Standard Operating Procedure 7 (SOP 7)

Decontamination of Medical Devices Prior to Service,

Repair or Disposal
Why we have a procedure?

Healthcare organisations should keep patients, staff and visitors safe and have
procedures in place to ensure that all reusable medical devices are properly
decontaminated prior to use, maintenance and disposal, and that the risks associated
with decontamination facilities and processes are well managed. This procedure is in
compliance with CQC Fundamental Standards- sections A and E of Regulation 15:
Premises and Equipment. The intention of this regulation is to make sure that the
equipment that is used to deliver care and treatment is clean, suitable for the intended
purpose, maintained, stored securely and used properly.

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?

Authorised Staff of diagnostic and therapeutic equipment

Ward/Department Managers

When should the procedure be applied?

This procedure should be applied when a re-useable medical device requires
decontamination: after each use and prior to servicing, maintenance, repair or final
disposal.

Devices intended for single-use only do not require decontamination, except where they
are implicated in an adverse incident and may need to be sent to the manufacturer for
investigation. In this situation, contact the manufacturer to find out the most appropriate
method of decontamination.

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How to carry out this procedure

Decontamination requirements should be considered before reusable medical devices

are acquired to ensure they are compatible with the decontamination procedures and
equipment available.

Decontamination after Each Use

All re-useable medical devices must be decontaminated after each use and always
prior to servicing, maintenance, repair or final disposal. (Refer to Infection
Prevention and Control Decontamination Procedures and the Manufacturer’s
recommendations for decontamination methods)
Once decontamination is complete the item should be labelled accordingly

Decontamination Prior to Servicing, Maintenance, repair or Final Disposal

Prior to servicing, maintenance, repair or final disposal the ward/department must
ensure that decontamination has taken place following the manufacturer’s
recommendations
A decontamination status label must be attached to the equipment waiting for
collection/servicing or repair (see Decontamination Status Label)
Any loaned items being returned to a manufacturer or supplier should also be
decontaminated
After decontamination devices should be stored in accordance with legislation and
best practice requirements

Classification of Infection Risk Associated with the Decontamination of Medical

Devices:

What do these terms mean?

CQC - Care Quality Commission is 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

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 Decontamination Flow Chart

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 Decontamination Status Label

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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 to support
this procedure
Ensure that all aspects of medical device maintenance are addressed by appropriate
procedures
Oversee all aspects of decontamination and disposal of all medical devices

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

Team Leaders/Ward & Department Managers/Senior Nurses/Operational Managers

All clinical wards/departments must have in place a procedure where by all medical
devices are functionally checked in accordance with the manufacturers user guides
prior to use on a patient and decontaminated in line with Trust infection prevention
protocols at regular intervals and in line with manufacturers recommendations

Infection Prevention & Control Team

Advise accordingly in line with this procedure
Advise on decontamination methods of re-useable medical devices in line with the
manufacturers’ recommendations

The Medical Physics and Clinical Engineering department

Technical and clinical support of the equipment and staff during its life time
Planned end of life replacement and correct disposal of the old equipment

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.

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-12-7

State if SOP is New or Revised New

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
April 2015
completed
Month/year SOP was approved November 2015

Next review due December 2018

Disclosure Status ‘B’ can be disclosed to patients and the public

re-usable medical devices, sterilization of
Key words relating to this SOP equipment, disinfection of equipment, cleaning
of equipment, decontamination certificate

Review and Amendment History

Version Date Description of Change
Dec
1.0 New Procedure established to supplement Medical Devices Policy
2015

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2015