medical devices policy - solent.nhs.uk · management of medical devices and equipment page 1...

Management of Medical Devices And Equipment Version 2

Management of Medical Devices (Equipment)

Please be aware that this printed version of the Policy may NOT be the latest version. Staff are reminded that they should always refer to the Intranet for the latest version.

Purpose of Agreement

To ensure the safe use and management of medical devices (equipment) throughout the whole life cycle. Ensure the Trust complies with relevant standards and obligations (NHSLA, CQC and CNST) and/or any subsequent required standards, clinical 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

Version 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 Policies

Website Location N/A Keywords (for website/intranet uploading)

Devices; equipment


MANAGEMENT OF MEDICAL DEVICES (EQUIPMENT) Policy 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)–

Specification 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) 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


1. INTRODUCTION & PURPOSE 1.1 This document outlines procedures and guidelines for the systematic management of

medical devices and equipment throughout the whole life time cycle Appendix 1. It also ensures safe and effective use of medical devices (equipment) by all staff and that Solent NHS Trust ‘The Trust’ meets all statutory 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 Quality and Safety, the Clinical Negligence Scheme for Trusts (CNST), NHSLA Risk Management Standards, Procedural documentation from the Medicines and Healthcare Products Regulatory Agency (MHRA) and/or any subsequent required standards associated with clinical governance requirements that identify any patient safety issues or organisational Health and Safety risks. The Trust will put in place systems that manage risk issues at an acceptable level or where possible removes them totally.

1.2 The Trust places high importance on a systematic approach to medical devices

(equipment) and coordinates this through a central service function which controls:

Acquisition of new devices

An approved device/equipment library for standardisation of devices management

Use of devices on loan – no matter the source

Competency monitoring in safe use of devices

Devices transferred to the organisation (e.g. on establishment of a new organisation)

Maintenance and Decontamination of devices

Disposal of devices. 1.3 It is important in terms of management of medical devices (equipment) to be able to identify

and specify how each device has been acquired i.e 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.

1.4 The Medical Devices Group (MDG) will agree the Trusts Standardised List of Medical

Devices (equipment). Once placed upon this list all purchase requisitions relating to items of medical devices (equipment) will be raised by the relevant local manager and authorised by the appropriate service manager responsible for the funding where this is different and processed through a central 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.

1.5 This policy has therefore been developed to provide local guidance in order to aid

compliance to the framework offered by the MHRA. Whilst this is a “stand alone” document, it is recommended that it be used in conjunction with MHRA publications and NHS guidance and relevant local Trust policies.

1.6 This policy is therefore aimed at:

Those who are planning purchase/procurement medical devices (equipment)


Those who manage and/or use medical devices (equipment)

Those who manage distribution, collection, cleaning, disposal/scrapping, recycling, repair of medical devices (equipment) whether used in an area or loaned to patients/clients/carers

Those advising/educating patients/clients/carers other staff in the safe use of medical devices (equipment)

Those using medical devices (equipment) in demonstration areas

Those involved in research, development and trials.

1.7 The components involved in safe use of medical devices include design and manufacturing

(technology), management systems (process) and use of the medical device (people). To maximise effectiveness and minimise risk, management of medical devices involves the whole medical device lifecycle 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/replacement/sterilization/disposal

Maintenance and repair

Records

Adverse event reporting

Communicating and acting upon Safety Advice and Alerts 2. SCOPE & DEFINITIONS

2.1 Scope

2.1.1 The scope of this policy covers the whole time life cycle of a device or equipment. The

policy does not extend to include high volume consumable products that have a low risk for the safety of the user or the client. Certain elements of this Policy do not apply to single use devices and equipment i.e maintenance and management. This Policy should be read in conjunction with ‘Devices in Practice – a guide for health and social care professionals’: MHRA 2001; ISBN 1 84182 359 7.

2.1.2 “Solent NHS Trust is committed to the principles of Equality and Diversity and will strive to

eliminate unlawful discrimination in all its forms. We will strive towards demonstrating


fairness and Equal Opportunities for users of services, carers, the wider community and our staff.

2.1.3 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. 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.

2.1.3 The policy will also be promoted and commended as good practice to partner agencies

such as social services and voluntary organisations (e.g. Social Care and Red Cross) and formal external contractors of the Trust.

2.2 DEFINITIONS

2.2.1 Equipment includes medical devices. A medical device is identified using the 2002 Medical

Device Regulation definition and covers 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:

Diagnosis, prevention, monitoring, treatment or alleviation of disease; including computer software designed for this purpose

Diagnosis, monitoring, treatment or alleviation of, or compensation for, an injury or handicap

Investigation, replacement or modification of the anatomy or of a physiological process

Control of conception.

2.2.2 As this is a very broad definition it must be noted that consumables and single 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, e.g. infusion pumps, defibrillators and therefore warrant greater management control.

3. Roles and Responsibilities

3.1 Medical devices (equipment) represent a substantial asset of many NHS organisations. Clear

understanding of the lines of responsibility and accountability is therefore essential if the devices are to be managed in a strategic and efficient manner. This section sets out these lines of responsibility and accountability.

3.2 Trust Board/Chief Executive

3.2.1 The overall accountability for the safe and effective management of medical devices

(equipment) resides with the Chief Executive as Accountable Officer to the Trust Board. 3.3 Delegated responsibility

3.3.1 A designated accountable director has the overall responsibility of Medical Devices in order

to exercise financial and risk control more strategically and will coordinate a biannual Strategic Medical Devices Meeting to include the Finance Director. This meeting will act as an oversight committee to review performance against national standards and set financial priorities for a medical device (equipment) planned replacement programme including review of procurement.


3.4 Medical Devices Group (MDG) 3.4.1 The Medical Devices Group will support the identified Director in 5.2 above. Terms of

Reference are attached at Appendix 1 and be chaired by the Head of the Podiatry and Equipment Clinical Business Unit.

3.4.2 This established Medical Devices Group has a membership which includes representatives

from Clinical Business Units in all areas of the TRUST operating medical devices (equipment), including Infection Control.

3.4.3 One of the main objectives of the Medical Devices Group is to approve and standardise the

use of medical devices (equipment) used within the Trust and to ensure the Health and Safety Committee are aware of compliance with National Standards

3.5 Specialist Equipment Panels

3.5.1 Equipment panels using specialist advisors within the Trust will meet remotely or formally to

determine appropriate single purchase requests. 3.6 Owner of a Device

3.6.1 The ‘owner’ of a device will normally be the Head of Service/ Ward or Department.

Responsibilities of the “owner” of a device are set out in Appendix 2, “Guidance on the acquisition of medical devices”.

3.7 Medical Devices Controllers (Equipment Controllers)

3.7.1 Medical Devices Controllers (equipment controllers) will be appointed by the service

manager and report to MDG. It is recommended that an annual update training programme will be available for Equipment Controllers.

1.2.1 They will be known to all users of medical devices (equipment) within their department(s);

and to other appropriate people. A register of equipment controllers will be kept and maintained by the centralised medical devices services function.

3.7.3 The main duties of a medical devices controller (equipment controller) are to ensure:

Devices are used with confidence in order to provide a safe, effective, efficient and cost effective service to patients

The identification of permanent staff authorised to use equipment

Information, instruction/supervision, training and guidance is provided to staff to ensure that those involved with each stage of the management of the device understands and is enabled to fulfil their duties and responsibilities, and that staff training needs are met

The concept of 'ownership' of medical devices (equipment) both by clinical and non- clinical departments within the Trust is established thereby clarifying responsibility

The standardised list of diagnostic and therapeutic equipment used within the organisation is maintained.

3.7.4 Each service is responsible for ensuring that any new device/equipment is registered on the

centralised inventory through formal notification with the Medical Devices Group. 4. PROCUREMENT & SELECTION


4.1 It is essential that devices and equipment of good quality with adequate performance and conforming to relevant specifications / standards are procured. Arrangements must be made during procurement to provide and use expert advice in all cases. This relates to acquisitions of all descriptions – new purchases, loans, transfers of medical devices (equipment) funded from donated monies etc. All staff must follow procurement guidance in line with Standing Financial Instructions.

1.2 The procurement process and standardisation of medical devices (equipment) purchase

across the Trust will result in:

Reduced risk – evaluated and clinically approved medical devices (equipment), combined with an increased familiarity of use by staff will improve both patient/client and staff safety

Reduce adverse incidents relating to medical devices (equipment)

Training in the use of medical devices (equipment) becoming more manageable

Compliance with relevant aspects NHS initiatives, Essential Standards (Care Quality Commission), Controls Assurance for Medical Devices Management, MHRA guidance, Clinical Governance, NHSLA Risk Management Standards for NHS Trusts providing Acute, Community, or Mental Health & Learning Disability Services and the Clinical Negligence Scheme for Trusts

Financial benefits through volume purchases of medical devices (equipment) and rationalisation of consumables stocked

An increased flexibility in the location at which medical devices (equipment) can be used

Optimum maintenance of medical devices (equipment), including staff training in routine maintenance, provision of test medical devices (equipment) and spare parts

Optimisation of medical device asset management

Improved business planning

Assessment and recognition of health and safety and manual handling issues.

4.3 Identification of availability of expert advice

4.3.1 The ultimate responsibility for the selection and acquisition, loan or “transfer in” of a piece

of medical device (equipment) lies with the Service Manager advised by the standardised list.

