In response to safety concerns and proposed regulatory action related to industrial use of ethylene oxide (EtO), the FDA Center for Devices and Radiological Health is taking additional steps to advance innovation in medical device sterilization, including recognition of new standards and updates to technical information reports.
AdvaMed has filed comments with the EPA regarding proposed regulations of ethylene oxide and their impact on patient care.
The voluntary program is designed to help companies advance alternative and innovative ways to sterilize approved medical devices, including changing radiation sources, in a least burdensome regulatory approach.
If finalized, EPA’s proposals are estimated to cut EtO emissions to the air from commercial sterilization facilities by 80% per year and apply more protective standards to control those emissions under the law. But MedTech advocates are concerned that the EPA is overlooking the controls already in place and a lack of alternatives that could lead to patient risks.
2020 should be a pivotal year in which the microcosm of medical devices moves out of the shadows and joins the mainstream healthcare conversation.
The goal of the voluntary program is to streamline the submission process. The agency also announced that it has selected participants for its EtO Innovation Challenges.
Stakeholders warn that more EtO facility closures could have a catastrophic result.
Six medical societies sent a letter to the agency over concern that limiting EtO sterilization will also limit the availability of certain devices to patients.
Will more medical devices be impacted?
The agency is encouraging the industry to develop sterilization approaches that either don’t rely on ethylene oxide or reduce emissions from this method.