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FDA Updates the Recognized Consensus Standards Database with New Sterilization Documents

At the end of July 2023, the United States Food and Drug Administration (FDA) issued a release indicating that they have recognized the following sterilization standard and Technical Information Reports (TIRs) to help advance innovation in medical device sterilization processes. These have since been added to the latest update of the Recognized Consensus Standards database, known as “List 60,” and include:

  • New sterilization standards and technical information reports:
    • ISO 22441:2022
    • AAMI TIR104:2022
    • AAMI TIR17:2017/(R) 2020
  • New versions of recognized standards
  • Revisions to some standards’ extent of recognition and extended transition periods for two standards

The sterilization documents noted above are:

  • ISO 22441:2022: 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
  • Two Technical Information Reports associated with medical device sterilization:
  • AAMI TIR104:2022 Guidance on transferring health care products between radiation sterilization sources
  • AAMI TIR17:2017/(R)2020 Compatibility of materials subjected to sterilization

The inclusion of these new documents within the Recognized Consensus Standards database is a great step in providing additional sterilization alternatives for device manufacturers in light of current limitation and regulation trends being applied to ethylene oxide (EO) sterilization technology.


Why Is This Important?

There has been a significant industry wide effort in the last 5 years to reduce the EO gas concentrations used to sterilize medical devices, which in turn reduces any potential worker exposure and residual emissions of the sterilant gas at the EO sterilization facilities. For the past few years, state and local Environmental Protection Agencies (EPAs) have demonstrated increasing vigilance on EO sterilization facilities related to occupational and community exposures. In 2022, a group of plaintiffs, including the Sierra Club, sued the U.S. EPA Administrator, Michael Regan, under the Clean Air Act, accusing the EPA of failing to review sterilization facility emission standards as required every eight years. The EPA recently settled that lawsuit by agreeing to a court order, enforcing the March 2024 deadline of its final review on commercial sterilization standards and emissions controls on manufacturers of the EO gas and companies/ facilities that use the gas.

EO sterilization facilities have been actively addressing these concerns in multiple ways, with capital improvements within the facilities to ensure containment and emission controls that are as efficient as possible to reduce any short or long-term exposures to the surrounding communities and to employees.

In conjunction with The Association for the Advancement of Medical Instrumentation (AAMI) and the United States Food and Drug Administration (FDA), joint meetings of key stakeholder leaders in the medical device and sterilization industry launched the initiative to collaborate and focus on reducing EO concentrations and streamlining the path for alternative sterilization modalities. One main objective is a significant reduction of EO gas levels used in the sterilization cycle itself. Optimization of the EO sterilization cycle has been successful with new or repeated EO sterilization validations of existing devices using concentrations that are over 50% lower than previously validated cycles.


How Can NAMSA Help?

At NAMSA, we’re known for our ability to design custom protocols that not only meet client’s testing budgets, but are also backed by a complete documentation package that fulfills all necessary regulatory requirements for steriliazation validation. The use of other traditional sterilization modalities like gamma, electron beam or steam can be considered if moving away from EO sterilization, but material compatibility considerations need to be evaluated as part of any change in a sterilization method. Non-traditional methods such as vaporized hydrogen peroxide, chlorine dioxide and nitrogen dioxide are other low temperature alternatives that may be explored, if material considerations eliminate the traditional methods.

NAMSA has a dedicated team of EO sterilization validation experts to work with medical device companies to review, design and validate (or re-validate) current EO sterilization processes, and to optimize an EO sterilization cycle that may currently use a higher concentration of EO gas. Contact us today to begin your sterilization validation project.

Ed Arscott

Ed Arscott, BS

Ed has a long history with NAMSA, starting in 1987 and progressing to the role of Manager of Microbiology and In vitro Toxicology. After a 14-year stint with Depuy/J&J, he returned to NAMSA in 2013 as a Senior Product Development Specialist. In this role, Ed provides consultation on various aspects of medical device development, including terminal sterilization methods, packaging shelf-life studies, and cleaning efficacy validation. He is also a subject matter expert for auditing external contract laboratories and sterilization vendors. Ed's recent projects include coordinating the design and validation of a new cleanroom and conducting an epidemiological risk assessment for a reusable oral medical device.