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Author: Sallie McLaughlin, Senior Microbiology Consultant

If the sterilization of medical devices falls within your roles and responsibilities, it is critical to understand the current state of changes in ethylene oxide (EO) sterilization validation.

In February 2019, the Illinois EPA closed a large EO sterilization facility, located in Willowbrook, Illinois, and at this time it appears it will not reopen. The closure and new mandates to lower emissions spurred product shortages for medical devices across the country. The COVID-19 pandemic, which increased demand for many medical devices, further impacted the supply chain in the U.S. 

As companies get back to work, it is critical to understand the impact of the new requirements to lower EO gas concentration in EO cycles and how this may impact timelines for requalification of EO cycles, developing new cycles, and costs associated with changes to EO sterilization.

Continue reading to learn more about:

  • Ethylene oxide sterilization of medical devices
  • Relationship between the FDA and the EPA
  • Updates to the sterilization requalification process
Ethylene Oxide (EO) Sterilization for Medical Devices

According to an FDA literature review, approximately fifty percent of sterile medical devices are sterilized with ethylene oxide (EO).

EO sterilization is a low-temperature gaseous process used to kill bacteria, viruses, and other microorganisms remaining on the device from manufacturing and packaging processes. EO is a popular sterilization method because of its compatibility with materials commonly used in medical devices, including most plastics.

As a point of comparison, gamma irradiation, the second most common medical device sterilization method, while faster, is known to cause material discoloration and can significantly impact the stability of plastic components on the device. Therefore, radiation is not a viable sterilization option for all medical devices.

EPA’s Role in Regulating Sterilization Facilities

The U.S. Environmental Protection Agency (EPA) is the governing body that enforces the Clean Air Act. Sterilization facilities that emit ethylene oxide must adhere to its regulations.

The FDA is working with the EPA to develop processes and procedures to ensure the safety of medical devices and reduce the product shortages that are an unintended consequence of the enforcement of these new regulations. The FDA is committed to reducing what they call an over-reliance on EO for medical devices. In July 2019, they announced an innovation challenge to identify new sterilization methods and technologies with the goal to reduce EO emissions from the sterilization process to as close to zero as possible.

You can get the latest on Ethylene Oxide Sterilization for Medical Devices on the FDA’s website.

How EO Sterilization Mandates Impact Medical Device Manufacturers

While medical device manufacturers are used to annual sterilization requalification of their EO sterilization cycles, the next two years may be challenging as contract sterilizers work to reduce EO concentration in their cycles.

As your sterilizer works to meet the updated mandates, moving forward, you will need to validate a new EO sterilization cycle for your device that uses a lower gas concentration. 

Due to facility closures and backlogs, you may even need to switch sterilizing facilities to avoid delays in getting your product to end-users. This requires additional costs and time to validate the EO process at alternate facilities.

However, as you know, it’s not as simple as merely changing sterilizing facilities. PMA and 510(k) devices may have requirements to submit sterilization changes to the FDA. The FDA has announced a pilot program to allow sterilization providers to submit a master file when making certain changes between sterilization sites or changes to sterilization processes that utilize reduced EO concentration.  This program will help medical device companies with PMAs of Class III products as they may reference the Master File in a post-approval report.

You should reach out to your sterilizing facility as soon as possible to see what their plans are for meeting these new requirements. Failure to do so may result in added expense to the cost of your product and extend your timeline.

Lean Into Our Medical Device Sterilization Expertise

Understanding how the new EO sterilization validation mandates can impact getting products to market highlights the need to partner with consultants who understand medical device microbiology and sterilization.

No matter where you are in the product lifecycle, it is never too early to start developing sterilization protocols and identifying a method and facility that meets your organization’s product needs and quality requirements.  

Need to talk to a microbiology expert to revisit your product’s sterilization process and protocols?  Get started today.