DOCUMENT CONTROL:

Version: V9

Ratified by: Clinical Policies Review and Approvals Group

Date ratified: 1 October 2019

Name of originator/author: Head of Patient Safety

Name of responsible committee/individual:

Medical Devices Advisory Group

Unique Reference Number: 324

Date issued: 29 October 2019

Review date: October 2022

Target Audience This policy applies to Trust staff and any staff providing services under contract in both hospital and community services who are involved in any aspect of medical devices use and management.

Medical Devices Management Policy

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Section

CONTENTS

Page No

1. INTRODUCTION 4

2. PURPOSE 5

3. SCOPE 5

4. RESPONSIBILITIES, ACCOUNTABILITIES AND DUTIES 4

4.1 Board of Directors and Chief Executive 5

4.2 Nominated Lead Director 5

4.3 Committees and Groups with responsibilities 5

4.4 Head of Patient Safety 6

4.5 Head of Learning and Development 7

4.6 Managers 7

4.7 Medical Device Leads 8

4.8 Medical Device Link People 9

4.9 Medical Devices & Projects Officer 9

4.10 Purchasing Department 9

4.11 Information Technology (IT) Team 10

4.12 All staff 10

5. PROCEDURE/IMPLEMENTATION 11

5.1 Medical devices and the provision of personalised care 11

5.2 Medical Device management 11

5.3 Medical Devices procurement 12

5.4 Acceptance of New Medical Devices 13

5.5 Medical Device Inventory 13

5.6 Single - Use Medical Devices 14

5.7 Single - Patient Use Medical Devices 15

5.8 Medical Devices Used On-Trial/On-Loan 15

5.9 Equipment Loaned to Patients 15

5.10 Use of Medical Devices for non-designated purposes 16

5.11 The Maintenance and Storage of Reusable Diagnostic and Therapeutic Equipment

16

5.12 How Reusable Diagnostic and Therapeutic Equipment is Repaired

17

5.13 Failure of a Medical Device 18

5.14 Replacement/Disposal of Medical Devices 18

5.15 Reporting Medical Device Incidents 19

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Section

CONTENTS

Page No

5.16 Disseminating Medical Device Alerts 20

5.17 Medical Devices Risk Classification 20

6. TRAINING IMPLICATIONS 21

7 MONITORING ARRANGEMENTS 23

8. EQUALITY IMPACT ASSESSMENT SCREENING 23

9. LINKS TO ANY ASSOCIATED DOCUMENTS 24

10. REFERENCES 25

11. APPENDICES 26

Appendix 1 – Examples of Medical Devices used within the Trust 27

Appendix 2 – Pre Purchase Questionnaire 29

Appendix 3 – Medical Equipment On Trial/Loan Check List 32

Appendix 4 – Maintenance/Disposal Flowchart for Reusable Medical Devices

33

Appendix 5 – Mattress Audit Form 34

Appendix 6 – Declaration of Contamination Status 35

Appendix 7 – Waste Electrical & Electronic Equipment (WEEE) Returns Form

36

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1. INTRODUCTION

Unless medical devices are managed proactively and lessons learned from incidents, the same types of incidents will continue to occur. Good medical device management will greatly assist in reducing their potential for harm.

1.1 What are medical devices?

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 1. There are also occasions when software applications are considered to be a medical device. See https://www.gov.uk/government/publications/medical-devices-software-applications-apps for further information. Medical devices should be used in a manner which has regard to the dignity, comfort and safety of the patient and promotes their independence.

1.2 Role of the Medicines and Healthcare Products Regulatory Authority (MHRA)

The role of the 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 Appendix 4 for further details. 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

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2. PURPOSE

The purpose of this policy is to:

Support the effective implementation of the Trust’s Risk Management Strategy 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

The policy is set within the framework provided by the MHRA in April 2015, Managing Medical Devices, Guidance for Healthcare and Social Services Organisations and the relevant Care Quality Commission Fundamental Standards Regulations 2015.

3. SCOPE

This policy applies to Trust staff and any staff 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:

The terms medical device and equipment are used interchangeably in this policy to denote medical devices

Medical devices which are used in In-Patient services, in the community and in patients’ own homes

4. RESPONSIBILITIES, ACCOUNTABILITIES AND DUTIES

4.1 Board of Directors and Chief Executive

The Board of Directors and Chief Executive have accountability for medical device management throughout the Trust and to ensure that the responsibility for medical device management is delegated to others as appropriate.

4.2 Nominated Lead Director The nominated Lead Director with overall responsibility for medical device management is the Director of Nursing & Quality.

