Policy Number LCH-145

This document has been reviewed in line with the Policy Alignment Process for Liverpool Community Health NHS Trust Services. It is a valid Mersey Care document, however due to organisational change this FRONT COVER has been added so the reader is aware of any changes to their role or to terminology which has now been superseded. When reading this document please take account of the changes highlighted in Part B and C of this form.Part A – Information about this DocumentPolicy Name Guidelines for the Management of Medical DevicesPolicy Type Board Approved (Trust-wide) ☐ Trust-wide ☐ Divisional / Team / Locality ☒

Action No Change ☐ Minor

Change ☐ MajorChange ☐ New

Policy ☒ No LongerNeeded ☐

Approval

As Mersey Care’s Executive Director / Lead for this document, I confirm that this document:a) complies with the latest statutory / regulatory requirements,b) complies with the latest national guidance,c) has been updated to reflect the requirements of clinicians and officers, andd) has been updated to reflect any local contractual requirements

Signature: Date:Part B – Changes in Terminology (used with ‘Minor Change’, ‘Major Changes’ & ‘New Policy’ only)

Terminology used in this Document New terminology when reading this Document

Part C – Additional Information Added (to be used with ‘Major Changes’ only)Section /

Paragraph NoOutline of the information that has been added to this document – especially where it may

change what staff need to do

Part D – Rationale (to be used with ‘New Policy’ & ‘Policy No Longer Required’ only)Please explain why this new document needs to be adopted or why this document is no longer required

Part E – Oversight Arrangements (to be used with ‘New Policy’ only)Accountable Director

Recommending Committee

Approving Committee

Next Review Date

LCH Policy Alignment Process – Form 1

SUPPORTING STATEMENTS This document should be read in conjunction with the following statements:

SAFEGUARDING IS EVERYBODY’S BUSINESSAll Mersey Care NHS Foundation Trust employees have a statutory duty to safeguard and promote the welfare of children and adults, including: being alert to the possibility of child / adult abuse and neglect through their observation of

abuse, or by professional judgement made as a result of information gathered about the child / adult;

knowing how to deal with a disclosure or allegation of child / adult abuse; undertaking training as appropriate for their role and keeping themselves updated; being aware of and following the local policies and procedures they need to follow if they

have a child / adult concern; ensuring appropriate advice and support is accessed either from managers, Safeguarding

Ambassadors or the trust’s safeguarding team; participating in multi-agency working to safeguard the child or adult (if appropriate to your

role); ensuring contemporaneous records are kept at all times and record keeping is in strict

adherence to Mersey Care NHS Foundation Trust policy and procedures and professional guidelines. Roles, responsibilities and accountabilities, will differ depending on the post you hold within the organisation;

ensuring that all staff and their managers discuss and record any safeguarding issues that arise at each supervision session

EQUALITY AND HUMAN RIGHTSMersey Care NHS Foundation Trust recognises that some sections of society experience prejudice and discrimination. The Equality Act 2010 specifically recognises the protected characteristics of age, disability, gender, race, religion or belief, sexual orientation and transgender. The Equality Act also requires regard to socio-economic factors including pregnancy /maternity and marriage/civil partnership.

The trust is committed to equality of opportunity and anti-discriminatory practice both in the provision of services and in our role as a major employer. The trust believes that all people have the right to be treated with dignity and respect and is committed to the elimination of unfair and unlawful discriminatory practices.

Mersey Care NHS Foundation Trust also is aware of its legal duties under the Human Rights Act 1998. Section 6 of the Human Rights Act requires all public authorities to uphold and promote Human Rights in everything they do. It is unlawful for a public authority to perform any act which contravenes the Human Rights Act.

Mersey Care NHS Foundation Trust is committed to carrying out its functions and service delivery in line the with a Human Rights based approach and the FREDA principles of Fairness, Respect, Equality Dignity, and Autonomy

Liverpool Community Health NHS Trust

Guidelines for the Management of Medical Devices

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Version Number: 3.0

Ratified by: Patient Safety Group

Date of Approval: (Original

Version)January 2011

Name of originator/author: Alison Marsh – Medical Devices Practitioner

Approving Body / Committee: Clinical Policies Working Group

Date issued: (Current Version) September 2015

Review date: (Current Version) September 2016

Target audience: Organisation Wide

Name of Lead Director

/ Managing Director:

Craig Gradden, Medical Director

Changes / Alterations Made To Previous Version (including date of changes)

22/4/13 - Altered logo to new LCH logo and added ‘s’ to guideline

Changes / Alterations Made To Previous Version (including date of changes)

15/09/15 – New template. Updates to whole document & presented to the Patient Safety Sub - Committee.

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Contents

Section1 Background2 Equality Statement3 Introduction4 Scope5 Definitions6 Duties, Accountabilities and Responsibilities7 Management of Medical Devices8 Procurement9 Acceptance of Devices10 Medical Device Inventory ELMS System11 Decontamination of Devices12 Storage13 Maintenance & Servicing of Devices14 Medical Devices Prescribed on Loan15 The Deceased Patient16 Disposal17 Replacement18 Adverse Incidents & Accidents19 Training in the Use of Medical Devices20 Developments, Trials & Demonstrations21 Guideline Implementation Monitoring & Review22 Guideline Key Performance Indicators23 Related Documentation24 References

Appendices

Appendix A – Risk Categories of medical devices held on the ELMS system Appendix B – Decontamination formAppendix C – LCH Serious Incident Procedure Appendix D – Medical device risk classification Appendix E – Job request formAppendix F – Conditions of loan letterAppendix G – Pre-delivery Inspection template (PDI) Appendix H – Medical Devices Frequently Asked Questions Appendix I – CQC StandardsAppendix J – Management of Medical Devices Process Flowchart Appendix K – BGM Return Process for EQA POCTAppendix L – BGM Return Process for RepairsAppendix M – Process for the Management of Syringe Drivers Appendix N – Process for the Management of Scales Appendix O – Process for the Management of Fridges

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1.0. Background

Medical devices have been used by our clinicians for the benefit of the health and wellbeing of our community. The medical devices team was set up to manage all of the LCH devices ensuring service & maintenance was in place and that all devices were safe to use/fit for purpose.Liverpool Community Health NHS Trust is a provider of Quality health care & choice for our clients living in the community. We continue to seek new and innovative ways of working to deliver high standards & positive outcomes. We have the opportunity to transform the care our patients receive, improving their experience and developing an integrated approach to deliver a seamless journey for all our service users.

2.0. Equality Statement

The Organisation is committed to Equality and Diversity in employment & as a service provider. We will proactively take steps to improve our workforce diversity and to provide opportunities for all. We are committed to encouraging and promoting diversity and eliminating discrimination.We aim to ensure that our workforce is truly representative of the local community, that our culture values Equality and Diversity and recognises that diversity adds value and enables us to provide responsive and quality services to all patients and clients.

3.0 Introduction

This document outlines procedures and guidelines to ensure the safe and effective management of medical devices from procurement to decommissioning, identifying risk issues and removing or reducing them as far as possible. It ensures that the organisation complies with Care Quality Commission standards (CQC) – regulation 15 & 16 Outcome 11 & the Medicines and Healthcare Products Regulatory Agency, Managing Medical devices policy (April 2014).Competency based training with medical devices is provided to ensure all clinicians are confident & competent to use medical devices and to provide assurance that patient safety remains at the forefront of the organisation.Clinicians using diagnostic equipment and services should read this Guideline in conjunction with the guidelines on Lifting Operations and Lifting Equipment Regulations 1998 (LOLER 98) and the Provision and Use of Work Equipment and any local procedures.

4.0 Scope

This Guideline is relevant to all staff that use medical devices.

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5.0 Definitions

In the Guideline for the Management of Medical Devices the following definitions have been used:

Term DefinitionCare Quality Commission

The Care Quality Commission is the independent regulator of health and social care in England. www.cqc.org.uk

Contamination The soiling or pollution of devices or living material with harmful, potentially infectious, or other unwanted matter. In the clinical situation, this is most likely to be organic matter and infectious agents but may also include chemical residues, radioactive material, degradation products, packaging materials, etc. Such contamination may have an adverse effect on the function of a medical device and may be transferred to a person during use or subsequent processing and storage.

