Medical Device and Equipment Management Policy

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Policy Title:

MEDICAL DEVICE AND EQUIPMENT MANAGEMENT POLICY

Executive Summary:

The purpose of this policy is to ensure that all devices and equipment legitimately brought into the organisation:

1. Are suitable for their intended purpose 2. Offer compatibility with current equipment and clinical

practice 3. Meet clinical needs and are understood by the trained

users 4. Operates in a safe and serviceable condition 5. Complies with safety and quality standards 6. Identifies capital and revenue consequences for

budgetary purposes

The policy describes the systems and processes to manage the risks identified above. It has been designed to satisfy guidance published by the National Audit Office and the Medicines and Healthcare Products Regulatory Agency (MHRA).

Supersedes: V3

Description of Amendment(s):

Updated references Compliance – monitoring and reporting

This policy will impact on: All users of medical equipment and devices

Financial Implications:

Policy Area: Medical Device Management

Document Reference:

ECT002918

Version Number: V4.0 Effective Date: March 2018

Issued By: Medical Director Review Date: March 2021

Author: Medical Engineering Manager

Impact Assessment Date:

N/A

APPROVAL RECORD

Committees / Group Date

Consultation: Medical Devices Group October 2017

Risk Management Sub

Committee

January 2018

Approved by: Risk Management Sub

Committee

January 2018

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Contents: Section Title Page 1.0 Introduction 4 2.0 Legislation and guidance 4 3.0 Policy Statement 4 4.0 Medical device definition 5 5.0 Managerial and users responsibilities 5 6.0 Lifecycle management of devices 7 7.0 Evaluation, selection and acquisition 7 8.0 Standardisation 8 9.0 Single use devices 8 10.0 Acceptance testing of new equipment prior to use 8 11.0 Deployment and use of devices 8 12.0 Decommissioning and disposal 9 13.0 Reporting adverse incidents and disseminating medical device alerts 10 14.0 Manufacturer’s instructions: user and technical manuals 10 15.0 User training and competency assessment 11 16.0 Prescription and loan of devices to patients 12 17.0 Maintenance and repair of equipment 12 18.0 Monitoring compliance 14 19.0 Policy review 14 20.0 References 14

Appendices A Definition of a medical device 15 B New product request form 17 C Medical devices group – organisational make up 22 D Example fault reporting and contamination status form 23

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1 Introduction Medical devices and equipment play a key role in healthcare. They are vital for diagnosis, monitoring, rehabilitation and care. Effective management of this important resource is necessary to provide safe and high quality patient care, clinical and financial governance, including minimising risks relating to adverse incidents. There is a risk that the Trust could be subject to litigation if it could not be proved that there were management systems in place to deal with this. Good medical device management will greatly assist in reducing their potential for harm. 2 Legislation and guidance The MHRA recommends a medical device and equipment management system that promotes the safe use of medical devices for effective healthcare. Care Quality Commission: Guidance for providers on meeting the regulations (2015) references Regulation 15 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, states that equipment used by the service provider must be –

1) Kept clean and cleaning must be done in line with current legislation and guidance 2) Suitable for the purpose for which it is being used. It should only be used for its

intended purpose and by the person for whom it is provided 3) Stored securely, properly used and maintained in line with manufacturer’s

instructions 4) Appropriately located for the purpose for which it is being used. This means that it

must be available when needed, or obtained in reasonable time as not to pose a risk to the person using the service.

Providers must also ensure that staff and others who operate equipment are trained to use it properly. East Cheshire NHS Trust has a duty of care towards its employees and patients to ensure that they are not put at risk, e.g. from medical devices that are not managed appropriately, may be unsafe or unsuitable, are not maintained or who’s operation is not understood by the user. 3 Policy Statement This policy describes the systems to manage and mitigate the risks associated with the acquisition, deployment, planned preventative maintenance, repair and disposal of medical devices within the organisation. It also gives guidance on user training. Amongst others, this policy is based on the recommendations of the MHRA document Managing Medical Devices – Guidance for healthcare and social services organisations (April 2015).

