Medical Device Design - Human Factors Risk Manager (HFRM) / SHERPA Software Demo скачать в хорошем качестве

Medical Device Design - Human Factors Risk Manager (HFRM) / SHERPA Software Demo

As part of the medical device design process the usability and risks to do with the device have to be analysed. The Human Factors Risk Manager (HFRM) software can be used to analyse and reduce the risk of human error. It has been used by medical device manufacturers, e.g. someone in this area recently said that they are now doing their task analyses 7x faster. But the software does more then task analysis and it offers more than just speeding up the process. UPDATE: The software has recently been renamed to SHERPA (Systematic Human Error Reduction and Process Analysis) Software. This has better ties to the SHERPA methodological paper that provided the foundation for this work back in 1986. Medical Device Design is a highly regulated practice, which is a good thing! By the FDA in the US and MHRA in the UK. This means that the devices’ usability and risks need to be thoroughly assessed at the design and development stage. Some of the main standards for this area include 62366 that covers the application of usability engineering to medical devices; and 14971 that covers the application of risk management to medical devices. Whereas Human HAZOPs might be more common in industry the SHERPA software allows a very structured (and easy to operate) Hierarchical Task Analysis (HTA), it depending on the type of task steps there are different failure modes to consider, and then a complementary library of PIFs (Performance Influencing Factors) that increase or reduce the likelihood of failure. This is all integrated into one easy to use intuitive system. A risk matrix is also built into the system so you can pinpoint where the risks are in the system and create an argument for how these have been mitigated and controlled. IFUs (Instructions For Use) can also be drafted at the touch of a button, showing warnings where users need them. Training materials can also be devised detailing the knowledge and skill requirements for using the device. One example where we have deployed this in an innovative research project was investigating the potential for video training materials for different adrenaline pens. We were interested in how well the videos communicated the knowledge and skill requirements for using the device safely. However, the first step is knowing what information should be being communicated as a priority – this was not obvious! Following the SHERPA process as described above explored the devices usability issues and risks, and highlighted what the videos should be trying to communicate. The video above shows the SHERPA process being used for a syringe pump, but it could equally work well for a volumetric infusion pump, other large or small medical device in hospital, or a device to be used at home or a different care setting. It is ideal for wherever there are proceduralised tasks that could have high risks and human involvement – we want to minimise the risk of use error. This really enhances patient safety. Find out more about more about the SHERPA software here: https://www.humanreliability.com/soft... If you want to go straight to our FREE 30min training on how we use this software for Human Factors Safety Critical Task Reviews (HFCTR), including the process for Medical Device Design at a high level, then go here: https://the.humanreliabilityacademy.c...