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?
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.