Sample reusability in the validation of active implant gamma sterilization

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Insinööritieteiden korkeakoulu | Master's thesis
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Master's Programme in Mechanical Engineering (MEC)
The relentless growth of the global population has driven an increasing demand for healthcare services, escalating the need for medical devices. As the medical device sterilization market is poised to double by 2029, innovation in this domain faces the challenge of stringent regulations and ensuring patient safety. The quality of healthcare critically depends on the cleanliness and sterility of medical tools, particularly medical implants, where contamination could have catastrophic consequences. Stringent standards govern the sterilization of medical products, necessitating various tests depending on the implant type and sterilization method. However, the current methodology often results in samples that cannot be reused, imposing significant costs and environmental concerns. This master's thesis centers on identifying contact materials used in sterilization validation and investigates the possibility of cleaning and reintroducing implant components into the validation process. This not only reduces costs but also promotes sustainability by allowing component reuse. Additionally, the thesis designs a simulated product to serve as the worst-case scenario in sterilization validation. The focus of this study aligns with the development of telescopic implant. The telescopic implant offers a minimally invasive solution for treating leg length discrepancy, and its sterilization validation is crucial for commercial availability. Gamma radiation (VDmax) is the chosen sterilization method due to its suitability for complex implants. This thesis explores key areas, including: 1. Simulated Product Design: Creating a prototype closely emulating the most challenging implant for sterilization, aligning with ISO standards. 2. Reusability Investigation: Examining component reuse post-sterilization validation, with simulated bioburden testing and residue removal procedures for The Dummy. 3. Cost Analysis: Evaluating production costs and potential savings through component recycling. 4. Component Selection: Identifying reusable and replacement components. Utilizing ISO 11137-2's VDmax method for sterilization dose validation, this research aims to en-hance the sustainability and cost-effectiveness of implant sterilization validation, benefiting both the industry and patient safety. The result shows that reusing samples in the sterilization validation process is promising and achievable. Reusing samples in the sterilization validation shows clear economic benefits as well as reducing the waste which is a success from an environmental point of view.
Ekman, Kalevi
Thesis advisor
Hallila, Harri
Ritvanen, Antti
sterilization validation, medical implant, gamma sterilization, sample reusability
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