Decontamination A series of processes to enable a device to be safe for use on a patient or to be safely handled after being used on a patient. This is the process as follows:

Clean Disinfection

Disinfection A process used to reduce the number of viable infectious agents but which may not necessarily inactivate certain viruses and bacterial spores. Disinfection does not achieve the same reduction in microbial contamination levels as sterilization.

End user A person who uses the device on or for him/herself, as distinct from a professional user.

ELMS system A computerised system were all medical devices, details are store:- to ensure a record of date of purchase, service & maintainance due & completed dates, allocation of device to whom, staff member, team, LCH building. Bar codes are also generated for each device and the barcode number added to the ELMS for track and trace purposes. This information on the ELMS system also informs the medical devices team of devices that are coming into there decommissioning year therefore the medical devices team can ensure all devices are fit for purpose and the risks to safe use minimised as far as possible.

Liverpool Community Health NHS Trust (LCH)

Liverpool Community Health NHS Trust has overall accountability and responsibility. It is an Organisation that provides health services and ensures those services meet the needs of the local population www.liverpoolcommunityhealth.nhs.uk

MDSO- medical devices safety

Responsible for the safe use of medical devices throughout the trust by monitoring the MHRA & CAS alerts that come into

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officer trust via email and acting upon those alerts applicable to medical devices procured by LCH. To ensure action plans are developed and carried out to reduce or eliminate the risk to patient’s, staff & the organisation. The MDSO also reports LCH adverse incidents to MHRA ensuring action plans and updates are provided regularly.

Medical device This refers to 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 (birth control device)A medical device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means. This definition includes devices intended to administer a medicinal product, such as a syringe driver, or which incorporate a substance defined as a medicinal product, such as a drug-eluting stent.Any device, instrument, apparatus, implement, material, substance or other article used singularly or in combination together with any accessory thereto which is intended by the manufacturer. (For risk category of devices see Appendix A).

Medicines and Healthcare Products Regulatory Agency (MHRA)

The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency that is responsible for ensuring that medicines and medical devices work, and are acceptably safe. www.mhra.gov.uk

National Patient Safety Agency

The National Patient Safety Agency, a special health authority was established in 2001 to improve the safety of NHS patient care, by promoting a culture of reporting and learning from adverse incidents across the NHS. www.npsa.nhs.uk

Patient Throughout this document the word ’patient’ is used and can include families and carers where relevant.

Planned Preventive Maintenance (PPM)

The correction or prevention of faults by a programme of inspection and replacement of parts in order to keep the medical device performing as intended by the manufacturer.

Repair The restoration of a device to correct working order, after it has either broken down or stopped working properly. The repair process may also include maintenance or reconditioning.

Responsible An organisation that either uses devices or loans them to end-

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organisation users.Single patient use medical device

A device that must only be used on one patient, but may be used for more than one procedure on that patient before disposal e.g. reusable feeding tubes.

Single-use medical device

A device that is intended to be used on an individual patient during a single procedure and then discarded. It must not be used on another patient.

User Professional user and/or end-user.

6.1 Duties, Accountability and Responsibilities

6.2 Chief Executive Officer (CEO) is the accountable officer, and as such the CEO is responsible for ensuring that systems and processes are in place for medical devices and is delegated to appropriate Executive representatives: the Trust also has an appropriate Governence Structure in place to manage the risks associated.

6.3 Medical Director is responsible for the delivery and management of all NICE Guidance audits & the medical devices policy, and to identify any risks associated with non-delivery.

6.4 CEDAS Strategic Operational Manager is responsible to the Medical Director for the effective implementation of the Medical Device Guidelines and all associated procedures ensuring full track and trace functionality of medical devices to enable robust asset management.

6.5 Medical Devices Safety Officer (MDSO) reports any LCH adverse incidents to the MHRA and other official agencies ensuring the affected device is taken out of service and a replacement sought through the medical devices team. The MDSO also ensures any alerts received from the MHRA/CAS applicable to medical devices are action planned immediately for processes to be put in place to minimise/resolve any risks to patient’s, staff & the organisation.

.6.6 The Medical Devices Patient Safety Group monitors the implementation of the

Trust Medical Devices Guidelines in order to meet assurance standards laid down by the NHS Litigation Authority; Act as an advisory group to the procurement of medical devices; Monitor new medical devices that come into the Trust and ensure that:

Guidelines are developed for managers regarding their responsibilities in relation to training.

Receive assurances from the Medical Devices Practitioner that competency based training for medical devices is being delivered to clinicians in line with the MHRA Medical devices Policy (2014).

Ensure the use of medical devices and individuals competency is audited yearly.

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Discuss MHRA/CAS alerts and any for action & local LCH risks, delegate tasks to members were applicable and provide a key report to the Patient Safety Sub-Committee.

6.7 Patient Safety Sub-Commitee will ensure they: Receive and review medical device related adverse and near miss trend

reports; Ensure that there are robust systems in place to manage risk associated

with the purchase, use, maintenance, repair and disposal of reusable medical devices and equipment in line with MHRA Managing Medical Devices Guidance (2014) for healthcare and social service organisations. This Guidance states the Medical Director is appointed with overall responsibility.

Will prioritise submitted business plans in order of purchase within the financial resources available.

6.8 All Clinicians are responsible for ensuring they understand the requirements of this Guideline to ensure compliance with Liverpool Community Health NHS Trust’s legal obligations and their professional registration. All Clinicians will ensure requirements as described by this Guideline and its associated procedures involving their use of medical devices for service users/ patients are understood and complied with by the individual user.

6.9 MEDICAL DEVICES TEAM:-

Medical Devices Manager

Medical Devices Practitioner

Medical Devices Support

Medical Devices Clerk

Medical Devices Driver

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6.10 Employees and Others have a duty to assist their employers in complying with their statutory duties. All health care professionals are accountable for ensuring they use medical devices safely and in line with relevant training and instructions, legislation and guidance.

6.11 All Users of devices including Temporary, Agency Staff, or Contractors will; Ensure that they read, understand and comply with this Guideline; and Inform their manager of any circumstance that prevents compliance with

the Guideline.

7.1 Management of Medical Devices

Precise instructions have a crucial role in the safe and effective use of medical devices. It is the responsibility of the medical devices team to ensure that instructions are received with new devices and are fully explained during any necessary training. If manufacturers’ training is required it is the responsibility of the Medical Devices Practitioner to implement and/or organise this in- conjunction with the Learning and Development Beareau (LDB) and if required to seek advice from the Medical Devices Safety Group and the Procurement Department.

The purpose of medical devices management is to ensure that the safety, availability and suitability of equipment is adhered to (CQC Outcome 11, Regulation 15 & 16):

Is for its intended purpose Is understood by the users Is in a safe and serviceable condition. Meets safety and quality standards and requirements Can be decontaminated in line with manufacturers’ and infection Control guidelines (refer to the Liverpool Community Health

Environmental Disinfection and Decontamination of Reusable Devices Guideline)

Is stored in appropriate and controlled conditions (e.g. for medical devices such as infusion sets, catheters, etc.)

Not modified without written supplier approval The user must be confident, competent & can verify training in the medical

device has been achieved. Satisfies the above in a cost-effective manner Ensures were possible standard medical devices are procured across the

trust to provide continuity for clinicians & standard training & competency requirements.

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8.0 Procurement

8.1. When buying in a new medical device not procured previously by the trust the final selection of the device should be made in close consultation with Procurement, and the Medical Devices Clinical User Group who are responsible for the clinical use of the equipment. Relevant technical and financial information must also be taken into account.

8.2 Prior to the purchase/loan of any medical device consideration must be given to the following:

The user’s requirements and performance of the devices; Safety and compliance with standards and information updates; Electro-magnetic compatibility; Compliance with devices standardisation across the Trust; Manufacture’s support – spare parts availability, maintenance, training etc; Training and competency assessments – and any resources required; Financial aspects – capital, revenue, maintenance and spare costs; and Cleaning and decontamination

The manufacturer or supplier will be required to state in writing that the device complies with the relevant safety requirements.

