National Perioperative Data Standard Programme

Following a Direction from the secretary of state, and in response to the Independent Medicines and Medical Devices Safety Review: First Do No Harm, NHS England has developed an information system to collect, curate and analyse surgical device and implant data relating to patients. 

The information system captures and links data for procedures which use implantable medical devices (class III and IIb), as well as alternative data for equivalent non-device procedures.

Data modules have been developed to capture the relevant patient, clinical and speciality specific information as defined in the requirements specification. To minimise burden on health care organisations, existing data held by NHS England will be used to populate data where possible.

The system is designed to collect both historic and current data directly from NHS and independent health care organisations for all surgical specialities, initially focusing on pelvic floor surgical procedures, including the use of mesh or its alternatives. The data being collected covers information about the procedure, including the patient, clinician and device details, clinical details (including risk and post-operative complications) and surgical speciality specific data.

Use of the system will improve the quality of patient care by enabling:

• greater visibility of implants and device procedures across the country
• investigation of problems and prompt action when required
• monitoring of patient outcomes using the manufacturer of device or implant, hospital and surgeon information 
• better understanding where outcomes fall below an expected performance

Additionally, data in the modules will be used for 'secondary' purposes such as:

• healthcare planning
• commissioning services
• national tariff reimbursement
• developing national policy

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.

The Data Provision Notice (DPN) provides further detail about the legal basis for the collection, analysis, publication and dissemination of Surgical Devices and Implant Data.

The Surgical Devices and Implants Core Dataset (SDICDS) has been approved as an Information Standard by the Data Alliance Partnership Board (DAPB) at NHS England.

The Information Standard defines the data items, definitions and associated value sets to be extracted or derived from local information systems. Learn more about the DAPB3103: Surgical Devices and Implants Core Data Set including the associated ISN and standard documentation.

As of 1 July 2022 this replaced the core data items found in the  Surgical Devices and Implants Data Technical Output Specification (v1.0.01). Health Care Organisations (HCOs) should be working with system suppliers, to collect and submit data as detailed in the Information Standard as well as the clinical and pelvic floor data items specified as part of the Direction and Data Provision Notice.

An updated technical output specification detailing the items for submission has now been made available. The Technical Output Specification (TOS) v1.0.05 is an update to v1.0.01.

NHS England expects all organisations to align to the TOS 1.0.05, however organisations are permitted to submit data using TOS v1.0.01 during a transition period.

Organisations in scope 

All health care organisations (HCOs) and independent health care sector organisations (IHCSOs) providing NHS funded care in England must submit data to this collection in line with the technical specification and specialities in scope as defined by the nation specific Data Provision Notices (DPNs).

Independent health care sector organisations (IHCSOs) are requested to submit data and, although they are not currently mandated to participate, it is in their interest to do so. The clinical insights derived from this information system will lead to improvements in clinical practice, better patient care and improved patient outcomes.

Procedures in scope 

Activity involving the implant, revision or removal of Class III or Class IIb implantable devices, including information regarding alternative procedures for pelvic floor surgery is within scope. This is to enable the comparison of patient outcomes associated with surgical devices and implants with alternative procedures.

A list of pelvic floor procedures has been identified by our Clinical Classifications team and approved by the Mesh Registry sub group committee. 

The list provides HCOs with details of all pelvic floor procedures that are in scope for collecting and reporting data on. These include:

• procedures using a Class III or Class IIb implantable medical device which is implanted, revised, or removed
• alternative procedures not using a Class III or Class IIb implantable medical device

What data will be collected

The Technical Output Specification sets out what data needs to be collected.

Main changes to v1.0.05

Operation date time is now a single data item. In the event where time is not captured organisations can default time to 00:00:00.

OPCS codes used to submit in-scope procedures has been removed from the core data set and moved to the clinical section. OPCS is not a point of care tool and is not designed to be used in theatre. The data item has moved to the clinical section as an interim measure until health care organisations are able to implement SNOMED CT.

How the data will be submitted

We have developed data submission options in partnership with organisations across the UK. These include data uploads via the Message Exchange for Social Care and Health (MESH) and data input through a web form. Additional guidance for MESH setup and submission is available.  

An example CSV template has been made available to demonstrate how the new repeating groups along with the existing core, clinical and pelvic floor data items will need to be constructed for submission. Please make sure each column is as specified in the CSV. 

When the data will be collected

Data submission options have been made available in partnership with organisations across the UK. These include data uploads via the 

The surgical devices and implants data collection includes historical data from 2017. This is a year before the recommended pause (2018) in mesh procedures, with some organisations able to send data from earlier periods. The historical data is intended to set a benchmark recognising that the numbers could reach pre-pause levels for any procedures reintroduced.

How the system has been developed

The system has been developed with stakeholders from across: NHSx, Medicines and Healthcare Products Regulatory Agency (MHRA), NHS England and Improvement, the Department of Health and Social Care (DHSC), patients, and clinicians.

There were a series of test data submissions from NHS and independent health care organisations across England who took part in a pilot. 

We are also working with the UK's devolved administrations to gather additional insights for development. 

NHS England is establishing a Medical Device Information System, which will operate in accordance with regulations that will set out how medical device information from NHS and independent healthcare organisations across the UK is collected, analysed and used.

MDIS will build on the design and base infrastructure of the Surgical Devices and Implants Information System and will help trace high-risk implantable medical devices over the next 3-5 years after a device has been implanted.

MDIS vision

MDIS will be a UK wide system underpinned by a central patient-identifiable database for all implanted medical devices and will include outcomes and comparator data. 

In time, the system will enable interoperable message exchange and alerting across the health and care system. This will ensure a consistent UK wide approach to the monitoring of medical device safety. It will allow recalls and alerts where issues are identified and will provide an improved flow of appropriate data to clinical registries and regulators.

For further information please refer to:

• MDIS Factsheet
• How a medical device information system might work in practice

NHS England is running a proof of concept for the extraction and curation of raw data directly from independent health care organisations’ theatre/perioperative or electronic patient record (EPR) systems.

The aim is to:

• demonstrate how advanced curation technologies could be used to routinely collect perioperative data
• minimise the burden of data collection on health care organisations
• help establish perioperative data flows from health care organisations
• compliment and support the Acute Data Alignment Programme (ADAPt) as it aims to move towards a common set of standards for data collections, performance measure methodologies and reporting systems across NHS and private healthcare.

Anaesthetics Advanced Data Curation Initiative

NHS England is running a proof of concept for the extraction of anaesthetic data directly from health care organisations’ anaesthetic systems.

The aim is to:

• demonstrate how NHS England advanced curation technologies can be used to routinely collect perioperative data
• minimise burden of collection for health care organisations
• help establish perioperative data flows from health care organisations
• support the capture of the anaesthetic record, which has been identified as a core component of the National Perioperative Data Standard.

For support on your Surgical Devices and Implants data submission, please contact your NHS England Data Liaison Team at [email protected]