No abstract

Selection of a sterilization modality for a medical device is a critical decision that requires sterility assurance subject matter experts (SME)s to work collaboratively with various company functions. The sterility assurance SME is responsible and accountable for the sterilization modality decision for a product. The modality selection process starts with the sterility assurance SME partnering with research and development to ensure that the sterilization modality allows the device to deliver its intended function in patient care. After the sterilization modality is selected, the sterility assurance SME needs to work with other partners, including quality, supply chain/logistics, operations, and regulatory, to ensure that the selected sterilization modality is appropriately integrated into the end-to-end process. Collaborative partnerships between sterility assurance experts and key partners regarding sterilization modality selection reduce the potential for negative impacts within the end-to-end sterility assurance process, including impacts on product functionality, increased regulatory approval timelines, and inefficiencies and risks throughout the supply chain. This article describes aspects of a comprehensive approach to sterilization modality selection, including critical information necessary to address each of the key considerations.

Due to its complexity, sterilization has been perceived by some professionals who lack sterility assurance expertise as a “black box” process. Historically, medical device manufacturers have selected one of the available industrial sterilization options: dry heat, moist heat, gamma, or ethylene oxide (EO). The preselection of a sterilization modality (method) typically is made without understanding its impact based on qualified sterilization processes for existing products, capability, or resources required for the specific processes. Early engagement with sterilization subject matter experts (SMEs) can redirect the decision to preselect a legacy modality and help foster innovation and operational agility. Recent focus on supply chain flexibility and sustainability by the medical device industry has been affected by concerns surrounding cobalt-60 shortages and EO emissions. These factors drive the need for early involvement with sterility assurance SMEs in the product development process and the exploration of multiple sterilization modalities. This article highlights the importance of exploring multiple sterilization modalities during the product development stage to support sustainable business continuity plans.