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Medical devices management policy

Contents

  1. Policy summary
  2. Introduction
  3. Purpose
  4. Scope
  5. Procedure or implementation
  6. Training implications
  7. Monitoring arrangements
  8. Equality impact assessment screening
  9. Links to any other associated documents
  10. References
  11. Appendices

1 Policy summary

Medical devices are an integral part of the diagnosis, treatment, support and care of patients. The trust recognises the risks to patients, staff and others that may arise with the use of medical devices, and that good medical device management will assist in minimising these risks.

2 Introduction

The term medical device is legally defined in the Medical Devices Regulations 2002 as an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which is intended by the manufacturer to be used for the purposes of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease
  • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or physical impairment
  • investigation, replacement, or modification of the anatomy or of a physiological process
  • control of conception

Examples of medical devices used within the trust are shown in appendix A.

There are also occasions when software applications are considered to be a medical device.

See GOV.uk for more information (opens in new window).

The role of the medicines and healthcare products regulatory authority (MHRA) is to protect and promote public health and patient safety. It does this by ensuring that the manufacture and use of medicines and medical devices meet appropriate standards of safety, quality, performance and effectiveness (see managing medical devices, 2021).

The MHRA:

  • investigates adverse incidents involving medical devices and equipment
  • issues safety warnings
  • provides advice and guidance on safety and quality issues
  • acts as the UK competent authority, the regulator for the medical devices industry

3 Purpose

The purpose of this policy is to:

  • support the effective implementation of the trust’s risk management framework by setting out the arrangements for minimising the risks associated with the use of medical devices, including selection, purchasing, acceptance, deployment, training, monitoring, traceability, maintenance, storage, decontamination, repair and disposal in accordance with legislation and guidance
  • support the provision of personalised care through the use of medical devices in a way that has regard to the dignity, comfort and safety of patients and promotes their independence, using best interest provisions where required

4 Scope

This policy applies to trust colleagues and any colleagues providing services under contract in both hospital and community services who are involved in any aspect of medical devices use and management. This includes but is not limited to medical devices which are used in inpatient services, in the community and inpatients’ own homes.

For further information about responsibilities, accountabilities and duties of all employees, please see appendix H. For monitoring arrangements please see section 7.

5 Procedure or implementation

5.1 Quick guide

  • Personalised care, actively listen to patients’ preferences and thoughts wherever possible about what they need and how it is used. This includes respecting issues such as religious beliefs, consent, running cost issues.
  • Procurement:
    • use the trust best buy list when purchasing medical devices
    • new devices need to be approved by the medical devices advisory group
  • Inventory:
    • all re-usable medical devices should be logged on the trust medical devices database
    • devices loaned to patients should include manufacturers’ instructions and documentation explaining cleaning instructions, how to obtain consumables, and contact details in case of query or malfunction
  • Maintenance:
    • servicing or electrical testing of devices is according to manufacturers’ instructions
    • all items undergoing servicing will be issued with a test date label
    • the medical devices database requires updating when services are completed
    • all broken equipment will be repaired as required via the same route as servicing
  • Incidents and alerts:
    • failures in operation of a medical device are reported via IR1 system
    • applicable medical device alerts, and field safety notices are cascaded via the trust alerts system

5.2 Medical devices and the provision of personalised care

Medical devices should be used in a manner which has regard to the dignity, comfort and safety of the patient and promotes their independence. This will be achieved by:

  • actively listening to patients’ preferences and thoughts wherever possible about the equipment they need and how it is used. Religious belief will be respected regarding consent to use medical devices. If devices are advised which will result in a running cost to the patient for example electrical equipment, but the individual does not want to or is unable to fund the running costs, alternative equipment or care will be determined. It must be recorded in the clinical records if consent is not given for the use of medical devices
  • supporting the patient to understand how and why the equipment is being used, this includes ensuring that information about medical devices is provided in a format to meet the patient or carer’s individual requirements
  • taking care in the way colleagues use the equipment to make sure the patient is comfortable and safe. Individual requirements such as pregnancy will be taken into consideration if relevant when issuing any medical devices
  • using the equipment in a way that ensures the person’s privacy and dignity
  • taking account of the training needs of patients with regard to any equipment they are given to use themselves
  • using best interest provisions where appropriate (refer to Mental Capacity Act policy)

5.3 Medical device management

Medical devices should:

  • be properly maintained, safe to use and operated by colleague(s) or others suitably trained and skilled to use the devices
  • be suitable for purpose
  • be installed, used and maintained in accordance with manufacturer’s operating specifications and instructions, legislation and guidance from expert bodies
  • be available in sufficient quantities to meet the needs of people who use the service
  • be subject to an appropriate, monitored and recorded service, testing, and maintenance programme
  • be subject to required security patching and software updates
  • be traceable where possible
  • be de-commissioned or replaced at the time recommended by the manufacturer or other expert body
  • promote wellbeing or independence
  • be comfortable and maintain the dignity of the patient
  • be compliant with all relevant legislation and guidance
  • be stored safely and securely to prevent theft, damage or misuse
  • be able to be safely decontaminated as per the trust infection prevention and cleaning and decontamination of the environment and patient equipment procedure for reusable and single patient use devices

All medical devices will be selected and procured in accordance with MHRA recommendations and the trust’s requisitioning, ordering and receipt of goods procedure. If the purchasing department require a pre-acquisition questionnaire (appendix B) completed for each new medical device, they will forward one to the device supplier for completion. The pre-acquisition questionnaire covers detailed information about the device, its safety standards, servicing, repair and maintenance, spare parts, training and decontamination or reprocessing. All medical devices are purchased according to the ‘best buy’ standardisation list produced by medical devices advisory group (MDAG).

