Standard Operating Procedure 3 (SOP 3)

Acceptance of Medical Devices from Manufacturers/ Suppliers Why we have a procedure? When equipment has been purchased, loaned or trialled, it must undergo acceptance testing. This procedure is necessary to ensure all staff involved in the purchase, loan or trial of medical devices follow the correct process for the acceptance of medical devices. Adherence to this procedure will ensure that all relevant safety tests and other checks are undertaken to demonstrate compliance with CQC Regulation 12: Safe Care and Treatment. It will also ensure that the equipment is suitable for the intended purpose in compliance with CQC Regulation 15: Premises and Equipment. All acceptance and commissioning undertaken will follow the criteria stipulated in MHRA’s Managing Medical Devices (2014).

What overarching policy the procedure links to? Medical Devices Policy

Which services of the trust does this apply to? Where is it in operation? Group Mental Health Services Learning Disabilities Services Children and Young People Services

Inpatients   

Community   

Locations all all all

Who does the procedure apply to? Team Leaders/Ward and Department Managers/Senior Nurses/Operational Managers whose Group/department wishes to trial, loan, lease or purchase a medical device Procurement Managers and Buyers involved in the purchase of medical devices

When should the procedure be applied? When medical devices have been purchased, loaned or trialled by the Trust

Acceptance of Medical Devices from Manufacturers/Suppliers

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How to carry out this procedure When equipment has been purchased, loaned or trialled it must undergo acceptance testing which will be carried out by MPCE. Firstly details of order number/ward/site must be forwarded to MPCE when the order has been raised, these details must be provided by Procurement or the Department/ Ward Manager All equipment, except for large items will be delivered to the relevant section of MPCE Department to allow all appropriate checks to be undertaken Once acceptance testing is complete the equipment will be entered onto the the Trust Medical Device asset register by MPCE and allocated an inventory number and a user training identification label Where applicable an electrical safety test will be carried out and a label attached to the mains cable/device All new devices will be allocated a training risk status of High, Medium or Low. A label will be attached identifying its category The medical device will then be delivered to the relevant ward/department

What do these terms mean? CQC - Care Quality Commission are the independent regulator of health and adult social care in England. They make sure health and social care services provide people with safe, effective, compassionate, high-quality care and encourage them to improve MHRA - Medicines and Healthcare products Regulatory Agency is a government body which was set up in 2003 to bring together the functions of Medicines Control Agency (MCA) and Medical Devices Agency (MDA). These include the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents MPCE - Medical Physics and Clinical Engineering Department provides a device management service to the Trust. Medical device management includes a wide range of activities: Advice and assistance with equipment evaluation prior to purchase Help with Deciding on the model that most fits the user department needs Preparation ready for implementation of the device which includes commissioning the equipment and training the staff how to use it Technical and clinical support of the equipment and staff during its life time Planned end of life replacement Correct disposal of the old equipment

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Acceptance of Medical Devices Flow Chart Devices procured must follow Trust procedure for procurement of medical devices

Small/portable devices will be delivered direct to EBME contractor at Medical Physics Department New Cross Hospital For acceptance testing of large devices they are to be delivered to point of use with testing being carried by the contractor service provider onsite

The contractor will be advised of order via the Trust Micad Helpdesk. The Trust Micad system will raise inventory number for the devices and devices will also be registered on the contractor’s system

The contractor will liaise with user to arrange a convenient time to carry out acceptance tests if the device is being delivered to direct to point of use

Following completion of acceptance testing of small/portable devices the contractor will deliver to the end user or arrange transport with Trust transport services

The contractor will provide Medical Device Trainers with details of all new devices to ensure the information is captured on the training database

The contractor will carry out acceptance testing process in accordance with MHRA Management of Medical Devices (2014)

On completion of acceptance tests and following delivery to user the contractor will complete and close its own database and Micad jobs

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Where do I go for further advice or information? Medical Devices Group Ensure that the Trust has access to appropriate expert advice as required Oversee the evaluation and procurement of all products classified as medical devices by MHRA Ensure that financial implications are considered at all stages in relation to medical devices and develop close working with the Capital Programme lead within the Finance Directorate Nominated Medical Device Leads (Clinical Groups) and Team Leaders in Community Services Ensure that requests for medical devices include the Risk Assessment, Acceptance Checks, training and maintenance arrangements Ensure medical devices are purchased to meet the needs of the users and ensure the best practicable patient experience within budgetary constraints to meet clinical need, whilst allowing for ease of decontamination and maintenance Ensure a common procedure is followed for accepting new devices into service including identifying significant risks associated with use, repair, cleaning and disposal and updating the inventory of new equipment as set out in the standard procedures which support the implementation of this policy Team Leaders/Ward & Department Managers/Senior Nurses/Operational Managers Identify the level of clinical risk and training required for medical devices in use within their service Retain instruction manuals, technical instructions etc. relating to medical devices and make them available to end users All clinical wards/departments have responsibility for having an up-to-date inventory of all their medical devices within the area under their control and work closely with MPCE in keeping their list up to date Infection Prevention & Control Team Advise accordingly in line with this procedure The Medical Physics and Clinical Engineering department Assist the Trust to develop an ‘approved products list’ for all medical devices used across all departments Ensure all medical non-disposable devices in use are CE marked Preparation ready for implementation of the device which includes commissioning the equipment and training the staff how to use it Training Staff may receive training in relation to this procedure, where it is identified in their appraisal as part of the specific development needs for their role and responsibilities. Please refer to the Trust’s Mandatory & Risk Management Training Needs Analysis for further details on training requirements, target audiences and update frequencies.

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Monitoring / Review of this Procedure In the event of planned change in the process(es) described within this document or an incident involving the described process(es) within the review cycle, this SOP will be reviewed and revised as necessary to maintain its accuracy and effectiveness Equality Impact Assessment Please refer to overarching policy Data Protection Act and Freedom of Information Act Please refer to overarching policy

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Standard Operating Procedure Details Unique Identifier for this SOP is

BCPFT-CLIN-POL-12-3

State if SOP is New or Revised

New

Policy Category

Clinical

Executive Director whose portfolio this SOP comes under Policy Lead/Author Job titles only Committee/Group Responsible for Approval of this SOP

Deputy Chief Executive & Director of Resources Medical Devices Group Medical Devices Group

Month/year consultation process completed

April 2015

Month/year SOP was approved

November 2015

Next review due

December 2018

Disclosure Status

‘B’ can be disclosed to patients and the public

Key words relating to this SOP

‘Purchase, loan, trial of medical device’, ‘safety tests’, approval of medical device’.

Review and Amendment History Version

Date

Description of Change

1.0

Dec 2015

New Procedure established to supplement Medical Devices Policy

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