4.3.2 Acquisitions will be made in line with the guidance set out in the appendix Manufacturer’s

instructions must be followed in all cases. 4.4 The Trust’s procurement procedure will ensure that:

Medical devices (equipment) used on the Trust’s behalf complies with the recommended standards particularly those relating to safety

Procurement is coordinated and controlled through a single service function

Users are aware of the lifetime technical and revenue implications of the medical devices (equipment) used in their service area


A standardisation of common types of medical devices (equipment) is achieved in order to lessen possible confusion of operation and to facilitate ease of training, maintenance and medical devices (equipment) availability

To keep maintenance and revenue cost to a minimum

To prevent purchase of medical devices (equipment) outside of the approved route. Any services working outside approved systems will be identified through non purchase order and finance managers and reported where inappropriate.

4.5 The selection and purchase of medical devices (equipment) is made taking into account all

available guidelines in compliance with the user needs, compatibility with existing medical devices (equipment) and Medicines and Healthcare Products Regularity Agency guidelines. Any request for purchase of medical devices (equipment) not on the standardised list can only be processed if the user has followed this policy.

4.6 Appendix 2 identifies the full responsibility of the person authorising the acquisition of the

device or equipment. This section is to reinforce that responsibility for the whole life cycle of the device/equipment and to ensure appropriate people and processes are utilised.

5. DEVELOPMENTS, TRIALS, DEMONSTRATIONS AND ‘INNOVATION MANAGEMENT’

5.1 No research trials of medical devices (equipment) should be commenced without the

written permission of MDG, and the Trusts R&D lead. 5.2 All requests for evaluations should be made to the (Medical Devices Group) prior to making

any arrangements with external companies. The Medical Devices Group will consider the request and make a decision if the evaluation should go ahead.

5.3 Evaluation of any equipment/device requires time, effort, suitable clinical environment and

clients/patients. It is therefore advisable to reduce trials in clinical settings as far as practically possible.

5.4 It may prove beneficial to arrange a trial of a medical device (equipment) by various

suppliers. All trials must be carried out on the supplier’s indemnity,

5.5 All research in the NHS must be carried out in accordance with the Research Governance Framework.

5.6 Before setting up an agreement with a commercial company to trial a piece of medical

device (equipment) contact should first be made with the Research Lead for guidance regarding the necessary governance checks.

5.6.1 ‘Innovation management’ ensures that new ideas, innovative solutions to problems,

inventions and better ways of working are given the best chance of being recognised. 5.6.2 The Trust intends to encourage all of its employees to make these sorts of contributions by

giving them the advice and support they need to maximise the benefits. 5.6.3 With appropriate good management of innovation, potentially valuable intellectual property

(IP) can arise. It is intended that innovations and IP from any sector of the Trusts’ activities should be appropriately ‘exploited’ which can mean anything from dissemination throughout the Trust or the NHS, to commercial exploitation in order to access wider markets and other healthcare systems.

5.6.4 Commercial companies usually wish to own the intellectual property regarding a device

being trialled outright, but there may be some opportunity for the Trust to benefit from their involvement in the trial of a device.


5.7 Any electrical/mechanical medical devices (equipment) purchased by the Trust must undergo a formal acceptance procedure in accordance with Appendix 6. These tests must conform to legal requirements in place at the time.

6. RISK MANAGEMENT

6.1 Risk Management of medical devices (equipment) should conform to the Trust’s Policy and

Strategy for Risk Management, together with the process for Risk Assessment and Incident Reporting. The ‘owner’ of the device is therefore responsible for risk assessment and the placing of that risk on the Trust’s Register as appropriate/necessary.

7. MAINTENANCE & SERVICING

7.1 Medical devices (equipment) should remain safe, serviceable and reliable throughout the

working life. Maintenance of such device (equipment) will be undertaken by a suitably qualified person as recognised by the Trust

7.2 It is the service manager’s responsibility to ensure that all medical devices (equipment) are

available for service and maintained on a regular basis. 7.3 A formal system is in place to ensure that the devices (equipment) functions safely and

accurately throughout its life. Such systems do provide for:

Day to day maintenance by the user

Performance /preventative maintenance by in-house team or external contractors

Breakdown and repair maintenance

Information regarding planned preventative maintenance (PPM) dates and contact information details are to be held with the device (equipment) including contact details for breakdown and repair if different.

7.3.1 A service specification with contracted providers for PPM and/or repair includes details of:

Activity and volume

Qualifications of technical service providers.

Requirements and responsibilities of both parties.

Training and education

Details of maintenance and repair schedules provided and excluded

Condemning and Disposal

Support

Annual report 7.4 The user will undertake any routine maintenance in accordance with the training or

instructions given by the manufacturer or supplied in the user manual. 7.5 Defective equipment must be taken out of circulation immediately and placed in a non

clinical area whever possible with a secure notice stating not to be use. The reason, details


of who has been notified with dates and details including contact of the person who has ‘decommissioned’ its use.

7.6 The medical device inventory held by the Providers contains data on three groups of

devices defined by service level:

Full Service. Devices receiving full management service including planned maintenance. Fee charged for these items

Repair Service. Devices receiving management and repair service but excluding planned maintenance. These items are judged not to require planned maintenance and as number of repairs per year are low, no fee is charged

Inventory only. Devices listed for inventory purposes only e.g. facilitating identifying devices for recall following safety notice. It is assumed the Commissioners assess the need for alternative maintenance provision. No fee charged.

8. DECONTAMINATION OF MEDICAL DEVICES (EQUIPMENT)

8.1 Decontamination is the total process used to remove organic matter and micro-organisms

from an item and render it safe for use. Effective decontamination involves application of rigorous techniques to make both medical devices (equipment) and the environment safe to minimise the risk of healthcare associated infection. Medical devices (equipment) can pose significant hazards to patients if they are inadequately or inappropriately reprocessed.

8.2 Organisations have a responsibility to keep patients, staff and visitors safe by having

systems in place to ensure that all reusable medical devices (equipment) are properly decontaminated prior to use or repair and that the risks associated with decontamination facilities and processes are well managed.

8.3 Decontamination issues associated with medical devices will be discussed and reported to

both MDG and the Infection Prevention and Control Committee The Director of Infection Prevention and Control (DIPC) is responsible to the Board. Service Leads are responsible for the effective, and technically compliant, provision of decontamination services and will monitor and regularly review the decontamination procedures. The Service Leads will designate local Decontamination Leads to manage the operational implementation.

8.4 Personnel at all levels should have a sound general knowledge of the principles, design

and functions of decontamination equipment used within their work area and/or required for their role. They must be trained on those types and models of decontamination equipment with which they are concerned and have some knowledge of the basic elements of microbiology in order to ensure personal safety and the safety of others.

8.5 Where local reprocessing takes place managers are responsible for ensuring a

documented training scheme is in operation with individual training records for all staff involved in reprocessing medical devices (equipment). Staff must be deemed competent and properly trained by the manager or other individuals nominated by the manager. Individual training records, detailing the individual’s core competencies and any other training, should be maintained and updated regularly. Line managers are responsible for maintaining these records.

8.6 In the Trust’s primary care settings, the manager of the practice is responsible for ensuring

that systems are in place for ongoing staff training (see also section 11.5)

8.7 The requirements needed to decontaminate medical devices (equipment) should be considered before reusable equipment is acquired, to ensure they are compatible with the decontamination equipment available. Consideration must also be given to the commissioning, validating and revalidating of medical devices (equipment) and


decontamination equipment and a planned maintenance programme delivered by properly trained and competent staff.

8.8 All medical devices (equipment) are designated either as single-use, single patient-use or

reusable devices. The following definitions apply:

8.9 Single-use: A device that is used once, on a single patient, and then disposed of

8.10 Single Patient-Use: A device that can be used more than once on a single patient.

8.11 Reusable: A device that can be reused on multiple patients; provided it is adequately decontaminated between uses.

8.12 Single use instruments should be used where possible. Medical devices (equipment) that

are intended for single use must not be decontaminated unless they are implicated in an adverse incident and may need to be sent to the Medicines and Healthcare products Regulatory Agency (MHRA) or the manufacturer for investigation. In this situation, the manufacturer must be contacted to find out the most appropriate method of decontamination.

8.13 Single Patient-Use, Medical devices (equipment) that can be reused for an individual

patient must be decontaminated between each use as instructed by the manufacturer and local policy. They must be stored appropriately to prevent the medical device (equipment) becoming contaminated in between use.

8.14 Reusable medical devices (equipment), For medical devices (equipment) that are reusable

the choice of decontamination method must reflect manufacturer’s instructions and be appropriate for the degree of risk associated with the intended use of the medical device (equipment) (Table 1)

8.15 Table 1

Risk Application of Item Recommendation High Risk In close contact with broken skin or

broken mucous membrane Introduced into sterile body area

Cleaning followed by Sterilisation

Medium Risk

In contact with mucous membranes Before use on immunocompromised patients Contaminated with particularly virulent or readily transmissible organisms

Cleaning followed by disinfection or sterilisation

NB where sterilisation will cause damage, cleaning followed by high level disinfection may be used as an alternative

Low Risk In close contact with broken skin or broken mucous membranes

Cleaning

DB2006 (05) November 2006

8.16 Loaned items subject to inspection, maintenance, repair or disposal, either on site or at the manufacturer's or agent's premises, should be decontaminated beforehand. Any loaned items being returned to a manufacturer or supplier should also be decontaminated. Once decontamination has been completed the items should be labelled accordingly, and a declaration of contamination status form completed (See Appendix 15). This should be readily accessible to the recipient of the medical device (equipment).

