FDA rule to require latex labeling
Activists say HCWs need more protection
Responding to numerous reports of severe allergic reactions among health care workers and patients, the U.S. Food and Drug Administration has proposed a regulation requiring medical device manufacturers to label all devices containing natural-rubber latex and to remove hypoallergenicity claims from latex medical gloves and other latex medical devices,1 but those who have long pushed for the law protest that it does not go far enough to protect workers.
The new law would require all latex-containing medical devices "that may directly or indirectly contact living human tissue to be labeled with a statement identifying the product as one which contains natural rubber latex and which may cause allergic reactions," the proposed regulation states.
It also prohibits manufacturers from labeling latex and latex-containing medical devices as hypoallergenic. The FDA finds that labeling "false and misleading," the proposal says, because it implies those products can be used safely by latex-sensitive persons.
"FDA has received reports of sensitivity to medical gloves labeled as hypoallergenic.’ FDA believes that this term, traditionally used with cosmetics, erroneously implies that the user . . . is assured that the risk of an allergic reaction to the chemicals or other materials in the products would be minimal. . . . [C]urrent manufacturing processes cannot remove from devices the natural latex proteins below the level to which some individuals may be sensitive. Thus the risk of allergic reaction remains," the document states.
Dennis E. Marlowe, director of the office of science and technology in the FDA’s Center for Devices and Radiological Health, says the FDA is "trying to get control of the vocabulary surrounding gloves" and other latex medical products.
"Hypoallergenic’ has a certain connotation accepted by the public, but once a person is sensitized to latex protein, any exposure will elicit a reaction, so hypoallergenicity can’t be achieved," he says. "We have to break the habit of [erroneously] using that term. There’s going to be a vacancy in the vocabulary until a new word or phrase is found to replace it."
Marlowe says the agency will take steps to quantify protein levels present in latex medical products and to require that those products be labeled with their protein content.
Hospital Employee Health twice contacted the Healthcare Industry Manufacturers’ Association in Washington, DC, for comments on the proposed regulatory changes, but a spokesperson said the organization was not prepared to respond.
Warning label not strong enough?
Devices affected by the proposed rule (see partial list on p. 126) would be required to be labeled with one of the following statements: "This product contains natural rubber latex which may cause allergic reactions in some individuals"; "This product has components that contain natural rubber latex which may cause allergic reactions in some individuals"; or "This product is made from natural rubber latex which may cause allergic reactions in some individuals." Options are provided so manufacturers can choose the language most appropriate for their products, and the FDA will consider comments recommending alternative language for the proposed labeling statements.
One activist who is not happy with the rule’s present language options is Lisa Borel, DMD, a West Chester, PA, dentist who was forced to give up her practice after 10 years because of severe latex allergy. She now suffers from latex-related occupational asthma, requires oxygen when she leaves home, and says she winds up in the intensive care unit "on a regular basis." Unable to work for the past two years, Borel is co-executive director of the Education for Latex Allergy Support Team and Information Coalition (ELASTIC), a national organization with nearly 9,000 members, most of whom are latex-sensitive HCWs.
Borel says the proposed warning language is not strong enough to alert device users to the true dangers of latex exposure.
"People need to know latex can cause a life-threatening reaction. If people see that proposed warning, they’ll think it’s [referring to] only a rash. There’s a big difference between dermatitis and asthma or anaphylaxis. Continued use of latex products in a sensitive individual can have disastrous results," she states.
In addition, Borel would like to see a federally mandated education component of the labeling requirement with instructions about appropriate glove selection and warning signs of latex sensitivity.
Two years in the making, the proposed regulation is designed to help ameliorate the pervasive problem of latex sensitivity among HCWs. The 1996 Hospital Employee Health reader survey asked employee health practitioners whether any workers at their facility have a diagnosed latex allergy. Seventy-five percent of respondents said yes up from 62% in 1995 with some indicating that 25 or more employees are affected.
Since 1988, the FDA has received about 1,000 reports of allergic and anaphylactic reactions experienced by HCWs and patients associated with latex-containing medical devices.
The occupational illness has grown to epidemic proportions over the past five years, with current reports estimating that between 8% and 17% of exposed HCWs are at risk for latex reactions ranging from chronic dermatitis to urticaria, asthma, and anaphylaxis.2-7 It is believed that the rise in latex allergies has resulted not only from increased occupational exposure to latex, but also from a change in latex gloves’ allergenicity. (See related story in Hospital Employee Health, September 1995, pp. 109-115.)
The numbers of HCWs who have been forced out of their careers due to severe latex sensitivity is rising steadily, with many forming and joining activist education and support groups such as ELASTIC. Another such group is Allergy to Latex Education and Resource Team (ALERT), founded by Sue Lockwood, a former surgical tech in Milwaukee. Unable to work for the past five years due to severe latex allergy, Lockwood was one of the first of a gradually increasing number of HCWs to win a worker’s compensation case. (See related story in Hospital Employee Health, February 1994, pp. 13-18.)
Adhesives can contaminate nonlatex devices
Although the organization "in general" supports the proposal, ALERT’s comments to the FDA come from "a clinical perspective," Lockwood says. ALERT makes the following points not addressed in the proposal:
• The packaging of many medical devices is sealed with latex adhesives. When packages are opened, some of the adhesive can come into direct contact with the device being removed, so even nonlatex devices can become contaminated with latex.