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4 Medical device definition The Medical Devices Directive (MDD) 1998 harmonised the regulatory requirements for medical devices within the EU, including the UK, and defines a medical device as: Any instrument, apparatus, appliance, material or article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

Diagnosis, prevention, monitoring, treatment or alleviation of disease

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

Investigation, replacement or modification of the anatomy or of a physiological process, which does not achieve its principle intended action in or on the human body by pharmacological, immunological or metabolic means, but may be assisted in its function by such means.

This policy is applicable to ALL medical devices and equipment in use within the Trust, either purchased directly or through Trust funds, public donations, loan, lease, hire, consumables deals and free gifts. A non-exhaustive list of types of medical devices can be found in Appendix A. 5 Managerial and Users Responsibilities 5.1 Chief Executive

The Chief Executive is the duty holder on behalf of the Trust Board and has ultimate responsibility for all policies and their implementation.

5.2 Medical Director

The Medical Director is accountable for ensuring that there are systems and processes in place for the safe use and management of Medical Devices across the trust.

5.3 Director of Finance and Facilities (DoFF)

The Director of Finance and Facilities is the Executive Director responsible for maintenance services and assumes delegated responsibilities of the Chief Executive for maintenance. He/she has overall responsibility for the Estate Services, including the Medical Engineering Department.

5.4 Medical Devices Safety Officer (MDSO)

The Medical Devices Safety Officer (Clinical and Professional Development Training Manager) is responsible for coordinating medical device safety and management arrangements across the organisation. He/she is the key point of contact for medical device related queries and is responsible for reporting medical device related adverse incidents to MHRA and other official agencies.

5.5 Head of Estates

The Head of Estates has responsibility for the Estate Services, including Medical Engineering.

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5.6 Estates Operations Manager

The Estates Operations Manager has operational responsibility for the Estate Services, including Medical Engineering. He/she ensures that existing resources are used in an efficient manner.

5.7 Medical Engineering Manager

The Medical Engineering Manager is the author of the policy and will monitor, evaluate and review the policy within the Medical Engineering Department. He/she has managerial responsibility of the Medical Engineering Team, maintenance, inspection, repair, and decommissioning of the Trust medical equipment in line with current legislation and will ensure that the policy is implemented within the Medical Engineering Department. The Medical Engineering Manager is not responsible for medical devices and equipment that are managed under separate service contracts by other departments.

5.8 Medical Engineering Team

The Medical Engineering Team will be responsible for ensuring that reusable portable electro-mechanical medical equipment is appropriately acceptance checked and documented accordingly, following notification of receipt. All in-house maintenance will be carried out in accordance with MHRA and manufacturer’s guidance and time frames where applicable.

5.9 Procurement Team

The Procurement Team is responsible for ensuring that newly delivered medical devices and equipment are compatible with the specifications set out in the purchase order document. They act as primary liaison between the Trust and the supplier in the event of damaged or inappropriately delivered equipment.

5.10 Medical Devices Facilitators

The Medical Devices Facilitators are responsible for ensuring appropriate updating of the medical devices training records and devices register following notification of receipt of or withdrawal of equipment from the Trust.

5.11 Deputy Directors/Heads of Service and Ward/Department Managers

The managerial responsibility for the implementation of this policy remains with the Deputy and Associate Directors, General and Operational Managers and Ward/Department Managers. They should ensure that key clinical staff are identified and are responsible for the operation implementation and monitoring of this policy within their own clinical and other areas of work. They are responsible for ALL devices in use on their areas at all times. Therefore as owners of this equipment, it is their responsibility to ensure that all their equipment is maintained adequately to the manufacturer’s recommendations and timeframe, including external maintenance contract provisions. Incidents relating to medical devices should be reported via the Datix incident reporting system.

5.12 All users of medical devices

All users of medical devices are responsible for ensuring that appropriate acceptance checks have been carried out on newly delivered equipment, that it is fit for purpose, is serviceable and safe to use, and that its operation is understood.

