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FDA: Too Little Too Late

Claims resulting from latex exposure in the workplace continue to crowd the court dockets at epidemic levels. Injured workers have filed workers' compensation claims and claims against the manufacturers, distributors and suppliers of health care products. In the State of New Jersey, where the Court has consolidated the matters for pre-trial purposes, a trial date of February, 2000, has been set for Court-selected test cases.

In 1987, the US Centers for Disease Control (CDC) published a report that indicated a need for all health care workers to routinely use appropriate barrier precautions when contact with blood or other body fluids of any patients is anticipated.

In September of 1998, the FDA, called for an identity statement to be placed on products containing natural rubber latex (NRL), ""Caution: This product contains natural rubber latex which may cause allergic reactions." The FDA at that time also prohibited manufacturers from labeling NRL products as "hypoallergenic."

On July 30, 1999, the US Food and Drug Administration (FDA) released a draft with guidance on medical (latex) examination gloves. The document was released for comment purposes only. It represents the FDA's current thinking on medical gloves. When implemented, it will supercede the FDA's "Guidance for Medical Gloves" which was first published in 1997. Unlike the Occupational Safety and Health Administration (OSHA), which recently recommended a far reaching program to enhance safety in the workplace and limit the exposure of workers and the general public to the hazards of latex protein, the FDA has limited its guidance to only the medical arena and the specifications of the gloves themselves.

The new FDA draft guidance is concerned with chemical sensitization issues from NRL glove products. It sets standards for surgeons' and examination gloves that are powdered and powder-free and imposes certain labeling requirements including an expiration date.

Neither the FDA nor OSHA has yet taken steps to ban latex gloves in the workplace or to prohibit their use in non-medical situations. Due to the inexpensive nature of this product as well as their ease of availability, latex gloves continue to be a threat to health care workers and the general public who suffer from latex sensitivity and the associated life-threatening conditions which arise from their use.

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