Surgical Devices and Implants Core Data Set
Summary
- Collections
- Information standards
- Data definitions and terminologies
- Reference data
- Dentistry
- Hospital
Documentation
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.
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.