is no longer as much of a concern the two products are priced similarly. In fact, she says, only 15% of hospitals use latex. Some surgeons continue to prefer powder-free latex gloves "but there is a growing trend to non-latex, e.g. polyisoprene, though they cost twice as much."
Even if the products are more expensive, Wolfe and Carome say, studies at major medical centers that made the switch such as Geisinger indicate greatly reduced workers' compensation claims for latex-related illnesses since transitioning to powder-free latex gloves.
"These studies indicate that healthcare facilities are likely to benefit financially by transitioning to powder-free, latex-free surgeons' and patient examination gloves as the result of decreased workers' compensation claims, employee sick days, occupational health clinic visits, and early retirements due to permanent disability related to latex allergies."