8.17 Occupational Health Monitoring. Certain chemicals are particularly hazardous and the risk

assessments may identify a need for measurement of occupational exposure levels within a unit, and the monitoring of staff health. It is a legal requirement that unit managers notify


the Occupational Health Department of all staff exposed to these agents in order that health surveillance and follow-up can be initiated. Refer to relevant Trust Occupational Health Policies. COSHH Regulations must be adhered too at all times.

9. MEDICAL DEVICES / EQUIPMENT INVENTORY

9.1 The Trust will maintain a centralised “Medical Devices ” (Equipment Inventory) through the

use of a single equipment service function as detailed in the Appendix 7 9.2 It is essential that the whereabouts of all medical devices (equipment) be known at all

times. Service Managers are accountable for the lifetime use of each medical device they have requisitioned and authorised. The equipment controller(s) may be delegated with the role to ensure that all acquisitions, transfers and disposals are fully recorded on the centralised system. Failure to record could result in medical device (equipment) being lost, or not being properly maintained leading to a degree of risk.

9.3 Each service area must ensure the central of all medical devices (equipment) in use in that

service area is accurate. The standardised list ensures that all procurement of additional or replacement items are purchased according to best clinical practice and supplies procedures.

10. ADVERSE INCIDENTS

10.1 An adverse incident is an event that gives rise to, or has the potential to produce,

unexpected or unwanted effects involving the safety of patients, users or other persons. 10.2 In the event of an adverse incident occurring the user must ensure that the incident is

immediately reported in accordance with the Trust’s Incident Reporting System. 10.3 Where practical the current medical device (equipment) should be immediately taken out of

service. Where duplicate devices of similar type exist, these may also need to be taken out of service and retained for further examination or disposal.

10.4 Medical devices (equipment) involved in adverse incidents together with other material

should be clearly identified and kept in quarantine, where practicable, until MHRA’s device specialists have been consulted. The state of the device at the time of the incident should be recorded for use in any subsequent investigation.

10.5 Local action will be taken as necessary to ensure the safety of clients/patients, users and

staff at all times. 10.6 In the event of an accident, incident or defect concerning medical devices (equipment), the

Medicines and Healthcare Products Regulatory Agency has responsibility for issuing of safety notices on a national level to all Trusts’. When these are received, they are circulated to the users and appropriate action is taken in compliance with the published notices.

10.7 A complete record of advice and recommendation issued by the Medical Devices Agency in

the past and MHRA will be maintained by the Director identified at 3.2 within the Trust. Notices will be distributed to appropriate people across the Trust.. Any recommendations contained in the aforementioned notices will be implemented in full by the Trust. See Appendix 13.

11. TRAINING & COMPETENCY

11.1 The Trust will have a process for self assessment competency specifically for all permanent

staff and other users of medical devices (equipment) and may provide in-house training and/or utilise external providers. Details of medical device training & competency must be


recorded, maintained by the ward/department manager and available for review in the ward or relevant clinical area.

11.2 Where patients/clients move between services and have been provided with equipment, the

Service from which the patient was last seen should ensure that instructions for the device are formally handed over with clinical information.

11.3 Systems must be in place to ensure all health care users and end users (e.g. patients and

carers) are trained in the safe and effective use of medical devices and staff are not permitted to use medical devices for which they or others have determined they are not competent. Staff who attempt to use a device for which they are not competent training may be subject to disciplinary procedures.

11.4 Where identified any health care worker will complete appropriate training before they use

or operate any medical device. Training should include selection, storage, assembly, use/application, cleaning/decontamination, pre and post use checks or calibration, disposal, risk awareness and fault identification. Training will be documented & exceptions reported to the Medical Devices Group via the Risk Manager.

11.5 Appendix 8 provides managers with a medical device training plan and staff with a self

assessment checklist. All patients and carers must receive training in how to use the device. This should be supported by written guidance. The manufacturer’s instructions should provide some information but this should be tailored to the needs of the individual patient or carer.

11.6 Written guidance should cover the following:

The name of the device

The operation and control of the device

Checking of the device while in use

Recognition of a device failure or fault

Action to be taken in the event of a device failure or fault

Individuals to be contacted in an emergency. 11.7 Written guidance must also cover cleaning and decontamination procedures. A medical

devices / equipment competency schema for each device contemplated for introduction to the clinical area, should be sought prior to procurement. Where unavailable, development should be requested from the Medical Devices Group.

11.8 Records about medical devices training organised by the Learning & Development Service

are kept on a Training Inventory; line managers must record all other medical devices training to be kept within the staff member’s personnel record that logs both formal and informal training. A self assessment checklist for staff is also available and will be included in the local induction checklist for new employees.

11.9 Content of the training undertaken should be recorded and filed in the staff member’s

personnel file. 11.10 Training Needs Analysis - Services or the MDG may identify training needs and

commission the Learning and Development team to acquire appropriate programmes. 11.11 Training Competency Schema will be considered by the Medical Devices Group to indicate

a minimum frequency for updates that will be reported through the Education


Representative to inform the Training Needs Analysis. It is recognised that equipment used infrequently will need more thorough update. However, staff will be offered more frequent update if they identify though self assessment in Appendix J that this is required.

12. STORING MEDICAL DEVICES (EQUIPMENT)

12.1 Following acceptance of medical devices (equipment) they will be stored in accordance

with the manufacturer’s instructions pertaining to shelf life and storage conditions. 13. SINGLE USE AND SINGLE PATIENT USE DEVICES AND OTHER HEALTH CARE

PRODUCTS 13.1 Single use items are classed as consumables for the purpose of this policy. The inventory

needs to have a record of the type of single use, consumable Medical Device items used but no other detail. Devices designated by the manufacturer as suitable for single use only will not be reutilised under any circumstances. In these circumstances offences may be being committed under 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 1994.

13.1.1 Single use items are devices and other health care products that are designed for a single

use or during a single procedure on the same patient. Following the completion of the procedure or planned use the device is to be safely disposed of.

13.2 Single Patient Use items are reusable items that are intended to be used more than once

but on the same person/patient. Use of this device/product can occur over a period of time but on the same patient. Manufacturer’s instructions regarding cleaning, maintenance and repeat use must be followed. The form of reprocessing between each use must be identified in line with DB2000(04).

13.3 HSC 1999/178 states:

‘Devices designated for single episodes of use may not be reused under any circumstances whatsoever’

13.4 Appendix 11 provides examples of single use labels.

14. EQUIPMENTPRESCRIBING DECISIONS

14.1 Staff with appropriate professional qualifications and suitable training and experience, and

working within the approved list of equipment, will make prescribing decisions within the Trust. The prescription of medical device (equipment) is the responsibility of the prescribing professionals and subject to the staff member’s professional code of conduct. Each service will maintain lists of health and social care professionals who are approved prescribers and will keep records of training on behalf of MDG.

14.2 A competency assessment framework will be used to assess staff in the prescribing, use

and management of medical devices (equipment). 15. CUSTOM MADE DEVICES


15.1 Custom made devices are provided by services specifically authorised by MDG (see 1.7). ‘Custom-Made Device’ means any device specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient, whether NHS, private or independent. The above mentioned prescription may also be made out by any other person authorised by virtue of his professional qualifications to do so.

15.1.1 Each service providing custom made devices is required to comply with the Medical

Devices Directive. These appliances do not need to be CE marked but the manufacturer (this may also be the prescriber) must supply a certificate stating the following:

This is a custom made appliance that has been manufactured to satisfy the attributes, characteristics, properties and features specified by prescriber for the above named patient. This appliance is intended for exclusive use by this patient and conforms to the relevant essential requirements specified in Annex 1 of the Medical Devices Directive (93/42/EEC) and the Medical Devices Regulations 2002 (SI 2002 No 618). Any relevant essential requirements not met are listed (e.g. overleaf).

15.2 Annex VIII of the Medical Devices Directive defines the requirements that must be met by

the manufacturer of a custom-made device. The manufacturer of a custom-made device must draw up a statement for each device which contains the following information. A copy of the statement must accompany the device back to the prescriber:

1. Data allowing identification of the device in question (unique device identification)

2. A statement that the device is intended for exclusive use by a particular patient,

together with the name of the patient

3. The name of the medical practitioner or other authorised person who made out the prescription and, where applicable, the name of the clinic concerned

4. The particular features of the device as specified in the relevant medical prescription

5. A statement that the device in question conforms to the essential requirements set out

in Annex I of the Directive and, where applicable, indicating which essential requirements have not been full met, together with the grounds

6. Each service issuing Custom Made Appliances Records is required under the

regulations to keep the following records and is responsible for ensuring manufacturers comply with the Regulations for the devices it issues:

Unique device identification (e.g. serial number from manufacturer / issuer)

Copy of manufacturer’s certificate and statements (see above)

Date of purchase / provision

Regular checks and servicing

The information contained in the declarations should be kept for a period of time of at least five years.

15.3 In addition, services will keep records of manufacturers’ MDD registration numbers.

15.3.1 These are obtained either through a trade association (e.g. Dental Laboratories

Association) or through the Medicines and Healthcare Products Regulatory Agency (MHRA). There are also approved lists of materials, from the TRUST. The NHS Counter


Fraud and Security Management Services (CFSMS - http://www.cfsms.nhs.uk/) audit records from time to time.

