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.
Last edited: 13 January 2023 10:15 am