Safer Sterilisation Guidelines for Medical Devices from the FDA
Food and Drug Administration (FDA) recently recognized new medical device sterilization standards as an alternative to the use of ethylene oxide (EtO). Ethylene oxide is a commonly used method for sterilizing medical devices, but there have been regulatory efforts by the US Environmental Protection Agency (EPA) to limit its use due to concerns about its potential harm to workers and communities.
New Methods Transform the Industry
The FDA’s Center for Devices and Radiological Health (CDRH) has acknowledged a new international consensus standard called ISO 22441:2022. This standard outlines the use of low-temperature vaporized hydrogen peroxide for sterilizing medical devices. The adoption of this standard provides device makers with an important alternative sterilization method.
Additionally, the CDRH has also recognized two standards from the Association for the Advancement of Medical Instrumentation (AAMI). These standards are technical information reports related to medical device sterilization. They aim to advance sterilization methods and assist manufacturers in making changes to radiation sterilization processes.
If you need guidance on navigating the latest medical device sterilization standards, then Contact Us to implement the newly recognized low-temperature vaporized hydrogen peroxide and radiation methods for your medical device .
The move comes as the EPA proposed rules to restrict the amount of EtO emissions released into the environment by medical device sterilizers. Both the medical device industry and the FDA have expressed concerns that such limitations on EtO sterilization could lead to supply constraints and shortages of medical devices.
To address these concerns and develop alternatives to EtO sterilization, the FDA has been working on initiatives like the Radiation Sterilization Master File Pilot Program. This program, launched alongside the EPA’s proposed rules, aims to facilitate the use of radiation sterilization as an alternative method for certain medical devices. The adoption of these standards aims to provide device manufacturers with viable options while addressing environmental and regulatory concerns surrounding EtO use.
Ensure compliance with FDA requirements and maintain a resilient supply chain. Contact us now to optimize your sterilization processes and stay ahead in the industry. Let’s strategize for success together!