4.3 Committees and Groups with responsibilities The Quality Committee is responsible for monitoring and promoting effective

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health and safety measures at work (HASAWA, 1974, s 2 (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, staff and patient training

Repair and maintenance

Single use devices

Response to medical device alerts

Sharing best practice

Reviewing medical device risks

Incident reports

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

4.4 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 e.g. National Patient Safety Agency (NPSA), Health and Safety Executive

Analysing incidents and near misses involving medical devices reported via the Safeguard (IR1) electronic incident reporting system and reporting on them within the quarterly incident report to promote learning and ongoing improvements

Chairing the MDAG

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4.5 Head of Learning and Development Services Medical Device training is mandatory in association with the required clinical skill. The Head of Learning and Development is responsible for the implementation of the Mandatory Risk Management Training Policy and associated Training Needs Analysis, providing reports on compliance to the Human Resources and Organisational Development Group. See Mandatory and Statutory Training Policy The Head of Training and Development will work with Managers 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

Source the relevant expertise to deliver training where required

Ensure that timely and accurate training records are maintained on the electronic staff training record system

4.6 Service Mangers 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 such as Electroconvulsive Therapy (ECT) 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/carers within their service areas with regard to any equipment patients/carers are given by staff 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 staff are authorised to use

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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 staff

All staff under their control are suitably inducted and trained in line with Training Needs Analysis (TNA) and that staff are made of this policy and associated procedure including decontamination procedure

Releasing staff to attend training and liaising with the Head of Learning and Development to identify any additional medical device training required

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 staff 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

4.7 Medical Device Leads – usually a member of clinical staff 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 Medical Devices Advisory Group

To progress actions agreed by the MDAG within their Business Division.

To liaise with the Information Governance Team regarding devices which contain patient identifiable information?

To feed back to 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 staff and there should be at least one per Business Division.

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4.8 Medical Device Link People The responsibilities of the Medical Device Link Person role includes but is not limited to:

To liaise with Medical Device Lead for area under their control/clinical staff, making them aware of any issues/problems

To ensure new devices in their area are logged onto the Safeguard database within 48 hours of receipt

To log any changes to their Medical Devices on the database as they occur e.g. change of location, servicing arrangements, disposing of etc.

To receive reports from the Safeguard 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 / Medical Devices & Projects Officer

Medical Device Link People are usually administration staff and there should be at least one per Care Group.

4.9 Medical Devices & Projects Officer Duties of the Medical Devices & Projects Officer include:

Overseeing the inventory and liaise with the company who maintain databases where required

Facilitating the appropriate staff access rights to the inventory

Is a point of contact and provide support/advice to staff regarding use of the inventory

Provide inventory updates/reports to the MDAG and other groups as required

Updates User Guides

Cross checks information from Specialists within the Trust and contract activity periodically against the inventory.

Assist in the development of relevant audit tools and data collection for Medical Devices and liaise with Clinical Audit and Internal Audit where required.

Liaises with Medical Engineering Departments, contracts and purchasing staff regarding servicing requirements of equipment for contracts and SLAs

4.10 Purchasing Department

The Purchasing Department is responsible for purchasing devices from

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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 staff to purchase.

4.11 Information Technology (IT) Team All software and applications must be approved for installation by the IT Team who will also checks licence requirements and installation restrictions.

4.12 All staff who use medical devices Duties of staff who use medical devices include but are not limited to:

Fully implementing 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 well-being

Utilise the mental Capacity Act (2005) where required

Take account of the training needs of patients/carers with regard to any equipment the patient/carer is given to use themselves. Link in with the Head of Learning & Development where appropriate

Report incidents and near misses involving medical devices via the Safeguard (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/guidance are carried out prior to use of medical devices including safe decontamination.

Ensuring they have received sufficient training i.e. 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 member of staff should consult their Manager and the manufacturers’ instructions

Ensuring that prescribing decisions involving medical devices will be made by staff with appropriate professional qualifications and suitable experience

Preserve the Trust’s assets and keep unnecessary expenditure to a minimum

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

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5. PROCEDURE/IMPLEMENTATION

5.1 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 e.g. electrical equipment, but the individual does not want to/is unable to fund the running costs, alternative equipment/care will be determined. It will be recorded in the patient notes if consent is not given for devices for any reason

Supporting the patient to understand how and why the equipment is being used. This includes ensuring that information about medical devices will be provided in a format to meet the patient/carer's individual requirements

Taking care in the way they 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. Preference for a male or female health professional will be taken into consideration where required

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)

5.2 Medical Device management

Medical devices should:

