Following a Direction from the secretary of state, and in response to the Independent Medicines and Medical Devices Safety Review: First Do No Harm, NHS Digital has developed an information system to collect, curate and analyse surgical device and implant data relating to patients.
The information system captures and links data for procedures which use implantable medical devices (class III and IIb), as well as alternative data for equivalent non-device procedures.
Data modules have been developed to capture the relevant patient, clinical and speciality specific information as defined in the requirements specification. To minimise burden on health care organisations, existing data held by NHS Digital will be used to populate data where possible.
The system is designed to collect both historic and current data directly from NHS and independent health care organisations for all surgical specialities, initially focusing on pelvic floor surgical procedures, including the use of mesh or its alternatives. The data being collected covers information about the procedure, including the patient, clinician and device details, clinical details (including risk and post-operative complications) and surgical speciality specific data.
Use of the system will improve the quality of patient care by enabling:
- greater visibility of implants and device procedures across the country
- investigation of problems and prompt action when required
- monitoring of patient outcomes using the manufacturer of device or implant, hospital and surgeon information
- better understanding where outcomes fall below an expected performance
Additionally, data in the modules will be used for 'secondary' purposes such as:
- healthcare planning
- commissioning services
- national tariff reimbursement
- developing national policy