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Surgical Devices and Implants Data Collection

Data Provision Notice to underpin the submission of data by both NHS and independent sector providers in respect of the national reporting of surgical device and implants activity.

Overview

NHS Digital has been directed by the Secretary of State for Health and Social Care to establish and operate a single Surgical Device and Implant Registry to facilitate  the national reporting of activity relating to any surgical device or implant across both the NHS and independent health care sector.

This helps address requirements raised by the Independent Medicines and Medical Devices Safety Review: First Do No Harm (Cumberlege Report).

The data submitted will be processed for the following purposes:

  • to enable surveillance of specific medical devices through linkage to other data assets including patient outcomes, to enable the earlier identification of potential issues with a specific surgical device or implant which may warrant further investigation e.g. by the Medicines and Healthcare products Regulatory Agency (MHRA) which could result in a product recall
  • to compare medical device outcomes to those of alternative procedures for the same medical conditions which do not result in a surgical device or implant
  • to support identification of a cohort of patients and verify their latest address and deceased status as part of a patient recall for review or removal of a particular implanted device in the event of a product recall being issued.

This Data Provision Notice sets out the legal requirements on NHS Digital and the consequential obligations on data providers to submit the data to NHS Digital.


Scope

This Notice is served on:

All health and care organisations in England which undertake surgery involving surgical devices and implants: 

  • Health Care Organisations providing NHS-funded care
    • NHS Health Care Organisations
    • Independent Health Care Organisations
  • Independent Health Care Organisations providing non NHS-funded care

Legal basis


Period

This collection started on a pilot basis in April 2021 but is now formally mandated for all in-scope organisations.

Data should be reported as follows:

  • any future implant, revision or removal of in-scope devices should be reported to NHS Digital within 10 working days of the procedure occurring
  • where possible, a retrospective submission of historic data for in-scope procedures undertaken since 1 July 2017 should be provided as a one-off submission

Read the Data Provision Notice

and find out more about the Programme.


Updates

29 June 2022: This webpage has been updated to remove content which now sits on the Programme's webpage (link above).

2 March 2022: Version 2.3 of this Notice has been updated to reflect the move from pilot status.

Last edited: 29 June 2022 3:50 pm