. Risks associated with pelvic mesh surgery

To set up the Risk Assessment and Risk reduction process for the new pelvic mesh medical device intended to treat pelvic organ prolapse in women aged between 30 and 70 years old, it's important to follow specific standards, such as ISO 14971:2019 - the international standard for the application of risk management to medical devices. In addition to ISO 14971:2019, you may refer to the following standards depending on the specific device requirements and regulations in your region: 1. ISO 13485:2016 - Quality management systems for medical devices 2. IEC 60601 series - Medical electrical equipment 3. ISO 10993 series - Biological evaluation of medical devices 4. ISO 11137 series - Sterilization of health care products 5. EN standards as applicable to the specific device and geography Below is a step-by-step description of how to perform the Risk Assessment and Risk Reduction process for the pelvic mesh medical device. 1. Establish the risk management process Create a cross-functional risk management team that consists of representatives from various relevant departments, such as R&D, quality, clinical, regulatory affairs and manufacturing. Develop a Risk Management Plan (RMP) that outlines the approach, roles, responsibilities, and activities related to risk management throughout the lifecycle of the device. 2. Identify hazards and hazardous situations Create a comprehensive list of potential hazards associated with the device, either from the device itself or from interacting with other systems or equipment. These hazards might include, for instance, infection, pain or organ disturbance in the pelvic region. 3. Estimate and evaluate the risks For each identified hazard, assess the potential associated harm and consider the severity of the harm and the probability of harm occurring. Risks can then be scored and ranked accordingly using an established risk evaluation criteria. 4. Identify risk control measures For each identified risk, determine the control measures to be put in place to mitigate the risk. This may involve multiple layers of risk control, including inherent safety by design, protective measures, and information for safety. For example, in the case of potential infection risk, ensure the device is sterile and any instruments used during implantation are sterilized. 5. Implement risk control measures Incorporate the identified risk control measures into the design of the device or into manufacturing processes, as appropriate. This could involve designing the mesh to minimize pain, and thoroughly informing the surgeon and the patient about postoperative care. 6. Evaluate residual risks After the risk control measures have been implemented, reassess the residual risks to ensure they are acceptable. If necessary, continue to iterate upon and implement additional risk control measures until the residual risks are acceptable. 7. Risk management reporting Document the entire risk management process in a Risk Management Report (RMR), which summarizes the risks and control measures, and includes a final evaluation of the overall risk-benefit analysis. 8. Monitor and update risk management Continuously monitor and review the performance and safety of the device throughout its lifecycle. This includes post-market surveillance and vigilant reporting systems to collect data on any new risks, incidents or adverse events, and update the risk management process accordingly. Lastly, it is essential to comply with local regulatory requirements and certifications, as well as any ongoing revisions of the ISO/BSI/EN standards as they are continually updated.