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 Inpatients Community Locations
Mental Health Services all
Learning Disabilities Services all
Children and Young People Services 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
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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 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 Revised
Policy Category Clinical
Executive Director Deputy Chief Executive & Director of
whose portfolio this SOP comes under Resources
Policy Lead/Author
Medical Devices Group
Job titles only
Committee/Group Responsible for
Medical Devices Group
Approval of this SOP
Month/year consultation process
June 2019
completed
Month/year SOP was approved September 2019
Next review due September 2022
Disclosure Status ‘B’ can be disclosed to patients and the public
‘Purchase, loan, trial of medical device’, ‘safety
Key words relating to this SOP
tests’, approval of medical device’.
Review and Amendment History
Version Date Description of Change
Jun
1.1 SOP Reviewed with no changes made
2019
Dec
1.0 New Procedure established to supplement Medical Devices Policy
2015
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