Be properly maintained, safe to use and operated by staff 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 approved, monitored and recorded service, testing, and

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maintenance programme

Be subject to required security patching and software updates

Be traceable where possible

Be de-commissioned and/or replaced at the time recommended by the manufacturer or other expert body

Promote well-being and/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 v1.2 for reusable and single patient use devices

5.3 Medical Devices procurement 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 2) 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/reprocessing. All medical devices are purchased according to the ‘best buy’ standardisation list produced by MDAG. No new Medical Devices should be purchased unless the Manager has:

Sought advice from MDAG/Best Buy List, relevant Trust policies and any appropriate Trust Advisor e.g. Back Care Advisor Manual Handling Team, Resuscitation Officer and Infection Prevention and Control Team

Undertaken a risk assessment of its design, function, performance, maintenance requirements, life cycle costs and staff 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/hire of the device

Sought advice from the IT Department if the equipment is to be connected to the Trust’s Network or any IT equipment and completed IT Pro-Forma document

Sought advice from the Information Governance Team if the equipment is

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to store PID (person identifiable data) and completed DPIA

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

5.4 Acceptance of New Medical Devices

All new medical devices will be delivered to the Purchasing Department. Purchasing 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/audit purposes; they will then be delivered to the relevant areas

IT must be informed when installation onto a network is required

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

Is complete and in good condition without visible defects

Is in full working order and meets performance expectations

Meets relevant safety inspections e.g. electrical testing

Has controls set to the correct level for its purpose (where applicable)

Has gone through the correct requirements of Lifting Operations and Lifting Equipment Requirements Regulations (LOLER) where required. There is a recommended list from the Health & Safety Executive - How the Lifting Operations and Lifting Equipment Regulations apply to health and social care 12/12 http://www.hse.gov.uk/pubns/hsis4.pdf and Provision and Use of Work Equipment Regulations 1998 (PUWER)

All software and apps must be approved for installation by IT Services who will also checks licence requirements and installation restrictions

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

5.5 Medical Device Inventory New medical devices should be inputted onto a web-based inventory (on the Safeguard 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 ‘Safeguard Risk Management Systems Web Asset Module User Guide’

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and support is provided on an as and when required basis by the Medical Devices & Projects Officer.

5.6 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 will 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 Reasons Not To Re-Use Single Use Medical Devices - Reprocessing single-use devices may affect the capabilities and/or 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 and 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. For single use emergency care equipment a stock of spares for instant replacement must be available.

2

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5.7 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/reprocessing between each use. Information on cleaning each device will be provided.

5.8 Medical Devices Used On-Trial/On-Loan It is the responsibility of staff to fully consider the risk exposure, when approached by manufacturer sales representatives endeavouring to market their products. This may result in the product/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 etc.) 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/on loan, the checklist in Appendix 3 must be completed by the Manager of the department.

5.9 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

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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 & maintenance instructions

Cleaning/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 on their patient notes 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/decontamination procedures are followed in line with manufacturer’s instructions. All equipment should be tested prior to the loan period to ensure it is working as required – this should be recorded. 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 kept with the patient notes.

5.10 Use of Medical Devices for non-designated purposes

1. Generally devices should not be used for any purpose other than that intended by the manufacturer, or

2. 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 will 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.

5.11 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 4 provides further information. Contracts are in place for specialist servicing such as hoists, assisted baths,

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weighing scales, audiometers, ECT equipment, bladder scanners, gym equipment etc. All other devices are covered by locality based contracts/agreements: Doncaster – a contract with a single private provider. Rotherham – A service level agreement with Rotherham NHS Foundation Trust. North Lincolnshire – A service level agreement with North Lincolnshire and Goole NHS Foundation Trust. Servicing/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/due date. The medical devices database should be updated by the Medical Devices Link Person following servicing in accordance with the User Guide. 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 re-charging or servicing requirements must also be maintained when equipment is being stored. The Trust will ensure that patients, staff 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. Mattress Audit – all in-patient areas carry out a monthly Mattress Audit using the form attached at Appendix 5. All results are kept locally in the in-patient areas as evidence that the audit has been undertaken. Patient Equipment and General Cleaning Checklist – a daily checklist is available for staff use.