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6 Lifecycle Management of Devices

The management of medical devices involves its lifecycle. This requires a systematic

approach to the following:

Acquisition, including identifying the need for the device.

Acceptance checking pre-use

Deployment

Maintenance and performance verification

Repair

Disposal of redundant/obsolete devices, including safe decommissioning

A vital part of effective medical device management is the creation and maintenance of equipment inventories for equipment in use within the Trust. The Medical Engineering Department is responsible for maintaining a computerised inventory of the equipment it maintains. Clinical departments are responsible for the creation and maintenance of local inventories for equipment that is NOT maintained in-house by Medical Engineering, to ensure that it is maintained appropriately by external service providers within recommended timescales. Financial information relating to equipment deemed to be “capital purchases” is identified at point of purchase and is added to a financial asset register managed by the Trust’s Estates Department. This inventory is for financial capital charging purposes and does not relate to equipment maintenance.

7 Evaluation, selection and acquisition

The evaluation, selection and acquisition of a medical device is made taking account a

number of factors:

Requirements for the intended medical procedure or treatment

Suitability for the intended purpose or application

Safety issues and limitations of use

Compatibility with existing systems/equipment

Ease of use

Availability of and scope of training

Decontamination and disposal procedures

Maintenance and testing requirements

Whole life costs – acquisition, maintenance and consumables, training and risk

Reliability and previous performance

All requests for evaluation or acquisition of any medical device or equipment can only be processed in accordance with this policy. A ‘new product/service request form’ must be completed (See Appendix B for example) and submitted. The forms can be obtained from the Procurement Team, and once completed will be passed to the medical devices group (See appendix C) for consideration. If the group considers that there are areas of non-

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conformity with the proposed equipment, and/or that the Trust may not meet its statutory requirements, they will advise the user accordingly. 8 Standardisation

East Cheshire NHS Trust, wherever practical, operates a standardisation policy when purchasing new medical devices or equipment. This ensures that unless there are valid clinical, technical or financial reasons, similar and up to date models of equipment from the same manufacturer are purchased to ensure:

Ease of user training

Reduction of risk due to device familiarity

Availability of in-house technical and training expertise

Cost benefits in terms of consumable usage

Cost reduction due to economies of scale if external service contract required

Rapid exchange of equipment between clinical areas in the event of failure or

incident

In the event of technically advanced equipment being introduced to the Trust, evaluations will take place and the standardisation policy reviewed in agreement with the medical devices group and affected parties.

9 Single Use Devices

Single use medical devices are designed to be used on an individual patient during a single procedure and then discarded. These devices are NOT intended to be reprocessed and used on another patient. The device labelling or user instructions identify the device as disposable and not to be used again. It is Trust policy that no item designated as single use will be reprocessed or reused under any circumstances. This universal symbol signifies single use items:

10 Acceptance Testing of New Equipment Prior to Use

Acceptance checks are defined as those tests and checks that need to be performed on newly delivered equipment and devices as they enter the organisation for the first time. Simple checks on delivery can avoid trouble and save time. Finding out that a device is broken or inappropriate, only when someone tries to use it for the first time, can delay or interrupt treatment. It may also make it harder to establish where and when the problem arose and may invalidate warranties. Refer to the guidance document “Acceptance Checking of Medical Devices and Equipment entering the organisation” for more information. The medical engineering team are responsible for ensuring that newly delivered reusable portable electro-mechanical medical equipment, entering the organisation via medical engineering, is appropriately acceptance checked and documented accordingly, following notification of receipt.

