On November 25, 2019, the FDA announced updates on its campaign to improve medical device sterilization techniques. The FDA introduced a new, voluntary program “Ethylene Oxide Sterilization Master File Pilot Program” that accelerates the documentation processes for sterilization providers and device manufacturers.
The Impact of Ethylene Oxide on Device Sterilization and its Regulation
Ethylene oxide (EtO) is the most widely used sterilization technique in the industry, sterilizing around 50% of all medical devices. It is the only method that effectively sterilizes devices made of plastic, resin, metal, or glass without damaging or altering its properties. The FDA currently regulates EtO sterilization using a robust standard program, which encourages sterilization providers and device manufacturers to follow the FDA-recognized voluntary consensus standards (ANSI AAMI ISO 11135:2014, ANSI AAMI ISO 10993-7:2008®2012). These standards include methods on developing, validating, and controlling EtO sterilization processes, details on the acceptable levels of residual EtO left on the device, and information on preventing long term and occupational exposure to EtO. Adherence would allow for industry standardization and would streamline regulatory review and quality assurance assessments. With the current system, if any changes are made to the sterilization process since the original PMA submission, a PMA supplement must be submitted.
The Innovative Goals of the FDA
Prior to announcing this pilot program, the FDA announced a series of innovation challenges, in which 11 participants worked directly with the FDA to accelerate the development of new sterilization techniques. On July 15, 2019, the FDA created the following two public innovation challenges:
- Identify New Sterilization Methods and Technologies – Ensures compatibility with many materials, including packaging materials and sterile barriers, and ensures that the method or technology has the potential to be scalable for large volumes of devices.
- Reduce Ethylene Oxide Emissions – Attempts to lower the levels of EtO while maintaining quality assurance. This may be accomplished through capturing EtO emissions and transforming them to harmless byproducts, detecting and containing the emissions within the facility, and minimizing the toxic and carcinogenic effects that EtO has to workers and neighboring communities.
Actionable items that resulted from these studies include the reduction of paper in sterile device packaging, which would decrease the sterilization load and the resulting amount of EtO being used.
The Pilot Program – Summary
The main change implemented within this program is the ability for companies who sterilize single-use medical devices using fixed chamber EtO to submit a Master File when making changes between sterilization sites or when making changes to sterilization processes that reduce EtO concentrations. PMA holders of Class III devices subject to premarket approval are allowed to reference the Master File submitted by their sterilization provider in a postapproval report instead of submitting a PMA supplement. Therefore, the Ethylene Oxide Pilot Program seeks to ensure patient access to safe, high quality medical devices while providing new, innovative ways to sterilize medical devices that will reduce the negative environmental and health issues of EtO emission.
The Pilot Program – How to Get Involved
Nine eligible participants may be selected for the EtO Pilot Program starting November 26, 2019. Program participation is limited to the following qualities:
- Are you a sterilization provider of a single-use device that is provided sterile?
- Are you in good compliance standing with the FDA?
- Do you have an approved fixed chamber EtO sterilization process for the device in an existing PMA?
- Are you proposing any of the following changes?
- A change from a conventional EtO cycle at an existing PMA-approved sterilization site to a conventional EtO cycle at a different site for the same sterilization provider
- A change from a conventional EtO cycle at an existing PMA-approved sterilization site to a reduce/optimized EtO concentration cycle at the same site for the same sterilization provider
- A change from a conventional EtO cycle at an existing PMA-approved sterilization site to a reduced/optimized EtO concentration cycle at a different site for the same sterilization provider
If these requirements apply and you are interested in participating in the program, sterilization providers must submit a Master File to the FDA for review and partner PMA holders should submit a postapproval report referencing their sterilization provider’s existing Master File. For more information on the specific information and procedures, check out the Federal Register article Center for Devices and Radiological Health Ethylene Oxide Sterilization Master File Pilot Program.