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Federal Government Debates Latex Regulations

 Federal agencies have not yet been able to reach a consensus regulation of latex gloves, exposure to which has resulted in a growing epidemic of allergic reactions.

In September of 1997, the Food and Drug Administration (FDA) issued a final rule (Federal Register, Volume 62, page 5102) requiring cautionary statements in the labeling of all medical devices that contain natural rubber likely to come in contact with humans. The rule provides that such products must contain the following cautionary statement in bold print: "Caution: This product contains natural rubber latex which may cause allergic reactions." Additionally, the FDA issued a final ruling that the labeling of medical devices that contain natural rubber, likely to come in contact with humans, shall not contain the term "hypoallergenic".

Lawsuits Increase
Over the last few years, there has been a significant increase in the amount of workers' compensation claims filed against employers on behalf of individuals who have suffered latex allergic reactions. Additionally, a significant number of claims have been filed against the manufacturers, suppliers and distributors of latex gloves and products. The claims filed in the Federal District court throughout the United States have been joined in one action for pretrial management and discovery in accordance with a Multi-District Litigation Order issued by the court. 

The Occupational Safety & Health Administration of the United States Department of Labor has issued a technical information bulletin in draft form to alert field personnel to the potential allergic reactions in some individuals using natural rubber latex (NRL) products, particularly gloves, in the workplace setting. OSHA has indicated that a "safe zone" may need to be established to protect workers who are already sensitized to NRL. It has indicated that health care facilities may be required to develop policies and procedures for reducing the risk of NRL allergies in the workplace. It has also recommended that there be mechanisms for reporting and managing cases of allergic reactions. Since the allergic reactions may be systemic and immediate, OSHA has recommended that the fundamentals of an emergency response (i.e., assuring airway, breathing and circulation) remain of primary importance if a worker develops symptoms requiring resuscitation, that these situations should be anticipated in the workplace, and that provision of immediate access to non-natural rubber containing equipment be considered. 
It should be noted that, once NRL allergy occurs, allergic individuals continue to experience symptoms, which have included life-threatening reactions, not only on exposure to NRL in the workplace but also upon receiving or accompanying a family member receiving healthcare services at inpatient as well as office-based settings.

Congressional Hearings
The regulation of NLR products has been a concern both for the federal government and for individual states. The Federal government has initiated agency evaluations and Congress is conducting oversight investigatory hearings on latex allergies in the healthcare industry. Some state governments are now considering enacting legislation in order to protect the health of those exposed to NLR products. 

Jon L. Gelman, Attorney at Law • 1450 Valley Road • Wayne, NJ 07474-0934
Tel: 973.696.7900 • Fax: 973.696.7988 • Toll Free: 888.696.7900


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