5.12 How Reusable Diagnostic and Therapeutic Equipment is Repaired Equipment is repaired when required via the same routes as described in Section 5.11 for maintenance. Staff should:

Never try to undertake repair work, which should only be undertaken by a qualified technician

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Never use broken equipment – alternatives must be sourced if necessary e.g. loan from other department

Broken items must be removed to a separate storage area or clearly labelled as broken until repair work is undertaken

The medical devices database should be 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. The Decontamination form at Appendix 6 should be attached to the item

5.13 Failure of a Medical Device In the event of there being a failure in the operation of a medical device, staff must:

Take any necessary action to protect the wellbeing of patients and staff

Seek immediate advice from their Manager, and either the manufacturer, or their local Medical Engineering/Servicing Department, or Pharmacist if required

The manager should contact the Medical Devices Project Officer to identify maintenance/repair route

Report the incident via the incident reporting system. A defective/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

5.14 Replacement/Disposal of Medical Devices – see flowchart at Appendix

4 All medical devices/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

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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/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 & Electronic Equipment (WEEE) Returns Form attached at Appendix 7 should be completed for appropriate items which need disposing of. A Decontamination Form (Appendix 6) should 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 07-01 Safe Management of Healthcare Waste available on the Gov.uk website and the Trust Waste Policy. Arrangements must be made to ensure patient data is erased where applicable. If staff 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.

5.15 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 (staff and users/carers)

Incompatible ancillary equipment, such as leads, infusion sets

Inadequate documentation, such as missing service history or instructions

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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 Safeguard (IR1) electronic incident reporting system and will be analysed and reported on within the Patient Safety monthly report 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. See Section 1.3 of this policy for the primary causes of medical devices incidents and refer to the Trust Incident Management Policy for further guidance.

5.16 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 action 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 staff via the Medical Devices Safety Officer. A record of the action taken as a result of the FSN will be maintained.

5.17 Medical Devices Risk Classification Appendix 1 provides a list of devices/equipment that is currently in use at the Trust and provides a risk classification for each one. Medical devices will be categorised by managers into one of the following three groups:

High Risk

Medium Risk

Low Risk 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, an annual update should be undertaken to ensure correct use of device is undertaken. The names of staff undertaking training and level of competence should be recorded on ESR or within an accessible training register in the clinical area.

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Training should identify cleaning methodology and how to access correct maintenance of the device. 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. 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.

6. TRAINING IMPLICATIONS Principles of Training

No staff 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 staff will also be provided with full written and verbal instructions if required

During training, staff 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 & Development Service for capture on the training database – Oracle Learning Management System (OLM)

The Training Needs Analysis (TNA) for this policy can be found in the Training Needs Analysis document which is part of the Trust’s Mandatory Risk Management Training Policy located under policy section of the Trust website. The Trust believes that the following levels of training and frequency of training are adequate to provide safe clinical practice. This is based on current national drivers and the Trust internal TNA process via a blended learning approach and reference to this Policy.

High risk medical devices Annual update and via Performance and development Review or in line with manufacturers’ instructions where indicated

Medium risk medical devices In line with manufacturers’ instructions where indicated or according to professional competency e.g. needles/syringes, gym equipment, baths etc.

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Low risk devices After basic training, as and when required or in line with manufacturers’ instructions where indicated

Refer to Mandatory and Statutory Training Policy for some of the medical device relevant training which is included within e.g. 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 e.g. an 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/ 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 i.e. attendance sheets from training must be forwarded to Learning & Development to update staff personal records

Authorisation of Staff to use Equipment The manager of the service will determine which staff can use equipment according to their job role and competency, each area’s Training Needs Analysis (TNA), and the local induction process. Recording of Staff Training Staff training is recorded on the Trust’s Oracle Learning Management System/Electronic Staff Record (ESR). RDaSH facilitators or external facilitators must ensure the completed approved Attendance List is forwarded to the Learning and Development Service at the RED Centre following each

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training session, for population onto the Electronic Staff Records (ESR) to ensure accurate reporting of training for compliance reporting. Individuals who did not attend training sessions are determined by the Learning and Development Service by reviewing the individuals who originally booked on the training against the attendance lists. Monthly Did Not Attend (DNA) reports are produced for Human Resources. This highlights areas where staff were booked on training and failed to attend or where courses had to be cancelled due to low uptake. This information is shared with Associate Nurse Directors highlighting individual members of staff. Staff training and risk level of medical devices in each service is monitored by an on-going programme of audit reports by the Learning and Development Service. Where training is undertaken in the workplace/clinical environment, a register of that training should be kept and maintained.

7. MONITORING ARRANGEMENTS

Area for Monitoring

How Who by Frequency Reported to

Medical Device Incidents & update

Report Head of Patient Safety

Quarterly Medical Devices Advisory Group

Medical Device Alerts

Report Head of Patient Safety

6 monthly Quality Committee

8. EQUALITY IMPACT ASSESSMENT SCREENING The completed Equality Impact Assessment for this Policy has been published on this Policy’s webpage on the RDaSH website.

