Proposed EtO Rules for Sterilization and the Regulatory Impact

by | Jul 25, 2023 | Cancer, FDA, ISO, Medical Devices, Radiation, Regulatory, Sterilization, Validation

In April of this year, the FDA published two proposed regulations that, if finalized, would put limits on how much EtO can be used to sterilize products among other workplace/occupational hazard requirements. EtO, or ethylene oxide, is commonly used in the medical device industry to sterilize finished devices. Some examples of devices that are sterilized with EtO include gowns/drapes, heart valves, pacemakers, surgical drills, and catheters among many others.[1]

The commonality of the colorless, odorless gas to sterilize devices may also be causing public harm according to the FDA and the EPA. In 2022 the EPA published a list of EtO sterilization plants that may be linked to increased cases of cancer in nearby communities. Since then, the FDA and the EPA have partnered together to draft the two new proposed regulations that would limit the amount of EtO that can be released into the environment, how much can be used in production, and would mandate certain PPE for people working with the substance.[2]

Considering this, the FDA announced this week that CDRH has recognized a new international consensus standard for sterilization of medical devices. ISO 22551:2022, Sterilization of health care products – Low temperature vaporized hydrogen peroxide – Requirements for the development, validation and routine control of a sterilization process for medical devices utilizes vaporized hydrogen peroxide as an alternative to EtO. This alternative method will support both the FDA’s aim to maintain sterility assurance for manufacturers/devices while also secure the EPA’s goal of reducing environmental and occupational hazards.

The FDA has put in place several voluntary programs such as the Radiation Sterilization Master File Pilot Program, which aim to continue to conversation with industry to find alternative ways to sterilize approved medical devices.[3]

The experts at EMMA International have already kicked off various projects to support medical device manufacturers conduct sterilization validation and comply with the proposed regulatory framework. If you need support, call us at 248-987-4497 or email info@emmainternational.com to learn more!

Resources:

[1] FDA (July 2023) Sterilization for Medical Devices retrieved on 7/24/2023 from: https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices

[2] Al-Faruque, F. (April 2023) EPA proposes rules on EtO with implications for medical device sterilization retrieved on 7/24/2023 from: https://www.raps.org/news-and-articles/news-articles/2023/4/epa-proposes-rules-on-eto-with-implications-for-me

[3] FDA (April 2023) CDRH Announces Radiation Sterilization Master File Pilot Program retrieved on 7/24/2023 from: https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-radiation-sterilization-master-file-pilot-program

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