Sterilization Facility Shutdowns Could Spell Medical Device Shortage; FDA Urges Firms To Assess 'Downstream Impacts'

US FDA says the closing of at least two sterilization facilities due to environmental hazard concerns could lead to a device shortage. The agency is working with stakeholders to come up with mitigating strategies, including finding new sterilization methods and facilities. The issue has prompted FDA to plan a public hearing later in the year to strategize on solutions and an innovation challenge to come up with new sterilization methods. In the meantime, to help industry understand its latest thinking on ethylene oxide for sterilization use, FDA has launched a website to provide resources and updates, including the latest sterilization facility closures.