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Medical Devices Policy - solent.nhs.uk

Management of Medical Devices And Equipment Page 1 Version 2 Management of Medical Devices (Equipment) Please be aware that this printed version of the Poli cy may NOT be the latest version. Staff are reminded that they should always refe r to the Intra net fo r the la test version. Purpose of Agreement To ensure the safe use and management of Medical Devices (equipment) throughout the whole life cy cl e. Ensure the Trust complies with relevant st andards and oblig ations (NHSLA, CQC and CNST) and/or any subsequent required standards, clin ical governance requirements and/or additional obligations introduced by Policy organisations and/or Regulatory bodies. Document Type X Policy SOP Guideline Reference Number Solent NHST/ Policy /RK/07 Versi on 1 Name of Approving Committees/Groups Integrated Governance And Performance Committee Operational Date March 2014 Document Review Date December 2014 Document Sponsor (Name & Job Title) Judy Hillier, Director of Nursing and Quality Document Manager (Name & Job Title) Mike Townson - Head of Clinical Business Unit - Podiatry and Equipment Services Document developed in consultation with Health & Safety, Quality Improvement Group, Medical Devices Gro

1 Introduction and Purpose 3 2 Scope and Definitions 4 3 Roles and Responsibilities 5 4 Procurement and Selection 6 5 Developments, Trials and Demonstrations 8

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Transcription of Medical Devices Policy - solent.nhs.uk

1 Management of Medical Devices And Equipment Page 1 Version 2 Management of Medical Devices (Equipment) Please be aware that this printed version of the Poli cy may NOT be the latest version. Staff are reminded that they should always refe r to the Intra net fo r the la test version. Purpose of Agreement To ensure the safe use and management of Medical Devices (equipment) throughout the whole life cy cl e. Ensure the Trust complies with relevant st andards and oblig ations (NHSLA, CQC and CNST) and/or any subsequent required standards, clin ical governance requirements and/or additional obligations introduced by Policy organisations and/or Regulatory bodies. Document Type X Policy SOP Guideline Reference Number Solent NHST/ Policy /RK/07 Versi on 1 Name of Approving Committees/Groups Integrated Governance And Performance Committee Operational Date March 2014 Document Review Date December 2014 Document Sponsor (Name & Job Title) Judy Hillier, Director of Nursing and Quality Document Manager (Name & Job Title) Mike Townson - Head of Clinical Business Unit - Podiatry and Equipment Services Document developed in consultation with Health & Safety, Quality Improvement Group, Medical Devices Group NHSLA & Operational Policy Steering Group Intranet Location Policies; Operational Polici es Website Location N/A Keywords (for website/intranet uploading) Devices .

2 Equipment Management of Medical Devices And Equipment Page 2 Version 2 MANAGEMENT OF Medical Devices (EQUIPMENT) Polic y and Supporting Guidelines CONTENTS Page No 1 Introduction and Purpose 3 2 Scope and Definitions 4 3 Roles and Responsibilities 5 4 Procurement and Selection 6 5 Developments, Trials and Demonstrations 8 6 Risk Management 9 7 Maintenance & Servicing 9 8 Decontamination of Medical Devices (equipment) 10 9 Medical Devices (equipment) Inventory 12 10 Adverse Incidents 12 11 Training 12 12 Storing Medical Devices (equipment) 14 13 Single Use Items 14 14 Prescribing Decisions 14 15 Custom made Devices 14 16 Medical Devices (equipment) Replacement 16 17 Equipment on Loan 17 18 Policy monitoring /improvement Indicators 17 19 Benchmarking 17 20 Policy Monitoring 17 21 Review by the Board 19 22 Related Policy and procedure references 20 Appendices 1 Medical Devices Life Cycle 21 2 Guidance on the Acquisition of Medical Devices (equipment) 22 3 Medical Devices Controller (Equipment Controller) Specifica tion Job 31 4 Sources of Advice for Acquisitions 32 5 Transfer of Medical Devices (equipment) 33 6 Acceptance Testing 34 7 Medical Devices (equipment) Inventory 36 8 Staff Training 37 9 Written Guidance on Use of Medical Devices (equipment)

3 40 10 Glossary of Abbreviations 42 11 Single use labels 43 12 Reporting adverse incidents 44 13 Example of clinical staff cleaning frequency 46 14 MHRA declaration of contamination status 47 15 Training and competencies 48 16 Authorised Users & Training Needs Analysis 49 17 Medical Devices Group Terms of Reference 53 Management of Medical Devices And Equipment Page 3 Version 2 1. INTRODUCTION & PURPOSE This document outlines procedures and guidelines for the systematic management of Medical Devices and equipment throughout the whole lif e time cy cl e Appendix 1. It also ensures sa fe and effective use of Medical Devices (equipment) by all staff and that Solent NHS Trust The Trust meets all st atutory requirements for user and patient safety. The Policy is also designed to ensure that the Trust complies with the requirements of the Care Quality Commission (CQC) Essential Standards of Qualit y and Safety, the Clinical Neglig ence Scheme for Trust s (CNST), NHSLA Risk Management Standards, Procedural documentation from the Medici nes and Healthcare Products Regulatory Agency (MHRA) and/or any subsequent required st andards associated with cl inical governance requirements that identify any patient sa fety issues or organisational Health and Safety risks.