15.3.2 These records may be incorporated into clinical records or may be kept separately in a

central location for a service. Examples of services providing such custom devices are Podiatry and Dental Services.

15.3 Each service user should have specific information given under the Regulations:

Name of device

How to use device (including cleaning and decontamination)

Responsibility for checking device in use

Recognising device failure or fault

Action to be taken for device failure or fault

Reporting untoward events (e.g. to manufacturer/supplier)

Emergency telephone numbers.

15.5 This information will usually be in the form of written instructions, either in the form of a Trust leaflet, or service specific leaflets, which may be produced by other authorities.

16. MEDICAL DEVICES (EQUIPMENT) REPLACEMENT

16.1 All medical devices (equipment) reach a stage at which replacement must be considered. If

any of the following seven criteria apply, the device is no longer serviceable and must be replaced:

Worn out beyond economic repair

Damaged beyond economic repair

Unreliable (per the service history)

Clinically or technically obsolete

Spare parts no longer available

More cost effective or clinically effective devices have become available

Unable to be cleaned effectively prior to disinfection and or sterilisation. 16.2 A replacement programme for medical devices (equipment) should be based on the criteria

for replacement outlined in 19.1 above and developed by each service and approved by the sub committee of The Board with recommendations from the MDG. Advice about the application of these criteria should be sought as necessary. Each service should be identifying funds for a planned replacement programme. Sufficient funds should be allocated from the relevant service budget at the outset of each financial year to take account of the planned equipment replacement programme for that year.

16.3 Custom made appliances that no longer fit the clinically intended purpose should be

replaced: they cannot be redistributed to other users but should be suitably disposed of. Certain appliances fall within specific regulations that make them part of the property of the

http://www.cfsms.nhs.uk/)


patient (e.g. dentures, prosthetic cardiac valves etc and other long term inserts) and whilst they may be replaced, the patient must be consulted about their disposal (if the patient agrees) otherwise the patient has the right to keep these.

16.4 Some appliances may no longer be suitable for the clinically intended purpose for a particular client but may be suitable, after reprocessing, for use with a different client.

16.5 MDG can provide advice regarding appliances as at paragraphs 19.3 and 19.4.

16.6 Disposal of devices deemed no longer serviceable must be managed by each service area

in line with agreed Trust policies and procedures. 17. EQUIPMENT (MEDICAL DEVICES) ON LOAN

17.1 Loan medical devices (equipment) has two categories, they are:

20.1.1 Medical devices (equipment) loaned to clients/patients from the Equipment Store and Wheelchair Service or other services

Medical devices (equipment) loaned to other clinical users either inside or outside the NHS.

17.2 Managers of all wards and departments are responsible for ensuring that all medical

devices (equipment) allocated to the area of their responsibility are fully maintained and fit for use.

17.3 They are also responsible for ensuring that all staff, patients and carers required to use or

operate this medical device (equipment) are trained in its use, care and maintenance. Medical devices (equipment) should not be loaned unless it is fit for use, regularly maintained and that the manager concerned is confident that those using it are trained to do so.

17.4 Return of loaned medical devices (equipment):

Systems will be developed at a local level to ensure the appropriate collection of medical devices (equipment) when it is no longer required by the end user

All returned medical devices (equipment) must be decontaminated as specified in the Trust cleaning and decontamination policy prior to reissue.

18. IMPROVEMENT INDICATORS

18.1 The Medical Devices Group will develop a transition plan to show improvement indicators,

which demonstrate increased performance in medical devices management over a given period of time.

18.2 These will be tabled to the Essential Standards and Quality Improvement Group for

agreement in due course. Medical devices (equipment) purchased and maintained via a formal Section 31 agreement with the Local Authority will be subject to performance reporting to the Section 31 management group responsible for the area managing these devices.

19. BENCHMARKING

19.1 The National Audit Office recommends that Trusts’ seek to reduce the different models of

each type of medical devices (equipment) in use and accordingly, introduces a replacement strategy that promotes standardisation of medical devices (equipment), in order to minimise costs and the staff training burden while ensuring that all clinical needs are covered.


20. MONITORING COMPLIANCE OF THIS POLICY

Standard Process for monitoring compliance

Evidence required to support compliance

Frequency Responsibility of

Designated Committee

Standard 2 - Criterion 7: Medical Devices Training The organisation has an approved documented process for ensuring that all staff are trained to safely use diagnostic and therapeutic equipment appropriate to their role, that is implemented and monitored.

duties Policy will be reviewed to ensure the duties detailed within it are appropriate

Report and minutes

Bi Annually Head of Podiatry & Equipment Clinical Business Unit

Medical Devices Group

inventory (or links to an inventory) of diagnostic and therapeutic equipment used within the organisation

The standardised lists and medical device (equipment) inventories will be reviewed

Report and minutes

Annual Head of Podiatry & Equipment Clinical Business Unit


process for identifying which permanent staff are authorised to use the equipment identified on the inventory

The standardised lists and medical device (equipment) inventories will be reviewed

Report and minutes



process for determining the training required to use the equipment identified on the inventory and the frequency of updates required

The training required to use equipment identified on the inventory and the frequency of updates required will be reviewed

Report and minutes



process for ensuring that the identified training needs of all permanent staff are met

The process for ensuring competencies and training of staff for using medical devices (equipment), to ensure that

Report and minutes




identified training needs of permanent staff are met.

Standard 3 - Criterion 6: Maintenance of Medical Devices & Equipment The organisation has an approved documented process for managing the risks associated with the maintenance of reusable medical devices and equipment that is implemented and monitored

duties

requirement to have a systematic inventory of all reusable medical devices and equipment used within the organisation

process for ensuring that all reusable medical devices and equipment are maintained

Policy will be reviewed to ensure the duties detailed within it are appropriate A review of the inventory will be undertaken in conjunction with clinical staff and amendments to the inventory made as appropriate in order to ensure it is kept up to date An audit will be undertaken to ensure that the process for ensuring that all reusable medical devices and equipment are maintained

Report and minutes Report and minutes Report and minutes

Bi Annually Head of Podiatry & Equipment Clinical Business Unit


Annual Head of

Podiatry & Equipment Clinical Business Unit


Medical Devices Group Medical Devices Group

process for ensuring that all reusable medical devices and equipment are repaired

An audit will be undertaken to ensure that the process for ensuring that all reusable medical devices and equipment are repaired

Report and minutes



20.1 The policy will be monitored for effectiveness via the MDG on an annual basis and necessary reviews and audits identified. 20.1. The policy will be monitored for effectiveness via the MDG on an annual basis and necessary reviews and audits identified.

21. POLICY REVIEW

21.1 This policy may be reviewed at any time at the request of either staff side or management,

but will automatically be reviewed after twelve months and thereafter on a bi-annual basis. This review will include:

Accountability arrangements

Processes, including risk management arrangements


Capability

Outcomes

Internal audit findings. 21.2 Additionally the Board will, from time to time seek, independent assurance that an

appropriate and effective system of managing medical devices (equipment) is in place. 22. RELATED POLICY AND PROCEDURE REFERENCES

22.1 The Trust acknowledges the following sources of advice and reference:

1. General Medical Council Ethical guidance - Good clinical care http://www.gmc-

uk.org/standards 2. Medical Devices Agency (1998) Medical Device and Equipment Management for

Hospital and Community-based Organisations January 1998 DB 9801 3. Medical Devices Agency (2000) Medical Devices and Equipment: Repair and

Maintenance Provision June 2000 DB 2000(02) 4. Medical Devices Agency (2001) Devices in Practice ISBN 1 84182 359 7 5. Medical Devices Agency (2001) Equipped to Care The safe use of medical devices in

the 21st century October 2001 6. Medical Devices Agency (2002) Management of loaned medical devices, equipment or

accessories from manufacturers or other hospitals SN 2002(17) 7. Medical Devices Agency (2001)- Medical Devices - Reporting Adverse Incidents and

Disseminating Safety Warnings SN 2001(01) 8. Medical Devices Agency (2006) Reporting Adverse Incidents & Disseminating Medical

Device Alerts MDA/2006/001 9. MHRA (2003) Management of Medical Devices Prior to Repair Service or Investigation

DB2003(05) 10. National Audit Office (1999) Management of Medical Equipment in HNS Acute Trusts in

England June 1999 11. NHS Litigation Authority (2004) NHSLA Risk Management Standards for PCT April

2004. 12. PASA Trust Operating Purchasing Procedures Manual (TOPPM)

http://nww.pasa.nhs.uk/purchasing/shared/toppm//toppm.stm 13. Medical Devices Agency (2001) Guidance on the Sale, Transfer of Ownership and

Disposal of Used Medical Devices MDA DB9801 Supplement 2 Oct 2001 14. EN 14971:2000 Standard: The Application of Risk Management to Medical Devices 15. Department of Health (2004) Standards for Better Health July 2004 16. HSC 2000/32 Decontamination of medical devices 17. Chief Medical Officer (2002) Getting Ahead of the Curve. Department of Health. London 18. Chief Medical Officer (2003) Winning Ways Working together to reduce Healthcare

Associated Infection in England. Department of Health. London 19. Department of Health (2003) Controls Assurance Standard; Decontamination of Re-

usable Medical Devices. Department of Health, London 20. Department of Health (2003) Controls Assurance Standard: Infection Control.

