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 is developing an information system to collect, curate and analyse surgical device and implant data relating to patients.
The information system will capture and link data for procedures which use implantable medical devices (class III and IIb), as well as comparative data for equivalent non-device procedures.
Data modules will be developed to capture the relevant patient, clinical and speciality specific information as defined in the requirements specification. To minimise burden on providers, existing data held by NHS Digital will be used to populate data modules where possible.
Data collected will support establishment of clinical registries across surgical disciplines and the generation of new insights that benefit direct patient care. The initial speciality focus is urogynaecology, starting with data collection for a Pelvic Floor registry.
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 achieved by 'brand' of device or implant, hospital and surgeon
- 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
What data will be collected?
The data for collection is as set out in the Technical Specification. For organisations in scope to submit data please refer to the Data Provision Notice (DPN).
How the data will be submitted
NHS Digital is developing data submission options in partnership with providers across the UK. These include data uploads via the Message Exchange for Social Care and Health (MESH) and data input via a web based portal.
Organisations required to collect and submit data
All providers of NHS funded care must submit data to this collection in line with the technical specification and specialities in scope as defined by the nation specific DPNs.
Private healthcare providers are requested to submit data and, although they are not currently mandated to participate, it is in their interest to do so. The clinical insights derived from this information system will lead to improvements in clinical practice, better patient care and improved patient outcomes.
When the data will be collected
Surgical Devices and Implant data is mandated for collection, starting with pelvic floor procedural areas in England, from 1 April 2021. Other procedural areas can be submitted by providers that are ready to do so (where scanning solutions are in place, for example).
Roll-out for the devolved administrations is expected to start in the Spring 2021.
How the system is being developed
Agile development principles are being used to develop the system, with stakeholder input from:
- private providers/independent healthcare
- clinical bodies
- registry groups
- technical developers
The system has been developed following a series of test data submissions from NHS and private/independent healthcare providers across England in a series of pilots.
We have worked with provider sites across 7 regions (East of England, London, Midlands, North East and Yorkshire, North West, South, and South East), providing support with pilot activities. We are also working with the devolved administrations of the UK to gather additional insights for development.
The system is designed to collect both historic and current data directly from NHS and Private healthcare providers for all surgical specialities, initially focusing on pelvic floor surgical procedures, including the use of mesh or its alternatives. The data for collection 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.
If you would like to start sending data to the Surgical Implants and Devices Information System, please contact your NHS Digital data liaison team at firstname.lastname@example.org.