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11 Deployment and use of devices

Operational managers of healthcare services delivered on wards and departments are the designated “owners” of a wide range of medical equipment and devices. They are responsible for ALL devices in use on their areas at all times. This includes equipment that is owned by the department and also those items that have been borrowed, leased, hired or donated from whatever source. Any agreement by the Medical Devices Group for equipment to be used in trials does not preclude the need for the appropriate consent from patients. Therefore, equipment users intending to trial any medical device for evaluation purposes must obtain consent from any patient if the device is likely to be used as part of any treatment or therapy plan. All devices designated “high risk” by the Medical Devices Group must have operating instructions available to guide the user in the correct operating procedure to ensure the device is being used appropriately without increased risk to the patient or user. Managers and staff using the devices have specific responsibilities to reduce any risk associated with using and operating them. These responsibilities include:

Taking great care and visually inspecting all devices before use, ensuring that there are no signs of damage

Selecting the correct device for use, ensuring that it is appropriate to the patient's condition

Ensuring staff competency in using the device and have received training where necessary

Ensuring that the device is working properly and is set up safely

Monitoring the progress/function of the device

Monitoring the patient using or attached to the device

Knowing how to respond in the event of a problem with a device to reduce the risk to the patient

Ensuring any damaged or suspected faulty device is checked by a competent person

Storing all devices safely to avoid unnecessary damage

Keeping any battery-operated device charged up where required

Checking that the device is regularly maintained

Checking that any disposables are appropriate and safe to use 12 Decommissioning and disposal Decommissioning aims to make equipment safe and unusable, while minimising damage to the environment. Equipment deemed unfit for use should be decommissioned. This should include decontamination, making safe and unusable. This is to ensure that inappropriate persons do not use the equipment and expose themselves or others to hazards. Users should consult the Medical Engineering Department or the Estates department for advice before decommissioning commences. Disposal of electrical/electronic equipment should comply with the Waste Electrical and Electronic Regulations 2013. Consult the Medical Engineering Department or the Estates Department in the first instance. Some waste products need specialised disposal. Examples include:

wastes containing certain metals (e.g. Mercury above 3% and some batteries)

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oil wastes

wastes from coolants

radioactive waste

healthcare waste from human or animal origin

human waste from natal care, diagnosis, treatment or prevention of disease

Where applicable, equipment should be decontaminated before disposal or transfer to a third party and supplied with a certificate of decontamination. When returning medical devices to the manufacturer at end of life, or when transporting devices, ensure that they are appropriately packaged and secured. Issues that should be addressed include: strength of packaging materials, protecting sharp edges and ensuring that the device cannot get damaged during transit. Legislation applies to the transport of goods by road and rail:

The carriage of dangerous goods and use of transportable pressure equipment (amendment) regulations 2011

Chemicals (hazard information and packing for supply) regulations 2009

The radioactive material (road transport) regulations 2002 If a device stores patient identifiable data this should be securely erased or hard drives removed and sent to IT for destruction when the device is decommissioned. Data on any device should be forensically unrecoverable. 13 Reporting adverse incidents and disseminating medical device alerts For all incidents involving medical devices that occur within the Trust, in the first instance ensure that any patient and/or staff wellbeing and safety is not compromised, then immediately remove the item from use. The department manager must then be informed as soon as possible after the incident. Detailed guidance on what to do in the event of a medical device incident can be found in the “Incident Reporting Policy”. Also contained within the policy is guidance to equipment users on the requirement to report incidents involving medical devices to various external agencies. Once equipment involved in an incident has been removed from use, users must do the following:

Quarantine the suspect device, together with any associated consumables. DO NOT DISPOSE OF ANY SINGLE ACCESSORIES!

Inform Medical Engineering (Ext 1930) as soon as possible after the event. DO NOT CONTACT THE MANUFACTURER OR EQUIPMENT SUPPLIER!

The equipment should clearly labelled FAULTY EQUIPMENT – DO NOT USE. The department manager should then liaise with the Medical Engineering Department manager or Medical Device Facilitators who will determine if the equipment is safe to use.

From time to time, the Trust generates and also receives medical device safety alerts from external agencies such as the Medicines and Healthcare Products Regulatory Agency (MHRA), the National Patient Safety Agency (NPSA) and others through the Central Reporting System. These alerts are systematically reviewed and disseminated throughout the organisation via Datix. Equipment users are responsible for ensuring they read and act upon any safety alerts that are distributed to them.

