Medical Devices Outcomes Registry (MDOR)
Data Provision Notice to request the submission of data for the the Medical Device Outcome Registry (MDOR).
Overview
Procedures where medical devices are either implanted or are the primary mode of therapy cover hundreds of thousands of patients per annum. In recent years there have been several high-profile device safety issues and product recalls including metal on metal hip resurfacing, Poly Implant Protheses (PIP) implants and vaginal mesh, Aortic Stent Grafts and bioresorbable stents. In addition, there has also been a steadily increasing number of product recalls and safety concerns generally across medical devices. Currently, tracking of medical device usage is primarily paper-based and, as a result, it is not understood how many patients undergo a procedure with high-risk devices or how many are affected by device recalls or safety alerts.
Class III or IIb medical devices are high risk medical devices, as they either remain in the patient or have a significant therapeutic effect. The high-risk medical device procedures are either surgical or interventional procedures that employ a High-Risk Medical Device (High-Risk Medical Device Procedures).
The Medical Device Outcome Registry (MDOR) core data set addresses the Government’s response to the Independent Medicines and Medical Devices Safety Review: First Do No Harm (Cumberlege Report) Recommendation 7 which advocates a UK-wide technical solution, including NHS (England, Scotland, and Wales), healthcare organisations in Northern Ireland, and independent health care sector organisations across all four home nations:
'A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures.’
By collecting data to improve patient safety, vigilance and outlier analysis on consultant attribution and contextual information on procedures that are not High-Risk Medical Device procedures more generally, the MDOR also fulfils the Government’s response to the Paterson Inquiry:
‘The inquiry recommended that critical consultant performance data be collated and mandated for use by managers and professionals across the health system. This would provide an independent basis to perform appraisals, revalidation and performance management – based on the quantitative evidence of performance, which may highlight issues that are not otherwise apparent. This practice would:
- flag issues where a consultant is unaware of a problem
- allow them to learn and correct this
- identify rarer cases where a consultant is wilfully engaging in malpractice, such as Ian Paterson’
The MDOR will support improved patient safety by enabling analysis to facilitate surveillance of High-Risk Medical Devices through linkage of component data modules, including associated patient outcomes, to support patient focussed activities such as review or recall of specific patients and devices
Scope
Under section 259(1)(a) of the Health and Social Care Act 2012, this Notice is served in accordance with the procedure published as part of the NHS England duty under section 259(8) on the following organisations:
- all healthcare organisations, including Independent Health Care Organisations, for NHS funded care, that undertake a surgical or interventional procedure involving a Class III or IIb High-Risk Medical Device.
- independent health care sector organisations, providing privately funded care, in England on a voluntary basis*
Legal basis
NHS England has been directed by the Secretary of State for Health and Social Care under section 254 of the Health and Social Care Act 2012; to establish and operate a system for the collection and analysis of the information specified for this service. The direction and accompanying requirements specification are published on the NHS England website.
This information is required by NHS England under section 259(1)(a) of the Health and Social Care Act 2012.
The National Data Opt-Out will not apply to the submission of data to NHS England for this collection as the Data Provision Notice is a legal requirement with which the participating organisations must comply. Where NHS England disseminates data, the National Data Opt-Out will be applied in accordance with the national data opt-out policy.
In line with section 259(5) of the Act, all organisations in scope, in England, must comply with the requirement and provide information to NHS England in the form, manner and period specified in this Data Provision Notice.
This Notice is issued in accordance with the procedure published as part of an NHS England duty under section 259(8).
Publication
In accordance with section 260(1) of the 2012 Act, NHS England has a legal duty to publish all information it collects by complying with a request (unless it falls within section 260(2) of the 2012 Act, (which does not apply in this case).
A twice-yearly publication will be issued, in the public domain, to demonstrate health care organisation level compliance to the MDOR core data. This will be anonymous, aggregate, and small number suppressed, so that individuals (patients or clinicians) cannot be identified.
Dissemination
NHS England will disseminate information which it collects under these directions, back to the organisations which provided it, for their own patients, by virtue of its discretionary powers under section 261(5)(d) of the 2012 Act for the direct care purposes including:
- data will be made available via the NHS England Data Access Request Service (DARS)
- any dissemination will be subject to the organisations applying to access the data having a lawful basis to process it, NHS England having a lawful basis to disclose it
For more information about data dissemination and access please see the information in the accompanying Data Provision Notice.
Period
Submission to the MDOR data collection is uploaded on a daily basis to NHSE’s Outcome Registries Platform. Data can be entered throughout the 24-hour daily period, 365 days a year.
The collection facilitates close to event clinical validation and reporting, enabling clinicians both to review their coding and device attribution for accuracy as well as to review their own activity. Procedure details and barcode scanned devices may be inputted into the registry application either during the procedure, after the procedure or in bulk at the end of the day.
The collection is ongoing with no end date.
Updates
10 February 2025 Version: 2.0 - This Notice has been updated to reflect additional data requirements from the Pelvic Organ Prolapse and Stress Urinary Incontinence Registry (POPSUI), Orthopaedic Trauma Registry (OTR) and National Registry of Hearing Implants (NRHI).
Last edited: 10 February 2025 2:39 pm