Date published: 4 March, 2024
Date last updated: 4 March, 2024
Nursing, midwifery and care, Out of hospital care, Patient care, Virtual wards

Guidance on managing medical equipment within virtual wards (including Hospital at Home)

1. Introduction

Most virtual wards use medical equipment, devices and software. A good understanding of how to buy, use and manage these items is therefore fundamental to providing an effective virtual ward service. In addition, virtual wards are usually ‘technology enabled’, which means they manage patients via a digital platform.

This guidance describes what should be considered when designing, setting up and running services that involve the diagnostic and therapeutic use of medical equipment and devices with patients at home or in other remote settings. It provides insights into equipment and health technology management, to help those responsible for virtual wards and related services work effectively with clinical engineering services to deliver the best outcomes for patients.

Although the focus is virtual wards, the device management principles can be applied to a wider range of services that provide virtual and/or face to face out-of-hospital care to patients at their usual place of residence, including those set up and managed by or in collaboration with a third party.

This guidance has been developed by NHS clinical engineers, and is shaped by legislative requirements, relevant standards, organisational governance and safety responsibilities, and best practice professional advice.

‘Equipment’ in this guidance is used as a general term to describe the totality of both medical and non-medical devices and software. The term ‘medical device’ refers explicitly to items meeting the UK regulatory definition of a medical device, including certain types of software. This distinction is important when dealing with governance, performance, and liability issues. The scope of what is classed as a medical device and how these devices are regulated is set out in the UK Medical Device regulations. The conditions under which preparation of Medical Devices should be undertaken are defined by the Medical Devices Directorate or Regulations; clinical engineers can advise what is required by this. In this guidance, the term ‘technology’ is reserved for digital technologies used to manage patients and does not encompass all types of equipment.

2. Clinical engineering

Clinical engineering in healthcare focuses on delivering appropriate functional medical equipment, supporting the purchase, development and use of this equipment in a clinical environment.

Clinical engineers may be involved in the whole lifecycle of medical equipment from design, through procurement to decommissioning. They provide specialist knowledge and expertise to deliver the best outcome for patients. They help translate clinical need into detailed technical specifications, working closely with clinicians to find the most suitable, safe, efficient and cost-effective medical equipment for patient care. They also enable the NHS to get the best long-term value from its investment in medical equipment and address governance issues, working with clinical safety officers, medical device safety officers and others to manage overall risk and comply with standards and guidance.

Why it is important to involve clinical engineers in the establishment and management of virtual ward services?

Clinical engineers provide support for medical equipment in:

Equipment design and procurement:

  • ensure devices meet appropriate regulatory requirements
  • review equipment specifications and arrangements for technical support
  • evaluate device performance and support clinical suitability and usability assessments.

Preparing to use equipment:

  • advise on training and bespoke training materials
  • help review operational requirements and plan appropriate quality control, governance and safety measures
  • advise on device configuration, connectivity and data security.

Using devices:

  • track equipment and provide service support to devices in the field
  • help set up external contracts and performance indicators for equipment and software management.
  • equipment issue, repurposing, management and maintenance
  • bespoke equipment tailoring for patient need.

Decommissioning – taking devices out of use safely and sustainably.

Governance and safety:

  • carry out technical risk assessments
  • liaise with equipment suppliers
  • investigate incidents to identify and manage technical and use problems
  • monitor manufacturer and regulatory safety notices, updates and recalls.

Bringing the experience and expertise of clinical engineers into virtual ward projects as early as possible will optimise the selection, procurement and safe use of medical equipment. Their involvement will probably lead to cost savings, risk reduction and more effective services.

As virtual wards evolve, they will use more device types. Clinical engineers have useful expertise for planning the provision of safe and efficient higher acuity care at home, and increasing service resilience.

Areas where their expertise might be particularly valuable include:

  • Identifying suitable technologies and devices for use in virtual wards.
  • Planning for and monitoring systems for equipment support.
  • Establishing resilient and sustainable routes to obtain equipment and consumables such as blood pressure cuffs, probes and batteries.
  • Assessing the performance and robustness of devices in service and identifying ways to improve device design.
  • Checking multiple connected medical devices and software systems will operate properly in regular use and when being interrogated remotely.
  • Selecting software versions and configuring software menus and settings on more complex devices, to provide consistency. This includes checking that configurations have not been changed inadvertently by users or when equipment is maintained.
  • Assessing and sourcing specialist or bespoke solutions to enable those with disabilities to operate devices.

Section 3 gives more detail on how clinical engineers can support virtual ward services at each stage of the medical equipment lifecycle.

