The FDA has expanded its activities regarding ethylene oxide (EtO) as a device sterilant with the announcement of a new pilot program for existing 510(k) regulatory filings. This new program would allow the use of alternative methods of sterilization without requiring a new 510(k), and is designed to encourage manufacturers to shift to other methods and thus reduce the use of EtO.
The Advanced Medical Technology Association stated that more than half of all medical devices are sterilized with EtO, and listed a number of device types that are not well suited for other methods. While 20 billion devices are sterilized each year with EtO, the device industry accounts for less than 1% of all EtO use in the U.S., AdvaMed said.
This is not the first program the FDA has implemented in connection with EtO sterilization. In 2019, the agency issued two sterilization challenges to reduce the utilization of EtO. One of these was a challenge for development of novel sterilization methods for devices that are not reliant on EtO for adequate sterilization, while the other challenge was for development of technologies to suppress EtO leakage from facilities. The agency also held an advisory committee hearing in 2019, which led to a recommendation that device manufacturers move away from paper as a medium for labeling and instructions to electronic media when practicable.
The controversies surrounding EtO sterilization include questions raised in the states of Illinois and Georgia, with sterilization facilities in both states closing either temporarily or permanently. The FDA has also noted that facilities located in Italy had been closed temporarily, although that was undertaken because of concerns regarding falsification of records at the site rather than the environmental concerns that have driven the controversy in the U.S. The FDA has been working with manufacturers for several years to ensure that the availability of sterilization services does not hamper access to devices and surgical products, however.
The FDA announced this new program May 20, which is limited to single-use 510(k) devices subject to terminal sterilization. Participants will have to provide the FDA with documentation that a proposed change in sterilization method from fixed-chamber EtO sterilization to an alternative method is not likely to affect the safety or the effectiveness of a device cleared through the 510(k) program. Should the FDA accept the master file for the program, the manufacturer and the sterilizer can simply refer to the master file in documenting the change without requiring a new regulatory filing.
To take part in this pilot program, which is limited to nine sterilization providers, the sterilization facility must be in compliance with FDA regulations. Reusable devices and single-use devices sterilized for reuse are not eligible for the pilot, nor are combination products or devices regulated by the FDA’s Center for Biologics Evaluation and Research. Sterilization used in intermediate processing is also not eligible.
Participation in the pilot will require collaboration between the device manufacturer and the sterilization service provider, and the sterilization facility will be required to file information with the FDA regarding sterilization equipment qualification and requalification. The master file should also document and justify any common protocol deviations along with information on mitigations for those deviations. Upon entry into the pilot, the master file would have to be updated every six months for any changes made to sterilization methods for the device.
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