Formal competitive quoting and tendering should be carried out in line with Standing Financial Instructions (SFIs) to ensure best value is achieved.

Staff will need to select models which are standardised within the Trust, as this will promote ease of use and cost reductions as part of our ‘environment and sustainability for the future’.

On occasion, the Procurement Department may advise an alternative piece of equipment would be more appropriate. In such a circumstance, they will contact the requisitioner & the medical devices practitioner to discuss this and agree any changes prior to any orders being placed, and a clinical evaluation will be required.

The benefits of this system are:

Improved safety. Compliance with legislation. Expert help and advice. Cost of maintenance taken into account before purchase decision made.

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9.1 Acceptance of Devices

9.2 It is the responsibility of the receiver of a new medical device to ensure that prior to the use of the device a Pre-Delivery Inspection (Appendix G) is carried out & the documentation to support this procedure is completed with a signed copy of the condition of loan letter from the receiver of the device. (Appendix F). These documents will be kept with the MD team & filed.

This must include:-

If relevant an initial inspection and safety check, in accordance with MHRA Managing Medical Devices Guidance (2014), The Electrical Equipment (Safety) Regulations [34] for electrical equipment prior to placement on a patient.

Planned preventative maintenance schedule which will be uploaded to the ELMS system along with the details of the new device.

Appropriate training for users and technicians together with appropriate manuals/written guidelines.

Ensuring that all Devices are collected/delivered safely and appropriately by the Medical Devices Driver in line with the trust Infection, prevention and control policy.

9.3 This process will ensure that the purchased medical devices meet both the tendered specification and legal safety requirements. It also ensures all new devices are bar coded an added to the ELMS system.

10.1 Medical Devices Inventory–Electronic Management System (ELMS)

Good records are important in effective device management and therefore MUST be maintained with a robust track & trace system in place. LCH are users of ELMS to manage all medical devices used by the trust.

10.2 Local level asset registers of medical devices are held by each individual service and or ward area. These registers inform the teams what medical devices they have in the clinician’s possession or the base medical devices storage cupboard. It is the responsibility of their own designated person or team clerk to ensure the asset register is kept up to date regularly and a log book of their devices maintained for their own information and monitoring of the wareabouts of their devices, i.e.: name of patient and address where device is currently in use. Medical devices do not keep this information therefore it is paramount all teams detail this information to prevent loss of devices. Medical devices will have all teams/bases & clinicians devices on the ELMS system currently being uploaded with all medical devices across LCH & planned to go live by the end of the year. The ELMS system will ensure Medical Devices are kept up to date and accurate and that any service/repair or calibrations of all reusable medical devices are completed within its specified time frames. ELMS will ultimately replace local asset registers.

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10.3 The ELMS system also ensures compatibility with the main schedule of the medical devices held by Suppliers to LCH, and contains:

Name of Service, Directorate, Manager, list compile by and date Make / Model Manufacturer Serial Number Location of Equipment Maintenance contract details Barcode of device Risk Status

10.4 It is the responsibility of the Manager/Team Leader to ensure that their area has an up to date log book to log all medical devices that are taken out of the team base to be used in patient’s home long term, e.g. nebulizer, syringe driver.

10.5 All items which are listed on the ELMS schedule will be reviewed for regular maintenance and repair checks via a planned preventative maintenance report which can be obtained from the ELMS system. This is a part of NHS Litigation Authority risk management standards 1.3 (7) Schedules of equipment and their reporting processes which are reviewed six monthly by the Medical Devices Patient Safety Group.

11. Decontamination of Devices

Decontamination – is the process of rendering an article safe to handle, by cleaning with, or without disinfection or sterilisation.

Cleaning – is the physical removal of dirt, grease and organic matter which reduces the number of micro-organisms present.

Medical devices that have been in contact with patients or their bodily fluids have been implicated in transmission of health care related infection, and devices can also become contaminated with chemicals (which may be corrosive, irritant, toxic, cytoxic or radioactive).

Therefore all devices must be appropriately and adequately cleaned and decontaminated between patients, and prior to servicing or repair, in accordance with Trust guidelines. If the device is being sent for repair or servicing, a decontamination sheet (see Appendix B) must be completed and attached to the device by the member of staff in charge of the ward or department at the time to confirm that it has been appropriately cleaned; the device will not be moved, handled or accepted by the Medical Devices Driver without it.

ALL EQUIPMENT TO BE DISINFECTED OR STERILISED MUST FIRSTUNDERGO CLEANING. Please refer to the Environmental disinfection and Decontamination of reusable devices Guideline.

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11.1 Disinfection – is the process of killing or removing pathogenic micro-organisms, with the exception of bacterial spores and prions.

11.2 Sterilisation – is the process of rendering an article free from micro-organisms’, including viruses and bacterial spores. NB. Normal sterilisation methods will not destroy prions.

Boiling does NOT sterilise an item.

NB: Single use devices indicated by this symbol must not be reused:

They are for a single procedure and must then be discarded. They are not intended to be reprocessed and used again, even on the same patient, as it can affect their safety, performance and effectiveness, exposing patients and staff to unnecessary risk.

Single patient use devices (as opposed to single procedure devices) may be used several times for the same patient, with appropriate cleaning if required in between uses, but then must be discarded after the patient no longer requires it.

Clean decontaminated devices will be returned to the individual services and should always be stored in an area where they are protected from dirt and dust can be kept off the floor and, if possible, away from direct sunlight.

The Infection Control Nurses must be contacted for advice when planning to purchase any items or devices which will require decontamination.

Many moderate and minor risk items are suitable for cleaning and decontamination locally. Appropriate Personal Protective Equipment (PPE) must be used when undertaking cleaning and disinfecting processes.

12. Storage of medical devices

12.1 Following the acceptance of medical devices, they will be stored in such a manner as not to cause undue or premature deterioration to their condition, refer to: (CQC, Outcome 11, Regulation 16). Particular note should be made of labels on packaging indicating special storage requirments.

12.2 Storage must comply with health and safety regulations (e.g. moving and handling). Fragile equipment is stacked in a way so as not to sustain damage by falling, etc.

12.3 Equipment ready to be issued is physically seperated from equipment awaiting decontamination and/or repair.

12.4 Devices in storage having an identified shelf life undergo stock rotation to guard against stock being out of date and unnecessary wastage. Items that

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have

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been in storage for extended periods may be re-examined and/or tested prior to use.

12.5 Devices that include rechargeable batteries should either be left on charge or periodically recharged, in line with manufacturer’s instructions, to enhance battery life and maintain a state of readiness for use.

12.6 The medical devices team will store surplus devices which will be decontaminated prior to the driver collecting the device. The Medical devices team will check whether or not the device is due for decommisioning and if not will send the device for repair if needed. On return will be decontaminate and stored on site in decontaminated closed containers for re- issue when needed. At this point the device will be serviced prior to re-issueing to ensure a safe device that is fit for purpose.

13. Maintenance and Servicing of Devices

The Medical Devices team will ensure that all devices are maintained and checked for electrical and mechanical safety on a regular basis via the ELMS system & according to the manufacture’s recommendiations. Any supplier’s maintenance department supports this process (for medical devices maintained on their databases) by either providing this service from within their departments, or by arranging for a service contractor to do so.

Clinicians must:

13.1 Ensure they check the service and maintenance label on the device is up to date prior to use with a patient. Any discrepancies found the clinician must not use the device & report the device to the medical devices team by completing a job request form and emailing to: MedicalDevices@LiverpoolCH.nhs.uk

13.2 Medical devices stored by users in their departments must ensure there are designated lockable units were all devices can be stored when not in use. A log book must be kept in the unit for all clinicians to:

Document the device that has been taken out to use Date taken Name of patient the device is needed for & NHS no. (for the device to be

traceable if not returned to lockable unit) Check service label is up to date Clinicians signature

When the device is returned to the lockable unit the clinician must return to the original log and sign & date the returned device column. The device must then be decontaminated following local procedures for decontamination of a medical device & in line with the Infection Control policy. The device must be stored in the lockable unit complete with all its components if applicable – ready for the next clinician to use.