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

Indicate how this will be met

No additional requirements have been identified in relation to this policy. Privacy, dignity and respect underpin the implementation of this and the associated policies which set out a person centred approach to care, working in partnership with the service user and

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should also include how same sex accommodation is provided).

carers as appropriate.

8.2 Mental Capacity Act

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 individuals 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. For this reason all procedural documents will be considered, if relevant to reflect the provisions of the Mental Capacity Act 2005 to ensure that the interests of an individual whose capacity is in question can continue to make as many decisions for themselves as possible.

Indicate how this will be achieved All individuals involved in the implementation of this policy should do so in accordance with the Guiding Principles of the Mental Capacity Act 2005 (Section 1).

9. LINKS TO ANY ASSOCIATED DOCUMENTS

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

Aseptic non touch technique Policy

Bariatric Policy (Care of the Bariatric Patient)

Blood Transfusion Policy

Carbapenemase-Producing Enterobacteriaceae Multi Drug Resistant Organism Management (MDRO) Procedure v1. Difficile Infection Policy

Cleaning and Decontamination of the Environment and Patient Equipment Procedures (IPC Policy Manual)

Clozapine Clinic Protocols

Control of Substances Hazardous to Health (COSHH) Policy

Creutzfeldt-Jakob Disease (CJD) Procedure v1.1

Do Not Attempt Cardiopulmonary Resuscitation (DNACPR) – AdultsDo Not Attempt Cardiopulmonary Resuscitation (DNA CPR) – Child 16 and Under Policy

Electro-Convulsive Therapy (ECT) Clinical Guidelines Policy

Falls Prevention & Management Policy

Food Hydration and Nutrition Policy

Glycopeptide Resistant Enterococci/ Vanomycin Resistant Enterococci Management Procedure v1.1

Hoist and Sling for Safer Patient Use Policy

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Incident Management Policy

Information Governance Policy and Management Framework (includes Data Protection Policy content)

Mandatory and Statutory Training Policy

Mental Capacity Act (2005) Policy

Physical Assessment and Examination of Inpatients (Minimum Standards/MH and LD Services)

Portable Bladder Scanner Use SOP

Pressure Ulcers: Detection, Prevention and Treatment Policy

Prevention of Scalding and Drowning Policy

Requisitioning, Ordering and Receipt of Goods Procedure

Royal Marsden Clinical Procedures

Safe and Secure Handling of Medicines Policy

Safer Manual Handling Operations Policy

Sharps Procedure v1 (Safe Use and Disposal of Sharps)Isolation Procedure

Subcutaneous Fluids Administration for Adults Policy and Procedure

Syringe Driver – Administration of Drugs via the CME Medical T34 Syringe Driver SOP

Tissue Viability and Wound Care Manual

Tuberculosis (TB) Procedure

Wound Management Policy

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 Care Quality Commission (CQC) (2015) Fundamental Standards, Newcastle Upon Tyne, online: https://www.cqc.org.uk/what-we-do/how-we-do-our-job/fundamental-standards#hide1 last accessed 19th September 2019.

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Medicines and Healthcare products Regulatory Agency (2015), Managing Medical Devices, Guidance for healthcare and social services organisations, online:https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/421028/Managing_medical_devices_-_Apr_2015.pdf last accessed 19th September 2019. Medicines and Healthcare products Regulatory Agency (2011) Device Bulletin DB 2011 ‘Reporting adverse incidents and disseminating Medical Device Alerts’, online: https://webarchive.nationalarchives.gov.uk/20121206083542/http:/www.mhra.gov.uk/home/groups/dts-bs/documents/publication/con111568.pdf last accessed 19th September 2019 Medicines and Healthcare products Regulatory Agency (2018) Single-use Medical devices: Implications and Consequences or reuse online: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/743416/Single-use_medical_devices_implications_and_consequences_of_reuse.pdf last accessed 19th September 2019 Medical Devices Directive (MDD) 2007/47/EC The Medical Devices Regulations (2002). Statutory Instrument 2002 No. 618. ISBN 0110423178