How to involve clinical engineers

If you are establishing or managing a virtual ward service, contact the clinical engineering service associated with your lead provider or integrated care system (ICS). This may be based in an acute hospital or a large community trust. These services are well established and can be extended to cover virtual wards, including where devices are taken out of a trust to use on patients in other settings.

Local clinical engineering services have a variety of names: clinical engineering, biomedical engineering, electrical and biomedical engineering (EBME), medical equipment management service (MEMS) and medical physics. If you are unsure who to contact locally, the National Clinical Engineering Network hosted by NHS England’s Office of the Chief Scientific Officer can provide specialist advice and identify sources of appropriate expertise. Please email cso.england@nhs.net for this support.

3. Medical equipment management in virtual wards

Medical equipment management encompasses a life cycle that applies to all equipment, from initial specification to final disposal. The general six-stage process applies across a wide range of healthcare services and is designed to ensure medical equipment meets all statutory requirements; is suitable for its intended purpose; that all staff and, where appropriate, patients know how to operate the equipment safely; and is both cost-effective and efficient.

The six stages of medical equipment management are:

  1. Service specification
  2. Governance arrangements
  3. Design or selection and evaluation
  4. Preparing for use
  5. Putting into use
  6. Removal and disposal.

The sections below outline best practice guidance for the management of medical equipment in virtual wards, using the six stages, with a summary of the recommended practical steps provided in Appendix A.

The practical steps should be reviewed and implemented appropriately for all virtual ward projects including those involving third-party providers. This guidance is therefore for both those responsible for setting up and overseeing virtual wards, and the clinical engineering specialists who advise and support them. Advice on contacting clinical engineering services is given in section 2.2 above.

Developing a service specification

Many examples exist of medical equipment and devices being purchased in the belief that they will meet a particular clinical need but then turn out to be unsuitable or not fit for purpose. Without a clear well-informed purchase process, organisations have little basis on which to challenge a supplier over an inappropriate device or poor performance.

The same consideration applies to the digital technology used to manage patients in a virtual ward setting. The Guidance on selecting and procuring a technology platform considers key requirements for technology enablement of a virtual ward that involves remote monitoring, and includes a specification that can be tailored to meet local needs.

Before purchase of any device is considered, a comprehensive specification should be created that sets out service demands, clinical needs, technical requirements and any particular considerations. A good specification covers everything from the required accuracy and precision of measurement parameters to the safety, usability, durability and reliability of technology. It provides the performance criteria and clinical needs requirements against which candidate devices can be evaluated, and will be greatly enhanced by clinical engineering input. Specialised software and data management expertise is also needed where candidate devices will use wireless technologies or be otherwise connected to clinical information systems. Appendix B provides a good practice checklist of what a specification should cover.

Clear specifications are also essential when working with third-party providers.

Governance arrangements and responsibilities

It is crucial that governance arrangements are defined at the start of a project, to ensure medical equipment management is effective and risks are minimised.

Acute trusts have well-developed systems to manage their existing devices. Where a virtual ward is created under the management of, or in association with, an acute trust, the first option that should be considered is whether existing clinical engineering services and practices can be extended and adapted to cover this new application.

Organisations that do not have a robust structure to manage medical equipment will need to take advice from a local clinical engineering service on how to set up and maintain suitable processes. Please refer to the Medicine and Healthcare products Regulatory Agency (MHRA) Managing medical devices guidance for any equipment used in a healthcare context.

Virtual ward services should identify leads for the following actions:

  1. Develop service specifications. This action includes undertaking risk assessments, producing performance or purchase specifications, and overseeing the commissioning, acquisition and deployment of devices.
  2. Oversee clinical safety risk management with respect to devices and health IT systems. This action includes compliance to standards and guidance such as DCB 0160, DCB 0129 and the use of DTAC (Digital Technology Assessment Criteria) in: technology procurement; establishing arrangements for involving other stakeholders such as clinical safety officers, medical device safety officers and appropriate IT leads; and for determining clear lines of accountability.
  3. Set up and manage arrangements for ongoing patient and device support. This action includes tracking, auditing and monitoring devices and device-related services, investigating incidents, reviewing safety alerts, and any required modifications and recalls. This may require collaboration between those providing device support and other parties such as providers of connectivity and data storage systems.
  4. Set up and manage user training and ensuring ongoing competency in device use. This applies to clinical staff, patients and carers (as appropriate).

Selection and evaluation

Once a comprehensive specification has been created, the different items of equipment need to be reviewed and evaluated to check their suitability for a particular application. Local clinical engineering services can provide expert advice to support virtual wards through this process, including when working with third-party service suppliers.