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13.3 The medical devices team award medical devices contracts. The Medical devices team is responsible for directing the companies chosen ensuring that any medical devices held on the ELMS system are properly maintained, repaired and calibrated within its specified time frames as agreed in the contract and the records of such are retained in the department log books. Medical devices will have all details to hand on the ELMS system.

13.4 External bodies who supply their own medical devices and equipment for the purpose of health care provided by Liverpool Community Health NHS Trust,e.g. Care & Residential homes and Children’s Centre’s, must in accordance with compliance and legislation supply evidence to Liverpool Community Health NHS Trust, detailing their suitably assessed competencies, maintenance details and that effective monitoring takes place against all types of medical devices and equipment (Care Quality Commission Safety, availability and suitability of equipment - Outcome 11, Regulation 16).

Liverpool Community Health clinicians should check the non-LCH devices they are using have labels on the devices showing up to date service & maintenance. Do not use a device that does not clearly show this & report the non-LCH device to the department manager.

13.4. Repair/breakdown maintenance

Devices repair/breakdown maintenance is prioritised based on need, e.g. high risk devices required for end of life and or walk in centre medical devices/waiting patients. This work may be undertaken by various suppliers; check the department’s inventory list where reference will be made to those contractors responsible for maintenance. Ensure the medical devices team is informed who will assist in the procedure to follow. In all cases of Job requests the medical devices team will use a sliding scale tool to advise if a repair or service is worthy on the device or should it be replaced with a new device. This process takes the age of the device and current value into consideration against the cost of the repair/maintenance cost.

To report a fault or breakdown, log an equipment job request via - http://nww.liverpoolch.nhs.uk/service-directory/medical-devices-team.htm, the Medical Devices Driver will collect from site the piece of equipment and return it to the user once repaired, unless otherwise specified (Appendix E).

When any device is being returned to any supplier for inspection, servicing or repair, the details of any fault should also be recorded on a decontamination sheet (see Appendix B).

A device being returned from inspection, service or repair will not require a decontamination tie or label as it will have had no patient contact. A device being returned from Aintree will usually have adhesive “service tape” attached, which is part of Aintree EBME departments quality assurance system: it notifies the user that the device has been repaired and that function checks may be required before use within the clinical area as settings will have been altered.

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A job request received by the medical devices clerk will be dealt with and you will be kept informed if there are any delays in you receiving your device back. The medical devices driver will collect the device and a repair/service/ maintenance request without complications will be completed and returned within 4-5 working days. If there is to be a further delay the medical devices team will inform the service requesting the repair and support to find a temporary device if necessary.

13.5 Medical devices needing replacement will require an email to the medical devices practitioner stating the details of the new device requested:

Name of the device Manufacturer Cost of the device (this can be found in the equipment catalogue in all

team bases) Rationale for the need of this device

Following approval from the MD practitioner the MD support will check with procurement the device is the standard used by LCH. If the device is not standard the MD practitioner will require a rationale for this. The medical devices team aim to ensure there is standardisation across the trust to support familiarity and the safe use of devices. The medical devices support will order the device requested and ensure all checks are carried out when the new device arrives to site (PDI).

13.6 When a new device is received to the MD team site a pre-delivery inspection a (PDI) form will be completed for each item and a condition of loan letter will be issued for each item. The completed PDI will be completed by the medical devices team this ensures the item received from the manufacturer was delivered with no damage to the device or packaging and the device works as per the instructions and manufacturers guarantee. This ensures the safety of the device prior to delivery to a team. Every item will receive a barcode which relates it to the ELMS system for track and trace purposes. All existing devices will also receive a barcode and the device details to be uploaded to Elms (this is currently a programme of works).

14. Medical devices prescribed or loaned (including those items on loan to Patients or any other agencies through the medical devices team)

14.1 Any medical device on trial or on loan to Liverpool Community Health NHS Trust must be treated identically to those purchased by Liverpool Community Health NHS Trust in terms of training requirements, acceptance testing, risk assessments, storage, servicing, maintenance and adverse incident reporting.

14.2 Local procedures must incorporate the collection / testing / checking and decontamination of the loaned equipment when it is no longer needed.

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14.3 Any equipment loaned or prescribed to a patient must be noted in the patient record and held locally within the departmental log; this process will allow for the correct management procedures to be followed and in-line with risk standards, updates will be required as part of the ELMS tracking procedures, allowing for correct accountability of local and organizational schedules to be maintained. It also alleviates the risk of accountability for any lost or stolen items.

14.4 The following details MUST be accounted for and held locally in the team medical device log book to highlight when a device or piece of equipment is loaned to a patient from team base :

Make Model Serial number Patient detail; name, address etc. Date loaned to patients Person responsible for loaning the equipment

14.5 It is the referrer’s (clinician’s) responsibility to ensure that the loaned equipment is checked & used correctly and safely as per the conditions of loan letter (Appendix F) sent out with all medical devices. It must be documented in the patient’s notes that it has been demonstrated if applicable, by whom, and that written instructions are available, and these functions are a requisite of the CQC Outcome 11, Regulation 16. (Safety, availability and suitability of equipment)

15.0 The deceased Patient

The clinician who performs last offices for a patient in their care is responsible for removing any reusable medical devices insitu, cleaning the device and returning it to the clinical team/base/hospital/hospice who owns it. If unable to locate ownership please contact medical devices who will arrange to collect the device from the clinician and arrange return to the correct owner team/base/hospital/hospice.

16.1 Disposal

16.2 LCH sites needing to dispose of re-usable medical devices must contact the medical devices team. Smaller items will be collected via the medical devices driver and brought back to the MD team who will decommission if old or obsolete. Larger items will be decommissioned on site arranged by the medical devices team.

The Waste Electrical and Electronic Equipment Regulation (WEEE) will impose duties on Liverpool Community Health NHS Trust for the safe disposal of electrical equipment (see Waste Management Guideline).

V3 March 2015 Page 19 of 42

17.1 Replacement

Medical Devices may require replacement.

17.2 Replacement may be required for the following reasons:-

Wearing beyond economical repair Damaged beyond economical repair Unreliability (MHRA) Clinically/technically obsolete Spares not available More cost/clinically effective devices now available Unable to be cleaned effectively

17.3 Upon receipt of any new/replacement device it is essential that old devices are disposed of, in accordance with both the Environmental Disinfection and Decontamination Guideline and the Clinical Waste Guideline & following the decommissioning policy.

17.4 If action is to be taken for disposal all details MUST be recorded on the ELMS system. This service can be facilitated by Aintree Biomedical Engineering Department only for equipment identified on their schedule. In all instances contact the medical devices team who will support to facilitate the decommissioning & disposal.

17.5 Lost medical devices – Complete datix; inform medical devices via email to the medical devices team. If a replacement device is needed it will be issued via the MD team and charged to the originator’s team budget. Medical devices will complete a losses form and submit to the finance department.

18.1 Adverse Incidents & Accidents

18.2 A device related adverse incident is an event which can produce, or has the potential to produce unwanted effects involving the safety of patients, users or other persons. It is important to report all device-related adverse incidents so that these can then be investigated thoroughly and action taken as appropriate; Comprehensive guidance on reporting adverse incidents is contained in Device Bulletin DB2008/ (01) Liverpool Community Health NHS Trust will ensure that all adverse incidents are reported in line with legislation.

18.3 Any incidents involving a Medical Device or piece of equipment must be reported to the Health and Safety Department via the on-line Datix Incident Reporting System which is also maintained and managed by the Health & Safety Risk Management team, for appropriate flow chart information please see Appendix G.

18.4 If an adverse incident occurs, the staff member must:

V3 March 2015 Page 20 of 42

a) Immediately check and take steps necessary for the well-being and protection of the patient or client, and other staff members.

b) Take the medical device involved out of action, remove it from service or quarantine the device. Advice must be sought from the Risk Management Department & the medical devices team prior to placing the device back in service or disposing of the device.

c) Seek advice from the Infection Control Team before items are to be stored in quarantine, items to be sent off site for inspection will require decontamination and labelling in accordance with Liverpool Community Health NHS Trusts Environmental Decontamination Guideline. Contact the medical devices team should any devices be quarantined or need to go off site for inspection.

d) Collect and retain other material evidence such as packaging if available, recording the condition of the medical device and when the incident occurred.

e) Report the Incident via the Datix Incident Reporting System. Details must include the date and time of the incident; the details of the medical device affected; and details of any error messages or failures and any remedial action taken at the time.

f) Inform their line manager and report to the Medical devices Safety Officer who will liaise with the MDP to obtain assurances locally the device has been taken out of service & ensure any actions needed to ensure the safety and security of others are implemented. The MDSO will support & monitor, report the incident to the Medicines and Healthcare Products Regulatory Agency.

