FDA adds to momentum to limit use of powdered latex gloves in hospitals

New labeling will give hospitals greater choice

Concerns over latex allergy are causing a rapid shift in glove use at hospitals, as state and federal regulators move to limit the use of powdered latex gloves.

The Food and Drug Administration (FDA) will release a final regulation later this spring that sets recommended maximum levels of protein and powder content of latex gloves and requires labeling of those ingredients. For the first time, hospitals will be able to purchase gloves based on their protein or powder content.

Some state legislatures are considering bills to address latex allergy, and New Jersey’s Department of Health is considering guidelines that would urge hospitals to eliminate powdered gloves.

The FDA and many latex experts contend that a switch to powder-free gloves can greatly reduce the incidence of latex allergy among health care workers. The U.S. Occupational Safety and Health Administration and the National Institute for Occupational Safety and Health have both recommended the use of powder-free gloves.

"The research has clearly shown what the problem is," says Gordon Sussman, MD, associate professor of medicine at the University of Toronto and a leading researcher of latex allergy. "I don’t think there’s much doubt. It’s the proteins in the latex, [and] the powder acts as a carrier."

Even without required limits, hospitals are rapidly moving away from the more allergenic powdered gloves. The FDA estimates that powdered glove use will decline from 65% of the market to 20% within four years, lowering the annual number of allergic reactions to about 4,800. Based on reports to the Adverse Experience Reporting System, the FDA estimates that there are currently 43,500 allergic reactions to latex medical gloves each year.1

Lower protein and powder content would further reduce allergic reactions to about 1,000 cases a year, the FDA asserts.

By deciding not to ban powdered gloves, some latex allergy experts say the FDA did not go far enough in its proposed rule, which doesn’t become effective until two years after it is finalized and doesn’t remove even the most allergenic gloves from the market.

"I believe the data are strong enough to say that the powdered natural rubber latex glove is . . . the primary factor that elicits occupational exposure to health care workers," says Robert Hamilton, PhD, associate professor of medicine at Johns Hopkins University School of Medicine in Baltimore. "I think [the FDA rule] is a positive move, but I don’t think it’s going to be sufficient."

Hospitals increasingly are powder-free

The risk of latex allergy and what should be done to prevent it have stirred controversy and provoked hundreds of lawsuits against glove manufacturers. (See Hospital Employee Health, November 1999, p. 126.) Some consumer and union groups have called for a federal ban on powdered gloves, while latex backers have cautioned against a backlash that could lead to the use of gloves with less durability.

"Inconsistent federal and state initiatives to ban the use of powdered natural rubber latex gloves, lacking a sound scientific basis, have potentially ominous and costly implications for physicians, hospitals, and other health care providers," stated F. Samuel Eberts III, assistant general counsel for Allegiance Healthcare Corp. of McGaw Park, IL, in a response to federal and state measures that was released on a latex Web site (www.ppdnet.com/latex_gloves.htm).

Allegiance, a leading manufacturer of latex and synthetic medical gloves, supports the FDA rule but believes customers should have the option of using powdered varieties, says spokeswoman Donna Gaidamak.

"We’ve got clinical educators who work with our customers and try to help them set up protocols and identify latex-sensitive individuals," says Gaidamak. "If one of our hospital customers wants to go in that direction [of powder-free gloves], we’re happy to support them."

Powder-free gloves cost, on average, $5.80 per 100, compared to $3.90 for powdered gloves, according to an FDA analysis. That amounts to about two cents more per pair.

Yet some medical organizations have endorsed a switch to powder-free gloves, including the American College of Surgeons in Washington, DC, and the American College of Allergy, Asthma and Immunology in Arlington Heights, IL.

While it is rare for hospitals to ban latex gloves altogether, the switch to powder-free gloves is becoming more commonplace as a relatively painless way to protect sensitized workers, who can be exposed through particles on airborne powder.

For example, the two hospitals in the Heritage Valley Health System in Sewickley, PA, switched to a powder-free environment on the advice of a hospital task force. Powder makes it easier to don and remove gloves, but the powder-free gloves haven’t led to any problems, says Mary Ann Gruden, MSN, CRNP, NP-C, COHN-S/CM, an employee health nurse practitioner at Sewickley (PA) Valley Hospital.

"I have not heard any complaints from the staff with regard to using a powderless glove," she says. A task force of surgeons and operating room staff is considering alternatives to latex, as well, she says.

With the proposed FDA rule that would require labeling, Gruden says the hospital could consider purchasing only low-protein gloves to further reduce exposure. "It would also encourage manufacturers to provide the best gloves as their product, realizing that lower levels of powder and protein decrease the risk to employees but provide the same level of protection," she says.

A multidisciplinary task force at Dartmouth Hitchcock Medical Center in Lebanon, NH, conducted trials in which various health care workers tested different brands and types of gloves for tensile strength, comfort, and dexterity. "We phased out any powdered latex exam gloves in the institution and replaced them with nothing but powder-free latex," says Kathleen Golden McAndrew, MSN, ARNP, COHN-S, CCM, department director and nurse practitioner in the hospital’s section of Occupational Medicine.

Dartmouth-Hitchcock has increased its stock of vinyl and nitrile gloves and created an algorithm to help employees determine which glove would be most appropriate for different tasks.

"We’re encouraging everyone to use latex-free wherever possible," McAndrew says.

