3. EO sterilization shortageThe medtech industry and regulators continue to struggle with environmental, health and business ramifications of using ethylene oxide (EO) to sterilize disposable medical devices.
Just when it appeared a major Sterigenics EO plant in Willowbrook, Ill., would reopen soon, a judge granted three surrounding communities their own say in the matter. The plant’s sudden closure in February over what the state termed excessive emissions of the carginogenic sterilant caused device shortages and a push by the FDA to find alternatives and reduce EO emissions.
Also in July, an investigative report targeted EO emissions from medtech sterilization plants in two Atlanta suburbs, raising concerns among residents and government officials. BD called the report “misleading” and Sterigenics said it was voluntarily upgrading emissions controls.
FDA is looking for options amid medtech’s sterilization crisis