The steps include:

  1. Confirm medical equipment conforms to relevant CE/UKCA regulations and appropriate device standards. For more information, see the resources in Appendix C.
  2. Check whether candidate devices meet the performance criteria set out in the service specification and clinical needs requirements.
  3. Review manufacturer specifications, obtain a completed Pre-Acquisition Questionnaire (PAQ), make further enquiries and carry out detailed evaluations as necessary.
  4. Review the design, robustness, anticipated lifetime and technical support arrangements for candidate devices.
  5. Assess device technical performance, including the quality of construction, accuracy and precision, battery lifetime and ease of replacement, any operational limitations, and related product Safety Alerts and Field Safety Notices.
  6. Check validation of devices and whether any inherent bias in device algorithms or other characteristics have been minimised, including clarification of how device performance is checked.
  7. Assess suitability for use in the intended environment, including training and operational requirements, ease of use and user acceptance, robustness, availability and cost of consumables, and available processes for cleaning and decontamination.
  8. Identify any potential concerns or training issues that might arise.
  9. Establish any data storage, security and access requirements, and assess compliance with relevant cybersecurity and data protection standards and legislation. Check interoperability with existing software and hardware systems.

The list above is not exhaustive. Organisations will have a process for selecting and evaluating medical equipment that can be applied or adapted for use in virtual ward settings.

Preparing for use

Once a robust selection and evaluation process has been completed, detailed preparations can be made to roll out and support the equipment that has been acquired and finalise how it will be supported. The steps below set out the key elements in this process that virtual ward services will need to consider, with support and expertise from clinical engineers:

  1. Agree which organisation will become the responsible owner of each device and ensure it is logged as the owner with the supplier.
  2. Agree how devices will be configured and set up for different patient groups and applications, including arrangements for device connectivity (where relevant).
  3. Plan the logistics for handling devices. These should cover delivery, storage, provision to the end user, removal and re-use or disposal, including arrangements for cleaning and decontamination. Storage needs to be secure and must keep devices and any consumables safe from damage or interference when not in use, which can be a challenge in home environments.
  4. Undertake and document risk assessments of devices in use and of planned support arrangements. Review the adequacy of contingency measures to deal with potential problems, including the resilience of consumable supplies (where relevant) and any requirement for back-up devices.
  5. Consider device power consumption and the cost and continuity of electricity supply and/or battery replacement when placing them in a home setting.
  6. Train users/patients/carers and support staff in how to prepare devices for use, operate them and carry out any user maintenance and performance checks. Check individuals are confident in device use and keep records of initial and subsequent training delivery and competency assessment.
  7. Supply users with the manufacturer’s instructions for use, for the make and model of device they will be using, in an accessible format. Where required, issue bespoke documentation that highlights key issues – such as only using a device within its validated temperature range and what to do if a device is dropped or damaged. Keep records of what documentation has been supplied and provide updated versions as these are issued.
  8. Set up logistical arrangements for device support, including the supply and delivery of consumables, preventative servicing and test/calibration schedules if applicable, and procedures for device maintenance or swap out when problems are encountered.
  9. Set up quality control systems to check device performance and pick up systematic measurement errors. Review any incident reports relating to device use or associated data security. Reassess risks at regular intervals.
  10. Assess whether networked and connected devices will work correctly in their intended setting and can operate alongside other existing equipment.

Note, the above is not an exhaustive list and each local clinical engineering service will have a process and guidance for preparing medical equipment for use.

Putting into use

Once preparations are complete, devices can be rolled out. Clinical engineers can provide advice and expertise on the key activities involved in doing this, for both new and reused devices, and:

  1. Arrange for the delivery, acceptance, installation, commissioning and operational testing of each batch of devices, and check they are working correctly.
  2. Add asset labels and the name of the support service provider, and centrally record each device’s unique identification number.
  3. Set up handover arrangements to deliver each device to its end user/patient/carer, including recording where items are located and who is responsible for setting up, checking, operating and managing them at each location. This includes tracking the allocation of decontaminated and reused devices.
  4. Inform users of arrangements for device monitoring and support. Provide contact details to report faults and queries.

This list is not exhaustive but sets out the essential steps required to put an authorised medical device into use.

As the service moves into ‘business as usual’, other basic activities will include ongoing monitoring of device condition and performance, carrying out any maintenance and support activities, and reviewing/investigating incident reports.

