When and how to perform hazard identification of medical devices скачать в хорошем качестве

When and how to perform hazard identification of medical devices

As a continuation of our risk management theme for the next several weeks, Rob Packard is going to explain when during the product development cycle you should be performing hazard identification. This should be part of your risk management plan and a subset of your overall design and development plan. If you divide the design process into five (5) phases, in which phase would you place hazard identification? A. Design Planning B. Design Inputs C. Design & Development Planning D. Design Verification & Validation E. Design Release "B" is the correct answer. For example if you are developing an implant, one of the user needs is that the device is sterile. Therefore, a hazard is that the device will not be sterile. This creates a hazardous situation and may result in harm (i.e. infection). The severity of harm could be as extreme as death for infections. Therefore, it is important to identify this hazard at the beginning of the design process (i.e. Design Inputs Phase). Then you can design risk controls such as sterile packaging (e.g. thermoformed blister with Tyvek lid-stock), materials that are compatible with the sterilization method (e.g. EO Sterilization), and a specification for sterility assurance level (i.e. SAL = 10^-6). The design inputs are documented as testing requirements and applicable standards, while the hazard identification documentation is an input to design (i.e. inputs from risk management activities). We also explain how to perform hazard identification. The steps of the process are: 1. identify hazards listed in the TPLC database (http://www.accessdata.fda.gov/scripts...) 2. identify serious incidents reported in other national medical device databases and registries 3. review complaint data for similar devices your company manufactures 4. review public customer feedback on social media platforms if applicable 5. perform a clinical literature review of similar devices (i.e. State-of-the-Art Review) 6. brainstorm potential hazards from Table C.1 in Annex C of ISO 14971:2019 7. review and document answers to the 37 questions in Annex A of ISO/TR 24971:2020 8. review available product-specific guidance documents and standards for known hazards (e.g. IEC/TR 80002-1:2009, Application of ISO 14971 to medical device software) The above process is time-consuming and may require multiple people in your company. As with all risk management activities, these are supposed to be performed and reviewed by a risk management team. If you would like to learn more about the risk management process, please view our blog on IVDR risk management requirements: https://medicaldeviceacademy.com/ivdr... We are also offering addition risk management training webinars on our website: https://medicaldeviceacademy.com/risk... https://medicaldeviceacademy.com/2497...