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14 Manufacturer’s Instructions: User and Technical Manuals Manufacturers of medical devices provide both user and technical instruction manuals relating to the safe and proper use of the device. Therefore, all items of medical devices and equipment within East Cheshire NHS Trust should be supported by both user and technical instruction manuals. The Medical Engineering Department will take responsibility, within the organisation, for the receipt and distribution of all instruction and technical user manuals relating to newly delivered Medical Equipment entering the organisation via Medical Engineering. Clinical and Associate Directors, through their clinical operations managers, have the responsibility for ensuring that user manuals for equipment used within their areas are made available to the clinical end-user. All clinical staff should be aware of the location of user manuals, whether written or electronic, relating to any device they intend to use and be competent in the use of the device. All devices should be checked for the correct supply of user and technical manuals when the device enters the organisation. Refer to the guidance document “Acceptance Checking of Medical Devices and Equipment Entering the Organisation” for further information. User manuals will accompany the device to its intended location. User manuals should be either attached to the device or stored locally in a location that is both accessible to users and known to them. All technical service manuals pertaining to medical equipment will be retained within the Medical Engineering Department. 15 User Training and Competency Assessment Managers and staff members are responsible for identifying which individuals should use medical devices and identify appropriate training in accordance with the requirements of the particular device. The Medical Devices Facilitators will seek assurance from equipment users that they have received adequate training in the safe and proper use of the device. Training may take the form of formal classroom teaching, informal training on the wards, or external training. Training must be delivered by appropriately trained trainers (in-house or external) or experienced individuals identified and evidenced locally as competent. It is the responsibility of Managers and staff to ensure that all training received is recorded on ESR. This can be done by either providing copies of registers to the Medical Devices Facilitators or by directly sending registers to the Learning and Development administration team. The assessment of user competency in accordance with requirements for individual devices should be established and managed locally. It is recommended that medical device competency assessment is aligned with the process for assessment of other core clinical competencies which takes the form of an initial self-assessment followed by formal or peer assessment.

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Records on competency assessment should be maintained locally unless the competency is assessed as part of formal training, in which case, it will be recorded on ESR. In accordance with MHRA requirements, staff must update high risk medical device training every 3 years. There are some exceptions such as ALS training where automated defibrillator competency is assessed and updated every 4 years. All exceptions must be approved through the Risk Management sub group. All healthcare professionals are responsible for ensuring that, as part of their continuing professional development, they acquire and maintain competency and disseminate knowledge and skills in the use of medical devices. 16 Prescription and Loan of Devices to Patients As medical devices become more sophisticated and frequently used, there are risk implications for the healthcare professionals and patients who use them. Prescription of a medical device is the process that ensures only the most appropriate item of equipment is given to a patient or carer as part of an overall treatment plan. Clinical risk is reduced by permitting only appropriately trained healthcare professionals to prescribe a medical device for use by patients. The person prescribing will need to have the knowledge and skills to ensure that:

an appropriate device has been selected

the device has been appropriately maintained and decontaminated

it has been adjusted (if necessary) for the individual patient

the patient or carer is educated and supported in its use

appropriate documentation has been completed Competency in the correct use of medical devices will ultimately result in a reduction in clinical risk and the delivery of high quality care. 17 Maintenance and repair of medical equipment Operational managers of healthcare services delivered on wards and departments within the Trust are the designated “owners” of a wide range of medical equipment and devices. They are responsible for ALL devices in use on their areas at all times. Therefore as owners of this equipment, it is their responsibility to ensure that all their equipment is maintained adequately to the manufacturer’s recommendations and timeframe. Advice on equipment maintenance issues can be sought from the Medical Engineering Department Manager, extension 1930. The majority of medical equipment maintenance in the Trust is provided ‘in house’ by Medical Engineering. Equipment not maintained by Medical Engineering is maintained by external service contracts with equipment suppliers. Clinical departments will maintain a local inventory of all equipment serviced and maintained via external service contracts. It is their responsibility to ensure that all equipment is maintained to the manufacturer’s recommendations and timescales. For all ‘in house’ maintenance work Medical Engineering has a planned maintenance programme, which aligns to MHRA guidance, and that provided by equipment

