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British Orthopaedic Foot and Ankle Registry – Where are we now, and where are we going? Lyndon Mason, Edward Wood and Paul Halliwell
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Where we are in 2021
Lyndon Mason is a Consultant Trauma and Orthopaedic Surgeon in the Liverpool University Hospitals Foundation Trust. Lyndon is the foot and ankle trauma lead in the Liverpool Orthopaedic Trauma Service and has published widely on foot and ankle trauma management. He is the Chairperson for the Outcomes Committee in the British Orthopaedic Foot and Ankle Society.
26 | JTO | Volume 09 | Issue 04 | December 2021 | boa.ac.uk
n the 21st of February 2018, the then Secretary of State for Health and Social Care in the UK, Jeremy Hunt, issued a statement in the House of Commons in response to the reports about harmful side effects from medicines and medical devices. A review was commissioned to consider how to strengthen the patient voice in order to help build a ‘system that listens, hears and acts – with speed, compassion and proportionality’1. Patient groups had campaigned for years, if not decades, to achieve this acknowledgement. An independent safety review was commissioned for medicines and medical devices led by Baroness Cumberlege, with specific investigation of two medicines and one medical device.
reported outcomes measures (PROMS)”. This recommendation is important due to its need for centralised data collection on all patients with implantable devices and the prospective collection of PROMS data on all patients. In July 2021, the government published their response to the Cumberlege report (Figure 1)3. In chapter 8, the government accepted the aforementioned recommendation number seven, legislating through the Medicines and Medical Devices Act 2021, to give power to the secretary of state to regulate for the establishment of a UK-wide Medical Device Information System (MDIS). Central to the development of the MDIS is PROMS. Patientcentred registries have been high on the agenda at BOFAS for some time, and we have been working closely with the BOA as part of the Trauma and Orthopaedic Registries Unified Structure (TORUS) project for several years, which includes the majority of the musculoskeletal registries outside the National
On 8th July 2020, the First Do No Harm Report (otherwise known as the Cumberlege Report) was published (Figure 1)2. The review found that the system in which patients concerns could be raised regarding medicines and medical devices was “disjointed, siloed, unresponsive and defensive”. A total of nine recommendations were made. Recommendation number seven was of particular importance to orthopaedic registries. It stated that “A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can then be linked to specifically created registers to research and audit the outcomes in terms of both Figure 1: The Cumberlege report and governments response. the device safety and patient
