Manufacturers of most types of medical devices must ensure that their products are free from bacteria and other substances that could transmit infectious diseases to patients and healthcare workers. This requirement applies to single use medical devices, as well as to certain device types that can be reused after suitable reprocessing. Industrial sterilisation processes can involve the use of various chemicals and techniques, including gamma irradiation, moist heat and ethylene oxide. However, all sterilisation processes must be controlled and independently validated to ensure the effectiveness of the sterilisation process.
Requirements for the development, validation and routine control of sterilisation processes for medical devices and other healthcare products are described in ISO 11135 (for ethylene oxide), ISO 11137 (for radiation) and ISO 17665 (for moist heat). In summary, an effective sterilisation process includes comprehensive documentation of a manufacturer’s validation protocols and reports, along with related laboratory compliance data. For sterilisation processes involving reprocessing, a comprehensive risk management assessment must also be completed. This documentation becomes part of the product design dossier or technical file, which is generally required for medical device approval or placement on the market.
Medical device manufacturers often face a number of issues in implementing and maintaining appropriate sterilisation process and controls. The science of sterilisation is complex and requires expertise in a number of technical areas, such as microbiology, chemistry and engineering. Standards applicable to the control and validation of industrial sterilisation processes are extensive, and it can be difficult to determine in advance how a given standard’s requirements will be interpreted by regulatory authorities during the conformity assessment process. In addition, regulatory requirements applicable to sterilisation processes and validation can change in light of new scientific information. These and other issues can slow the regulatory review and approval process for medical device manufacturers.
TÜV SÜD Product Service provides global medical device manufacturers with services for testing of sterilisation and sterile packaging processes, including services for safe reprocessing of reusable devices according to international standards. This includes on-site assessments of sterilisation processes, review of sterilisation documentation prior to submission to regulatory authorities for regulatory compliance and audits of quality management systems.
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