No new medical devices should be purchased unless the manager has:

  • sought advice from MDAG or best buy list, relevant trust policies, and any appropriate trust advisor, for example, the Learning and Development and Infection Prevention and Control team
  • undertaken a risk assessment of its design, function, performance, maintenance requirements, life cycle costs and colleague’s training requirements
  • ensured that the medical device can be decontaminated to a safe standard to reduce the risk of cross infection
  • sought advice around suitable manufacturers and suppliers
  • undertaken an assessment of cost effectiveness against purchase or hire of the device
  • sought advice from the information technology (IT) department if the equipment is to be connected to the trust’s network or any IT equipment and completed the IT pro forma document
  • sought advice from the Information Governance team if the equipment is to store PID (person identifiable data) and completed data processing impact assessment (DPIA) (staff access only) (opens in new window)

Please note that this purchasing section is not relevant for purchasing of devices using the FP10 prescription method. Where patients are prescribed dressings or appliances via FP10 prescriptions, the prescriber would consider the criteria in line with prescribing guidelines and formularies.

5.5 Acceptance of new medical devices

  • All new medical devices will be delivered to the Stores department who will make arrangements for the delivery of the device to the department within the locality.
  • Resuscitation equipment should then be sent to the resuscitation officer for checking or audit purposes; they will then be delivered to the relevant areas.
  • it must be informed when installation onto a network, connection to a computer, or linking to a clinical system is required.

Checks should be carried out when equipment is first delivered to each Department to ensure the equipment:

This may need to be carried out by a colleague or by a trained engineer depending on the equipment.

5.6 Medical device inventory

New medical devices should be inputted onto the web-based inventory (on the Ulysses system) by the medical device link person in each service across the trust (except for single-use items). This inventory contains information about each device such as its manufacturer, location, and servicing date. The inventory is monitored and updated by the medical device link people. Guidance on how to use the inventory is provided by the ‘asset web user guide’ and support is provided on an as and when required basis by the medical devices and projects officer.

5.7 Single use medical devices

All single-use medical devices should have this symbol on the packaging or the device:

After a single use device has been used on an individual patient during a single procedure it must be discarded. It must not be reprocessed and used again, even on the same patient. All equipment must be disposed of in accordance with the guidance given in HTM 07-01 safe management of healthcare waste available on the department of health website and the trust waste policy.

Legal implications, anyone who reprocesses a single use device and passes it to a separate legal entity for use has the same legal obligations under the Medical Devices Regulations as the original manufacturer of the device. If the device is not considered “fit for its intended purpose” the re-processor and professional user may be committing an offence under one or more of the following acts:

  • Health and Safety at Work Act 1974
  • Part 1 of the Consumer Protection Act 1987
  • The General Product Safety Regulations 1994
  • The Medical Devices Regulations 2002

Reprocessing single use devices may affect the capabilities and the materials from which the device is made. Single use devices may not be designed to allow thorough decontamination and, if applicable, re-sterilisation processes. Many problems caused by inappropriate re-use fall into one or more of the following categories:

  • inadequate cleaning and decontamination
  • material alteration, mechanical failure
  • potential for cross infection
  • reactions to endotoxins
  • retaining residues from chemical decontamination agents

Health circular 1999/178, variant Creutzfeldt-Jakob disease (vCJD): Minimising the Risk of Transmission states that “devices designated for single episodes of use must not be reused under any circumstances whatsoever”.

Also see Creutzfeldt-Jakob disease (CJD) procedure (IPC manual) for further information.

Medicines and Healthcare products Regulatory Agency (2021) Single-use medical devices: implications and consequences of reuse.

For single use emergency care equipment a stock of spares for instant replacement must be available.

5.8 Single patient use medical devices

Single patient use means the medical device may be used for more than one episode of use on one patient only; the device may undergo some form of decontamination or reprocessing between each use. Information on cleaning each device will be provided.

5.9 Medical devices used on-trial or on-loan

It is the responsibility of colleagues to fully consider the risk exposure, when approached by manufacturer sales representatives endeavouring to market their products. This may result in the product or items of equipment being left for use on a trial basis. Manufacturers providing equipment for a trial must deliver the equipment to or liaise with purchasing to comply with MHRA guidelines and complete the NHS indemnity form. Managers must be engaged and oversee the trials process.

