---
title: FDA recognizes new medical device sterilization standards
description: Amid a regulatory effort by the US Environmental Protection Agency (EPA) to limit the use of ethylene oxide (EtO), the Food and Drug Administration (FDA) on Monday announced that its Center for Devices and Radiological Health (CDRH) has recognized a new international consensus standard on the use of low temperature vaporized hydrogen peroxide to sterilize medical devices.
image: https://blog.botable.ai/hubfs/230120_fda_hq_1200x1000-jpg.jpg
---

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# FDA recognizes new medical device sterilization standards

![](https://blog.botable.ai/hubfs/230120_fda_hq_1200x1000-jpg.jpg)

 

# FDA recognizes new medical device sterilization standards

[Originally posted on RAPS.org by Michael Mezher](https://www.raps.org/News-and-Articles/News-Articles/2023/7/FDA-recognizes-new-medical-device-sterilization-st)

Amid a regulatory effort by the US Environmental Protection Agency (EPA) to limit the use of ethylene oxide (EtO), the Food and Drug Administration (FDA) on Monday announced that its Center for Devices and Radiological Health (CDRH) has recognized a new international consensus standard on the use of low temperature vaporized hydrogen peroxide to sterilize medical devices.  
   
The standard, 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*, offers “an important alternative sterilization method” to device makers, said Suzanne Schwartz, director of the Office of Strategic Partnerships and Technology Innovation within CDRH.  
   
The center also recognized two standards from AAMI related to technical information reports related to medical device sterilization “intended to advance device sterilization methods and assist manufacturers making changes to radiation sterilization processes. The two technical information report standards are AAMI TIR17:2017/(R)2020 *Compatibility of materials subjected to sterilization* and AAMI TIR104:2022 *Guidance on transferring health care products between radiation sterilization sources*.

“Many manufacturers sterilize their products according to the information provided within voluntary consensus standards, including those for various sterilization processes. When the FDA recognizes standards, it means the FDA finds them acceptable and a manufacturer can make a declaration of conformity to the standards to meet a premarket submission or other requirement,” Schwartz said, adding that the moves “further support supply chain resiliency.”  
   
In April, out of concern that EtO emissions could be harmful to workers and residents of nearby communities, EPA proposed two much anticipated rules that would restrict how much EtO can be released into the environment by medical device sterilizers. Both medical device industry groups and FDA have expressed concerns that limitations on EtO sterilization could lead to medical device supply constraints and shortages. (RELATED: *[Medtech groups warn EPA of ‘devastating’ impact of proposed EtO rules](https://www.raps.org/news-and-articles/news-articles/2023/6/medtech-groups-warn-epa-of-%E2%80%98devastating%E2%80%99-impact-of)*, *Regulatory Focus* 29 June 2023; *[EPA proposes rules on EtO with implications for medical device sterilization](https://www.raps.org/news-and-articles/news-articles/2023/4/epa-proposes-rules-on-eto-with-implications-for-me)*, *Regulatory Focus *11 April 2023)  
   
FDA has also been working to develop alternatives to EtO for medical device sterilization and [launched](https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-radiation-sterilization-master-file-pilot-program) a voluntary Radiation Sterilization Master File Pilot Program alongside EPA’s announcement of the proposed rules in April. The radiation pilot program follows a similar pilot [launched](https://www.federalregister.gov/documents/2019/11/26/2019-25631/center-for-devices-and-radiological-health-ethylene-oxide-sterilization-master-file-pilot-program) in 2019 to facilitate makers of Class III devices subject to premarket approval (PMA) requirements to reduce the amount of EtO used to sterilize their devices.

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