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manufacturers, for their schedule of servicing. All maintenance and calibration is as per manufacturer’s guidance and timescales. The planned preventative maintenance system utilises a computerised register of medical equipment, which highlights equipment that is due for maintenance, the servicing that is required and also the timescale for completion of the work. It is therefore important for users, subject to their immediate clinical needs, to make their equipment available upon request for routine maintenance at any given time. In house test equipment, used in the calibration and testing of medical equipment, is calibrated in accordance with the test equipment manufacturer’s guidance via external companies. Records of medical devices maintained by Medical Engineering are kept for a period of 11 years. The computerised database gives an electronic record of maintenance history; whilst the paper records are archived after a period of no less than 2 years and are send to a specialised documents retention company. The paper records can be recalled for inspection at any time should there be a genuine requirement to examine them. Where high risk equipment on the Medical Engineering Register is identified as being past the recommended maintenance date, a late notification letter will be sent to the owner to inform them that the particular piece of equipment needs maintenance, and that arrangements should be made to facilitate this. If no response is received within 30 days from the date of notification, and the equipment maintenance is still outstanding, the issue will be escalated in the form of a letter to the Business Unit Manager for action. After a further 30 days, if no response is received, and the equipment maintenance is still outstanding, the details of the equipment will be placed on a ‘Not Located Register’ held in the Medical Engineering Department. In the event of a fault occurring with an item of medical equipment, the user must remove the equipment from use and inform the appropriate maintenance provider. Under no circumstances must users attempt to repair the equipment themselves. It is important for users to be mindful of the fact that items of re-usable medical equipment intended for repair and used in the treatment of patients may become contaminated with hazardous substances during use. Users are reminded that the policy” Decontamination of Medical and Laboratory Prior to Repair or Maintenance” provides guidance on this. Equipment and device users are encouraged to familiarise themselves with the contents of this document. The policy referred to above states that ALL items of equipment intended for service, repair, inspection or transportation either within or external to the Trust MUST be provided with a “Medical Equipment Fault Reporting and Contamination Status Form” (see Appendix D). The forms are available in a duplicate booklet format from the Medical Engineering Department, Ext 1930. If equipment, that is maintained in house by Medical Engineering, develops a fault, then users can contact the department directly to raise a reactive maintenance request on Extension 1930. As per Trust policy, a Medical Equipment Fault Reporting and Contamination Status Form must accompany the equipment prior to repair. If items are presented to hospital staff or contractors for service or inspection on hospital premises, or dispatched to suppliers, without a declaration of contamination status and without prior agreement, they may rightly refuse to handle such items until suitable

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decontamination has been applied and a declaration provided. This may result in delays to the repair and/or incur additional costs. 18 Monitoring Compliance

The Risk Management Sub-committee will receive and approve:

Review of ‘Medical Device and Equipment Management Policy’ and periodic

updates

6 monthly compliance audit reports

KPIs Monitored by Monitoring Frequency

Information reported to

Performance review undertaken to ensure policy compliance in relation to planned preventative maintenance activity delivered in house by Medical Engineering

Estates Compliance and Performance Officer

6 monthly Estates Statutory Compliance Group, Risk Management Sub-committee

Policy Review Medical Engineering Manager

3 yearly Medical Devices Group, Risk Management Sub-committee

19 Policy Review A formal review of this policy will be undertaken by the Medical Engineering Manager within 3 years of the date of issue or as necessary due to the publication of new legislation or guidance. 20 References Care Quality Commission: Guidance for providers on meeting the regulations (2015) Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 MHRA: Managing Medical Devices – Guidance for Healthcare and Social Services Organisations April 2015 The Medical Devices Directive (MDD) 1998 Waste Electrical and Electronic Regulations (WEEE) Regulations 2013 The Carriage of Dangerous Goods and use of Transportable Pressure Equipment Regulations 2009 Chemicals (Hazard Information and Packing for Supply) Regulations 2009 The Radioactive Material (Road Transport) Regulations 2002 Guidance document Acceptance Checking of Medical Devices and Equipment Entering the Organisation, East Cheshire NHS Trust 2016. Policy for the Decontamination of Medical and Laboratory Equipment prior to repair or maintenance, East Cheshire NHS Trust 2016.

