Question to the Department of Health and Social Care:

To ask His Majesty's Government what safeguards they have in place to ensure high quality and precise data are entered into the medical devices outcomes register.

The Medical Device Outcome Registry (MDOR) will significantly improve the quality of data available to improve patient safety and outcomes in high-risk medical device procedures.

NHS England will monitor data quality in the MDOR via regular audits and feedback reports so they can make improvements and provide additional support where required. They are also expanding upon the Data Quality provider certification and award scheme currently active in the National Joint Registry. This is with a view to covering all registry procedures with a particular emphasis on collecting data on medical devices and consultants, Patient Reported Outcome Measures and patient feedback indicators. NHS England have mandated registry submission and will be monitoring compliance and ascertainment against Secondary Uses Service procedure data, to resolve any data completeness or quality issues.

MDOR has native barcode scanning, including Unique Device Identifier (UDI) barcodes, so will result in the whole of England having an available UDI scanning solution without having to implement a separate system. The registry will accept bulk uploads from existing providers’ solutions, including Scan4Safety, that meet the data quality and completeness requirements. The Outcomes and Registries programme will support provider adoption of digital solutions that enable medical device traceability on the electronic patient record. The aim is to have full data submission by NHS England and independent sector providers by the end of the year.

NHS England will be working with various Scan4Safety programme initiatives across England and the four nations, focussing upon medical device traceability and device-based procedures to enable scanning of device data into the patient record.