2020 should be a pivotal year in which the microcosm of medical devices moves out of the shadows and joins the mainstream healthcare conversation.
With May 26, 2020 quickly approaching, every day counts.
The company developed the device as an alternative to reusable duodenoscopes, enabling the use of a new and sterile product for each procedure.
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.