Stakeholders must appreciate that controls are essential to avoid the possibility of risk exposure to both the clinician and patient. The controls will allow the trust to:

  1. comply with MHRA guidelines, which require supplier indemnity to be assured via the completion of standard NHS indemnity forms available from the purchasing department. Any gifts also require an indemnity form to be completed, a service history should be provided, and a serial number kept with the department and the purchasing department
  2. ensure that the relevant medical engineering department (through local SLA and so on.) are fully aware and have carried out the required safety checks as required
  3. ensure processes for safe storage, maintenance, calibration and eventual disposal of the device are in place and recorded with the loan agreement
  4. ensure all the training needs have been identified, and appropriate training provided prior to use of the devices

If all the key issues have been fully considered and the decision made to accept the medical equipment on trial or on loan, the checklist in appendix C must be completed by the manager of the department.

5.10 Equipment loaned to patients

Equipment is usually loaned to patients via community equipment services. However, the trust loans certain equipment to patients such as suction machines and syringe drivers.

When devices are loaned to patients, the following should be provided:

  • a written copy of manufacturers’ instructions, alternative formats will be arranged if required. A failure to pass on the manufacturers’ instructions may lay the healthcare organisation open to legal liability
  • training in the use of the device
  • equipment care and maintenance instructions
  • cleaning or decontamination instructions
  • how to obtain consumables
  • malfunction instructions, actions to take
  • details about how the device will be returned
  • contact details for any queries

Any equipment loaned to patients is recorded in their clinical records so that the location of equipment is known. This record includes the make, model and serial number. It should be ensured that all equipment is returned at the end of the loan and that the normal cleaning or decontamination procedures are followed in line with manufacturer’s instructions. All equipment must be tested prior to the loan period to ensure it is working as required.

Documentation is available from the print website for the majority of loaned equipment, and covers all the above requirements. The documentation is carbonated so that one copy can be signed and left with the patient and the other copy can be saved electronically into the patient’s clinical records on SystmOne.

5.11 Use of medical devices for non-designated purposes

  • Generally devices should not be used for any purpose other than that intended by the manufacturer.
  • Modified in any way prior to use.

There is a clear risk to the trust in the local modification of devices, or in the use of equipment for non-designated purposes, but where there are demonstrable clinical advantages, the trust does not wish to ban such activities outright. New uses of devices for unauthorised purposes must be approved by the medical devices advisory group.

It should be noted that modification of equipment or use of any equipment for other than its intended purpose is a clear breach of the terms of the manufacturer’s warranty. If a patient suffers harm in the process the trust would have no redress, even if the equipment was found to be faulty.

5.12 The maintenance and storage of reusable diagnostic and therapeutic equipment

The arrangements for the maintenance and repair of medical devices within the trust localities are as below and appendix D provides further information.

Contracts are in place for specialist servicing such as hoists, assisted baths, weighing scales, audiometers, electroconvulsive therapy (ECT) equipment, bladder scanners, Oxehealth, gym equipment and so on.

All other devices are covered by locality based contracts or agreements:

  • Doncaster, a contract with a single private provider.
  • Rotherham, a service level agreement with the Rotherham NHS Foundation Trust.
  • North Lincolnshire, a service level agreement with North Lincolnshire and Goole NHS Foundation Trust.

Servicing or electrical testing of equipment where required is carried out in accordance with guidance from each trust and according to manufacturers’ instructions.

Each company will ensure a test label is attached to the medical device including the date tested and next test date or due date. The medical devices database must then be updated by the medical devices link person following servicing in accordance with the user guide.

5.12.1 Storage Of equipment

Service manager and team have the responsibility to ensure that all equipment is stored correctly and in accordance with manufacturers’ instructions and to minimise deterioration when not being used. Any battery recharging or servicing requirements must also be maintained when equipment is being stored.

The trust will ensure that patients, colleagues and visitors are kept safe by having systems to ensure that all re-usable medical devices are properly decontaminated prior to use, repair or disposal. For further guidance refer to the trust’s cleaning and decontamination of the environment and patient equipment procedure.

5.12.2 Mattress audit

Inpatient areas carry out a monthly mattress audit (see appendix E) electronically on the tendable platform.

5.12.3 Patient equipment and general cleaning visual or cleaning check

A checklist is available for colleague use which can be found in the infection prevention and control manual.

5.13 How reusable diagnostic and therapeutic equipment is repaired

Equipment is repaired when required via the same routes as described in section 5.12 for maintenance.

Colleagues must:

  • never try to undertake repair work which should only be undertaken by a qualified technician
  • never use broken equipment, alternatives must be sourced if necessary, for example, loan from other department
  • remove broken items to a separate storage area or clearly label as broken until repair work is undertaken
  • ensure that the medical devices database is kept up-to-date with broken items by the medical device link person, in accordance with the user guide
  • make sure that any equipment going for repair has been appropriately decontaminated, in accordance with the trust cleaning and decontamination of the environment and patient equipment procedures and manufacturers’ instructions. If appropriate, the declaration of contamination status form (appendix F) can be used.

