The 1980s saw increasing emphasis on the manufacture, sale and use of natural rubber latex devices intended to protect the public from AIDS and other bloodborne pathogens. The decade now ending saw an increasing emphasis on regulation and legislative activity involving latex allergy from the use of those natural rubber latex medical devices.
The insurgence of allergic reactions to latex is somewhat shrouded in theory and conjecture but it is thought to be related to the increased use of latex-containing products during the 1980s. Factors contributing to latex allergy may be the migration and surface availability of naturally occurring water soluble protein constituents from natural rubber latex products.
Less shrouded is the past, present, and future parallel development of regulatory and legislative activity resulting from allergic reactions registered by users, especially healthcare workers, of natural rubber latex (NRL) medical products. Those regulatory and legislative developments have varied in implementation from slow to quick depending on the organization or body of concern and their stake in the outcome. For example, the FDA took five (5) years to promulgate and effect NRL user labeling regulations.
The current decade is replete with regulatory activity with most a response to increasing litigation against manufacturers of NRL products, predominantly medical gloves.
After recognizing the need to protect healthcare workers from AIDS, the Centers for Disease Control published recommendations which became known as "Universal Precautions" in 1987 (MMWR 1987: 36:25-185). These guidelines effectively caused an explosion of medical glove use for protection against bloodborne pathogens. This universe of use expanded dramatically throughout the 1990s. By mid-decade, latex allergy was becoming well recognized as an occupational issue stemming from an expanding population and frequent use by healthcare workers.
In succession the FDA, OSHA, and NIOSH issued documents on latex allergy and related issues. First, the FDA published a Medical Alert entitled, "Allergic Reactions to Latex-Containing Medical Devices," dated March 29, 1991. This alert advised healthcare professionals to identify latex-sensitive patients and treat allergic reactions. Importantly, the alert identified latex proteins as the primary source of adverse latex allergic reactions. Also offered were five recommendations from taking patient histories to use of medical identification bracelets. Within two months the FDA issued an advice notice to all manufacturers of latex devices outlining possible deficiencies in the manufacturing process which could contribute to these adverse reactions.
Second, OSHA promulgated the Bloodborne Pathogens standard (OSHA 29 CFR 1910.1030 (d)(3)(i)), effective March 1992, requiring glove availability and use for occupational exposures by employees to blood or other potentially infectious materials. The regulation not only requires glove use in the presence of all blood or body fluids, but also requires special glove availability for employees allergic to the gloves normally provided. Additionally, the rule necessitates replacement when worn gloves are contaminated or compromised. Disposable glove reuse is prohibited.
Third, in 1997, as a result of increasing latex allergy reports, NIOSH issued an alert, "Preventing Allergic Reactions to Natural Rubber Latex in the Workplace." This alert also contained a warning of allergic reaction outcomes and described a number of steps workers should take to protect themselves from natural rubber latex exposure. If latex gloves are chosen, provide reduced protein, powder-free gloves to protect workers from infectious materials and to avoid possible airborne protein exposure. The use of non-latex gloves is recommended for activities unlikely to involve infectious material contact.
Since 1995 the FDA has begun to take a leading role among government agencies in the arena of public health protection with the issues of NRL labeling requirements, latex studies, and standards activity, in conjunction with the American Society for Testing Materials to develop test methods, product performance requirements, and powder and protein residual limits.
The CDC recently joined the FDA in an effort to develop a selection and use program for gloves in the healthcare setting. The program is administered under the Public Health Service and includes NIH, OSHA, NIOSH, USCPSC, FDA, CDC, and ASTM. To date, a proposed work development plan has been generated to help establish a document with a plan scheduled for promulgation in 18 to 20 months.
During the last half of this decade there was increased interest by state legislatures in regulatory restraint on the selection and use of latex medical products, specifically medical gloves. This activity was promoted by various consumer and support groups who are directly affected by latex allergies. These groups have lobbied state representatives for legislative action to ban the use of powdered latex gloves. To date, pending legislation in Indiana, Minnesota, Nebraska, New York, Oregon, and Wisconsin has stalled and the bills are inactive in those legislations.
Unlike the past, future development, manufacturing and distribution of medical gloves will be highly regulated, more diverse in material use and performance requirements, and require more consumer education in a non-generic market.
As this decade ends, it is incumbent on manufacturers to actively and fully respond to developing federal labeling regulations; to support participation and influence of other federal agency policies; to work with national and international standards setting bodies and to meet consumers expectations of safe and effective glove products for all of their needs.
