MEDICAL DEVICE STERILIZATION AS A PUBLIC HEALTH PARADOX

Abstract:

Medical device sterilization processes are a public health paradox. Sterility is necessary to assure product safety, yet emissions from the most common form of industrial sterilization, ethylene oxide (EtO), cause cancer. The connection between ethylene oxide and health risks has existed for decades, though recent litigation, state legislation, and advocacy efforts have illuminated the risks. This Article explores the large-scale EtO emissions in Willowbrook, Illinois caused by a facility run by Sterigenics, a corporate entity with facilities across the United States. The Sterigenics case study will be utilized to examine the scope of adverse health and environmental effects; the local, state, and federal agencies and entities involved; the ensuing advocacy, community engagement, and litigation; state legislative responses; and opportunities for coordination to ensure responsive environmental and public health regulation and policy. This Article will identify significant gaps in regulation, controls, and reporting, and question whether federal regulatory agencies may rely on existing legislation and regulation or should implement new mechanisms to enhance protections and support technological advancements in emissions controls.

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