Industrial Sterilization: Challenging the Status Quo, Driving for Continuous Improvement

This industrial sterilization supplement of the Association for the Advancement of Medical Instrumentation's (AAMI's) BI&T journal is the second in what is hoped to be an ongoing series of publications based on industry-led collaborations inspired by the 2019 Kilmer Conference. In the first supplement, which was published in 2020,¹  manuscripts were invited based on targeted needs identified in consultation with the Kilmer Conference community. For this second publication, the call for submissions focused on the need for case examples of successes and challenges and discussions surrounding collaboration and innovation to support product transfers between sterilization modalities, ensuring ethylene oxide (EO) process optimization, and overcoming challenges with reusable medical devices.

In addition to providing content for this supplement, the robust response to the call for submissions sets the stage for another publication in this series and provides subject matter for webinars.

As we address current industry challenges and prepare for new healthcare products of the future, we are on a journey toward challenging the status quo. Many of the early works that led to the development of standards from AAMI, the International Organization for Standardization, ASTM International, and the Parenteral Drug Association appeared in peer-reviewed publications such as the Kilmer Conference proceedings, which are now available digitally at no charge.² 

Looking back at this early research that laid the groundwork for “what” we do today as an industry, we are reminded of the importance of publishing the “why” of sterility assurance and sterilization processes. It is important to understand that standards are written to provide the fundamentals that should be explored for validation, maintenance, and controls for sterilization processes and that additional testing might be required to adequately ensure that the product can be produced reproducibly over periods of time. If we do not understand the “why” behind standards, the adaptations needed for new products may not be adequate.

The work published in this supplement builds on that legacy and provides a stronger foundation for evolving new best practices. We look back, we evaluate the science that has been done, and we reexamine it in the context of what we have learned in the interim. Did limitations exist in available technology and equipment when a method was developed? Were certain tests put into place to look for information that we now have other ways to find through more accurate measurement systems? Were the drivers (e.g., product microbiological quality, regulatory acceptance, equipment/measurement limitations) behind a sterilization process developed 30 years ago the same as the drivers today? As an industry, we need to challenge the status quo and push for continuous improvement to avoid falling into the trap of following a standard without understanding the science behind it.

In addition to challenging the status quo, as scientists, we need to continually challenge ourselves to understand science and adapt to new product needs. The strength of the peer-review process is the process of obtaining multiple perspectives from colleagues with similar or complementary expertise to our own. Diversity of background, thought, and experience provides an opportunity to ask questions that authors may not have considered. This includes all aspects of a product life cycle and decisions that have end-to-end supply chain consequences. The power of feedback is to improve ourselves in areas that we may not see on our own.

Although our goal in publishing this supplement is to advance the science of sterilization, some of the most useful lessons come from sharing our mistakes. Figuring out what doesn't work is an important step toward figuring out what does. Even when things work well, we may fail to look at other options that could provide a better solution. A common trap is always doing the same thing because it is comfortable—be it defaulting to a single sterilization modality because it's available or relying completely on external expertise for decisions that are inherent to the safety and efficacy of our healthcare products.

Typically, the sterility assurance professional selects and validates the sterilization process during the research and development process, and the driver may be based on speed to market. These decisions have long-term consequences on healthcare product supply chains, as the selection and validation of sterilization processes may have used higher EO concentration cycles or higher radiation sterilization doses than necessary. For this reason, we are highlighting the need to look at selection and validation of sterilization processes for both speed to market and long-range consequences to meet the drivers of the end-to-end supply chain.

Finally, by publishing new research and methods, we lay the groundwork for supporting new standards and guidance to meet the needs of an ever-changing industry, whether it's a novel sterilization method to deal with sensitive materials, a transfer between sterilization modalities, process optimization to meet capacity demands or sustainability initiatives, or the complexity of procedures associated with the safe reuse of medical devices. Peer-reviewed publications help to improve the standards over time, thereby allowing “lessons learned” to be adopted into the standards for clarification and/or expansion.

On behalf of both the Kilmer Collaboration Teams and the Industrial Advisory Board, we challenge you to share your data, your successes and failures, and your expertise to publish and peer review for the benefit of our entire industry. The authors thank the contributors and editors who helped make this supplement a vital component in challenging the status quo and driving for continuous improvement in industrial sterilization.