FDA requires latex labeling for medical devices
December 1, 1997 7 minutes read
FDA requires latex labeling for medical devices
Warning designed to prevent allergic reactions
In response to reports of allergic reactions among health care workers and others, the U.S. Food and Drug Administration is requiring all latex-containing medical devices to be labeled with a hazard warning, making it easier for HCWs to identify and avoid products containing latex.1
The new regulation also requires that "hypoallergenic" claims on latex-containing medical devices be removed because they incorrectly imply that those devices can be used safely by workers sensitive to latex. Such claims currently are found on many medical devices that contain reduced levels of latex proteins, but evidence indicates that some people who are extremely latex-sensitive still could react to low protein levels.2
Devices that contain natural-rubber latex will be required to carry the following statement on the label: "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions." Medical devices that contain dry natural rubber must be labeled with this statement: "This Product Contains Dry Natural Rubber."
Medical devices containing natural-rubber latex in their packaging also are subject to the rule, and must bear this labeling: "Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions." Likewise, devices containing dry natural rubber in their packaging must be labeled this way: "The Packaging of This Product Contains Dry Natural Rubber."
The rule applies only to devices with latex that actually comes in contact with a person. Examples of products that may contain natural-rubber latex include surgical and examination gloves, catheters, tracheostomy tubes, condoms, wound drains, and cuffed airways. The FDA rule explains that dry natural rubber products need not carry the potential health hazard statement because of the much lower levels of latex proteins produced by the dry natural rubber process.
Products that may contain dry natural rubber include syringe plungers, vial stoppers, and injection ports on intravascular tubing.
The new federal regulation responds to reports the FDA has received regarding sensitivity to natural latex proteins contained in medical devices. Over the last 10 years, the FDA has received more than 1,700 reports of allergic and anaphylactic reactions among HCWs and patients, including 16 deaths. No HCW deaths have been attributed to latex allergy. Allergies among HCWs continue to rise, with increasing numbers becoming so sensitive that they are forced to abandon their careers.
While the FDA estimates that less than 1% of the general population is latex-sensitive, HCWs are at greater risk due to their constant exposure to latex-containing medical devices, especially latex gloves. Estimates of latex sensitivity prevalence among HCWs range from 8% to 17%.3,4
Catheter tips implicated in deaths
Last year, the FDA issued a proposed regulation that generally was met with enthusiasm by activist groups and others who have been pushing for federal guidance that might lead health care institutions to eliminate or minimize latex products in the workplace.5 (See Hospital Employee Health, November 1996, pp. 125-128.)
Mel Stratmeyer, PhD, chief of the FDA’s health sciences branch, says the agency became involved in latex allergy issues in 1990 when a number of deaths from barium enema catheter tips were reported, especially among spina bifida patients.
"Once we came to the conclusion that the issue was latex, after quite a bit of research, we went to industry and also convinced them this was a problem, although we do not know what level of proteins induces a reaction in sensitive individuals. The real thrust behind the labeling requirement is that we’d like to know what has latex in it," he says. "Health care workers are probably the biggest group affected because they’re exposed to latex gloves. We’re trying to cut down sensitization, and if they are already sensitized, they can not only avoid gloves but also other products containing latex."
Stratmeyer says HCWs will benefit not only on the job, but also when they become patients themselves and must undergo medical procedures in which latex-containing items traditionally have been used.
Another recent federal action designed to help HCWs came earlier this year when the National Institute for Occupational Safety and Health (NIOSH) released an alert, warning that HCWs exposed to latex could experience allergic reactions ranging from skin rashes to anaphylaxis.6 (See Hospital Employee Health, September 1997, pp. 97-103.)
HCW groups applaud actions
"It’s an enormous stride forward," says B. Lauren Charous, MD, director of the allergy and respiratory care center at the Milwaukee Medical Clinic, where he diagnoses and treats a large number of latex-sensitive HCWs.
"It will permit physicians and surgery and procedural staffs, for the first time, to know whether they’re endangering people who are known to be allergic to latex. In addition, a lot of time has been wasted at hospitals not knowing what’s safe to use. I know of hospitals and clinics that are spending a huge amount of time writing and calling manufacturers to find out which things are [latex-]safe," says Charous, who also chairs the latex hypersensitivity committee of the American College of Allergy, Asthma, and Immunology (ACAAI) in Arlington Heights, IL.
