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.
CooperVision, Inc. and Pentax of America won the agency approvals, respectively.
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.
It’s time to embrace new technology and promote standardization to raise best practice protocols.
According to the FDA, more than 90% of products sterilized at the facility are medical devices.
Healthcare facilities need to make sure they have enough personnel and equipment that can manage device reprocessing.