5.14 Failure of a medical device

In the event of there being a failure in the operation of a medical device, colleagues must:

  • take any necessary action to protect the wellbeing of patients and colleagues
  • seek immediate advice from their manager, and either the manufacturer, or their local medical engineering and servicing department, or pharmacist if required
  • the manager should contact the medical devices and projects officer or other suitable person to identify maintenance and repair route:
    • where there is a failure in operation for the Oxehealth system, ward colleagues can contact the Oxehealth team in three ways:
      1. feedback forms via the screens (the screen in the nurses’ station and all portable devices have this functionality)
      2. via Oxehealth dedicated customer support email address
      3. via Oxehealth 24, hours a day, 7 days a week customer support phone line
  • report the incident via the incident reporting (IR1) system. A defective or faulty device must be taken out of use as soon as it is safe to do so, and labelled to ensure it is not reused, but otherwise left exactly as it was at the time of the incident. The evidence must not be tampered with in any way except for safety reasons or to prevent its loss. If relevant, a record should be made of all readings, settings and positions of switches, valves dials, gauges and indicators, together with any photographic evidence and eyewitness reports. In serious cases, this record should be witnessed, and the witness should also make a personal written record. The manager should report this to the head of patient safety

5.15 Replacement and disposal of medical devices (see flowchart at appendix D)

All medical devices or equipment will need to be replaced in any of the following situations:

  • worn out or damaged beyond economic repair
  • unreliable
  • clinically or technically obsolete
  • spare parts no longer available
  • more cost effective or clinically effective devices have become available
  • unable to be decontaminated effectively
  • manufacturers’ recall
  • in response to relevant medical device alerts

Any equipment regarded as requiring disposal due to the above reasons should be agreed by the relevant manager or director of service. For equipment with a value of £5000 or above, the director of finance and performance must be consulted for final approval and the trust asset register amended accordingly.

The equipment should be removed to an area where it cannot be used until collection for permanent removal, and clearly marked with a notice or stickers to prevent accidental re-use.

The waste electrical and electronic equipment (WEEE), equipment returns Form attached at appendix G should be completed for appropriate items which need disposing of. A declaration of contamination status form (appendix F) can also be completed if appropriate and kept with the item if possible. All equipment will be disposed of in accordance with the guidance given in HTM 07 to 01 Safe Management of Healthcare Waste available on the GOV.uk website (opens in new window) and the trust waste policy. Arrangements must be made to ensure patient data is erased where applicable. If colleagues are not sure how to erase patient data they should consult the device user manual. The medical devices database should be updated by the medical devices link person following disposal in accordance with the user guide.

Before sale or donation of medical devices for re-use, the potential for future liability against the responsible organisation should be considered. Advice must be obtained from the head of procurement.

5.16 Reporting medical device incidents

The primary causes of incidents with medical devices include:

  • inappropriate management procedures
  • inadequate instructions for use
  • inadequate servicing or maintenance
  • shortcomings in the design or manufacture
  • lack of policies for disposal and replacement
  • inappropriate use (including incompatible devices)
  • inadequate training (colleagues and users or carers)
  • incompatible ancillary equipment, such as leads, infusion sets
  • inadequate documentation, such as missing service history or instructions for use

The trust promotes an open and fair culture of safety where learning can take place and ongoing improvements in quality and safety can be made.

All incidents and near misses involving medical devices must be reported via the Ulysses (IR1) electronic incident reporting system (staff access only) (opens in new window) and will be reported to the medical devices advisory group by the head of patient safety to promote learning and ongoing improvements. These will be reported onwards to the relevant agencies such as the MHRA by the head of patient safety.

Refer to the trust incident management policy for further guidance.

5.17 Disseminating medical device alerts

Medical device alerts will be circulated to managers by the head of patient safety via an approved distribution list, and responses and identified actions required tracked to completion to provide robust evidence for assurance purposes.

Relevant manufacturers’ field safety notices (FSN) will also be presented to the medical devices advisory group and distributed to relevant colleagues via the medical devices safety officer. A record of the action taken as a result of the FSN will be maintained.

5.18 Medical devices risk classification

Appendix A provides a list of devices or equipment that is currently in use at the trust and provides a risk classification for each one.

Medical devices will be categorised according to their MHRA class into one of the following three groups:

  • high risk (class IIb and III)
  • medium risk (class IIa)
  • low risk (class I)

5.18.1 High risk device

A high risk device relates to items that have the potential to cause serious adverse effects or death should they be misused or fail.

Managers will make users aware that it is not safe to proceed until they have either self-verified as competent or have been trained and assessed as competent. Once initial training has been undertaken, updates should be undertaken as required to ensure correct use of device is undertaken. The names of colleagues undertaking training and level of competence should be recorded on ESR or within an accessible training register in the clinical area. Training should identify cleaning methodology and how to access correct maintenance of the device.