11. APPENDICIES

Appendix 1 – Examples of Medical Devices used within the Trust

Appendix 2 – Pre Purchase Questionnaire

Appendix 3 – Medical Equipment On Trial/Loan Check List

Appendix 4 – Maintenance/Disposal Flowchart for Reusable Medical Devices

Appendix 5 – Mattress Audit Form

Appendix 6 – Declaration of Contamination Status

Appendix 7 – Waste Electrical & Electronic Equipment (WEEE) Returns Form

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Appendix 1

MEDICAL DEVICES USED WITHIN THE TRUST AND THEIR ASSOCIATED RISK SCORE

Item Risk Score

Item Risk Score

Air mattress/pressure relieving mattress

Med ECT equipment High

Alcometer Low Emergency lifting cushion (ELK) Med

Apnea monitor/mattress Medium Enteral/PEG feed pumps Med

Audiometer Med Examination gloves Low

Bag valve mask High Examination lamps Low

Bath aid e.g. bath seats, shower chairs

Med Functional Electrical Stimulation machine (FES)

Low

Bath - assisted Med

Bed Low Glucometers Med

Bed alarm & other alarms Low Grinding machine Low

Bladder scanner

Med Hegar dilators Med

Blood analyser machine/blood gas machine

Med Height rules/ measures Low

Body fat monitor Low Hoists and slings High

Breast pump Med Hydroven Low

Camera Low Infusion pump High

Cervical cap/diaphragm Med Ligature cutter High

Commode Low Local anaesthetic

cartridge Med

Communication aid Low Long handled scissors Med

Condom Low Manual suction unit (v-vac) High

Contraceptive coil/IUD, Pre-packed coil insertion instruments & thread retrievers

Med Medication, sample and vaccine fridges

Low

Contraceptive implant & removal kit

Med Monitors –

digital audio Low

Cot sides Low

Defibrillator High Nebulisers Low

Docking station/care portal Low Needles/syringes

Med

Dressings Low Neuropathy screening device/ Monofilaments

Low

Drill and hand piece Low Opthalmoscopes/Otoscopes/ Auroscope/Occluding glasses

Low

Drug testing equipment Low Oxygen cylinder High

Ear irrigator & syringe Med Oxygen flow meters Med

ECG recorder/monitor/ machine Med Physiotherapy/gym equipment Med

Electric & hydraulic chair/couch Low Pocket mask Med

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Item Risk

Score

Pregnancy testing equipment Low

Pulse oximeter Med

Radiolase machine Low

Sharps boxes Med

Slings Med

Smokerlyzer Low

Sphygmomanometer/ Blood pressure monitor/Vital signs monitor

Low

Spirometers Low

Stethoscopes Low

Suction equipment e.g. Laerdal Suction Unit (LSU)

High

Syringe drivers/pumps High

Tendon hammers Low

TENS pain relief machines Low

Thermometers Low

Toileting aids Low

Tongue depressors Low

Ultrasound equipment e.g. Dopplers

Med

Urinary catheters & drainage bags

Low

Urine receiver Low

Vacutainer blood systems Med

Vaginal speculae Med

Vision charts Low

Weighing scales Low

Wheelchairs & walking aids Low

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Appendix 2

FORM PPQ – June 2006

Produced by NHS Purchasing and Supply Agency, Scottish Healthcare Supplies, Northern Ireland CSA Regional Supplies

Service and Welsh Health Supplies in conjunction with the Association of British Healthcare Industries

This form is intended to supply prospective purchasers with information about equipment being considered for purchase. It is intended principally for pre-purchase information on electrical medical, dental, ophthalmic and laboratory equipment. The form may also be used for other products, including non-electrical items, and to give

information prior to equipment being supplied on loan, in which case not all the questions will be relevant. Please ensure all relevant questions are answered.

For issue and completion by purchaser: PPQ Master Reference:

ST131

A unique reference (preferably ten characters maximum) must be given by the supplier: Supplier's Reference:

Generic Device Type: Equipment Model:

Country of Origin: Manufacturer:

Supplier:

Telephone No:

Fax No: e-mail:

CE MARKING

1. a) Does the product carry the CE marking? YES NO

b) If YES, to which EC Directive(s):

i) Active Implantable Medical Devices Directive (90/385/EEC) YES

ii) Medical Devices Directive (93/42/EEC) YES

If YES, state classification of device (93/42/EEC Annex IX)

iii) In Vitro Diagnostic Medical Devices Directive (98/79/EC) YES

If YES, is the device: For self-testing? YES Covered by Annex II: List A? YES List B? YES NO

For ii) and iii) above, Identification No. of Notified Body, if applicable

iv) EMC Directive (89/336/EEC or superseding directive)) YES

v) Low Voltage Directive (73/23/EEC) YES

vi) Other Directive(s) (please specify)