19.1 Training in the use of Medical Devices

19.2 All unsupervised users of medical devices within the Trust must be sufficiently competent to do so without risk of injury or harm to themselves, the patient or others. Health care professionals have a responsibility for ensuring that, as part of their continuing professional development, they acquire, maintain and disseminate knowledge and skills in the use of medical devices. All clinicians will require completion of a competency based assessment per device (using their training pack). All clinicians will update their pack yearly through self assessment accepted for two years followed by a competency based assessment for sign off each third year. During an individual’s Proffesional development review the training pack should be presented and discussed with their manager. Yearly random audits will be taken by the medical devices team to ensure compliance to medical device training & competence. The training pack and competencies can be found on the medical devices intranet page with thorough usage details in the pack.

19.3 Process for Ensuring that the Identified Training Needs of all Permanent Staff are Met.

V3 March 2015 Page 21 of 42

All staff must have:

Self-assessed their own competency against the competency statement for each device and have been observed as competent by an appropriate supervisor in the last two years prior to using any medical device you have identified in your training pack you use for your role.

Staff must ensure that prior to secondments, maternity leave etc., that the device is returned to their Line Manager for return to the Medical Devices Team.

Training may be given from an external source in the first instance which may be cascaded down through the department, or it may be given by the trusts clinical lead or other appropriate practitioners.

It is the responsibility of the deparment manager (or line manager / supervisor) to ensure that staff are given the appropriate opportunity to attend the training that is provided; and

Training courses on medical devices will be coordinated through the medical devices practitioner & in collaboration with the Learning and Development Bureau (LDB) , however if medical device training is provided locally within Directorates, or as work based learning it is imperative that signed attendance records are submitted to LDB within 48 hours of completion to ensure accurate record keeping and reporting mechanisms are adhered to.

20.0 Developments, Trials & Demonstrations

No medical devices will be used for developments, trials or demonstration without the written permission of Head of Governance and approved by Liverpool Community Health NHS Trust Board unless used by an LCH staff member during training sessions.

21.1 Guideline Implementation, Monitoring and Review

21.2 Responsibility for various aspects of medical devices management is shared by key personnel and service/department/ward managers, who are ultimately accountable to the Director of Finance and the Chief Executive Officer (CEO) for Liverpool Community Health NHS Trust.

21.3 Implementation of this procedural document will be monitored by the Medical Devices Patient Safety Group. The group is responsible for the development and monitoring of action plans in order to implement risk reduction measures and disseminate lessons learned and changes in practice. A report is sent to the Patient Safety Sub Committee following each monthly MDPSG meeting.

V3 March 2015 Page 22 of 42

22.1 Guideline Key Performance Indicators

Key performance is captured monthly in the medical devices manager’s template. The MDP produces this report to inform the Governance meeting. Key Performance is also captured in the MD weekly balance score cards (WBSC) but risk & safety alerts are not included in the WBSC.

The following indicators (a&b) will be monitored monthly in the manager’s template and taken from the medical devices dashboard and the risk registers & safety alerts & will be discussed in the governance meetings with the strategic operational manager.

a) Number of medical devices and equipment reported incidents related to medical devices monthly.

b) Number of medical devices incidents reported to Medicines and Healthcare Products Regulatory Agency monthly.

c) Number of medical devices ordered through Procurement related to the number added to local and central registers will be included in the MD team weekly balance score card which is discussed at the local CEDAS (community equipment disability advisory service) managers meeting monthly. All information can also be found on the ELMS system.

d) Percentage of medical devices completing planned preventative maintenance during the month.

e) Percentage of medical devices that have evidence of completed calibration checks within identified timescales monthly.

23.1 Related Documentation

Related Policies, Procedures - This document should be read in conjunction with:

Health and Safety Guideline Manual Risk Management Strategy 2015. Accident and Incident Reporting and Management Guideline (including SuI’s) Waste Management Guideline Standing Orders and Standing Financial Instructions Infection Prevention and Control Environmental Clean & Decontamination

Guideline Infection Prevention and Control Hand Hygiene / PPE / SP Guideline

V3 March 2015 Page 23 of 42

24.1 References

This Guideline is based on the guidance produced by:

Care Quality Commission: Essential Standards of Quality & Safety Care Quality Commission Outcome 11, Regulation 15 &16 – Safety, suitability and availability of equipment.

Medical Devices Agency 2014

Health & Safety Executive (HSE). (1999). Management of Health and Safety at Work Regulations SI 1999/3242. London: The Stationery Office. Available at www.hse.gove.uk

Devices in Practice: A guide for Health and Social Care Professionals 2001. Updated 2008.

DB 2003(5) Management of medical Devices prior to repair, service or investigation.

DB 2006(01) Reporting Adverse Incidents and Disseminating Medical Device Alerts. 2006.

Leaving hospital with a medical device www.mhra.gov.uk

Striation, disinfection and cleaning of medical equipment: Guidance on Decontamination from Microbiological Advisory Committee to Department of Health (MAC manual)

Medicines Healthcare Regulatory Agency (MHRA) (2014). Managing Medical Devices. MHRA. Available at: www.mhra.go.uk

Medical Devices Agency. (2000). Equipped to Care: The Safe Use of Medical Devices in the 21st century. MDA. Available at: www.mhra.gov.uk

Medical Devices Agency. (2000). Medical Devices and Equipment Management: Repair and Maintenance Provision. MDA. Available at: www.mhra.go.uk

Medical Devices Agency. (2001). Equipped to Care – The Safe Use of Medical Devices in the 21st Century. MDA. Available at: www.mhra.gov.uk

Medicines Healthcare Regulatory Agency (MHRA). (2005). Reporting Adverse Incidents and Disseminating Medical Device Alerts. MHRA. Available at: www.mhra.gov.uk

NHS Litigation Authority Risk Management Standards for Acute Trusts Primary Care Trusts and Independent Sectors of NHS Care 2010/11. Available at: www.nhsla.com

V3 March 2015 Page 24 of 42

National Audit Office. (1999). the Management of Medical Equipment in NHS Acute Trusts in England. London: The Stationery Office. www.nao.org.uk

NHS Estates. (2004). A Risk Based Methodology for Establishing and Managing Backlog. London: Department of Health. Available at: www.dh.gov.uk

The Good Governance Standard for Public Services. (2004). the Independent Commission for Good Governance in Public Services. London. Joseph Row tree.

The Health and Safety at Work etc. Act. 1974. London: The Stationery Office. Available at: www.opsi.go.uk

DB9801 Supplement “Checking & Testing of newly delivered Medical Devices”

DB2006 (04) Single-use Medical Devices Leaflet, One Liners Oct.2002

Lifting Operations and Lifting Equipment Regulations (LOLER)

V3 March 2015 Page 25 of 42

RISK CATEGORIES OF MEDICAL DEVICES APPENDIX AThis is not exhaustive but provides the risk categories of medical devices traceable on ELMS.

