Validation & Verification of Reusable Medical Devices

Abstract

Medical devices have played a significant role towards healthcare. From sticking plasters to X-ray scanners, dentures to hip joints and in-vitro diagnostic Devices that monitor diabetes or identify infections etc. Medical devices have always played a crucial in Diagnosing, preventing, monitoring as well as treating illness, and overcoming various kinds of disabilities. For any Medical Device to exist in the Market, ensuring the product is verified and validated according to the Regulation and relevant standards is important. Based on the nature and class of device, the extent of verification and validation test varies. Implants are considered to be the stringent medical devices existing in the market as they have to be maintained in their aseptic condition throughout their shelf life. This includes validation of the packaging material and the implant itself. Non-Sterile product do not pose any special storing conditions as they are not intended to be in their aseptic condition during their shelf life. There are also Reusable devices (eg. Instruments) which can be used multiple times by reprocessing them after every use. The use life of any non-Sterile product is determined based on the number of cycles and wear & tear on the product. Reprocessing of trays involves multiple steps like cleaning & disinfection, sterilization, storage. Cleaning can be done either manual or automated which will be followed by sterilization (Steam, EO, Gamma etc.) . So, to ensure that the medical devices follow all the quality parameters certain validation tests are performed on the medical devices so that they pass all the quality check according to the medical device regulations and become customer usable. Stryker T&E validation tests are performed in India as well as outside India, so after testing everything is documented and submitted to the respective regulatory bodies of that country in order to launch the product in that country. The role assigned during this project is to perform activities related to Sterility Assurance, in this role, I was responsible for all sterility assurance tests and their documentation. The report therefore presents formal correctness and compliance to Stryker divisional and corporate procedures and requirements, which are based on International Standards. The role also includes the adequacy of Design Verification and Validation of the Trays. The scope of this project is limited to reprocessing of trays i.e., Reusable medical devices supplied to the customers are sterile to the user and requiring the user to reprocess (i.e., clean and disinfect or sterilize) the device after initial use prior to the subsequent use on patient.