2. a) Is the product a ‘custom-made device’ (93/42/EEC)? YES NO

b) Is the product intended for ‘clinical investigation’ (93/42/EEC) or ‘performance evaluation’ (98/79/EC)? YES NO

If YES to a) or b) above, does the device comply with the UK Medical Devices Regulations? YES NO

MANAGEMENT SYSTEM STANDARDS

3. a) Is the manufacturer currently registered to any management system standards (eg ISO 9001, ISO 14001, ISO 13485)? YES NO

If YES, please state the standard(s) and certification body:

b) Is the supplier's service and repair organisation currently registered to any management system standards? YES NO

If YES, please state the standard(s) and certification body:

SAFETY STANDARDS

4. For products not CE marked to 1 b) i), ii) or iii) above, with which safety standard(s) does the product comply?

Standard Test House Certificate Number Date

SERVICE / SPARES / INSTALLATION

5. Is service/repair information available? YES NO If NOT f.o.c. please state current price Indicate contents below:

(Please state YES, NO or N/A)

Full circuit diagrams Fault finding procedure Preventative maintenance

Repair information Spare parts listing List of special tools/test equipment/etc

If YES, please state whether also available on: Disk Website If Web, please state address

6. a) In addition to the service/repair information/manual, will training be required before competent technical personnel can provide:

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(Please state YES, NO or N/A) First-line maintenance Calibration

Planned preventative maintenance Repair

b) Is the supplier able to provide this training for the purchaser’s or a third party’s technical personnel? YES NO

If YES, will this be free of charge? Or chargeable?

If NO, please indicate if details of an organisation that is able to provide this training are available on request? YES NO

Supplier's Reference:

c) Is the provision of service/repair information conditional upon completion of training? YES NO

d) In order to undertake maintenance/repair/calibration, is any special software/test equipment/tooling required? YES NO

If YES, please indicate that details of special software/test equipment/tooling are provided on a separate sheet: YES

7. a) Is the supplier able to provide an 'as required' repair/maintenance service in the UK? YES NO

b) Is the supplier able to provide a contract repair/maintenance service? YES NO

If YES, please confirm that details of repair/maintenance contracts are provided on a separate sheet. YES

c) i) If repairs are normally performed by the supplier on the purchaser's site, please state typical response time:

ii) If repairs are performed off-site, where will these be carried out?

Company: Location: Typical turn round time:

iii) Is free of charge loan equipment normally available? YES NO

8. Please state if repair parts will be available to the purchaser’s or a third party’s suitably trained and equipped personnel: YES NO

If YES, is the supply of repair parts conditional upon acquisition of repair information? YES Or training? YES NO

9. Please indicate when this model was first placed on the market:

10. a) For how many years from the date of last manufacture is the supply of spare parts guaranteed?

b) Is the product still in current production? YES NO If NO, indicate year of last manufacture:

11. Is installation necessary? YES NO

If YES, please confirm that details of all services required are provided on a separate sheet: YES

12. Will software upgrades be notified? N/A YES NO

IONISING RADIATION

13. Does the product contain a source of ionising radiation or is it capable of emitting ionising radiation? YES NO

DECONTAMINATION / REPROCESSING

14. a) i) Will the item be reprocessed (cleaned, disinfected, sterilised)? YES NO If NO, go to Question 15.

ii) If YES, is the item intended to be: Non-sterile for single use Sterilised Disinfected Other

iii) Is there a recommended maximum number of uses? YES NO If YES, please state:

iv) Are decontamination/reprocessing instructions supplied? YES NO

v) Are instructions available for safe disposal? YES NO

b) i) Is manual cleaning the only cleaning method specified before further reprocessing? YES NO

ii) What is the maximum temperature that can be used for thermal disinfection? Temp:

iii) Are there any restrictions on detergent/disinfectant types? YES NO If YES, please state:

Can the item be decontaminated using chlorine at 10,000

parts per million

YES NO If NO please state

reason:

iv) Can the item withstand autoclaving at 137 oC for 3 mins? YES NO

v) Is the item compatible with other sterilization methods? YES NO If YES, please state:

vi) Does reprocessing require the use of specified equipment? YES NO

If YES, please state equipment type (eg containers, processors, etc) and, where appropriate, parameters of operation (eg temp, pressure, etc):

c) i) Are tools required to aid dismantling/reassembly, or are lubricants required? YES NO

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ii) If YES, are they supplied with the device or available optionally? Supplied Optional Neither

d) Is decontamination/reprocessing training available? YES NO If YES will this be: Free of charge? Chargeable?

e) Are reprocessing instructions available on the Web? YES NO If YES, please state address:

WARRANTY

15. Please confirm that a copy of the warranty is provided on a separate sheet: YES

DECLARATION

When reference is made to this form and its attachments within the process of obtaining the item, we agree that the purchaser will be entitled to rely upon the

contents and subsequent non-compliance with the statements contained herein will entitle the purchaser to seek redress.