MEDICAL DEVICES RISK CATORGORIES

Anaesthetic Gas Scavenging System Digital Thermometer Carbon Monoxide Monitor

Autoclave Steriliser Enteral Feeding Pump Fibre optic Otoscope

Automated External Defibrillator(AED)

Nail Drill Otoscope/Auroscope

Insulin Pumps Tympanic Thermometer Hand Held Spirometer

Blood Glucose Meter Portable Ultrasound machine Weighing scales

Ear Syringe Machine Urinalysis Machine Stethoscope

Orthopantomogram scissors Tens Machine

Diathermy equipment Pre – filled syringes Audiometer

Haemoglobin Meter Colposcope Treatment Couches

INR Machine Tourniquet Enuresis alarm

Fridge Data Loggers Air Compressor Tape measure

Neonatal Respiratory Monitor Anaphylaxis kit Vitalograph

Vaccine Fridges Bladder Scanner Continuous passive motion

Podiatry drill Blood Pressure Monitor (Aneroid) Height measurement tool

Podiatry spray drill Blood Pressure Monitor (Electronic) Portable fridge

Volumetric Infusion Pump Blood Pressure Monitor 24hr Eye test cards

Suction Machine Imaging Equipment Training Dolls

Portable Suction Machine Nebuliser Magnifier Glass

Syringe Driver ECG Neck Brace

Vital Signs Monitor Laerdal Airway Battery charger unit

Mattresses Pulse Oximeter Pen Torch

Pressure cushions

Bed – standard hospital bed

Profiling bed

Mini Vascular doppler

Hoists

Stand aids

Bed rails

V3 March 2015 Page 26 of 42

NB: Please add above any medical devices you use but are not on the list & inform the Medical Devices team so it can be added to the archive list.

Mark against all medical devices you use or could potentially use in your area of work. These will then be you’re medical devices that you need to self-assess your competence against.

If training is required for any of your devices please contact LDB who will work in collaboration with the Medical Devices Practitioner/training & Competency Lead to facilitate you’re training.

V3 Page 26 of 42

Appendix B

Description of equipment e.g. Infusion Pump Code number:

Has the above medical device been decontaminated? (follow manufacturer’s instructions and/or Environmental & Decontamination Guideline

YES / NO

Are you aware of any fault?

YES / NO

Name (please sign and print):

Clinic / Practice / Dept. Date:

Please refer to the Environmental Disinfection and Decontamination Policy for more information

Descr

iption of Fault

Call reference if known

CONFIRMATION OF DECONTAMINATION

To be completed and attached to medical equipment awaiting transportation for

inspection, servicing or repair.

V3 Page 27 of 42

Appendix C

LCH Internal Serious Incident Procedure as of Jan 1st

2015 Day 2DoN / MD to

Incident Occurs

Incident reviewed by Governance Team via daily Datix review. Any possible SIs referred to

DoN and / or MD

No

Day 1 DoN and / or MD to review

Day 1SI / NE?

Day 1Yes

Day 1Governance Team to inform all Execs via email of SI and

CEO verbally

Day 1Governance

Team to enter incident on

StEIS

nominate SI Chair

Day 2 / 3 Governance Team to arrange SI Strategy

meeting

Day 35DoN and Clinical

Risk Co-ordinator to meet to ensure RCA

Report meets required standards

Day 32Chair and Head of Service to

“sign off” RCA report and consider Safeguarding referral.Send approved report to DoN

and Governance Team

Day 30SI Strategy

Meeting Reconvene

Day 14 SI Strategy Meeting to Reconvene

Day 5 / 6Duty of Candour

Head of Service to write topatient / carer offering apology

and inform staff member / Team involved

Day 5SI Strategy

Meeting to take place

Report meets required

standard?

NoYes

Day 40 Governance

Team to submit to CCG

To quality assure report i.e. findings,

root causes, recommendations,

action plan

Day 35 Provide

feedback to IO and Head of

Service / Team

Yes

Day 45 Panel Chair to meet with patient / family to review report and

offer explanation

Investigating Officer to update SI Strategy Meeting on progress

Day 37Changes made.

Report meets required standard?

Duty of Candour LCH requirements Ensure we act in an open and transparent in relation to

care and treatment provided to people who use our services

Inform the relevant person / people and staff member / team in person as soon as reasonably practicable after becoming aware that a safety incident has occurred (moderate + harm), and provide support to them in relation to the incident

Provide an account of the incident which, to the best of the health service body’s knowledge, is true of all the facts the body knows about the incident as at the date of the notification

Offer an apology. Follow this up by giving the same information in writing,

and providing an update on the enquiries. Keep a written record of all communication with the

relevant person. ENSURE DATIX BEING OPEN IS BEING UTILISED

Strategy Meeting to Determine ToR Reiterate Timelines /

Deadlines. Issue Investigating

resource pack Arrange Day 14

meeting Consider Duty of

Candour and formulate response to patient / carer

Consider Safeguarding referral

Day 2 Manager of

Service / Team informed and

internal RCA to be completed

Appendix D

Medical Device Risk Classification

Risk Level Definition Training and Competency Requirements

High

H

Devices that have the potential to cause serious adverse consequences or death should they be misused or fail.

STOP:Do not use the device

unsupervised unless you are competent to do so.

Formal training and certification of competency is required. May involve attendance at a formal training session or training may be given within the department by appropriate cascade trainer.When achieved, competency is certified on the device competency self-assessment statement sheet by the manager or other authorised supervisor.

Medium/Moderate

M

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

PREPATE TO PROCEED:After taking advice and

guidance from a safe user.

Formal training and certification of competency is required. May involve attendance at a formal training session or training may be given within the department by appropriate cascade trainerWhen achieved, competency is certified on the device competency self-assessment statement sheet by the manager or other authorised supervisor.

Low

L

Devices that would be unlikely to cause any serious consequences should they be misused or fail.

GO:Continue in a safe &

sensible manner.

No formal training is required, unless an issue is raised by self or manager.

Peer demonstration is an appropriate training method.

Review annually as part of PDR process.

V3 March 2015 Page 28 of 42

Appendix E Medical DevicesUnits 4-6 Graylaw Trading Estate

Wareing RoadAintree L9 7AU

Phone: 0151 296 7773/7776E-mail: medicaldevices@liverpoolch.nhs.uk

MEDICAL DEVICES EQUIPMENT JOB REQUEST

PLEASE LEAVE MEDICAL DEVICE IN RECEPTION AREA READY FOR COLLECTION AND ENSURE YOU HAVE COMPLETED AND ATTACHED A DECONTAMINATION SHEET TO THE

OUTSIDE OF EACH PIECE OF EQUIPMENT OTHERWISE THE COLLECTION MAY BE REFUSED

SITE: Date

Phone Number

Type of Equipment: Serial No: (Usually found on the back/base of equipment)

Service or Repair:

If device is faulty please explain:

Contact on site (two names required) who are fully informed of job request:

Rating Number (Please tick relevant option)1 Urgent: Action within 2 working days2 Non urgent: Action within 7 working days

-------------------------------------------------------------------------------------------------------

FOR INTERNAL USE ONLY

Equipment Returned to RequesterPage 29 of 42March 2015

Job Number:

Request Received:V3 Passed to Driver:

V3 March 2015 Page 30 of 42

Appendix F LIVERPOOL COMMUNITY EQUIPMENT SERVICESMedical Devices Team

Units 4-7 Graylaw Trading Estate

Wareing RoadL9 7AU

Tel: 0151-296 7776/7773Dear

Conditions of loan for the Provision of your Medical Device Serial No:

Client Information (in the following ‘equipment’ means any items provided to you by Liverpool Community Equipment Service, (Medical Devices Team).

1. You have been provided with equipment following an assessment of your service by an NHS Medical Device Team Member. The equipment delivered is and remains the property of Liverpool Community Equipment Service, Medical Devices Team and is on loan to you.

2. The equipment should only be used as instructed by the manufacturer instructions and must not be altered in any way.

3. The equipment is solely for the use of the above named service and must not be transferred to any other service.

4. If you no longer need the equipment you must not dispose of it yourself but should contact LCES, Medical Devices Team for it to be collected – 0151 296 7773/7776.

5. Do not remove any identification labels from the equipment.

6. As a condition of loan you must allow LCES, Medical Devices Team or its nominated contractors/agents to access the equipment for regular inspection and repairs.

It is essential that our engineers gain access to service and maintain this equipment.

By signing for our equipment, you have agreed to the Terms and Conditions which state in paragraph 6 of your receipt that “As a condition of loan you must allow LCES, Medical Devices Team or its nominated contractors/agents to access the equipment for regular inspection and repairs” when contacted.

If you have any queries please do not hesitate to contact the Team on 0151 296 7773/7776 or Medicines Distribution on 0151 295 3981.

Thank you for your co-operation.