5.18.2 Medium risk devices

Items that would have a significant impact on patient care or cause temporary adverse health consequences should they be misused or fail.

Managers will make users aware that the user seeks advice or guidance from a person who has a working knowledge of the main operational features of a device in this category. Once obtained, the user will be advised to proceed with caution but also to pursue formal training in use of the device.

5.18.3 Low risk device

Items that would be unlikely to cause any serious harm should they be misused or fail. Managers will advise the user to proceed in a safe and sensible manner. No formal training is necessarily required.

5.19 Bed rails management and safe use

Bed rails are used both within the trust and prescribed by trust staff for patients in their own home, to reduce the risk of patients falling out of bed and injuring themselves. The MHRA have received reports of incidents involving these devices, some of which have led to injury and death by asphyxiation as a result of entrapment of the head, neck or chest (Bed Rails: Management and Safe Use (2023)).

Beds owned by the trust have integrated bed rails. It is not safe to use removable bed rails on medical beds and they must be immediately taken out of use if found. This applies in the community too.

The current designated medical bed standard is: BS EN 60601-2-52: 2010 and A1:2015 “Particular requirements for the basic safety and essential performance of medical beds”. This standard contains requirements for the dimensions and function of medical beds intended for adults and includes information on the permissible gaps between rails and the rails and the bed frame. All medical beds purchased must meet this standard.

The length, width and height of the mattress should be checked to ensure that these dimensions are within the limits specified by the bed manufacturer and do not introduce gaps that could increase the risk of entrapment. If the mattress is not the right size, the bed rails may not fit properly and create entrapment gaps. Some manufacturers may also specify the density of static mattresses. Adequate and appropriate risk assessment and management should be carried out to prevent the occurrence of entrapment, death or falls related incidents associated with bed rails. Healthcare professionals or competent persons should carefully consider the benefits and risks of bed rails before they are prescribed for a patient, and a risk assessment should be completed before the bed rail is issued. This risk assessment should be reviewed as a minimum annually, or when there is a significant change in the patient’s condition or needs for example, weight loss.

There is a heightened risk of entrapment if adults with atypical anatomy (physical size less than 146 cm, mass less than 40kg or a body mass index of less than 17), are using standard adult medical beds. It is recommended that all gaps between the rail bars should be a maximum of 60mm. Risk assessments need to be carried out on the suitability of using a bed rail for a patient with atypical anatomy, as bar spacing and other gaps will need to be reduced.

Measures to mitigate the risks associated with bed rails and atypical anatomy should be considered as part of the initial risk assessment. These measures include:

  • use of a smaller bed to safely meet their needs, this would need to be hired from a reputable supplier
  • netting or mesh bed sides
  • inflatable bed sides and bumpers
  • ultra low height beds that minimise the risk of fall injuries
  • positional wedges to reduce movement across the bed
  • alarm systems to alert carers that a person has moved from their normal position or wants to get out of bed
  • fall mats that can be placed beside the bed to reduce the severity of the impact if the bed occupant does fall

Each of these options may act to introduce different hazards even though they reduce the risk of injury from falling out of bed or the risk of entrapment from bed rails, and so should be assessed and managed appropriately.

Other specific risks:

  • pressure mattresses create a risk as they raise the resting level of the patient relative to the top of the bed rail, which may increase the risk of the patient falling over the top of the bed rail
  • for bariatric beds, the correct mattress for the bed size must be used. The bed, mattress and rail system should be assessed as a collective in all positions, as risks may not be obvious in a single arrangement for example, lying flat versus sitting up in bed
  • gaps of over 60 mm between the end of the bed rail and the headboard which could be enough to cause neck entrapment
  • gaps over 120 mm from any accessible opening between the bed rail and the mattress platform
  • filling any gaps using blankets, bedding or pillows, as these can be compressed and may increase the risk of entrapment
  • using bed rails designed for a divan bed on a wooden or metal bedstead, this can create gaps which may entrap the occupant
  • using unsecure fittings or designs which permit the bed rail to move away from the side of the bed or mattress, creating an entrapment hazard
  • using only one side of a pair of bed rails when the other side is against a wall if this is not specifically permitted by the manufacturer, the single rail may be insecure and move. Some manufacturers supply a mattress retainer for use with single sided bed rails which reduces this risk
  • mattress combinations whose additional height lessens the effectiveness of the bed rail and may permit the occupant to roll over the top. Extra height bed rails are available if mattress overlays are to be used
  • mattress and bed rail combinations where the mattress edge easily compresses, introducing a vertical gap between the mattress and the bed rail

The MHRA has also received reports of entrapment in hospitals with side rails on trolleys. This guidance should also be followed where bed rails are used with trolleys, particularly if the patient is left unattended. Other entrapment hazards can be possible when using lateral turning devices where the patient is rolled against the bed rail, or bed grab handles (bed levers).

For further guidance please refer to the patient falls manual (prevention and management).