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APPENDIX A

Definition of a medical device

The list below is not exhaustive, but gives a sense of the wide range of products that the MHRA consider to be medical devices. Equipment used in the diagnosis or treatment of disease, or monitoring patients, such as:

Syringes and needles

Dressings

Catheters (urinary, cardiac)

Surgical instruments

Endoscopes

IV administration sets and pumps

Patient monitoring equipment (e.g. cardiac monitors)

Anaesthetic equipment

Surgical implants (e.g. orthopaedic prosthesis, bone cements, heart valves)

Powered implants (e.g. pacemakers, implantable defibrillators)

Radiology Equipment, including Ultrasound imagers and CT/MRI scanners

Radiotherapy Equipment

Dental equipment and materials

Ophthalmic equipment

Chiropody equipment

Sphygmomanometers

Thermometers

Physiotherapy equipment

Beds, mattresses and covers

Examination gloves Equipment used in life support, such as:

Ventilators

Defibrillators In vitro diagnostic medical devices and their accessories, such as:

Blood gas analysers

Blood glucose measuring devices

Hepatitis and HIV test kits

Urine test strips

Pregnancy test kits

Specimen collection tubes Equipment used in the care of disabled people, such as:

External prosthesis and orthoses

Wheelchairs and special support seating

Patient hoists

Walking aids

Pressure relief equipment

Aids to daily living

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Commodes

Hearing aids

Urine drainage systems

Domiciliary oxygen therapy systems

Incontinence pads

Prescribable footwear Equipment used by ambulance services, but not the vehicles themselves, such as:

Stretchers and trolleys

Resuscitators Other examples of medical devices include:

Condoms

Contact lenses and care product

Intra-uterine devices (IUD’s)

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APPENDIX B

Part 1 New Product/Service Request Form

STAKEHOLDER SECTION: For completion by a Trust Clinician ONLY. In confidence.

This information must not be shared with a Supplier Name

Job title

Service Line

Product Code and Description of Item including any required Consumables/ Accessories

If this an Equipment Trial/ Purchase

If Equipment Trial State Date of Intended Commencement and Finish Date

Company Name and Address

Have you been approached by the Supplier to evaluate this product/service?

Yes No

Name of commercial rep

Contact email Contact number

Is the product classed as a medical device? Yes No

Is the product CE Marked? Yes No

How will the product/service significantly improve clinical outcome, and/or service provision?

Will the introduction of this product/service, have a significant effect on Service Line/Lines in relation to cost savings/pressures? E.g. Has funding been identified

Will Training be required? If required who will provide and is there an additional cost?

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Will maintenance be required? If required who will provide it and is there an additional cost?

State Life expectancy of the Equipment and disposal/ replacement policy

Does the Equipment/ accessory require decontamination if required provide basic instructions

Name any Service Line Boards that the Trial Outcome Report will be Communicated to including Quality Impact Assessment

Has any Clinical Evidence been supplied? Yes No

Details:

Are there any current UK based NHS Reference sites which could be approached?

Yes No

Details:

Risk Assessment

RISK ASSESSMENT FORM (To be attached to Equipment Request Form)

IF EQUIPMENT WAS NOT PURCHASED/TRIALLED, THEN:

A) IMPACT (Score 1-5) =

Assessment of impact is as follows: (give the reasons for your score and describe implications to the Trust if equipment was not purchased/trialled).

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B) LIKELIHOOD OF OCCURRENCE (Score 1-5) =

If not purchased, assess how likely is the impact to occur. Give the reasons why you have come to your conclusion.

