Transition Away From EO Sterilization to Continue as Virus Fades

It’s not over just yet.
 
Eclipsed for the past year by COVID-19, medtech’s long-simmering ethylene oxide (EO) controversy could soon flare up (again) as the industry grapples with alternative sterilization methods for its products.
 
The U.S. Environmental Protection Agency (EPA) is expected to issue a final federal rule this year limiting EO emissions from commercial medtech sterilization plants. Considered a carcinogen, EO has been used for decades to clean medical equipment—from plastic tubing and surgical instruments to hospital gowns and artificial joints. Industry experts estimate the chemical is used to sterilize roughly half of all medical equipment, as it can efficiently kill germs without harming materials.
 
EO’s link to various cancers and physical ailments have spawned a slew of legal action against companies that operate sterilization facilities. Sterigenics closed its plant two years ago in Willowbrook, Ill., by order of that state’s Environmental Protection Agency, and then shuttered another in Georgia in August 2019 following an investigation by the Georgia Environmental Protection Division.
 
The shutdowns disrupted the medical device supply chain, prompting the U.S. Food and Drug Administration (FDA) to form a task force on EO sterilization. The agency also launched an “innovation challenge” in July 2019 to develop alternatives to EO sterilization and reduce ethylene oxide emissions to “as close to zero as possible.”
 
Meanwhile, the EPA earlier this year determined that community-specific warnings about EO risks do not have to be made immediately. The agency—still working on the final federal rule—has committed to notifying communities about EO risks by May 31 and has posted status reports on 25 facilities previously identified as high-risk based on known EO emissions and facility location.
 
Orthopedic Design & Technology’s January/February feature, “The Total Package,” examines the EO- and pandemic-induced challenges and changes facing packaging and sterilization companies. Stephanie McGee, vice president of sales and marketing for Command Medical Products Inc., was among the experts interviewed for the story. Her full input is provided in the following Q&A.
 
Michael Barbella: Why is it important for orthopedic manufacturers to consider sterilization and packaging early in the product design process?
Stephanie McGee: With the current state of sterilization capacity constraints, early on in the product design is the ideal time to consider material compatibility, packaging configuration and sterilization method. A sterilization SME is able to offer insight into the best sterilization method based on design inputs, material sensitivities, and density. If our customers are not tied to a particular method on a new design, we encourage them to consider their alternatives.
 
Barbella: How did COVID-19 impact your company? What lessons can providers like yours take from the pandemic and apply to their services going forward?
McGee: There are many lessons our organization has learned during this pandemic. We have periodically throughout the year looked at things we have done well and areas in which we can make process improvements. Communication was strong throughout the pandemic. Having very clear and constant communication channels within our organization as well as outside with our suppliers and customers allowed business to flow amidst significant fluctuations in demands, staffing, and work schedules. Our meetings tend to be more productive and focused and we hope to continue that trend as team members return to the office. 
Our organization was also able to capture the pride and compassion of our employees as we were building disposable devices that directly supported COVID-19 recovery. This fact resonated throughout our organization. As we worked extra hours to increase output, we were grateful to be a very small part of the recovery effort. This activity bonded us as a company and we shared in the comfort that the products we made were working to help those negatively impacted by this pandemic.
 
Barbella: COVID-19 has somewhat doused the controversy surrounding EtO health/environmental risk factors. Has the technology redeemed itself in light of skyrocketing demand for PPE, or is it just on the back burner for now? Will the debate resume once the pandemic is under control?
McGee: I believe the controversy was indeed overshadowed by the COVID-19 pandemic. I expect the debate will resume in 2021 but the context of the discussion may be slightly different. For example, the FDA worked closely with some EtO service providers to expand EtO sterilization capacity during the pandemic recovery to increase device output. This sterilization modality served the people and saved lives.
 
Barbella: Are there alternative sterilization methods being developed or available that can replace EtO with respect to scalability and material compatibility?
McGee: With the FDA’s open Innovation Challenge posed in Nov 2019, there is significant effort underway by industry leaders to establish a scalable alternative to EtO. Unfortunately, with so much emphasis on managing our businesses and employees safely through COVID-19, I am not able to comment on the progress although I am hopeful to see news soon.
Our business has several clients actively transitioning their product lines from EtO to Gamma and/or E-Beam. I expect the transition away from EtO to continue. We have other clients incorporating a transition strategy with their next-generation devices. It will be interesting to see what the sterilization landscape will look like in five to 10 years. For so long EtO and Gamma sterilization have been the go-to methods for medical devices. However, the social and governmental pressure over residuals and toxicity hang heavy over the EtO sterilization process. The lagging supply of cobalt 60 to support the global demands of multiple industries does not bode well for Gamma sterilization. With the combination of both equaling 90 percent of all medical device sterilization, an alternative is not a luxury but a necessity to current state processing.
I think this challenge is going to force the FDA to work closely with the medical industry, [U.S] EPA, and local EPD agencies to find reasonable measures to maintain safety while supporting the growing market needs. 
 
Barbella: How has the COVID-19 pandemic changed the packaging/sterilization industry (if at all)? Will these changes be permanent?
McGee: The COVID-19 pandemic has certainly rocked the marketplace. The culmination of the 2019 EtO facility shutdowns by Sterigenics and the onset of the COVID-19 pandemic seriously impacted the medical device industry globally. There was a race to secure sterilization capacity to reinstate supply for those caught in the shutdown. While alternate EtO sites worked to validate new cycles and customers, capacity was consumed by companies leveraging their BCP sterilization programs.
Even today, capacity is still a concern. We incrementally experience delayed processing times for sterilization loads due to backlog at various sterilization processing facilities.