Name: Position:

Company/Address:

Date:

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Appendix 3

Medical Equipment On Trial/Loan Check List

Indemnity Ref:

Supplier Details

Manufacturer/Supplier

Contact Telephone No.

Contact Name

Equipment Details

Description

Specific Model

Serial Number/s (Where Applicable)

Trial/Loan Details

Loan Reason - Trial/Testing Case /Procedure Specific

Site ……………………………………Ward/Department……………………………………………………...

Loan Co-ordinator………………………………………………….Loan Period………………………………

N/A Yes Tick Boxes As Appropriate

Decontamination Form

Function and E.S.T (Electrical Safety Tests) where applicable

User Instructions

Contents Check List (where applicable)

Decontamination Instructions/Training Identified and Agreed

Relevant Training Identified and Agreed

Moving and Handling Identified (where applicable)

Storage Identified and Agreed

User Calibration/Maintenance Identified and Agreed (where applicable)

Technical Maintenance Identified and Agreed (where applicable)

Site Services Identified (special requirements, where applicable) and Agreed

Consumables Identified and Agreed

Signed for the Trust: Signed for the Company:

The Loan Equipment scheduled above has been checked, verified as complete and removed from the Trusts premises. Decontamination Form Attached

Date……………………. Signed………………………………………… (Supplier)

………………………………………… (Trust)

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Appendix 4

Maintenance/Disposal Flowchart for Reusable Medical Devices

*N.B. If device is involved in an incident the item should not be decontaminated, serviced, fixed etc. until the investigation has been carried out. Please refer to Incident Policy for more details.

Following each use, the medical device is decontaminated in line with Decontamination Policy and Cleaning Policy. It is serviced according to this policy if required.

Device is not working properly* – take out of use & decontaminate. For hoists, put black and yellow tape and place a notice on the equipment saying ‘Do not use’. Attach Decontamination Form/ Certificate PCT 211 (Appendix 6).

Item is not serviced when required

For items with separate maintenance contracts e.g. weighing scales (see User Guide), contact company. For other general equipment contact engineers:

Doncaster – Key Health on 08700 420735

Rotherham – RFT Biomedical Engineering on 01709 424386

Scunthorpe – NLAG on 01724 282282 x2271

Medical Device Link Person to update database with service information

Complete Decontamination Form (Appendix 6) and Disposal Form (Appendix 7). Requires approval of Director of Finance if cost more than £5,000. Medical Device Link Person to update database with disposal information.

ISSUES

Device is serviced /repaired

Device is for disposal

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Appendix 5

Mattress Audit Tool

Ward: Date:

Bed area

Is mattress cover in good condition? If no, state-(ripped/torn/burn/ puncture holes, signs of perishing)

Is mattress cover visibly clean and free from stains?

Is the mattress foam in good condition e.g. no stains, no strike through?

Is the bed frame clean?

Are all pillow cases heat sealed and in good condition?

Record mattress number and make.

Actions/Comments

Signature

Mattress test: Examine the mattress. There should be no staining visible, examine for strike through especially around the zipped areas of the mattress.

NB. Audit to be conducted monthly or on patient discharge whichever comes first. Hard copies of this tool to be saved in IPC Evidence Folder in audit section.

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Appendix 6

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WEEE_001 EMS_OP_023 appendix 1

WEEE EQUIPMENT RETURNS FORM

Section a) To be completed by person requesting collection

Name: Designation:

EQUIPMENT LOCATION (Inc Department and room):

Equipment Details

(e.g. fridge, microwave etc..) Make Model

Asset Tag and/or Serial

Number (if applicable)

Section b) (to be completed by Departmental Manager or representative)

Name: Designation:

Cost Centre Code:

To arrange a collection;

Email form to rdash.logisticservices@nhs.net

Section c) (to be completed by Logistics Supervisor or representative)

PACKAGING REMOVED: Yes/No NUMBER OF BOXES

Item(s) placed in WEEE Storage Facility on Date: .…. / ….. / ……… d m year

Name: ………………………..… Date: ……………………………….…….

Issue 2

October 2010

As a printed document, this is not controlled. Check either the Environmental Management System

folder on the Trust Intranet or your Departmental Manager/Supervisor for the current version. Accessed/printed;

29-Oct-19

Appendix 7