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.
Viant Medical’s Grand Rapids, MI facility was hit with violations from the Michigan Department of Environmental Quality.
According to the FDA, more than 90% of products sterilized at the facility are medical devices.