Yours Sincerely

Nicky OreStrategic Services Manager

Signature of Recipient …………………………………………………………………

Date of Receipt …………………………………………………………………………

V3 March 2015 Page 31 of 42

Appendix G

Asset/ Device: Make:Model:Serial Number:

Delivery Date:

Inspection undertaken by: (Receiving staff member) In Capitals pleaseSignature: Designation: Team: Location:

Delivery inspection Yes or N/ADelivery note checked against device?Outer packaging undamaged?Goods checks with delivery note?Goods clean, inner packaging intact?

Product InspectionProduct intact – No signs of damage?Instruction manual included?Maintenance manual supplied?Warranty document included?Mains leads supplied? (if applicable)Accessories supplied? (if applicable)Storage Instructions clear?Expiry date clear (if applicable) Provide date in column:

Receiving processDevice receipted within departments budget records?Device added to departments asset register?New device asset sticker attached?Staff training arranged? To Include: Storage, General Maintenance & Infection control measuresTechnical Support Information Provided?

Functional Check (As per instruction manual)Passes self-test routineMoving parts operate correctlySwitches activate correctlyPAT test complete (if applicable)

This form is to be used when a service receives a new medical device

MEDICAL DEVICES PRE-DELIVERY INSPECTION (PDI)

V3 March 2015 Page 32 of 42

Medical Devices - Frequently Asked Questions (FAQs) Appendix H

Question AnswerHow do I log a job with you? Go to medical devices intranet page

http://nww.liverpoolch.nhs.uk/service- directory/medical-devices-team.htm complete an equipment job request sheet and send to medicaldevices@liverpoolch.nhs.uk.

How do I decontaminate? Clean thoroughly with a sani-cloth/alcohol wipes. A decontamination certificate also needs to be filled out and can be found on our intranet page. This is to be attached to the piece of equipment ready for collection.

How long will it take before I get my Medical Device back?

We currently have no agreement for turnaround times and this will be agreed as part of the contract. However we will aim to get the equipment back to you as soon as it has been repaired / serviced. Approximately 3-4 working days.

I have a BGM from a staff member who has left do I need to return this to you?

Yes, any blood glucose monitors belonging to users that have left the trust, gone on maternity leave or on long term sick needs to be returned to our team based in Graylaw following their exit interview.However you should complete an equipment job request and return it to us and our driver will collect the equipment for repairs /service/maintenance.

Does the cost come out of our team’s budget?

No any costs come out of Medical Devices Teams budget – this is identified as procurement for your service unless the BGM is lost.

Who is responsible for ordering/paying for Medical Devices?

This is currently under review. ..there is on-going negation to identify how the trust will identify the budget requirement for medical device management.You can order any medical device through the Medical Devices Practitioner who will check it is standard & order from Procurement, this will come out of your own services budget. It will be delivered to Medical Devices and a Pre-Delivery Inspection will be completed and sent out with the device. Medical Devices will add this to the ELMs system and arrange a service and maintenance schedule.

Who is responsible for the service and maintenance of fridges?

If a vaccine fridge needs servicing or repairing then a job would need to be logged with Medical Devices using their process.

V3 March 2015 Page 33 of 42

Where can I purchase consumables and who pays for them?

You can purchase any consumables through Medical Devices and your own service would pay for them.

Blood glucose monitor consumables are ordered via Medicines Management.

What is an asset register? This is currently under review to be transferred to an electronic system which will then become the responsibility of the Medical Devices Team to advise you when items are due for service.

Where do we take equipment? Our driver will collect and redeliver any medical devices.

Is there a standard catalogue of items that can be ordered?

This is currently being developed by our team and LCH staff will be notified once this has been completed and can be viewed.

Is there a user manual of my equipment?

Our team is currently seeking user manuals for each piece of equipment and LCH staff will be notified once they can view them. . each medical device should have a user manual at the point of delivery or when re-cycled by the

How often does my equipment require servicing/PAT/ Loler/calibrating?

Beds require PAT/Loler testing every 6 months. Blood Glucose monitors are EQA tested bi monthly. Any other medical device is serviced annually or in accordance with manufacturers guidance & managed by the electronic system through the Medical Devices team.

V3 March 2015 Page 34 of 42

CQC Standards Appendix I

Outcome 11: Safety, availability and suitability of equipment16. Safety, availability and suitability of equipment (Outcome 11)Guidance Area

Ensure equipment is adequate Y / N

Prompt 11A People are safe because, where equipment is provided or used as part of the regulated activity, the equipment is:

All providers Guidance Detail Available in sufficient quantities to meet the needs of people who use the service.Guidance Detail Compliant with all relevant lawsGuidance Detail Installed, used and maintained correctly with reference to the specifications, manufacturer’s

instructions, legislation and appropriate guidance from expert bodies.Guidance Detail Properly maintained, tested, serviced and renewed under a recorded programme.Guidance Detail Safe to be usedGuidance Detail Stored safely and securely yo prevent theft, damage or misuse

Prompt 11B Peoples needs are met because staff using any equipment do so in a way that has regard to their dignity, comfort and safety and promotes their independence by:

All providers Guidance Detail Actively listening to their preferences and thought about the equipment they need and how it is used.

Guidance Detail Supporting the person to understand how an why the equipment is being used.

Guidance Detail Taking care in the way they use the equipment to make sure the person is comfortable and safe.

Guidance Detail Using the equipment in a way that ensures the persons privacy and dignity.

Guidance Area

Manage risk through effective procedures about equipment suitability Y / N

Prompt 11C People are safe because, where equipment is provided as part of the regulated activity, there are clear procedures followed in practice, monitored and reviewed. Wherever necessary these include:

All providers Guidance Detail Best interest meetings with people who know and understand the person using the services to ensure that treatment and care are taken that reflect the person’s best interest.

Guidance Detail Ensuring that all staff involved in using the equipment have the competency and skills needed, and where this is not possible, know what to do to ensure the people remain safe.

Guidance Detail How staff will know what to do when a person who uses services refuses to allow use of the equipment.

Guidance Detail How the equipment is maintained and used.Guidance Detail Identification, assessment and review of risk.Guidance Detail The arrangements for adverse events, incidents, errors and near miss reporting. These should

encourage local and, where applicable, national reporting, learning and promoting an open and fair culture of safety.

Guidance Detail The training of people who use services about any equipment they are given to use themselves.Guidance Detail What will happen in the event of electricity, water or gas supply failure, or other emergencies,

that affect equipment used to meet the needs of people who use services.Guidance Detail Where risks are identified, a plan for how these are to be managed.

Prompt 11D Where people who use services receive care, treatment or support that

All providers Guidance Detail Clear procedures that are followed in practice, monitored and reviewed for the use of medical devices. Whenever they are required these procedures include; implementing guidance issued by experts or professional bodies in relation to the medical devices used – acting on alerts

V3 March 2015 Page 35 of 42

involves the use of medical devices, the provider has:

an expert or professional body or a product manufacturer.

Prompt 11E People who use services, receive care, treatment and support from a service that:

All providers Guidance Detail Takes into account relevant guidance, including that from the Care Quality Commission’s Schedule of Applicable Publications

Guidance Area

Providing personalised care through the effective use of medical devices Y / N

Prompt 11F People who use services, receive care, treatment and support hat:

All providers Guidance Detail Ensures the medical devices used to meet their needs are; not reused if they are manufactured for single use only – only modified in line with manufacturer’s instructions or guidance – only purchased if the meet the necessary legal requirements – available when they are required for use – supplied with the necessary technical information so that the risk of using them incorrectly is minimised – permanently installed where appropriate, in accordance with manufacturers requirements and published guidance – only used by the person, or by staff, once they know how to use and operate them correctly – routinely maintained in line with the manufacturer’s instructions and by people who are competent to do so – repaired when they break down by people who are competent to do so – disposed of or recycled, safely and securely.

Guidance Area

Additional prompts for specific service types Y / N

Prompt 11G When equipment is used in a person’s own home:

DCC, DCS, DEN, RCA, RSM, SHL, SLS

Guidance Detail Staff address any concerns in a timely manner where they have identified problems around the safety of the equipment.

