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BIOHAZARD PLASTIC BAGS SHOULD NOT BE REGULATED AS MEDICAL DEVICES

This article was originally published in The Gray Sheet

Executive Summary

BIOHAZARD PLASTIC BAGS SHOULD NOT BE REGULATED AS MEDICAL DEVICES, Hershey Industries President Henry Herbst argues in a June 9 petition to FDA. The agency informed Hershey via an April 1992 letter that because biohazard waste bags are "used in medical facilities by medical personnel to prevent the spread of disease in man," the bags are considered devices. Classification of the product has not yet been established, FDA's Kent Berthold, office of compliance and surveillance, notes in the letter. Hershey says its products, like those of other biohazard bag manufacturers, are used to collect contaminated waste and soiled items in hospitals; the bags are then either decontaminated by steam autoclave at the facility or disposed of off-site. "It is our sincere belief that naming this product a medical device will adversely impact the manufacturers and consumers, and add unnecessary costs to the production of this product," Herbst says. "Furthermore, this product is distinct and different from a 'Sterilization Wrapper' under regulation 880.6850 because the material being sterilized is disposed of and never used or handled again." Hershey is located in Hillside, New Jersey.
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