Removal, reuse and disposal

Decommissioning and disposal of medical equipment is the final stage of the device management lifecycle. Clinical engineers can support local services by informing policy. Key considerations for this stage include:

  1. Ensure disposal arrangements and costs for devices and consumables are factored into each project, in a way that meets sustainability criteria and avoids transferring costs onto another organisation, a patient or the environment.
  2. Ensure patient risks and service liabilities are minimised, by tracking the physical withdrawal of items from service.
  3. Arrange for the safe collection, cleaning and decontamination of devices as appropriate to ensure safety and minimise overall environmental impact, whether devices are being reused or disposed of.
  4. Update the status of device records to indicate reuse or disposal.

Appendix A: Good practice recommendations for the management of medical equipment in patients’ homes and community settings

  1. Establish robust governance arrangements and identify responsibility for every aspect of the project.
  2. Involve clinical engineers as early as possible in virtual ward initiatives and projects, including in the specification and selection of medical devices and other equipment, the assessment of risk and quantification of resource implications.
  3. Identify clinical needs and develop a comprehensive requirement specification that sets minimum requirements for device accuracy, precision, usability, reliability and safety.
  4. Develop a detailed technical specification for device performance and other characteristics, including conformance with particular regulations and standards.
  5. Evaluate and select candidate devices and associated software systems based on clinical and technical requirements and factors including user needs, IT and cybersecurity considerations and cost.
  6. Set up clear management arrangements for the service that provide operational support for end users and address identified risks.
  7. Establish clear management arrangements for medical and other equipment used in the virtual ward service.
  8. Set up arrangements to ensure clinical staff are suitably trained and updated in medical device and other equipment use and are also able to train patients and carers.

Appendix B: Reference guide to developing clinical requirements and device specifications

Clinical effectiveness (diagnostic devices example)

  • What clinical decisions will the device(s) support? Is there a guideline for decisions that should be made for readings/trends at different levels?
  • What therefore is the required accuracy, precision and frequency of readings?
  • What is the risk of a false negative or false positive result and what mitigating action will be taken?

Human factors usability (in general)

  • Is training/guidance available and clear, for the use/management/
    interpretation of readings of the device?
  • Could aspects of the design lead to errors in device use or interpretation? Are any settings not obvious? Are there limits on period of operation?
  • Is the device to be used with other devices and software (such as a smartphone)? If so, are these sufficiently usable for all potential operators?

Equity and Inclusion

  • Is the design of the device(s) inclusive- i.e. appropriate to all users and subjects?
  • Do the dimensions and design accommodate a broad range of users (the full range possible)?
  • Are all instructions, associated apps and other written artifacts accessible in terms of language, format and readability?
  • Does the device’s performance depend in any way on a subject’s characteristics? If so, how can any variability be mitigated?

Device-specific areas

  • Identify recommended technologies and assess their suitability for the desired application.
  • Specify device measurement characteristics (eg accuracy range and reproducibility) and limitations (technical and clinical).
  • Address any known common measurement errors, and measurement or interpretation bias.
  • Specify any requirements for compatibility with existing equipment, software and operating procedures, including software and IT systems.
  • Ensure that the device complies with relevant regulations and standards, including cybersecurity and data handling where applicable.
  • Look for any potential system vulnerabilities, whether in physical design or in software. How sensitive is the device to normal handling and to accidental damage?
  • Identify any specific device management requirements, including user and quality control checks and calibration/performance checks. Is specialist equipment needed to maintain or support the device?
  • Look for common failure modes, causes of output misinterpretation and ongoing support issues.
  • Specify compatibility with any required cleaning and decontamination regimens.
  • Enquire about long-term operating and lifetime costs.
  • Consider sustainability and supply resilience issues. How is the manufacturer addressing net zero considerations?
  • Confirm expected lifetime and the availability of manufacturer service support in the UK. Look at the resilience of supply chains for consumables and any common replacement parts or accessories.
  • Check the availability of user training from the supplier.
  • Review the format, content and quality of user instructions and training materials.
  • Check the availability of training, manuals and support for maintenance personnel and any requirements for specialised device management, including device and software configuration and updates.
  • Check the availability and cost of any dedicated consumables and the availability of generic alternatives.
  • Does the device and any associated software meet NHS data standards?
  • What controls will be applied to the use of non-medical devices to generate and/or transmit clinical information?
  • What controls will be in place regarding patient identifiability in generated, transmitted and stored data, particularly where remote service agents have access to devices and systems?
  • Does the possibility of automated data interpretation have any implications for the integrity of data and performance of measurement systems?