Department of Health, London 21. National Institute for Clinical Excellence (2003) Infection Control: Prevention of

healthcare-associated infections in primary and community care. 22. Lifting Operations & Lifting Equipment regulations 1998 (1998/2307) 23. Provision & use of work equipment regulations 1998 (SI 1998/2306) 24. Medicines and Healthcare Regulatory Agency: http://www.mhra.gov.uk 25. Devices in Practice – a guide for health and social care professionals (2001)

http://nww.pasa.nhs.uk/purchasing/shared/toppm/toppm.stm

http://www.mhra.gov.uk/


Medical Devices Policy Appendix 1

Medical Device Life Cycle

Identification of need

Safe disposal Risk Evaluation

Planned replacement

Prioritisation & financing

Device Evaluation

Safety advice Incidents & Alerts

Maintenance

Medical Device

Lifecycle

Device standardisation

Purchase

Prescribing

Device Deployment

Commissioning

User training Inventory management



Procurement process and request forms

GUIDANCE ON THE ACQUISITION OF MEDICAL DEVICES (EQUIPMENT)

The ‘owner’ of the device, with advice from clinical leads and equipment controllers, will be responsible for the acquisition of medical devices (equipment). Guidance in respect of good practice to be followed is outlined below:

1. Selection Criteria

Life cycle/replacement (how long will the device last). Fitness for intended application (must meet user organisation's performance specification, but unnecessary features may be a disadvantage e.g. complicated devices may break down more frequently and be harder to use). Guarantee/warranty (compare terms, and assess whether these are negotiable). Safety (ensure relevant safety and performance standards have been complied with. Do MHRA publications reveal persistent problems, ensure pre-purchase questionnaires been completed where necessary) Reliability (review whether other users have experienced problems or failures). Service support. (Ensure spares are readily available and service support is guaranteed for the required period of time together with appropriate response times) Maintenance requirements (intervals between service, frequency and complexity of checks and calibration needed during operation). Technical advice (identify whether the manufacturer give free access to technical advice, for professional users and technical staff? Through a 24-hour help line). Diversity (will this choice increase the number of types of device in use, and could this be to the detriment of safety)

2. Acquisition Process

This includes purchase of new equipment, transfer “in”, loan, acquisition from families / donations etc. –

Ensure that appropriate technical and clinical evaluations have been undertaken. Ensure that the equipment / device meets service need, and conforms to any TRUST policy regarding purchase of standard make or model. Ensure that the medical device (equipment) complies with all relevant statutory and safety standards. Ensure that there are sufficient funds to meet purchase / loan and installation costs, identify and ensure provision for life cycle costs (e.g. service and consumables; safety measures; utilities; and installation/disposal costs). Ensure that the equipment / device is subject to an “acceptance procedure” before being put into use. To ensure that when a device or puece of equipment is approved for purchase that it has been enyrted accurately on the central record




Ensure that users of the medical device (equipment) are issued with, understand, and comply with manufacturers instructions (revised for adequacy). Identify key employees whose responsibility it will be to keep documents (, training records etc) up to date. Trainers should be kept up to date in use of medical devices (equipment). Risk assessment – visit operational and other areas to ensure action is taken to reduce risk. Ensure that medical devices (equipment) are used on an appropriate basis e.g. “single use” medical devices (equipment) used once only etc. Ensure that this is an agreed procedure for medical devices (equipment) used on multi-use basis to be properly cleaned and de-contaminated prior to re-use. Ensure that further maintenance arrangements are agreed prior to purchase.




MEDICAL DEVICE ORDER FORM - PROCESS A (Used for Replacements and additional items)

Medical Device Reference Number (previously assigned) *without this reference number the order will not be processed

Device: Maker /Model:

Catalogue Number (maker) Quantity

Price per unit (exVAT) £

Cost Centre Account Code Transfer Point

Location Details:

ServiceSelect Location Site Room / Ward

Maintenance:

Maintenance Provider Select Costs £

Decontamination Provider Select Costs £

Annual PAT safety check needed? Yes No

Planned Preventive Maintenance required? Yes No

Training

Required before use? Yes No

Supplier Training Yes No

In House Training Yes No

Authorisation

I am satisfied that the request meets the criteria for purchase and that:

This purchase has been evaluated to ensure it represents a cost-effective option Advice from the relevant advisor has been sought Appropriate storage is available Appropriate planned preventative maintenance has been established and will be recorded Methods of cleaning / decontamination have been established in line with policy Instruction manuals will be available to all users User training has been arranged and recorded. This item will be subject to appropriate acceptance and pre use checks

Name Date 24-Aug-11




Medical Device Action Record

(For Medical Device Panel use only)

Reference Approval Number : Approval Declined Reason:

Device name :

Manufacturer :

Model :

Description :

Intended Use – tick all that apply

Clinic W ard Home Other

Training

In House Supplier Not required

Maintenance Provider

CES Estates PCT Estates Car Other Clinical Eng PHT Clinical Eng SUHT

Maintenance as per manufacturers guidance or local agreement will be charged to the service purchasing equipment.

Cleaning Arrangements

CES CSSD Local arrangements

Charged per case or Annual contract

Disposal Costs

Disposal agreed as part of purchase cost Annual fee

Disposal to be charged at time of disposal

Date Agreed




Approval Record Notes Once approval to purchase has been agreed, a Manufacturer and model will be identified that best matches the needs for the intended use.

This manufacturer will then be linked to the unique reference number. If another manufacturer is identified or a newer model is available, then a new form will need to be completed and a new reference number generated.

If the cost of maintenance, cleaning and disposal have been included at the time of purchase, then no further charges will be made to that service.

In all other instances a separate contract will need to be put in place for cleaning, maintenance and disposal. This will be recorded on the Record Form so that costs may be charged appropriately. Once a piece of equipment is agreed and has a unique reference number, no further changes may be made by a service for future provision without application to the Medical Devices Committee for approval.

If a service other than the original applicant wishes to procure a registered piece of equipment, then the existing arrangements for that equipment under the reference number will apply.




MEDICAL DEVICE CONSIDERATION FORM – Process B (only for Devices not purchased before)

Service please select Location Contact Name

Device Selection

Has a formal evaluation of candidate models been carried out? Yes No

If ‘Yes’ attach documentation with this application.

Device type: Estimated Cost per unit (ex VAT) £

Suggested Manufacturer

Suggested Model :

Describe function of this device

Have you consulted with:

Supplies team Clinical Eng. Decon. Estates ICT Clinical Specialist advisor

Justification/clinical reasoning (you may attach supporting information)

Required by (date) Number of Units

To be added to Permanent stock list One off Purchase Donated Rental

Intended Use – tick all that apply

Hospital Clinic Home

Other

Pleases specify: Who is the intended user/s?

What is the expected frequency of use per device? Select most appropriate

Is the Device available as a Single use item? Yes No

Does the Device require consumables? Yes No


Estates PCT Estates Carillion Clinical Eng PHT Clinical Eng SUHT Supplier / contractor CES



Are consumables available via Supply Chain Yes No

If not how will these be acquired?

Does this device present the patient with any potential hazards? Yes No

If YES How are will these risks be minimised? Please specify in detail:

Training Tick all that apply

Will training be required? Yes No

If ‘Yes’ will this be provided

In House By Supplier Other

please specify:

Training in place or included in purchase price Yes No If ‘No’ how will this be funded?

Maintenance Tick all that apply

On which site(s) will this equipment be used?

Is Planned Preventative Maintenance required? Yes No

Is Routine repair/ maintenance required? Yes No

Is an annual PAT safety check required (mains power only)Yes No

Which maintenance provider will be used?

N/A Is Cleaning/ Decontamination required? Yes No

Frequency of Cleaning Select Level Select Costing agreed

Who will carry this out Please select

Are there any special storage requirements? Yes No

If ‘Yes’ please provide details. If appropriate, explain how this device will meet the patients’ needs in terms of comfort, independence and dignity.




Disposal (tick all that apply)

Device contains hazardous material. e.g. Biological contamination, Mercury, ionising radiation

Contains Electrical parts inc. batteries

Does the Manufacturer offer a disposal/ take back service? Yes No

Does the purchase cost include Disposal costs? Yes No

Disposal Costs

Disposal agreed as part of purchase cost

Disposal to be charged at time of disposal

Medical Devices Panel

Would a service representative like to attend the panel review meeting if required to provide further information?

Yes No

Purchase Details

Cost Centre Account Code Transfer Point

Governance Declaration by Manager

I am satisfied that this request meets the following: This equipment has been evaluated to ensure it represents a cost-effective option The equipment is clinically appropriate and effective Advice from the relevant advisor(s) has been sought Appropriate planned preventative maintenance has been established Methods of cleaning / decontamination have been established in line with policy Instruction manuals will be available to all users User training has been arranged and recorded. This item will be subject to appropriate acceptance and pre use checks

Name Date




Notes on Completion of Medical Device Consideration Form

Prior to purchasing any new medical devices the items must first be subject to scrutiny by the Medical Devices Selection Panel.

In order for a decision to be made it is important to complete the form as fully as possible

Once approved this equipment will be assigned a reference number so that any future purchase proceed without the need to complete the form again.

For Existing Items only the GREEN form need to be completed

Device Selection:

What do you need and W hen do you need it. How many units are you expected to order

Usage:

Frequency of use will determine robustness of model needed

Where possible a single use item should be used.