• Latex gloves used in hospitals and medical offices often are removed from the boxes they came in and placed in dispensers, so users never have the opportunity to see the original boxes that would bear the warning labels.
"The clinician has the right to know about the latex content of the gloves; therefore, we recommend that the regulation specify that devices remain in their original packaging, which must be clearly visible," says Lockwood.
The proposal suggests that the warning message might be conveyed by using a symbol, especially on smaller devices. ALERT opposes the idea, stating that a symbol might not be recognized or interpreted accurately. "The implications for education are vast, and we discourage relying on a symbol in place of written labeling," she adds.
Both ELASTIC and ALERT are concerned about nonmedical latex items not regulated by the FDA. These would include other latex gloves often referred to as utility, protective, or general purpose gloves commonly used by housekeepers and food service workers in hospitals. Also included are many other latex products used by workers in other industries, as well as the general public. The two organizations are urging the FDA to launch discussions with other federal agencies that have broader jurisdiction.
A 4,000-member physicians’ organization has consistently pushed for regulatory reform to help protect HCWs and others at high risk of allergic reactions to latex.The American College of Allergy, Asthma and Immunology (ACAAI) in Arlington Heights, IL, last year issued a position statement calling for significant changes in occupational health guidelines and government regulations. (See related story in Hospital Employee Health, September 1995, pp. 109-115.)
Specifically, the ACAAI called for the FDA and other government agencies to:
• establish maximum levels of extractable latex allergen in gloves;
• "fast track" the approval process of diagnostic reagents for latex allergy;
• conduct or fund epidemiologic studies to identify causes of latex allergy and minimize risk factors;
• address issues of patient-worker safety in the medical setting;
• consider content labeling for consumer products that contain latex rubber.
While the proposed regulation addresses content labeling, it doesn’t deal with the maximum extractable protein levels gloves can contain or with other measures considered necessary, says B. Lauren Charous, chairman of the ACAAI latex hypersensitivity committee and a latex allergy specialist at the Milwaukee Medical Clinic, where many of his patients are allergic HCWs.
"These initial steps are excellent, but they don’t go far enough," he says. "What the FDA has done is a first step. The other points still need to be addressed in a comprehensive way."
First, although the FDA plans to establish latex products’ protein levels, studies show that protein does not necessarily correlate accurately with antigenicity, Charous points out.
"[Measuring protein levels] is not enough, because you could still sell high-allergen gloves. Gloves have to be measured for allergens. Allergens are proteins, but there can be lots of proteins. One glove that was a high protein releaser had a lot of caseinate [a milk-derived protein] in it. It released a lot of casein, but casein is not allergenic to most people. It has nothing to do with latex allergy. The point is that these gloves are actually low-allergen gloves. That’s the problem with measuring proteins. They’d be measuring something, but they’d be measuring the wrong thing, not the right thing," he says.
Judging the safety of gloves by protein levels will produce two results, he adds: latex-sensitive HCWs will react to them, and even more workers will become sensitized to latex.
Second, Charous notes that the FDA has taken no steps to fast-track the approval process for diagnostic skin-test reagents.
"We still have people using either home-brew latex test methodology or not testing," he says. "We need interim approval of reagents that are in common usage in both Canada and Europe. Right now there’s nothing. We’re the only industrialized country where no skin-test reagent is available, and for the diagnosis of a possibly life-threatening entity, that is just not acceptable."
Last year, the FDA approved the first blood test to measure latex antibodies (see related story in Hospital Employee Health, May 1995, pp. 66-68), but Charous says the test "misses a significant number of people, including people with a history of anaphylaxis." A skin-prick test would be more sensitive, allowing more HCWs to be properly diagnosed.
Third, Charous says the ACAAI is not aware of any comprehensive epidemiologic surveillance programs that have been undertaken to identify the causes of latex allergy.
"It’s critical," he states. "We need to know the risk factors for latex allergy. We need to know the progression of latex allergy, and we need to know the effect of the reduction of latex allergen in hospital and clinic settings. There are some small studies but nothing longitudinal. These are important questions."
Finally, the ACAAI calls upon the Centers for Disease Control and Prevention and the U.S. Occupational Safety and Health Administration to cooperate in developing institutional guidelines for latex safety. The ACAAI has helped develop a set of guidelines that will be distributed to hospitals and other medical settings soon.
References
1. Department of Health and Human Services, Food and Drug Administration. Latex-containing devices; user labeling; proposed rule. 61 Fed Reg 32,617 (1996).
2. Arellano R, Bradley J, Sussman G. Prevalence of latex sensitization among hospital physicians occupationally exposed to latex gloves. Anesthesiology 1992; 77:905-908.
3. Berky Z, Luciano J, James W. Latex glove allergy A survey of the U.S. Army Dental Corps. JAMA 1992; 268:2,695-2,697.
4. Jacobelli A, McCullough J, Ownby D. The prevalence of latex allergy in high-risk medical personnel [abstract]. J Allergy Clin Immunol 1993; 91:216.
5. Lagier F, Vervloet D, Lhermet I, et al. Latex allergy in nurses. J Allergy Clin Immunol 1992; 90:319-322.
6. Safadi G, Safadi T, Terezhalmy G, et al. Latex hypersensitivity: A study of prevalence in a dental practice [abstract]. Ann Allergy Asthma Immunol 1995; 74:57.
7. Yassin M, Lierl M, Fischer T, et al. Latex allergy in hospital employees. Ann Allergy 1994; 72:245-249.
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