TOTAL RISK SCORE (Multiply AxB) =

Authoriser …………………………………….…………………… Directorate Lead/ Clinical Director

Part 2

For completion by the Medical Devices Group Name

Has the information, submitted been reviewed and confirmed as correct?

Yes No

References Checked? Yes No

Comments:

Additional Information:

Has the new product /service request been Approved By The Medical Devices Group

Yes No Date

Comments/Outcome re discussion:

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Authorisation of Product/Service Request Product/Service accepted by Procurement

Is the product/service for consideration already On National or Regional Contract

No

Yes Please state which framework

Yes No

Comments

Product/Service accepted by Infection Control

Yes No

Comments

Product/Service accepted by Medical Engineering

Yes No

Comments

Product/Service accepted by Moving and Handling

Yes No

Comments

Product/Service accepted by Clinical Professional Development Training Manager

Yes No

Comments

Product/Service accepted by Head of Safety Risk and Resilience

Yes No

Comments

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Part 3 Risk Classification by Medical Devices Group To be completed if item(s) Purchased

Is This Items a High/ Medium/ Low Risk? Comments

Email sent to ESR for inclusion on Medical Device Data Base

Date

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APPENDIX C The Medical Devices Group comprises representation from the following areas, approved by the Risk Management sub-committee:

The Medical Director

Infection prevention and control

Medical Devices Safety Officer (MDSO)

Procurement department

Medical engineering

Moving and handling

Clinical professional development training

Clinical risk management

Clinical directorates

Other professionals as appropriate In summary, the group is responsible for providing information and assurance to the Trust Board, via the Risk Management Sub-committee, that it is safely managing all issues relating to medical devices via the integrated governance structure, and that newly acquired medical devices used by staff and others on behalf of East Cheshire NHS Trust:

Are safe

Are appropriate with the trust’s purchasing strategy

Are and can continue to be adequately maintained

Are funded, including installation, training, maintenance and revenue costs

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APPENDIX D MEDICAL EQUIPMENT FAULT REPORT No. 0000000 & CONTAMINATION STATUS FORM Equipment user to complete Parts 1,2 & 3 and attach white copy to the item requiring attention. PART 1 EQUIPMENT

DEVICE TYPE/MODEL/NAME

ASSET/SERIAL NUMBER

DESCRIPTION OF FAULT/CONDITION: (report the last settings & what you consider to be the problem) INCIDENT REPORT: If this equipment was involved in a clinical incident, please quarantine the device along with any other material evidence (e.g. infusion giving-sets etc) and supply the incident report number: …………

PART 2 DECLARATION OF CONTAMINATION STATUS (tick box A or B giving details as required) Advice on decontamination can be obtained from the Cleaning Policy contained in the Infection Control Manual and also the policy for the Decontamination of Reusable Medical and Laboratory Equipment and Devices Prior to Repair, Service, Inspection or Transportation.

A This equipment / item HAS NOT been used in any invasive procedure or been in contact with

blood, other body fluids, expired gases or pathological samples. It has been externally cleaned prior to inspection, service, repair or transportation. (now go to part 3)

B This equipment / item MAY have become exposed internally or externally to hazardous

materials as indicated below (please appropriate box). It has been externally cleaned prior to inspection, service, repair or transportation.

Blood Chemicals Any other Biohazard (Please state)

Body Fluids Substances Hazardous to Health

Pathological Samples Radioactive Contamination

If the device could not be decontaminated please state why: ……………………………………………………………………………………………………………………………………….

IT IS ILLEGAL TO SEND CONTAMINATED ITEMS THROUGH THE POST PART 3 I declare I was the last user of this equipment and have taken all reasonable steps to ensure the accuracy of the above information. Signature: ……………………………………… Name of Trust or organisation: …………………………………………… Print Name: …………………………………... Ward/Department: ……………………………………………………………… Job title:…………………………………………. Date: ………………………………..Tel no: ……………………………………… Equipment sent to: …………………………………………………………………………………………………………………………….