Please state if any consumable items needed for the device to be operated and if they are readily available via SBS Procurement Hub ( Solent Supplies / ProCure )

Training: You need to consider the competency measures for staff or end users expected to operate the device.

Maintenance: Consider the implications of who will maintain it, how much will it cost If this needs decontaminating between patient uses, has this cost been factored in and costed.

Disposal: All items incur a cost at time of disposal. All electrical items have added costs associated with their disposal which should be factored in to the purchasing decision. Service may have to bear this cost individually as there may not be a central disposal process.

Outcome: After the panel has reached a decision you will receive the Blue Action Record for that device. This should be kept on file so that any future purchases may be processed speedily.


MEDICAL DEVICES POLICY Appendix 3

MEDICAL DEVICES CONTROLLER (EQUIPMENT CONTROLLER)

Job Specification Definition of an equipment controller taken from HEI 98, Paragraph 49 is:

‘The person may be a clinician, a nurse, a physiotherapist, or a radiographer, for example, dependent upon the clinical department concerned and local conditions and specialities. They have the authority to represent all aspects of use of medical device (equipment) within their field of responsibility’.

This interpretation of the equipment controller’s role is a person who has the responsibility to see that the medical device (equipment) is used properly [user training], is fit for purpose [trials, evaluation, purchase procedures], is safe and serviceable [acceptance testing and maintenance], and has an up-to-date /asset register.

The main responsibilities of the equipment controller are as follows:

Formulate and maintain an accurate of all medical device (equipment) for a designated site Liaise with colleagues on site to ensure coordination/effective communication. Liaise with relevant contactors for all medical device (equipment) servicing e.g. EBME Take appropriate action as identified following maintenance to ensure that repairs and servicing are carried out regularly and promptly Keep accurate records of any new medical device (equipment), transfers and/or disposals Verify that any decontamination procedures have been carried out prior to maintenance/repair

The persons appointed to the position of equipment controller must be encouraged to have ownership of all medical devices (equipment) on site and ensure it is kept safe and fit for the purpose it is designed for.



SOURCE OF ADVICE FOR ACQUISITIONS

NHS Supplies

Medical equipment controllers

Service heads/leads

External equipment manufacturers / suppliers

Specialist staff e.g. equipment store specialist staff or clinical specialists

Medical Devices/ Decontamination Controls Assurance Groups

PASA

EBME

MHRA

DLF

This is not intended to be an exhaustive or definitive guide to advice for acquisition. It is intended to illustrate the possible areas of expertise open to enquiry.



TRANSFER OF MEDICAL DEVICES (EQUIPMENT)

In order to keep a good track on all medical devices (equipment), it is essential to know the location at all times. Failure to have this information can result in medical devices (equipment) not being maintained.

To assist all Equipment Controllers, this is an example of a standard transfer note which shows the sort of information which would normally be kept for record keeping and tracking.

Please ensure every time a medical device (equipment) moves location/site the transfer note is fully completed and kept in the file with a copy sent to the inventory administrator.

Equipment:

ID/ Serial No ..........................................................................................................

Present Site/Location:

Transferred/Loaned to:

Site/Location:

Left [Date}:

Authorised:

Accepted by:

Returned [Date}:

Signature:

Name:

Copies to: file Inventory administrator



ACCEPTANCE TESTING FOR NEWLY DELIVERED MEDICAL DEVICES (EQUIPMENT)

1. Safety & functionality

All clinical staff across the TRUST should check the safety and functionality of newly delivered medical devices (equipment) prior to utilisation. This should include:

Checking that the correct product, complete with manuals and accessories, has been supplied

Provide assurance that product items have been delivered in good condition and working order

Ensure that risks associated with using a product for the first time have been minimised;

Ensuring that all appropriate statutory and mandatory testing of the medical device (equipment) has taken place prior to its use, including PA testing

2. Reusable medical devices (equipment).

The Trust will ensure that all devices intended for repair or maintenance are safe to handle. In respect of reusable medical devices (equipment) staff should ensure:

The device is recorded on the Trust medical devices (equipment) inventory in accordance with the requirements Ensure that appropriate maintenance support is initiated Compliance with relevant safety legislation as appropriate Labels and documentation are developed and attached to the device as appropriate, identifying new devices and advising monitoring of the introduction All medical devices (equipment) returned for servicing and repair are properly decontaminated

3. Other requirements

Managers should identify and organise:

Training needs Requirements for planned preventative maintenance Technical support needs of users Apply labels and other documentation as required

In addition records should be maintained identifying that the above procedures have been complied with.



4. Loaned medical devices (equipment).

Procedures for the delivery of medical devices (equipment) will attend to safety issues including avoidance of cross-infection, delivery of the correct item and commissioning. Clear procedures will be developed relating to different types of medical device (equipment) in order to contribute to greater safety and minimise risk.

5. Record keeping

Records of procedures followed in respect of acceptance testing for new medical devices will be maintained at a local level across the TRUST business areas.



MEDICAL DEVICES (EQUIPMENT) INVENTORY 1. Introduction

The Trust is committed to maintaining and developing a single comprehensive up to date medical devices (equipment) inventory This will contain details of all reusable medical devices (equipment) in use by permanent staff across the Trust.

2. Functions of the

Accurate and accessible records are a key factor in effective device management. The primary function of the inventory will be to ensure there are comprehensive records of devices in use and ensuring prompt planned preventative maintenance and repairs are put in place.

Secondary functions of the inventory include providing and logging service histories and generating management in formation about the running costs of medical devices (equipment).

3. New devices

The inventory will be updated on an on-going basis. Clinicians will be required to notify the inventory administrator of any additional medical devices (equipment) being brought into use within the Trust in accordance with instructions issued. Accurate and consistent record keeping will be required with clear records developed and maintained from the outset. This will enable the Trust to trace individual products throughout their whole life. HSC 1999/53 identifies that records should be retained for eleven years in respect of products supplied.

4. Annual review

An annual review of the inventory will be undertaken in conjunction with clinical staff and amendments to the inventory made as appropriate in order to ensure it is kept up to date. Additionally the Medical Devices Group will review the inventory on an annual basis.

5. Format of the inventory

The medical devices (equipment) inventory will be maintained in a format similar to that identified below

Min Est Equipment Purch Exp Repl Eqp No Description Manufacturer Model Year Age Life Cost

Rep Prty Premises Specialty Location

Training requirements

Service Level

Last Seen

Service No



STAFF TRAINING 1. Introduction

All staff within the TRUST will be trained to an appropriate level in order to ensure the safe and effective operation of medical devices (equipment) in use within the TRUST and by patients of the TRUST at all times.

2. Adverse incident reporting

Staff will be made aware of and where necessary trained in adverse incident reporting requirements for medical devices (equipment) and be able to risk assess all medical devices (equipment) for normal usage. All adverse incidents must be reported via the TRUST incident reporting system and via the MHRA website.

3. Safe operation of medical devices (equipment)

Professional users of medical devices (equipment) will be adequately trained and qualified persons who operate a device for the benefit of a patient or client. This will include understanding the normal operation of devices encompassing:

Awareness of differences between different device models, where safety or function is potentially affected; Assembly and disassembly of the device where appropriate Setting of controls Effective linking of the device to a patient causing minimum discomfort Teaching the end user how to use the device Recognising malfunctions and taking appropriate action Cleaning and decontamination procedures See appendices 14 & 15

4. Technical Supervisors

Technical supervisors are people with technical or managerial roles in medical device management who have an engineering, physics or technical training. They will organise training where necessary, ensure staff attend relevant course and check the quality of such course and supervise people working with new devices.

See appendices 14 & 15

5. End User Training

All end users of medical devices (equipment) will be provided with appropriate training in the safe and effective use of medical devices (equipment); this will include performing routine maintenance tasks. Additionally end users will be provided with manufacturers’ instructions. This will be further explained and expanded upon where necessary, in order to ensure the effective and safe operation of the device in question

Version 2

Management of Medical Devices And Equipme


6. The TRUST is committed to a competency based framework for training on use of equipment items. It would be usual for a service’s record of training to include a list of users competent to operate specific items of equipment.

Competencies will be set by manufacturers/suppliers and by appropriate staff designated by service managers. Users may be required to have these competencies re-assessed at regular intervals or when modifications to equipment occur. The ‘S’ drive has examples a competency framework which can be used. S:\Primary & Community Care Directorate\Clinical Learning & Development Forum\competences KSF Professional portfolio\Competencies. Also see appendices 14 & 15

Each service manager / equipment controller will hold the competencies require for each medical device (equipment) with the standardised list (& ) for the clinical area. One example appears below for Washer Disinfector equipment.

Name of staff member: Sponsor: Southampton Salaried Primary Dental Care Service

COMPETENCY

ARE A DATES OF ASSESSMENT (minimum 1 assessment per

competency) SIGNATURE OF ASSESSOR

that competency achieved 1. Once machine is ready (drained system) open door wearing gloves

2. Check detergent level (at least 15mls for a cycle). Replenish when needed.

3. Place all instruments onto trays ensuring they are not overloaded with instruments touching and place into carrier.

4. Place all handpieces into handpiece ports, ensuring any ports not in use have caps place upon them.

5. Ensure the carrier is in the correct position (locked into place).

6. Ensure that spinners can be moved around and are not blocked by any instruments.

7. Close door. 8. Select standard cycle and press green key on keypad. This should take around 30 minutes and the LCD display will advise the progress of the disinfection cycle. Once completed this will beep for 5 seconds.