6 Training implications

6.1 Principles of training

  • No colleagues are to operate any medical device until they have been trained and are proficient in the use of it.
  • When training is undertaken, as well being given a demonstration of how the equipment works, colleagues will also be provided with full written and verbal instructions if required.
  • During training, colleagues will be given the opportunity to ask questions, and express any concerns they may have in relation to the equipment.
  • Any refresher training which is required will be organised by the manager with attendance sheets sent to learning and development service for capture on the training database.

It is the responsibility of each area to ensure that staff members receive the appropriate training required for medical devices used within their role and environment and that any gaps in medical devices training is discussed and recorded in the staff members performance and development review (PDR).

All staff responsible for the prescription, provision, installation, and maintenance of bed rails should receive suitable training to enable them to effectively assess a patient before prescribing or issuing a bed rail. The training should include the risk assessment process in accordance with trust policy, and inform the staff member of the risks posed by equipment.

The trust believes that the following levels of training and frequency of training are adequate to provide safe clinical practice:

  • competence and update via PDR
  • after basic training, as and when required or in line with manufacturers’ instructions where indicated, or in line with mandatory and statutory training where indicated

Refer to mandatory and statutory training manual for some of the medical device relevant training which is included within example, resuscitation training and manual handling training.

The purchaser of devices must consider that all training issues are carefully considered prior to the equipment being bought in adherence to the trust requisitioning, ordering and receipt of goods procedure.

Any training needs identified must be raised with the head of learning and development who is responsible for co-ordinating and arranging a trust-wide approach to medical device training needs.

Medical device training requirements that involve a particular clinical skill or interpretation of results in relation to that medical device example, an electrocardiogram (ECG) machine or Glucometer will be competency based with use of the RDaSH care and clinical skills assessment tool (CCAST). Training based purely on functionality of the medical device does not require a competency based approach.

Key trainers must have been trained by the trust lead specialist or supplier or manufacturer.

Elements of the key trainers role are:

  • a professional and relevant delivery of the subject-matter
  • the content of the training is based on manufacturer’s guidance material allowing for a consistent trust wide approach
  • appropriate assessment tools are developed and incorporated into training packages

All the required documentation is completed for individual, departmental and trust records for example, attendance sheets from training must be forwarded to learning and development to update colleagues’ personal records

6.2 Authorisation of colleagues to use equipment

The manager of the service will determine which colleagues can use equipment according to their job role and competency, and the local induction process.

6.2.1 Recording of colleague training

RDaSH facilitators or external facilitators must ensure the completed approved attendance list is forwarded to the learning and development service following each training session, for population onto ESR to ensure accurate reporting of training for compliance reporting.

Where training is undertaken in the workplace or clinical environment, a register of that training should be kept and maintained.

As a trust policy, all colleagues need to be aware of the key points that the policy covers. Colleagues can be made aware through a variety of means such as:

  • all user emails for urgent messages
  • one to one meetings or supervision
  • continuous professional development sessions
  • posters
  • daily email (sent Monday to Friday)
  • practice development Days
  • group supervision
  • special meetings
  • intranet
  • team meetings
  • local induction
  • monthly clinical briefing email

7 Monitoring arrangement

7.1 Medical device incidents and update

  • How: Report.
  • Who by: Head of patient safety.
  • Reported to: Medical devices advisory group.
  • Frequency: Quarterly.

7.2 Medical device alerts

  • How: Report.
  • Who by: Head of patient safety.
  • Reported to: Medical devices advisory group.
  • Frequency: Quarterly.

8 Equality impact assessment screening

To access the equality impact assessment for this policy, please email rdash.equalityanddiversity@nhs.net to request the document.

8.1 Privacy, dignity and respect

The NHS Constitution states that all patients should feel that their privacy and dignity are respected while they are in hospital. High Quality Care for All (2008), Lord Darzi’s review of the NHS, identifies the need to organise care around the individual, “not just clinically but in terms of dignity and respect”.

As a consequence the trust is required to articulate its intent to deliver care with privacy and dignity that treats all service users with respect. Therefore, all procedural documents will be considered, if relevant, to reflect the requirement to treat everyone with privacy, dignity and respect, (when appropriate this should also include how same sex accommodation is provided).

8.1.1 How this will be met

All employees, contractors and partner organisations working on behalf of the trust must follow the requirements of this policy and other related policies. All health employees must also meet their own professional codes of conduct. Medical devices should be used in a manner which has regard to the dignity, comfort and safety of the patient and promotes their independence.

8.2 Mental Capacity Act (2005)

Central to any aspect of care delivered to adults and young people aged 16 years or over will be the consideration of the individuals’ capacity to participate in the decision-making process. Consequently, no intervention should be carried out without either the individual’s informed consent, or the powers included in a legal framework, or by order of the court.

Therefore, the Trust is required to make sure that all staff working with individuals who use our service are familiar with the provisions within the Mental Capacity Act (2005). For this reason all procedural documents will be considered, if relevant to reflect the provisions of the Mental Capacity Act (2005) to ensure for that the rights of individual are protected and they are supported to make their own decisions where possible and that any decisions made on their behalf when they lack capacity are made in their best interests and least restrictive of their rights and freedoms.

