Latex gloves under fire again
By Myron Struck
Washington, D.C. — Latex gloves, a staple product in health care and cleanrooms industries, have come under attack by a public interest consumer watchdog group that contends the cornstarch used to make them easier to put on is an allergen causing more problems than it solves.
The attack, which calls for the U.S. Food and Drug Administration to issue a ban on powdered latex gloves, comes just months after the National Institute of Occupational Safety and Health issued a warning that cautioned workers exposed to latex gloves and other products containing natural rubber latex that they may develop allergic reactions such as skin rashes; hives; nasal, eye, or sinus symptoms; asthma; or even shock.
The warning has spurred the industry, and at least one manufacturer has moved to launch a new line of products, called Sterile N-DEX, which is based on a non-latex procedure glove that is nitrile based.
George Mack, general manager of Best Manufacturing (Menlo, GA) says: “It`s rare when you can truly say something is revolutionary, but this introduction comes as close as you can get.” The nitrile glove is the first non-latex sterile procedure glove for the medical industry, according to Best. The formal roll out in January followed a limited introduction at the Health Industry Distributor Association`s trade show in Chicago recently.
An estimated 2 percent of the general population and up to 21 percent of healthcare workers are sensitized to latex allergens. From August 1996 to August 1997, the FDA received 305 reports of allergic and anaphylactic reactions to latex gloves. In Oregon, a nurse reportedly died from latex shock. Fluid from a rubber tree is used to make latex products, and chemicals are added in the manufacturing process.
The attack on the powdered, latex-based gloves was launched by Public Citizen, a Washington, D.C., public interest group affiliated with noted consumer advocate Ralph Nader.
On January 7, Sidney Wolfe, the medical doctor who directs Public Citizen`s Health Research Group, Dr. Timothy Sullivan, Professor of Medicine at Emory University School of Medicine and Head of the Subsection of Allergy and Immunology at the Emory Clinic, and Public Citizen staff researcher Christine Dehlendorf filed a formal petition calling on the FDA to ban the powdered latex gloves as a “serious, unnecessary menace in hospitals and other health care facilities all over the country.”
“Safer alternatives such as powder-free gloves are easily and currently available, but too many hospitals are willing to cut corners and risk the health of their patients and employees,” Wolfe said in the petition to Dr. Michael Friedman, the lead deputy commissioner at the FDA. “As of last year, 26 percent of surgical gloves used in the United States were powder-free proving that this safer alternative is quite feasible.”
Many of the alternatives have been decried, however, as ineffective or subject to tearing as a result of not having a smoothing agent to allow easy use. That handicap led to the technological development at Best Manufacturing, which focused on a different medium than latex.
The Public Citizen petition calls on the FDA to ban cornstarch powder in the manufacture of latex surgical and examination gloves under section 516 of the Food Drug and Cosmetic Act, 21USC 360(f). The FDA`s reaction to the Public Citizen petition has been reported as sympathetic, but the government agency is opposed to an outright ban, pointing to the lack of alternatives.
Public Citizen cites epidemiological studies that show cornstarch can “inflame wounds and promote infection, and cornstarch-induced adhesions can produce intestinal obstruction, pelvic pain and infertility in patients” operated on by medical personnel wearing cornstarch-powdered surgical gloves. In addition, cornstarch acts as a carrier for latex protein/allergens, resulting in rhinitis, asthma and anaphylactic shock.
“Many health care workers have experienced such serious reactions to latex they have been forced to give up work,” Public Citizen said, complaining that the government`s 1997 warning, which goes into effect this September, is not strong enough. The lobbying group says that these warnings “are routinely ignored by the vast majority of health workers.”
Several major hospitals, including those at Harvard University, Boston and Miami have switched to latex-free gloves.
“If the FDA is to perform as a public health agency it must more definitively protect the millions of patients and tens of thousands of workers already allergic to latex,” Wolf said. “Unless definitive action is taken, not only will those people already allergic to latex continue to suffer serious, often life-threatening reactions, but the number of affected people will continue to rapidly increase as more and more exposure to airborne, latex-laden glove powder occurs.”
The Public Citizen report suggests that some surgeons are reluctant to use powder-free gloves because they perceive that they are more resistant to donning than powdered gloves. The group also says that concerns about the potential for leaks of powder-free gloves are ad dressed by the FDA`s quality control testing of medical gloves. The FDA`s guidance manual for manufacturers of medical gloves (issued December 12, 1990) describes the water leak method of testing used to ensure that all medical glove manufacturers meet a standard level of quality.
Hospitals have become concerned, in part because of potential concerns from workers and from patients. At the Mayo Clinic, a new innovative strategy to purchase gloves that markedly reduced the cost was developed. Since December 1993, Mayo Clinic has only used gloves with a low-latex allergen protein content.