The ACAAI last year issued its own set of guidelines for safe latex use and managing latex allergies in health care facilities.7 (See Hospital Employee Health, January 1997, pp. 5-7.)
Charous says the FDA rule "puts the onus on the manufacturer" and enables hospitals to avoid endangering latex-sensitive HCWs and patients.
"This is the second major step. First we had the NIOSH document; now the FDA is requiring labeling. I hope it’s the next step to the end of the problem," says Sue Lockwood of Grafton, WI, a severely allergic former surgical tech who established and became executive director of Allergy to Latex Education and Resource Team (ALERT), which provides education and support to thousands of HCWs and others nationwide.
Might hospitals decrease or eliminate the use of some latex-containing products, particularly latex gloves, as a result of the FDA rule?
Debra Adkins of Torrington, CT, a former nurse who can no longer work due to extreme latex allergy, says the labeling requirement will help hospitals choose safer products and might even prompt elimination of latex gloves.
"More and more hospitals all over the country are changing to the use of nonlatex gloves because they can’t afford the workers’ comp and ADA [Americans with Disabilities Act] suits that could hit them," says Adkins, director of the Education for Latex Allergy Support Team and Information Coalition (ELASTIC), a national activist education and support group.
Federal actions might even motivate some medical device manufacturers to eliminate their latex glove lines, she adds.
"All I can say is it’s not our intent," says the FDA’s Stratmeyer, who adds that he has not received any such direct feedback from manufacturers. "We haven’t seen a huge drop in market figures in the use of latex gloves, but the concern is always there. Time will tell."
The effective date of the labeling rule is Sept. 30, 1998, but a large manufacturer of latex medical gloves claims not to be concerned.
Robert Andrews, a spokesman for Johnson & Johnson in New Brunswick, NJ, tells Hospital Employee Health that although he "wouldn’t want to speculate" on the fate of the company’s latex glove lines, "if that was a concern of ours, we would not have put an even more stringent label on our products even before the FDA ruling."
The Johnson & Johnson label in use since March reads: "Caution: Natural rubber latex may cause an allergic reaction in some individuals. If a reaction occurs, discontinue use and consult a physician."
However, while Johnson & Johnson, as well as other manufacturers, generally were "cooperative" during development of the new rule, according to Stratmeyer, at least some of that support might arise from the fact that at least 45 federal lawsuits have been filed by HCWs against latex glove manufacturers nationwide, including a significant number of class action suits.
In addition, more federal agency action is expected. NIOSH recently launched a major five-year research initiative in conjunction with several health care institutions. Up to 1,000 HCWs will be studied to determine the effectiveness of interventions such as powder-free low-latex gloves and nonlatex gloves in reducing or preventing latex allergies. The agency also will study the course of latex allergy development. Also, the Occupational Safety and Health Administration (OSHA) currently is working on a draft of a document on occupational latex allergies that could be issued as soon as this year in the form of guidelines or a health warning.
The FDA continues to target latex allergies, as well, by "exploring the possibility of having a maximum limit for latex proteins, especially in gloves," says Stratmeyer.
References
1. Department of Health and Human Services, Food and Drug Administration. Natural rubber-containing medical devices; user labeling. 62 Fed Reg 51,021 (1997).
2. Kelly KJ, Viswanath K, Zacharisen M, et al. Skin and serologic testing in the diagnosis of latex allergy. J Allergy Clin Immunol 1993; 91:1140-1145.
3. Yassin M, Lierl M, Fischer T, et al. Latex allergy in hospital employees. Ann Allergy 1994; 72:245-249.
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. Department of Health and Human Services, Food and Drug Administration. Latex-containing devices; user labeling; proposed rule. 61 Fed Reg 32,617 (1996).
6. 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.
7. Sussman G, Gold M. Guidelines for the Management of Latex Allergies and Safe Latex Use in Health Care Facilities. Arlington Heights, IL: American College of Allergy, Asthma, and Immunology; 1996.
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