8.2.1 How this will be met

All individuals involved in the implementation of this policy should do so in accordance with the guiding principles of the mental capacity Act (2005).

There are many policies and SOPs which refer to medical devices. Please refer to the policy section of the trust website.

Safety alerts, rapid response alerts, guidance and directives relating to equipment published by expert and professional bodies including:

  • NICE
  • National patient safety agency (NPSA)
  • Medicines and healthcare products regulatory agency (MHRA)
  • Royal pharmaceutical society of Great Britain
  • Department of Health
  • Product manufacturers

10 References

11 Appendices

11.1 Appendix A Current list of medical devices used within the trust and their associated risk score

Please see the current list of medical devices in the trust and risk score on the medical devices page (staff access only) (opens in new window).

11.2 Appendix B Pre purchase questionnaire and form PPQ

11.3 Appendix C Medical equipment on trial and loan check list

11.4 Appendix D Maintenance and disposal flowchart for reusable medical devices

  1. Device is not working properly, take out of use and decontaminate. For hoists, put black and yellow tape and place a notice on the equipment saying ‘do not use’. Note, if device is involved in an incident the item should not be decontaminated, serviced, fixed and so on, until the investigation has been carried out. Please refer to incident policy for more details.
  2. For items with separate maintenance contracts, contact the company for example gym equipment. For other general equipment contact engineers:
  3. If device is serviced or repaired, medical device link person to update database with service information.
  4. If device is for disposal, complete disposal form(appendix g). requires approval of director of finance if cost more than £5,000. Medical device link person to update database with disposal information.

11.5 Appendix E Mattress audit tool

11.6 Appendix F Declaration of contamination status form

11.7 Appendix G Declaration of contamination status form

11.8 Appendix H Responsibilities, accountabilities and duties

11.8.1 Nominated lead director

The nominated lead director with overall responsibility for medical device management is the director of nursing and AHPS.

11.8.2 Committees and groups with responsibilities

The quality committee is responsible for monitoring and promoting effective health and safety measures at work (HASAWA, 1974, s2 (7), through communication and collaboration between the trust as employer and its employees on health and safety matters.

The medical devices advisory group (MDAG) has a remit which includes:

  • ensuring compliance with recognised standards
  • informing purchasing decisions
  • rationalisation of the type and number of devices required
  • acquisition, record keeping and equipment inventories
  • providing advice for the management of a medical device, colleagues and patient training
  • repair and maintenance
  • single use devices
  • response to medical device alerts
  • sharing best practice
  • reviewing medical device risks
  • reviewing incident reports and sharing the learning
  • patient and audit feedback
  • discussing contract feedback
  • improving communication about medical devices within the organisation
  • ensuring the involvement of clinicians in decisions about changes concerning medical devices. The group report via the head of patient safety to the quality committee through its minutes and by exception basis

11.8.3 Head of patient safety

The head of patient safety is responsible for the operational management of the medical device process and acts as the medical devices safety officer for the trust. Duties of the role include but are not limited to:

  • the development, management, monitoring and audit of the central inventory of all medical devices within the trust
  • acting as chair of the medical devices advisory group and updating other relevant committees regarding medical device management progress
  • ensuring that all relevant safety alerts are disseminated as appropriate
  • raising the profile of medical device management within the trust
  • acting as the medical devices safety officer for the trust. This includes reporting incidents and near misses involving medical devices through the MHRA adverse incident reporting system and to other relevant agencies as indicated for example national patient safety agency (NPSA), health and safety executive
  • analysing incidents and near misses involving medical devices reported via the Ulysses (IR1) electronic incident reporting system and reporting on them within the quarterly incident report to promote learning and ongoing improvements

11.8.4 Head of learning and development services

The head of training and development will work with managers and the medical devices advisory group to:

  • undertake the training needs analysis (TNA) for medical devices in association with the required clinical skill and to ensure that training and updates are delivered as required, either through a standalone programme or through competency based learning ensuring that the full training cycle including commissioning, recording and evaluating any intervention where learning and development have been involved

11.8.5 Service managers and team managers

Duty of managers includes but is not limited to:

