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NHS Pathways is a Class 1 medical device

NHS Pathways is a medical device. These are the instructions for use for NHS Pathways under the Medical Devices Directive.

Introduction

NHS Pathways is a telephone and digital triage Clinical Decision Support System (CDSS) that has been in use since 2005 within the Urgent and Emergency care setting. It is used in all NHS 111 and half of English ambulance services. This triage system supports the remote assessment of millions calls per annum. 

The system is owned by the Department for Health and Social Care and delivered by the Transformation Directorate of NHS England.

Calls using NHS Pathways are managed by non-clinical specially trained ‘Health Advisors’ who refer the patient into suitable services based on the patient’s health needs at the time of the call. The Health Advisors are supported by clinicians who can provide advice and guidance or who can take over the call if the situation requires it. 

Clinical providers of services using NHS Pathways (“Providers”) must enter into a licence agreement, which grants rights to use the system and sets various implementation, training, and operational requirements for Providers. This is managed by NHS Digital.

Host system suppliers (such as suppliers of IT systems used by Providers which have NHS Pathways embedded within them) must also enter into a licence agreement, which grants rights to use the system and sets various implementation and operational requirements (including a technical specification) for host system suppliers. This is managed by NHS Digital.

The NHS Pathways team support Providers in meeting the minimum standards and enforcing any breaches of the standards.

Product details

The system is built around a clinical hierarchy, meaning that life-threatening symptoms are assessed at the start of the call triggering ambulance responses, progressing through to less urgent symptoms which require a less urgent response (or disposition) in other settings.  NHS Pathways is not a diagnostic system and only assesses symptoms presented at the time of the call and signposts to next level of care.  

NHS Pathways is an interlinked series of algorithms, or pathways, that link questions and care advice leading to clinical endpoints known as “dispositions”. The system presents a series of questions in order that the most appropriate clinical response or disposition may be determined based on the answers given. A disposition will specify the skill set and time frame that a patient requires. The system triages both injury and illness presentations for all age groups (neonate, infant, toddler, child, and adult). In addition, special populations are included where relevant to the triage, such as pregnancy.

The NHS Pathways system was developed and is maintained by a group of experienced NHS clinicians (clinical authors) with an Urgent and Emergency Care background. The NHS Pathways clinical authoring team come from a variety of clinical backgrounds and are either a paramedic, nurse or doctor who are registered, licensed practitioners.

REF: NHS Pathways clinical decision support system

SN: Clinical release notes

Intended use

Pathways CDSS is an interlinked series of algorithms, or pathways, that link clinical questions and care advice, leading to clinical endpoints. Non-clinical Health Advisors are presented with a series of questions. Based on the answers given, the most appropriate clinical response with a specific level of care and time frame, is reached. 

Questions are asked in a clinical hierarchy, so life-threatening questions are asked early in the call, progressing through to questions about less urgent symptoms.

It is available to all ages and to anyone located in England.

NHS Pathways content-based services are used in the following settings: NHS 111, 999, Integrated Urgent Care Clinical Assessment Services, to assist in the management of patients presenting to Urgent Care.  


Safety information

Safety instructions

Safety instructions

Warning: Indicates a potentially hazardous situation which, if not avoided, could result in patient death or serious impact to the health of patients.

System releases of NHS Pathways CDSS are supported by training and release materials which all users must complete before being able to use the system in a live environment. 

The Pathways CDSS makes a clinical triage decision based on symptoms presented at the time of the call.

Users should take careful note of any disclaimers or warnings that appear on NHS Pathways’ webpage

Cautions

Cautions

Caution: Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate impact to the health of patients.

NHS Pathways CDSS (as well as PaCCs) is to be used by trained users such as Health Advisors and clinicians who have achieved accredited status via the training requirements and complete ongoing continuous quality improvement (CQI).

Clinicians are expected to apply their own clinical knowledge to further triage patients and are not expected to rely solely on the output from the NHS Pathways CDSS in order to appropriately manage and advise their patients. 

General precautions

NHS Pathways can only be used within the terms of the licence, anything else is a contraindication. 


Technical information

Pre-use requirements and dependencies

Use of the NHS Pathways CDSS requires embedding into a host system, the suppliers must adhere to the ‘licence to use’ and technical specification such as the use of Google Chrome 87.0 which has been verified for use. 

Licence agreement

Clinical providers of services using NHS Pathways (“Providers”) must enter into a licence agreement, which grants rights to use the system and sets various implementation, training and operational requirements for Providers. This is managed by the Transformation Directorate of NHS England. The NHS Pathways team support Providers in meeting the minimum standards and enforcing any breaches of the standards.

Host system suppliers (such as suppliers of IT systems used by Providers which have NHS Pathways embedded within them) must also enter into a licence agreement, which grants rights to use the system and sets various implementation and operational requirements (including a technical specification) for host system suppliers. This is managed by the Transformation Directorate of NHS England.

Host systems

The NHS Pathways system always sits within a host system procured by the Provider. 

Different systems are used by different Providers. 

The host systems are responsible for demographic detail collection to allow interaction with other host systems and technologies, for example, direct booking or integrated ambulance dispatch. 

Providers may also have their own local processes regarding the collection of information before launching the NHS Pathways system, for example, documenting the call reason or nature of call within 999. 

Software installation, upgrade and configuration

Releases of the system will be suitable for use in the live environment; release files are provided to system suppliers in accordance with terms outlined in the licence agreements. Training materials to support any new release of the system are provided, so that users are updated on the changes made.

Step-by-step instructions

Host system suppliers enable Providers to use the embedded NHS Pathways content. Providers will supply users with access details to these host systems, (into which NHS Pathways is embedded).

NHS Pathways supplies all training materials for the system to Providers to enable them to deliver required training themselves. 

Troubleshooting 

For identified clinical enquiries, users should refer to their standard operating procedures outlined within the ‘licence to use’.

Any IT or access issues are dealt with locally by the Provider.

Access NHS Pathways service information, such as monthly triage data.

Technical specifications

Technical specifications are held in our internal repository, available on request from NHS Pathways.


Regulatory information

This device fulfils the requirements of the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

This software product has been designed according to: 

  • ISO 13485:2016 - Medical devices - Quality management systems for medical devices 
  • ISO 14971:2019 - Medical devices - Application of risk management to medical devices 
  • IEC 62304:2006 And 1:2015 - Medical device software - Software lifecycle processes 
  • DCB0129:2018 - Clinical risk management: its Application in the manufacture of health IT systems

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Manufacturer information

NHS England
7 and 8 Wellington Place
Leeds
West Yorkshire
LS1 4AP 

Last edited: 23 July 2024 5:13 pm