Embracing Innovation Requires Intestinal Fortitude, an Understanding of History, and Measured Patience

Every week, if not every day, you can find a headline claiming that the sky is falling because of pending restrictions on ethylene oxide (EtO) sterilization. Depending on what side of the issue you are on, it is either “you will die because medical devices and therapeutics will not be available when EtO sterilization is banned” or “you will die because EtO sterilization is not banned.”  This rhetoric is untrue and always counterproductive.

In the highly regulated world of medical devices, pharmaceuticals, and healthcare, sterility is paramount. For decades, EtO has been the gold standard for one reason – it works really well at killing microorganisms and the scale is large enough to meet the throughput demands for high-volume products. That being said, what has also come to light is that this carcinogenic, mutagenic, toxic gas is not good for people who are exposed to it on a regular basis – this includes residents downwind of EtO emitters, workers who operate EtO facilities, and warehouse workers exposed daily to EtO processed goods. Both government and industry have a responsibility to ensure people are not unknowingly put at risk.

I am not going to provide a background on EtO sterilization, and the health risks associated with it because so much has already been written about it. If you want to get a fundamental understanding of the issues, Elise Reuter of MedTech Dive wrote an excellent article on the topic – EtO causes cancer.  Device sterilizers are scrambling to find alternatives.

Regulatory changes are afoot. The Environmental Protection Agency (EPA) announced a final rule on March 14^th that will reduce emissions by more than 90% at the ~90 EtO sterilization facilities in the United States. The cost of operating those facilities will increase when the new EPA rules go into effect. This ruling will create a gap between the demand and the supply for sterilization; this gap will be quickly filled by alternative sterilization modalities. Both history and tax law have taught us that when significant costs occur, people’s openness to alternatives and creativity increases. To be clear, there is no “silver bullet” sterilization method that will step in and displace EtO in its entirety. In fact, EtO will have a place for many years if not decades, because in the end, there are certain products that can only be sterilized by EtO. 

Industry’s typical resistance to mandated change is palpable, yet history provides ample examples of how mandates can serve as a catalyst for innovation, leading not only to compliance but also to advancements that benefit both the environment and public health.

Intestinal Fortitude and Leadership are Required.  

At large medical device and therapeutics companies around the globe, new product development efforts are carried out by technical teams and mid-level managers.  These people are not in a position to risk their careers, their kid’s college tuition, or their retirement to support a new sterilization technique that does not have the track record of EtO. It is not their responsibility to protect workers and members of the community. This decision must be made in the corporate boardroom. CEOs and Boards of Directors need to show leadership and commit both ethos and dollars to implementing viable EtO alternatives. These alternative sterilization modalities exist, and they need to be pursued.

Sure, there will be some bumps along the road. There will be delayed launches because the alternative sterilization modality/product compatibility topic needs further characterization; retraining to optimize operational workflows takes time; and capital investments required to improve throughput efficiency require comprehensive engineering design efforts. These are small hurdles in the big picture and ultimately, they will lead to improved effectiveness, efficiency, and cost savings.  These are not the decisions of mid-level managers. These are the decisions of C-suite leaders.

History Provides a Path to the Future

History shows that industry resistance to regulatory pressure can give way to innovation and improvement. One notable example is the phase-out of chlorofluorocarbons (CFCs) due to their role in ozone depletion. Initially, industries reliant on CFCs were resistant to change, fearing economic and operational disruptions. Yet, the necessity of compliance (aka government mandate) drove the development of alternative technologies and substances that not only met regulatory standards but also enhanced environmental sustainability.

Similarly, the automotive industry’s response to the Clean Air Act in the 1970s led to significant advancements in emission control technologies. Catalytic converters, once seen as an expensive burden, are now a standard feature that dramatically reduces harmful emissions and has paved the way for further innovations in vehicle efficiency and environmental impact.

There are a significant number of examples of government-mandated changes that industry and society have benefited from. Sometimes the change is a simple mandate – get it done by the deadline. Other times the change is affected through economic incentives – the solar energy industry was built on the back of tax credits. And, in other instances, it was government desperation – the vaccine market saw an unprecedented rate of new product development during the Covid-19 pandemic. The path of EtO change appears to be a soft mandate. This means that there will be time for the industry to transition in a rational, cost-effective manner

Sterilization Innovation is the Measured Response to EtO Replacement

There have been several EtO sterilization alternatives developed over the years, but the adoption rate has been extremely slow. The increased rate of EtO-alternative evaluations is at an all-time high, and the level of exploration will only grow as the EPA deadlines approach. These alternatives not only aim to meet regulatory requirements, but also enhance the safety and sustainability of sterilization processes.

Supercritical Carbon Dioxide Sterilization

Supercritical carbon dioxide (scCO₂) sterilization is a promising alternative to EtO. Supercritical CO₂ sterilization is uniquely penetrating and compatible with both biological and polymeric materials. Supercritical CO₂ is non-toxic, leaves no residues, and operates at lower temperatures, making it suitable for heat-sensitive medical devices. This method has been used in the medical device and regenerative medicine industries for more than a decade for the sterilization of low to mid-volume, high-value products. It offers a compelling solution that aligns with environmental and safety goals.

Nitric Oxide Sterilization

Nitric oxide (NO) sterilization is another emerging technique. NO is a reactive gas that can effectively kill a wide range of pathogens. It operates on the surface at low temperatures, making it ideal for delicate medical instruments. Additionally, NO decomposes into nitrogen and oxygen, posing minimal environmental impact. Although this technology is relatively new and requires further development for widespread use, its potential for safe and effective sterilization is significant.

Vaporized Hydrogen Peroxide (VHP) Sterilization

VHP sterilization involves vaporizing hydrogen peroxide to sterilize equipment and surfaces. This method is already in use for sterilizing hospital rooms and is being adapted for medical devices and pharmaceuticals. It offers rapid sterilization cycles with minimal to no toxic residues, aligning with environmental and safety standards.

Embracing Change for a Better Future

The transition away from EtO sterilization is not without its challenges. It requires significant investment in development, changes to manufacturing processes, and rigorous validation to ensure safety and efficacy. Because of this, the transition away from EtO will take time. This reality must be accepted, but that does not mean pressure to change should relent. In fact, if the federal government feels this issue is important and wants to speed up change, they should incentivize industry through proactive tax credits. To be clear, we are not suggesting an offset program, but rather a tax credit for capital infrastructure investment that will lead to a transformation of the sterilization industry. 

Conclusion

The regulatory pressure on EtO sterilization is real and it has merit. History teaches us that such pressures often drive meaningful innovation, but only when leaders step up and are willing to take a calculated risk. By embracing the opportunity to scale alternative sterilization methods, the industry will not only meet the regulatory standards, but will also advance public health. The path forward may be complex, but it is paved with the potential for significant positive impact – reduced costs, product innovation, safer communities, and healthier workers.

If you’re interested in learning more about Supercritical CO₂ sterilization technology and applications, contact us today.