  • undertaking a risk assessment for medical devices in the event of an emergency, or other failures that may affect the equipment. In some cases it is not necessary for this risk assessment to be recorded as it forms part of the pre-use checks undertaken by the user. A written risk assessment and checks prior to each use may be required for some high risk equipment
  • promoting and delivering personalised care within their services through the use of medical devices in a way that has regard to the dignity, cultural competence, comfort and safety of patients and promotes their independence
  • where consent to use a medical device is required, utilise the Mental Capacity Act (2005)
  • taking account of the training needs of patients or carers within their service areas with regard to any equipment patients or carers are given by colleagues to use themselves
  • having agreed strategies and records in place where a patient refuses to allow the use of equipment
  • ensuring that an up-to-date medical device inventory is maintained for areas under their control, and identifying which colleagues are authorised to use each item of equipment listed
  • where risks associated with medical devices are identified, advise senior managers, in order that these may be entered on the trust Risk Register and action taken to mitigate the risks
  • ensuring manufacturers’ instructions are available to colleagues
  • all colleagues under their management are suitably inducted and trained on the devices they use, and that colleagues are made aware of this policy and associated procedures
  • releasing colleagues to attend training and liaising with the Head of Learning and Development to identify any additional medical device training required via the performance development review
  • undertaking routine monitoring and audit in relation to this policy
  • organising the maintenance, calibration and testing of medical devices
  • the return of any medical devices which have been loaned to their area
  • acting on medical device alerts issued by the Head of Patient Safety and providing evidence for assurance purposes that any actions required have been completed
  • reporting adverse incidents involving medical devices via the incident reporting system
  • supporting colleagues to address any concerns in a timely manner where they identify problems around the safety or suitability of equipment in a person’s own home

11.8.6 Medical device leads, usually a clinical colleague in the service or care group area

The responsibilities of the medical device leads can be described as follows:

  • to attend the MDAG and raise pertinent issues
  • to discuss feedback from medical device link persons in their area at the MDAG
  • to progress actions agreed by the MDAG within their care group
  • to feed back to the Learning and Development team any training issues identified with the introduction of any new medical device equipment or issues with existing devices

Medical device Leads are usually clinical colleagues and there should be at least one per care group.

11.8.7 Medical device link people

The responsibilities of the medical device link person role include but is not limited to:

  • to liaise with the medical device lead for the area of work and clinical colleagues, making them aware of any issues or problems
  • to ensure new devices in their area are logged onto the Ulysses medical device database within 48 hours of receipt
  • to log any changes to their medical devices on the database as they occur, for example, change of location, servicing arrangements, and disposing of
  • to receive reports from the Ulysses system and check any issues highlighted against the database to ensure information contained is up-to-date, correct and comprehensive
  • to monitor service dates for medical devices and raise any overdue items with their medical device lead or medical devices and projects officer

Medical device Link People are usually administration colleagues and there should be at least one per care group.

11.8.8 Medical devices and projects officer

Duties of the medical devices and projects officer include:

  • overseeing the inventory and liaising with the company who maintains the database where required
  • facilitating the appropriate colleagues access rights to the inventory
  • being a point of contact and providing support or advice to colleagues regarding use of the inventory
  • providing inventory updates and reports to the MDAG and other groups as required
  • updating user guides
  • cross-checking information from specialists within the trust and contract activity periodically against the inventory
  • assisting in the development of relevant audit tools and data collection for medical devices and liaising with clinical audit and internal audit where required
  • liaising with medical engineering departments, contracts and purchasing colleagues regarding servicing requirements of equipment for contracts and SLAs

11.8.9 Purchasing department

The purchasing department is responsible for purchasing devices from manufacturers that are approved in accordance with medical devices directive (MDD) 2007/47/EC. The department is advised by MDAG regarding approved standard medical devices which are available for trust colleagues to purchase.

11.8.10 All colleagues

Duties of colleagues who use medical devices include but are not limited to:

  • fully implement this policy and bring to the immediate attention of managers any issues affecting the effective implementation of this policy
  • deliver personalised care through the use of medical devices in a way that has regard to the dignity, comfort and safety of patients and which promotes their independence and wellbeing
  • utilise the Mental Capacity Act (2005) where required
  • take account of the training needs of patients or carers with regard to any equipment the patient or carer is given to use themselves
  • report incidents and near misses involving medical devices via the Ulysses (IR1) electronic incident reporting system
  • address any concerns in a timely manner where they identify problems around the safety or suitability of equipment in a patient’s own home
  • use medical devices safely and in the prescribed manner including ensuring that any safety checks required by manufacturers’ instructions or procedures and guidance are carried out prior to use of medical devices including safe decontamination
  • ensuring they have received sufficient training, for example, verbal and, or written instructions and hence are competent to use a medical device before attempting to operate it. If there is any doubt, the colleague should consult their manager and the manufacturers’ instructions
  • ensuring that prescribing decisions involving medical devices will be made by colleagues with appropriate professional qualifications and suitable experience
  • preserve the trust’s assets and keep unnecessary expenditure to a minimum

Every colleague who uses medical devices must have ownership and responsibility for minimising the impact of risk.

Document control

  • Version: 10.2.
  • Unique reference number: 324.
  • Approved by: Clinical policies review and approvals group.
  • Date approved: 6 February 2024.
  • Name of originator or author: Head of patient safety.
  • Name of responsible individual: Executive director of nursing and allied health professionals and medical devices advisory group.
  • Date issued: 20 February 2024 (amendment).
  • Review date: November 2025.
  • Target audience: This policy applies to trust colleague(s) and any colleague(s) providing services under contract in both hospital and community services who are involved in any aspect of medical devices use and management.

Page last reviewed: December 10, 2024
Next review due: December 10, 2025

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