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We are currently developing the Open Registry infrastructure in South West England, and are bringing together medical device manufacturers (from the world's largest to the smallest) and NHS trusts, with their surgeons that already have relationships with specific manufacturers. Using the system: a patient example Imagine that you are in a consultation with your surgeon, who advises that the mitral valve in your heart needs to be repaired. Your surgeon advises that this procedure can be done with minimally invasive surgery. They recommend using Device-X and you ask, "Why, what evidence do you have that this will work best for me?" Your surgeon replies, "This is the best knowledge that we have." You and your surgeon would then access the Portal. You would search for Device-X, maybe with a specific Unique Device Identification number (UDI) and/or a GMDN code (all of this is presented in a browser to help you search for the correct device). You find from this search that Device-X has been used in patients in three different European countries. You also find that the latest evidence is that it is best suited for patients with large frames, indicating that you may well be better suited to Device-Y. In searching for Device-Y, you also search for the generic description of this device, and find that manufacturers A, D, J and P, all make similar devices of this size, suitable for your needs. Now you search for Adverse Incidents corresponding to Device-Y across all of these manufacturers, and find that there are incidents associated with manufacturers D and P. This enables you and your surgeon to make a better-informed choice about the device that is right for you. How do we acquire medical device data? We have developed a unique capability to acquire data in real-time during surgery, and in association with device manufacturers. Our tech pushes appropriate data into a local registry and this becomes the foundation of data acquisition across Europe. We are already working in Central and Eastern Europe, and are planning a major initiative in Ireland. The Advisory Board comprises: Medical device safety experts Regulatory and Compliance experts Cyber security and data protection experts Patient advocacy experts (unfilled) Notified Bodies (unfilled) The board is chaired by an expert who has been chief executive of two NHS Trusts and worked for NHS England. It is coordinated by a trained anaesthetist and clinical safety expert. The board is also supported by a roundtable of medical device manufacturers, who are committed to making this work happen. They are also committed to total transparency of data. They are funding this work. The support we have been receiving from medical device manufacturers has been astonishing. This is a major opportunity to contribute to patient safety and help transform the patient consent process. If you are interested in finding out more, please contact info@tcc-casemix.co.uk

Increased use of telephone and video consultations is expected during the current COVID-19 situation. In this video, the AccuRX (https://www.accurx.com/) system is being used. The system and process used by other practices may vary. A link to this video can be sent to a patient's phone by the surgery when a video appointment is booked so that they can prepare themselves for their video consultation.

Reports can be made for all medicines including: side effects (also known as adverse drug reactions or ADRs) medical device adverse incidents defective medicines (those that are not of an acceptable quality) counterfeit or fake medicines or medical devices safety concerns for e-cigarettes or their refill containers (e-liquids).