4 The Trust will put in place sy st ems that manage risk issues at an acceptable level or where possible removes them totally . The Trust places high importance on a sy st ematic approach to Medical Devices (equipment) and coordinates this through a central service function which controls: Acquisi tion of new Devices An approved device/equipment lib rary for standardisation of Devices management Use of Devices on loan no matte r the source Competency monitoring in sa fe use of Devices Devices transferred to the organisa tion ( on est ablishment of a new organisa tion) Maintenance and Decontamination of Devices Disposal of Devices . It is important in terms of management of Medical Devices (equipment) to be able to identify and specify how each device has been acquired loan; operating lease, hire, donated, consumable deals, free gift or rental Devices , lease purchase, purchased through public donations, funded by the Trust from capital or revenue budgets and those transferred to the organisation; as there will be different accountabilities relating to maintenance, record keeping and appropriate training.

5 The Medical Devices Group (MDG) will agree the Trusts Standardised List of Medica l Devices (equipment). Once placed upon this lis t all purchase requisi tions relating to items of Medical Devices (equipment) will be raised by the relevant local manager and authorised by the appropriate se rvice manager responsible for the funding where this is different and processed through a ce ntral control function. The authority of the MDG will be necessary in advance for the purchase of any Medical device not on the Trusts standardised list ; this will be known as a special purchase. Services will be approved for specific custom made appliances that can be provided without need for advance approval. This Policy has therefore been developed to provide local guidance in order to aid compliance to the framework offered by the MHRA.

6 W hils t this is a st and alone document, it is recommended that it be used in conjunction with MHRA publications and NHS guidance and relevant local Trust policies. This Policy is therefore aimed at: Those who are planning purchase/procurement Medical Devices (equipment) Management of Medical Devices And Equipment Page 4 Version 2 Those who manage and/or use Medical Devices (equipment) Those who manage distribution, collection, cl eaning, disposal/sc rapping, recy cling, repair of Medical Devices (equipment) whether used in an area or loaned to patients/ clients/ carers Those advisi ng/educating patients/clients/ca rers other staff in the safe use of Medical Devices (equipment) Those usi ng Medical Devices (equipment) in demonstration areas Those involved in research, development and trials.

7 The components involved in sa fe use of Medical Devices include design and manufacturing (technology), management sy st ems (proce ss ) and use of the Medical device (people). To maximise effectiveness and minimise risk, management of Medical Devices involves the whole Medical device lifecy cl e as Appendix A. This Policy therefore covers: Preparation for purchase including identification of need Purchasing/acquisition/storage Commissioning for use - Acceptance testing Management Instructions for use/ Training & authorised users Prescription/Selection Deployment Re-processing/replace ment/sterilization/disposal Maintenance and repair Records Adverse event reporting Communicating and acting upon Safety Advice and Alerts 2. SCOPE & DEFINITIONS Scope The scope of this Policy covers the whole time life cy cl e of a device or equipment.

8 The Policy does not extend to include high volume consumable products that have a low risk for the sa fety of the user or the client. Certain elements of this Policy do not apply to si ngle use Devices and equipment maintenance and management. This Policy should be read in conjunction with Device s in Practice a guide for health and social care professi onals : MHRA 2001; ISBN 1 84182 359 7. Solent NHS Trust is committed to the principles of Equality and Diversi ty and will strive to eliminate unlawful discrimination in all its forms. W e will st rive towards demonstrating Management of Medical Devices And Equipment Page 5 Version 2 fairness and Equal Opportunities for users of services, carers, the wider co mmunity and our st aff. The Policy should apply to independent contractors working on behalf of The Trust but it should be noted the Trust is not, at present, in a position to enforce the Policy on these individuals.

9 However, the Policy will be promulgated and commended as good practice to independent contractors including GPs working for the Trust s Out of Hours service. The Policy will also be promoted and commended as good practice to partner agencies such as social services and voluntary organisations ( Social Care and Red Cross) and formal external contract ors of the Trust. DEFINITIONS Equipment includes Medical Devices . A Medical device is identified using the 2002 Medica l Device Regulation definition and covers any device, instrument, apparatus, implement, material, substance or other articl e (used si ngularly or in co mbination) together with any accessory thereto which is intended by the manufacturer for: Diagnosi s, prevention, monitoring, treatment or alle viation of disease; including computer software designed for this purpose Diagnosi s, monitoring, treatment or alle viation of, or co mpensation for, an injury or handicap Investigation, replacement or modification of the anatomy or of a physi ological process Control of conception.

10 As this is a very broad definition it must be noted that consumables and si ngle use items may present minimal risk and will be listed on the central as purchase type only. However re-usable Medical Devices (equipment) are likely to be higher risk, infusion pumps, defibrillators and therefore warrant greater management control. 3. Roles and Responsibilities Medical Devices (equipment) represent a substantial asset of many NHS organisations. Clear underst anding of the lines of responsi bilit y and accountability is therefore essential if the Devices are to be managed in a strategic and effici ent manner. This section sets out these lines of responsibilit y and accountabilit y. Trust Board/Chief Executive The overall accountability for the safe and effective management of Medical Devices (equipment) resides with the Chief Executive as Accountable Office r to the Trust Board.


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