CDRH Pilot, Innovation Challenges Address Ethylene Oxide Hurdles

Posted November 26, 2019

The Food and Drug Association (FDA) Center for Devices and Radiological Health (CDRH) has launched a voluntary pilot project for industry to help facilitate new sterilization methods that use less ethylene oxide (EtO) and hasten approvals for sterilization site relocations. The new program is among the FDA’s recent efforts to prevent potential shortages of safe and effective medical equipment and to reduce reliance on EtO for device sterilization.

The primary participants in the Ethylene Oxide Sterilization Master File Pilot Program will be sterilization providers and manufacturers of premarket application (PMA)-approved Class III devices that would be affected by changes in sterilization location and processes. In short, the program will allow these manufacturers to reference a sterilizer’s “Master File,” which will contain any of the sterilizer’s changes in facility location and sterilization procedures, in a postapproval report instead of submitting a more time-consuming PMA supplement to the FDA. 

The program “will allow more nimble response to sterilization site closures by more quickly approving sterilization site relocations and speeding up the implementation of sterilization methods that reduce the amount of ethylene oxide needed to sterilize PMA-approved medical devices,” said CDRH Director Jeff Shuren, in a statement. “This could reduce the impact of ethylene oxide on the environment and on the public health while at the same time continuing to ensure patient access to safe medical devices.”

In the same FDA statement, Shuren also announced the 12 winners of CDRH’s two EtO innovation challenges. These challenges were created in response to the February 2019 closure of the Sterigenics’ medical device sterilization facility in Willowbrook, IL, and input from the FDA’s November 2019 public advisory committee on reducing EtO emissions for medical device sterilization.

The first challenge was to identify new alternatives to EtO sterilization methods and technologies for medical devices. The FDA selected five challenge participants in four categories from 24 applications:

  • NovaSterilis, supercritical carbon dioxide sterilization
  • Noxilizer, Inc., nitrogen dioxide sterilization
  • STERIS, accelerator-based radiation sterilization
  • STERIS, vaporized hydrogen peroxide sterilization
  • TSO3 (now part of Stryker), vaporized hydrogen peroxide-ozone sterilization

The second challenge was to develop strategies to reduce EtO emissions during medical device sterilization. The agency selected eight participants in four categories from 22 applications:

  • Abbot, enhanced EtO cycle design and processes
  • Andersen Scientific, Inc., EtO-flexible chamber technology
  • Becton, Dickinson and Company (BD), enhanced EtO cycle design and processes
  • DMB Apparatebau GmbH, reduced sterilant concentration
  • Medtronic plc, enhanced EtO cycle design and processes
  • Sterigenics U.S., LLC, enhanced EtO cycle design and processes
  • STERIS, enhanced EtO cycle design and processes
  • Taiwan Advanced Sterilization Technologies Inc., abatement strategy

Within 60 days of the FDA announcement, the above-named participants are expected to start the collaboration phase of the innovation challenge process. This will include creating a mutual understanding of the target technology profile, including its risks and benefits, and discussing the development of the technology or regulatory pathways going forward with the FDA.