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Surgical Devices and Implants Core Data Set

Enables the national reporting of activity relating to surgical devices and implants in health care settings.

Documentation

About this standard

Publisher
NHS England
Also known as
SDICDS
Reference code
DAPB3103 Amd 100/2021
Publication date
03/02/2022
Status
Active
Show definitions of statuses

Active. Active standards are stable, maintained and have been approved, assured or endorsed for use by qualified bodies.

Deprecated Deprecated standards are available for use and are maintained, but are being phased out, so new functionality will not be added.

Retired standards Retired standards are not being maintained or supported and should not be used.

Standard type
  • Collections
  • Information standards
Show definitions of standard types

Collections. A Collection is a systematic gathering of a specified selection of data or information for a particular stated purpose from existing records held within health and care systems and electronic devices.

Extractions. An extraction is a type of collection that is pulled from an operational system by the data controller and transmitted to the receiver without additional processing or transcription by the sender.

Information standards. Information standards are agreed ways of doing something, written down as a set of precise criteria so they can be used as rules, guidelines, or definitions.

Technical Standards and specifications. Technical standards and specifications specify how to make information available technically including how the data is structured and transported.

Contact point

enquiries@nhsdigital.nhs.uk

Quote ‘Surgical devices and implants core data set’ in the subject line.

Using this standard

Applies to
All organisations undertaking surgery involving surgical devices and implants.
Impacts on
Implementation of this information standard impacts all health IT systems suppliers providing systems to the above providers; suppliers should work with their customers to determine necessary changes.
Associated medias
Conformance date
01/07/2022
Effective from
01/06/2022

Topics and care settings

Topic
  • Data definitions and terminologies
  • Reference data
Care setting
  • Dentistry
  • Hospital
Dependencies

No known dependencies.

Related standards
  • ISB 0149-02 NHS Number for Secondary Care
  • SCCI0034 SNOMED CT
  • DCB0090 Health and Social Care Organisation Reference Data
  • DCB2094 Sexual Orientation Monitoring
  • DCB3103-01 Surgical Devices and Implants, Phase 1: Pelvic Floor Registry

Review Information

Scope
Health Services, NHS Services
Sponsor

William Vineall, Director of Acute Care and Quality Policy, Department of Health and Social Care.

Senior Responsible Officer

James Austin, Executive Director Data, Insights and Statistics, NHS England.

Business Lead
Emma Summers, Programme Head, NHS England.
Approval date
31/01/2022
Post Implementation review Date
30/06/2023
Legal authority
  • Section 250 of the Health and Social Care Act 2012

    This information standard is published under section 250 of the Health and Social Care Act 2012

  • NHS standard contract

    This collection is published under the NHS Standard Contract.

More information

This information standard is commissioned by the Department of Health and Social Care to support the Secretary of State’s strategic requirements to ensure patient safety in the use of surgical devices and implants and the equivalent requirements raised by the Independent Medicines and Medical Devices Safety Review: First Do No Harm (Cumberlege Report).

The standard specifies a patient level, core data set to enable the capture of nationally consistent data linking patients to specific implants or devices, inserted by specific clinicians at a specific location.

Data will be captured for any surgery involving the implanting, revision, replacement or removal of a Class III or Class IIb implantable medical device, defined as:

  • Any device, including those that are partially or wholly absorbed, which is intended:
    • to be totally introduced into the human body, or
    • to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure.
  • Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device.

Source: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

Note that this information standard has evolved from the work undertaken by NHS Digital in respect of an existing data collection (DCB3103-01, the Pelvic Floor Registry) but concentrates on mandating this core data set across all surgical devices and implants activity. At the same time NHS Digital will continue to progress the existing Pelvic Floor data collection under the authority of a separate Data Provision Notice.

From 1 June 2022 providers in scope of this information standard must be able to collect the information as defined in the Technical Output Specification for local use.

From 1 July 2022 providers in scope of this information standard that are NHS funded must begin submitting SDICDS submissions in accordance with this standard.

Data should be reported to NHS Digital within 10 working days of an in-scope procedure occurring.

Page last updated: 03 May 2024