9. Check the printout states pass. 10. If a fault occurs, the printout will state fail. Correctly refer to manual and clear fault. 11. Remove trays and handpieces. Pass through hatch to clean room for autoclaving and place in autoclave.

I agree that I am competent in all aspects of W asher Disinfector use (Pickles Coppice).

Signed:

Date:

I agree that

Is competent in all aspects of W asher Disinfector use (Pickles Coppice).

Signed: Date: Title, qualifications and Relationship to trainee Reviewed required <date>

nt



7. Safe use of medical devices (equipment)

Where necessary staff will be provided with training in the safe use of medical devices (equipment). Safety training for staff may often be undertaken in response to health and safety legislation including (but not limited to):

Health and Safety at Work Act Management of Health and Safety at Work Regulations Provision and Use of Work Equipment Regulations Manual Handling Operations Regulations.



WRITTEN GUIDANCE ON USE OF MEDICAL DEVICES (EQUIPMENT)

1. Introduction

Good clear instructions have a crucial role to play in the safe and effective use of medical devices (equipment). It is important that these are promulgated throughout the organisation and to end users as appropriate. In the event of revised instructions being issued by manufacturers, managers and clinicians will have a responsibility to ensure that the new instructions are passed to the relevant users and complied with consistently and are also relevant to the products in use within the TRUST. Records will be maintained by the relevant clinicians/ managers of up to date instructions for medical devices (equipment) in operation within the clinical area.

2. Medical devices regulations

Manufacturers of medical devices (equipment) are responsible for supplying appropriate instructions including information regarding how to use the device safely, taking into account the training and knowledge of potential users, the nature and frequency of the maintenance and calibration required to ensure that the devices operate effectively and safely at all times. In addition manufacturers are required to identify any special storage and handling conditions.

3. Issue of instructions to end users

Where loan medical devices (equipment) are returned without the manufacturers instructions previously supplied, new sets of instructions are required to be issued with the medical device (equipment) each time it is reissued. End users will be notified of the importance of complying with manufacturers instructions regarding the use of medical equipment and devices. This process will assist in minimising legal liability of the TRUST in the event of adverse incidents.

4. Litigation

In the event of litigation, user organisations may need to be able to call on evidence that instructions, whether written or verbal, were given, in respect of end users in respect of certain medical devices (equipment). It is vital therefore that such instructions are passed on to end users each time medical devices (equipment) is loaned, in particular to patients.

5. Evaluation of Instructions

Instructions supplied should be in such a format that is both suitable for end users and their carers. This may involve providing additional training or information where for example end users have particular problems such as disabilities or medical conditions. Consideration should be given to writing instructions locally where this is deemed to be in the best interest of the end user. This should be done carefully in order to minimise the potential for litigation. Issues to consider when writing instructions locally should include:



How the instructions should be provided, on the device itself, packaging or a leaflet provided Provision of clear precise instructions Print size Technical language Translation into other languages Provision of instructions in Braille or via audio tape.

All instructions developed at a local level should be issued to the manufacturer of the product for approval prior to issuing to an end user. Following receipt of a confirmation letter from the manufacturer they can then be issued to the end user.

Instructions and leaflets are required to conform to the specification outlined in the “NHS toolkit for providing patient information”.

http://www.nhsidentity.nhs.uk/patientinformationtoolkit/index.htm





GLOSSARY OF ABBREVIATIONS

Control of Substances Hazardous to Health (COSHH)

Counter Fraud and Security Management Service (CSFMS)

Department of Health (DH)

Director of Infection Prevention and Control (DIPC)

Disabled Living Foundation (DLF)

Electronics Bio-Medical Engineering (EBME)

Intellectual Property (IP)

Infection Prevention and Control Committee (IPCC)

Microbiology Advisory Committee (MAC)

Medicines and Healthcare Products Regulatory Agency (MHRA),

Medical Devices Group (MDG)

National Health Service (NHS)

National Health Service Litigation Authority (NHSLA)

National Patient Safety Agency (NPSA)

Occupational Therapist (OT)

Solent NHS Trust (TRUST)

Purchasing and Supplies Agency (PASA)

Research & Development (R & D)

Southampton University Hospitals TRUST (SUHT)


2 2

2 2

2 2

2 2

2 2


EXAMPLES OF SINGLE USE LABEL

Medical Device – for single use only. To be appropriately disposed of after use according to current guidelines












What is a medical device?

Medical Devices Reporting Adverse Incidents

Medical devices (equipment) are items used for the diagnosis and / or treatment of disease, or for monitoring patients as well as aids for daily living.

Examples of medical devices include:

../ Benchtop sterilizers ../ Blood glucose monitors ../ Defibrillators, monitors and scanners ../ Imaging equipment ../ IUDS and condoms ../ Surgical implants ../ Syringes and needles ../ Urine and blood test kits ../ Wheelchairs, walking frames and sticks

This is not a definitive list – reference must be made to the SCTRUST policy Management of Medical Devices (Equipment)

What is an adverse incident?

An adverse incident is an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of patients, or other persons.

Causes of incidents involving medical devices (equipment) may include:

../ Design or manufacture problems ../ Poor user instruction and training ../ Inappropriate local modifications ../ Inadequate maintenance ../ Unsuitable storage and use conditions

What should be reported?

Any adverse incident involving a medical device should be reported, especially if the incident has led to or, were it to occur again, could lead to:

../ Death or serious injury ../ Medical or surgical intervention (including implant revision) or hospitalisation ../ Unreliable test results (and risk of misdiagnosis).

Other minor safety or quality problem should be reported as these can help demonstrate trends or highlight inadequate manufacturing or supply systems

What happens to the device?

Devices that have been involved in an incident should be quarantined. They should not be repaired, returned to the manufacturer or discarded until the MHRA have been given the opportunity to carry out their own investigation. Further advice on this may obtained from your local equipment controller, medical devices group service representative or safety advisor – see below.

Remember



It is illegal to send contaminated items through the post.

How to report an incident

Adverse incidents should be reported at the earliest opportunity.

Report the incident in usual manner through the on line incident reporting system.



Example of clinical staff cleaning frequency Equipment Cleaning Methods After Use Daily Weekly IV stands (include wheels) Detergent wipe IV Pumps/ syringe drivers Detergent wipe Cardiac Monitors Detergent wipe Blood gas machines Alcohol wipes Dressing trolleys (include wheels) Detergent wipes Linen trolleys Detergent wipes Tea trolleys (drinks machines) Detergent wipes Note trolleys Detergent wipes Drugs trolleys Detergent wipes Blood pressure cuffs Detergent wipes Pillows Detergent wipes Mattresses Detergent wipes Cot sides Detergent wipes Wheelchairs Detergent wipes Personal nail clippers Detergent wipes Commodes- includes wheels /underneath

Detergent wipes

Cushions Detergent wipes Oxygen saturation probes Detergent wipes Wash bowls Detergent wipes Hoists Detergent wipes Pat slides Detergent wipes Standing Aides Detergent wipes Resuscitation trolley Detergent wipes Oxygen/suction equipment Detergent wipes Wall humidifier Detergent wipes Portable nebuliser Detergent wipes Catheter stands Detergent wipes Bed pan holders Detergent wipes Scales Detergent wipes Nurses station Detergent wipes Computers Alcohol wipes Dental Sterilization

NB: Refer to Isolation policy for cleaning of equipment used for infected patients.

NOTE: These are examples only and it is the user’s responsibility to ensure they comply with manufacturer’s guidelines.


t kn Contaminated items should not be returned without prior agreement of the recipient

* This form should accompany the item of equipment

Declaration of contamination status


From (consignor): ………………………….. To (consignee):

Address: …………………………………….. Address:

…………………………………….. ……………………………………………..

…………………………………….. ……………………………………………..

Reference: ………………………………….. Reference: ………………………………..

Emergency tel: ………………………………

Type of medical device (equipment) ……………………………………………………………

Manufacturer: ……………………………………………………………………………………...

Description of equipment: ……………………………………..................................................

Other identifying marks: …………………………………………………………………………..

Model No. …………………………………… Serial No ……………………………………….

Fault …………………………………………………………………………………………………

Is the item contaminated? Yes No Don’t know * State type of contamination: blood, body fluids, respired gases, pathological samples, chemicals (including cytotoxic drugs), radioactive material or any other hazard ………………………………………..

Has the item been decontaminated? Yes No Don’ ow

What method of decontamination has been used? Please provide details …………………………………

Cleaning ……………………………………………………………………………………………………………

Disinfection ………………………………………………………………………………………………………..

Sterilisation …………………………………………………………………………………………………………

Please explain why the item has not been decontamination? ……………………………………………

………………………………………………………………………………………………………………………

This item has been prepared to ensure safe handling and transportation:

Name: ………………………………………………. Position: …………………………………………………..

Date: ………………………………………………. Tel no. …………………………………………………….

Version 1


Decision analysis for determining training needs for use of a medical device

Service manager identifies users of device .

Temporary staff /infrequent user

Permanent staff/frequent

user

Self assessed competency

Self assessed competency

If yes use device

If no contact manager

If yes use device

If no contact manager

Device risk assessed for

necessity Evidence base

checked.