Educational programs also have prompted employees to seek treatment of dermatitis as soon as symptoms appear. That skin reaction is not always due to latex and may occur in response to chemicals in the glove or in response to other factors, such as trapped moisture, she notes.

McAndrew acknowledges that the changes have increased the cost of medical gloves. "How ever, as more and more demand is made for natural rubber latex substitutes, we’re seeing the prices go down," she says. "We hope that’s a continual process."

Latex allergy linked to exposure

Just what is the risk of latex allergy to health care workers? That question is still the subject of some debate.

Various studies show that 8% to 12% of health care workers are allergic to latex, compared to 1% to 6% in the general population.2,3 In fact, some studies have found much higher rates among workers with high levels of exposure.4 Yet efforts to determine more precise information on prevalence have been hampered by limitations of blood tests, which can show false positives or negatives.

Studies also often don’t provide information on actual exposure to latex, making comparisons less useful. For example, some health care workers may have duties that rarely require them to wear gloves, while others, such as operating room nurses, have extraordinarily high exposure. Conversely, some non-health care occupations may require workers to use latex gloves or other latex materials. (For a related article on prevalence of latex allergy, see p. 30.)

Sussman tried to determine the risk of latex allergy among health care workers at a hospital in Hamilton, Ontario, by following them for a year between 1994 and 1995 to record new cases of sensitization. At baseline, 12% of the employees had a positive skin-prick test for latex allergy.

Of those who tested negative (indicating no allergy), 227 used powder-free gloves and 208 used powdered gloves. A year later, only four conversions had occurred — two in the powdered glove group and two in the powder-free group. Only the employees using powdered gloves were symptomatic for latex allergy.5

The study doesn’t indicate that powdered and powder-free gloves are equivalent, says Sussman, who is head of allergy and the section of immu nology at St. Michael’s Hospital in Toronto. "If you have a resistant group of people you’re looking at, you may not see many conversions," he says, noting the high level of sensitization found at baseline. With few conversions to evaluate, the study’s conclusions are limited, he says.

In fact, the protein levels in the powdered gloves declined during the study period, Sussman reported. Protein levels in different batches of gloves may vary greatly, complicating clinical studies, he says.

"These results should not be interpreted to suggest that low-protein, powder-free gloves have no effect on reducing latex sensitization," Sussman states. "Additional studies involving larger populations for longer periods of follow-up are required." Despite the inconclusive results, Sussman says he recommends the use of powder-free gloves.

FDA sets recommended limits

The FDA’s proposed rule would define the term "powder-free" and would require manufacturers to measure and label the amount of powder and protein in all latex medical gloves.

The FDA found that powder levels currently range from 70 mg to 375 mg per glove in surgical gloves and from 50 mg to 426 mg per glove in patient examination gloves. The proposed rule would set a recommended limit of no more than 120 mg of powder and 1,200 mg of water-extractable protein per glove.

"One of the biggest issues is reducing the sensitization rate," says Mel Stratmeyer, PhD, chief of the health sciences branch in the office of science and technology at the FDA’s Center for Devices and Radiological Health. He notes that cornstarch powder "provides a route of exposure we’d like to see reduced."

But Stratmeyer acknowledges that the FDA rule isn’t likely to please those who want to see a complete elimination of powdered gloves. "The limit is not going to assure absolute safety at all for somebody who is sensitized," he says. "It’s based on what’s technologically feasible without causing a shortage in the market and all kinds of other considerations."

The FDA also is conducting its own research to determine the possible need for tougher regulations. An analysis of medical glove adverse event reports covered 2,396 reports between 1985 and March 1999.

Nurses working in an inpatient facility represented the largest group. Rash was the most common dermatologic symptom, and anaphylaxis and asthma were among the non-dermatologic symptoms.

The number of reports were "enough for us to take notice that there appears to be some problem that warrants investigation," says Brockton Hefflin, MD, MPH, medical officer in FDA’s division of postmarket surveillance.

To Hamilton, the solution is clear. "The most effective and possibly the least expensive [way to eliminate latex allergy] is avoidance," says Hamilton, noting that Johns Hopkins University has decided to convert to synthetic gloves, using vinyl for nonsterile examination gloves and nitrile for surgeon’s gloves. (See HEH, September 1999, p. 99.) Surgeons also may have to retain the option of using powder-free latex gloves. Hamilton also led a multicenter investigation of a new latex skin test reagent; its use is pending approval by the FDA.

"If you take the allergen out of the environment, you are improving that environment for the patient and for the worker in that environment," says Hamilton.

(Editor’s note: A copy of the proposed rule is available on the FDA Web site at www.fda.gov/ohrms/dockets/ 98fr/073099a.txt.)

References

1. Department of Health and Human Services, Food and Drug Administration. Proposed rule. Surgeons’ and patients’ examination gloves; reclassification. 64 Fed Reg 41,709 (July 30, 1999).

2. National Institute for Occupational Safety and Health. NIOSH Alert: Preventing Allergic Reactions to Natural Rubber Latex in the Workplace. DHHS (NIOSH) Pub. No. 97-135. Washington, DC: NIOSH; 1997.

3. Brown RH, Schauble JF, Hamilton RG. Prevalence of latex allergy among anesthesiologists. Anesthesiology 1998; 89:292-299.

4. Karvonen CA. Latex allergy in health care workers: What are the risks? AAOHN Journal 1999; 47:519-525.

5. Sussman GL, Liss GM, Deal K, et al. Incidence of latex sensitization among latex glove users. J Allergy Clin Immunol 1998; 101:171-178.