Prompt 11H People who use services receive care, treatment and support that:

ACS, AMB, CHC, CHN, DEN, DSS, DTS, HBC, HPS, LTC, MBS, MLS, PHS, RHS, RSM, SPC, UCS

Guidance Detail Ensures equipment required for resuscitation or other medical emergencies is available and accessible for use as quickly as possible. Where the service requires it, this equipment is tamper proof.

V3 March 2015 Page 36 of 42

Appendix J

MANAGEMENT OF MEDICAL DEVICES PROCESS FLOWCHART

Member of staff joins Trust / Given Induction checklist

M

edical Devices Team arrange pick up/collection of items via Medical Devices Driver and email individual who requested the job to advise job has been actioned.

Servicing is complete

Driver collects and returns to staff member/team

If staff member leaves

Medical Device is added back to stock and ready for re-issue?

HTTP://NWW.LIVERPOOLCH.NHS.UK/DOWNLOADS/SERVICES/CORPORATE/GOVERNANCE/RISK-MANAGEMENT/MEDICAL-DEVICES-GUIDELINE.PDF

IF SINGLE ITEM COSTS MORE THAN £500 THIS WILL NEED TO BE PRESENTEDVIA A BUSINESS CASE TO THE MEDICAL DEVICES SAFETY GROUP AS PER APPENDIX C WITHIN MEDICAL DEVICES

GUIDELINES E.G.

LINE MANAGER REQUESTS NEW REPLACEMENT OF ANY MEDICAL DEVICE IFBROKEN OR LOST VIA THE MEDICAL DEVICES TEAM WHO WILL LIAISE WITH PROCUREMENT REGARDING PURCHASING.

If

broken or lost DATIX COMPLETED

Item is broken or requires servicing Member of staff leaves the Trust, transfer team/service, commence

maternity leave or is on long term sick (as per Trust Sickness Policy)

1.0. If you are responsible for a Medical Devices you should complete decontamination form(2) for each item

2.0. Email to medicaldevices@liverpoolch. nhs.uk

If you are responsible for a Medical Devices you should complete decontamination form (2) and Equipment job request form (3)

Email to medi c ald e v ices @ l i v e r poolc h . n hs . uk

External Quality Assurance (EQA) is an essential component of POCT and includes all the measures taken to ensure that investigations are reliable. EQA measures the performance of the device and competency of the user.All POCT equipment must operate in compliance with the LCH External Quality Assurance process. Your BGM is a medical device. At point of issue of your designated BGM you have accepted that you are competent to utilise and understand your responsibility and accountability for this Medical Device.

Blood Glucose Monitor Return Process For

Repair OR EQA Point of Care Testing

FLOWCHART 1 – EQA POCT Appendix K

V3 March 2015 Page 37 of 42

EMAIL YOUR RESULTS TO EQA POCT & COPY IN THEMEDICAL DEVICES TEAM

pointofcaretesting@rlbuht.nhs.uk AND

medic a ld e v ic e s@ l i v erp o olch.nh s .uk PLEASE ENSURE YOUR EMAIL CONTAINS THE FOLLOWING

INFORMATION:NAME (i.e. John Smith)TEAM & LOCATION (i.e. ERT, Old Swan) METER NUMBER (i.e. 55325542121) GLUCOSE RESULT (i.e. 5.1 mmol/L) EQA DISTRIBUTION NUMBER (i.e. 0414)DATE TESTED (i.e. 05.05.15)

THEN USING THE SOLUTIONS YOU RECEIVE MARKED 1 &2, TEST AS INSTRUCTED TO OBTAIN YOUR TEST RESULTS

YOU WILL RECEIVE A TEST KIT IN THE POST BI-MONTHLY WITHINSTRUCTIONS TO:-

PLACE A TEST STRIP INTO YOUR MACHINEDOES

YOUR BGM REQUIRE EQA POINT OF CARE TESTING

IF BGM IS BROKEN OR IRREPAIRABLE PLEASE EMAIL MEDICAL DEVICE

TEAMmedic a ld e v ic e s@ l i v erp o olch.nh s .uk

IF YOUR BGM REQUIRES REPAIR PLEASE FOLLOW FLOWCHART 2

ALL EQA POCT AND REPAIRS ARE MONITORED AS PART OF THE CONTRACT

V3 March 2015 Page 38 of 42

Blood Glucose Monitor Return Process For

FLOWCHART 2 - REPAIRS

Appendix L

Repair OR EQA Point of Care Testing

E

xternal Quality Assurance (EQA) is an essential component of POCT and includes all the

measures taken to ensure that investigations are reliable. EQA measures the performance of the device and competency of the user.All POCT equipment must operate in compliance with the LCH External Quality Assurance process. Your BGM is a medical device. At point of issue of your designated BGM you have accepted that you are

DOES YOUR BGM REQUIRE REPAIR

EMAIL EQUIPMENT JOB REQUEST TO:medic a ld e v ic e s@ l i v erp o olch.nh s .uk

AND DETAIL ISSUE WITH BGM

C

OMPLETE AND ATTACH DECONTAMINATION SHEET VISIBLY TO

OUTSIDE OF BGMTHIS CAN BE FOUND ON THE INTRANET:

http://nww.liverpoolch.nhs.uk/service-directory/medical-devices- team.htm

MEDICAL DEVICES DRIVER WILL COLLECT THE BGM WITHIN 48

HOURS AND DELIVER TO POCT FOR REPAIR

POCT WILL CONTACT MEDICAL DEVICES TEAM TO ADVISE BGM IS

READY FOR COLLECTION (THIS WILL INCLUDE FULL DETAILS OF THE REPAIRS PROVIDED) OR IF THIS NEEDS TO BE REPLACED

M

EDICAL DEVICES DRIVER WILL COLLECT AND RETURN

REPAIRED OR REPLACEMENT BGM TO REFERRERA CONDITONS OF LOAN FORM WILL NEED TO BE S IG N ED BY THE

PRACTITIONERTHIS PROCESS FROM REFERRAL TO RETURN WILL TAKE

APPROXIMATELY 7 WORKING DAYS

ALL EQA POCT AND REPAIRS IS MONITORED AS PART OF THE CONTRACT

V3 March 2015 Page 39 of 42

Appendix M

Process for the Management of Syringe Drivers

Syringe Driver requires repair or maintenance.

Complete job request form and email to m e d i cald e v ices @ l i v erpoolch.nh s . u k

Decontaminate the syringe driver.

Complete decontamination form and attach it to the syringe driver

Medical Devices Driver will collect the syringe driver

S

yringe driver will be returned once work complete

V3 March 2015 Page 40 of 42

PLEASE DO NOT SEND SYRINGE DRIVERS BY POST

ALL SYRINGE DRIVERS MUST BE COLLECTED AND R E TURN ED BY THE MEDICAL DEVICES DRIVER

V3 March 2015 Page 41 of 42

Appendix N

Process for the Management of Scales

Scales re

quires calibration, repair or maintenance.

Complete equipment job request and email to m e d ical d e v ices @ l i v e rpoolch . nhs . uk

Decontaminate the scales - Complete decontamination form and attach it to the scales

Medical Devices Clerk will forward equipment job request to Accurate Weight

Accurate Weight will contact you to arrange a convenient date and time

PLEASE ENSURE SCALES ARE AVAILABLE ON SITE ON THE ARRANGED DATE

IF SCALES ARE NOT AVAILABLE ON PRE-ARRANGED DATE, PLEASE CONTACT MEDICAL DEVICES TEAM ON 0151 296 7773

V3 March 2015 Page 42 of 42

Process for the Management of Pharmacy/Vaccines Fridges

Vaccine Fridge fault noted on site

Foll

ow Cold Chain policy and contact

Medicines Management for Advice on Safety of Vaccines/Medicines

Co

ntact Medical Devices 0151 296 7773/7776

for report and service.

Com

plete Job Request form and email to

medicaldevices@liverpoolch.nhs.uk

Medical Devices arrange for fridge to be

serviced / repaired.

V3 March 2015 Page 43 of 42

Guidelines circulated and approved by the Medical Device Safety Group:

Signed:_ Date:

Guidelines circulated and approved by the Clinical Effectiveness Group:

Signed:_ Date:

Guidelines circulated and final approved by the Patient Safety Group:

Signed:_ Date:_