Rural and vulnerable populations could be placed at risk as the US Environmental Protection Agency (EPA) imposes new limits on the use of ethylene oxide (EtO) for medical device sterilization, Ryan Ortega, regulatory policy advisor for the Office of Product Evaluation and Quality for the Center for Device and Radiological Health (CDRH), said on 17 May at a meeting sponsored by the Food and Drug Law Institute (FDLI).
Ortega also discussed some of the ways the US Food and Drug Administration (FDA) is working with manufacturers to explore alternative sterilization methods as well as some of the current challenges in choosing sterilization methods…