Manager identifies

training plan

Identify training

plan with manager

Training /incl observation underatken

Manufacturer Instructions Rep liaison Module unit Regional centres of excellence

Mentorship level I.e. departmental rotation Specific learning outcomes.

Self assessment competency

completed again. Log with learninf and development Log with

Learning and Development

Management of Medical Devices And Equipment Develop Rep

Training

Feedback on quality of training experience



Authorised Users & Training Needs Analysis

Medical Devices

Representative list of common medical devices

The list below is not comprehensive but gives a sense of the wide range of products

that are considered to be medical devices:

Equipment used in the diagnosis or treatment of disease, or monitoring of Patients, such as:

syringes and needles dressings catheters (urinary, cardiac) surgical instruments

Topical Negative Pressure systems Hydrojet debridement Surgical power tools

IV administration sets and pumps patient monitoring equipment e.g. cardiac

monitors oxygen cylinders/tubing/masks etc anaesthetic equipment surgical implants ultrasound/diagnostic imaging Dental equipment & materials Ophthalmic equipment Podiatry equipment Sphygmomanometers Thermometers Physiotherapy equipment

External prostheses and othoses wheelchairs and special support seating patients hoists walking aids pressure relief equipment blood glucose measuring devices hepatitis and HIV test kits urine test strips pregnancy test kits specimen collection tubes

Pressure mapping systems ie seating and gait assessment

Doctors: Consultants & Others, Qualified Nursing, Allied Health Professionals Staff, Nurse Unqualified, Managers, Administration & Clerical - Support

Some of these groups will not be medical device users or have only limited specialist contact that does not involve patient care.


The table below details people who need to know how to operate the listed equipment. It does not imply knowledge of the clinical need or application of the technology.

Some = Some (usually in specialist areas) which will require training

Yes = There is a need for all/large majority of this group to use this equipment & receive training

No = There is no need for this group to use this equipment

Staff

Equipment

Drs. Consultants

Drs. Others

Qualified Nurses

Allied Health Professionals

Nurse Unqualified

Managers Admin & Clerical

Anaesthetic equipment Some Some No Some (Podiatrist)

No No No

Blood pressure monitoring equipment

Yes Yes Yes Yes Yes No No

Defibrillating equipment Yes Yes Yes Yes Yes Yes Yes ECG writers Yes Yes Some Some Some No No Exercising equipment Some Some Some Yes Some No No Feeding pumps No No Yes No Some No No Humidifying equipment Yes Yes Some Some Some No No Infusion equipment Yes Yes Some No No No No Oxygen Cylinders/Tubing/Masks

Yes Yes Yes Yes Yes No Some (porters)

Nebulising equipment and compressors

Yes Yes Yes Some Some No No

Pressure sore relieving equipment

No No Yes Yes Yes No No

Scales/weighing equipment

Yes Yes Yes Yes Yes No No

Suction equipment electrical, manual, foot & pipeline Laerdal Sution Unit

Yes Yes Yes Specialist

Some No No No

Tourniquet equipment Yes Yes Some No Some No No Syringes/needles Yes Yes Yes Some Some No No Catheters/drainage systems

Yes Yes Yes No Yes No No

Pulse Oximeter Yes Yes Some Yes Yes No No Ultrasound images/CT/MR Scanners/Bladder

Some Some Some Some Some No No

Opthalmic Equipment & Contact Lenses

Some Some Some No Some No No

Beds, mattresses & covers

No No Yes Some Yes No No

External Prostheses & Orthoses

Some Some Some Some Some No No

Wheelchairs No No Yes Yes Yes No Some (porters)

Hoists No No Yes Yes Yes No No Walking Aids No No Yes Yes Yes No No Blood Glucose Devices Yes Yes Yes No Yes No No Hepatitis/HIV Test Kits Yes Yes Some No No No No Urine Test Strips Yes Yes Yes No Yes No No Pregnancy Test Kits Yes Yes Some No No No No Specimen Collection Tubes

Yes Yes Some No Some No Some


Disinfecting & sterilising equipment

Some Some Yes Some Some No No

Ear Syringe No Yes Yes No Some No No Syringe Driver No Yes Yes No No No No Pentron vaginal sensor Some Some No No No No No Bed Pan Washer No No No No Yes No No Respiration Monitor No No No Some No No No Vitalograph Some Some Some Some No No No Intermittent Compression Pump - Limb

No No Some Some- Physio No No No

Flocare Pump No No Some No Some No No Detector Blood Flow No No Some Yes No No No Diathermy Yes Some No No No No No Ultrasonic Therapy No No No Some- Physio No No No

Classification of Occupational Groups

Dr. Consultant Consultant grade Drs.

Dr. Other Any medical personnel who do not fall into above category

Nurse Qualified All qualified nurses except nursery nurses & dental nurses

Allied Health Professionals i.e. Physiotherapists, Occupational Therapists, Pharmacists,

Speech & Language Therapists, Podiatrists

Nurse Unqualified Nursery Nurses, Dental Nurse and Health Care Support Workers

Managers Senior Managers & Managers

Admin & Clerical All administrative staff not included in “managers” & support

staff

SUCCESS CRITERIA / MONITORING EFFECTIVENESS

Auditable standards Fifty new purchase device items will be identified from service budget information each year and checked against the centralised management system for all reusable medical devices, diagnostic and therapeutic equipment used within the organisation A review of all non PO orders for medical devices and equipment will be reported to the MDG and back to service management level. A process for identifying which permanent staff are authorised to use the equipment identified on the A safe system for ensuring that all reusable medical devices and equipment are maintained and repaired. Documentation to demonstrate that all relevant staff are trained to safely use diagnostic and therapeutic equipment appropriate to their role An approved documented process for managing the risks associated with the maintenance of reusable medical devices and equipment. Evidence to ensure that the above is implemented and monitored

Audit process

Each standard will form part of an audit schedule The review or audit will be overseen by the MDG The appropriate tool and sample size will be determined according to the audit plan. Results will be presented to the MDG and reported to the Health & Safety Committee


• Actions will be monitored as part of the MDG action plan • An annual review of at least two standards will take place • Any non-compliance against a standard will be reported to the Health &

Safety Committee.



MEDICAL DEVICES GROUP (MDG)

Terms of Reference

Medical Devices Group Purpose of the Group The purpose of the MDG is to provide assurance to the Health & Safety Committee that an effective and robust system exists across Solent NHS Trust for the safe use and cost effective management of medical devices and equipment to protect staff and patients.

Reporting structure The Medical Devices Group (MDG) is a sub group of the Health & Safety committee which reports directly to the Integrated Governance and Performance Committee (IGAP) and through to the Provider Board.

Communication

Ensure the receipt of dashboard templates from the following interdependent groups/committees Health and Safety Committee Infection Prevention & Control Resuscitation Is their a moving and handling group? Decontamination associated with Medical devices and equipment will be managed through the MDG, any other areas of decontamination requirements will be managed through Infection Control.

Definition and Scope

A medical device can be defined as any instrument, apparatus, appliance, material or health care product, excluding drugs, used for a patient or client for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease diagnosis, monitoring, treatment or alleviation of an injury or handicap Investigation, diagnosis, replacement or modification of the anatomy of any physiological process control of conception

Frequency The MDG will meet bi-monthly and the MD chair will complete and forward a dashboard template to the Health & Safety chair at the end of each meeting. Template appendix B

Responsibilities

1. The MDG will identify and monitor safe systems and processes at each stage of the medical devices life cycle from device consideration to disposal.


2. The MDG will ensure the development, implementation and audit of a Solent NHS Trust wide policy and strategy for the management of medical devices to include: procurement; training; risk assessment; maintenance and replacement contracts

3. The MDG is responsible for assuring the Health & Safety Committee that there are sound systems and robust controls in place to ensure the provider organisation complies with its own local Medical Devices Policy and national NHSLA, CNST and CQC Essential Standards.

4. The MDG will act as an expert advisory group to inform and educate services and the organisation. The group will promote and foster awareness of good medical device practice across Solent Healthcare

5. The MDG will review and report all adverse events relating to medical devices and equipment reporting trends by service and equipment type. The Chair will alert the Health & Safety Committee immediately regarding any identified patient safety risk.

6. The MDG will identify and annual audit programme to ensure compliance with a policy standard.

7. The MDG will ensure a robust and current as the basis for all good practice.

8. Monitoring and review of all SLA’s relating to medical devices and equipment will be undertaken through the MDG, specifically this will include areas of procurement, clinical engineering and Estates.

9. The MDG will utilise finance advise to identify and plan a priority replacement programme and to identify efficiency savings through effective purchasing.

10. The MDG will advise on any capital developments where patients and equipment will be used.

11. Ensure appropriate arrangements are in place to facilitate effective cross-partnership working with Social Care, Voluntary Orgs, Secondary Care, Hampshire PT, MoD, HM Prisons

Membership Chair MDG Clinical representation and alternates to be identified by Clinical Associate Directors Clinical Advisor representation Equipment Services Manager Risk Manager Head of Clinical Engineering NHS Supplies Manager Estates Manager Learning and Development Patient user representative – as required Other representatives as necessary, this membership will be monitored by MDG and amended as appropriate to take into account changes to the Trust

Quorum The MDG will not be quorate unless there is a Chair, note taker and a minimum of two clinical service and two corporate function members from Solent NHS Trust.

medical devices policy - solent.nhs.uk · management of medical devices and equipment page 1...

Documents