Appendix C: Resources

Appendix D: Case studies

Sheffield clinical engineers help to find and implement a virtual ward solution

NHS South Yorkshire ICB were looking to purchase a solution to support the rollout of virtual wards across several trusts in the local health system.

Both the Director of Innovation/Head of Medical Physics and Clinical Engineering and the Head of Clinical Engineering at Sheffield Teaching Hospitals were instrumental in this project, providing expertise in technology, clinical engineering and clinical measurement. They helped specify the preferred service model by translating needs expressed by clinicians into clear and comprehensive procurement documentation and by working with informatics colleagues to identify and articulate requirements for digital connectivity and integration. The trust’s clinical engineering team was also involved at key stages of the tender process, including bench top testing of equipment and supporting clinical and patient evaluation of potential systems to check that all specifications were met.

Future involvement of the clinical engineering service will include help with virtual ward implementation and the monitoring of supplier performance.

This project has increased the visibility of clinical engineering across the region, leading to a recent request from Sheffield City Council to join a city-wide team looking at how to make technology-enabled care services more proactive and preventative. Clinical engineering involvement across the region will help multiple small- and large-scale projects get best value from their technology.

Clinical engineers in Cambridge bringing patient data into the EPR

The Head of Clinical Engineering at Cambridge University Hospitals became involved in the virtual ward programme following NHS England’s national announcement of the benefits and need for virtual wards to increase bed capacity. He now sits on the East of England virtual ward programme board, is a member of the operational delivery board for Cambridge University Hospital’s virtual ward programme, and is involved in specifying, sourcing and procuring equipment, working closely with clinical teams.

The virtual ward programme decided to take a different approach to many programmes, by not using cheap pulse oximeters. Their view is that observing data on a standalone dashboard works for short-term monitoring, but for long-term patient care, data should be uploaded to the EPR patient record and treated in a similar way to observations taken in hospital.

Clinical engineers at the trust used their expertise and external relationships to negotiate a strategic partnership with an existing supplier. This allowed them to use that company’s remote technology during Covid, when there was a need to protect staff but continue to take accurate physiological measurements. Working with the supplier, they have now developed an app that sends all physiological parameters via Bluetooth to a central server, from where results can be viewed. The next step is to integrate this data into the Epic EPR record, working in collaboration with the e-hospital IT team.

The clinical engineering team is also looking at how to take ECGs in patients’ homes in a way that enables storage and viewing of the resulting data in a single system. This will involve training patients and carers in how to take accurate measurements, especially if multiple ECG leads are required. Automated demographic and data checks will then link the ECG and accompanying report to the correct Epic EPR patient record.

Virtual ward services can experience significant operational demands for ‘day to day’ support from patients using medical devices independently. One clinical engineering service received many more calls when patients started using devices without the presence of clinical staff. Many of the reported faults were due to lack of user training and unfamiliarity with device operation, and easy to correct, such as batteries being flat or inserted the wrong way round, blood pressure cuffs being too loose or wrongly positioned, and hoses not fully plugged in. Some problems required closer inspection; for example, devices being accidentally dropped or damaged by pets. A few calls were due to device faults or connectivity issues that stopped data from being submitted smoothly to a central server. Resources to deliver this support should be included in virtual ward set up and delivery costs.

Appendix E: Acknowledgements

Task and Finish Group members

  • Angela Douglas, Deputy Chief Scientific Officer for England
  • Professor Dan Clark, Head of Clinical Engineering, Nottingham University Hospitals NHS Foundation Trust
  • Martin Lucey, Head of Clinical Engineering, University Hospital Southampton NHS Foundation Trust
  • Tracy Hammond, Medical Devices Safety Officer, Solent NHS Trust
  • Michael Ross, Head of Medical Technical Services, Southern Health and Social Care Trust
  • Dr Keith Ison, Co-ordinator, National Clinical Engineering Network

Contributors

  • Professor Paul White, Head of Clinical Engineering, Cambridge University Hospitals NHS Foundation Trust
  • Chris Hacking, Consultant Scientist, United Lincolnshire Hospitals NHS Trust
  • Professor Mark Tooley, Clinical Digital Advisor, West of England Academic Health Science Network
  • Zoe Harris, Senior Delivery Manager, NHS England
  • Jane Sproat, Assistant Director, Virtual Ward Primary and Community Care, NHS England
  • Seher Barrell, Head of Programmes, Office of the Chief Scientific Officer, NHS England
  • David Russell, Deputy Director, Virtual Wards, NHS England

Publication reference: PRN00722

Date published: 4 March, 2024
Date last updated: 4 March, 2024