Standard Operating Procedure 11 (SOP 11)

Battery Maintenance for Medical Devices

Why we have a procedure?
This procedure is to ensure batteries are regularly checked, replaced or charged to
ensure that medical devices are ready for use at all times. Adherence to this policy will
ensure that battery function and life is maintained. This is in compliance with CQC
Fundamental Standards- section E of Regulation 15: Premises and Equipment. The
intention of this regulation is to ensure that all equipment used by the service provider is
properly maintained. It states that all equipment must be maintained in line with
manufacturers' instructions. The procedure also complies with CQC Regulation 12: Safe
Care and Treatment- section B. The intention of this regulation is to ensure care and
treatment is provided in a safe way for service users and doing all that is reasonably
practicable to mitigate any risks.

Batteries will naturally discharge over time. If they are not tested and regularly replaced
or recharged, they may not operate correctly when required and may even become
damaged due to extensive discharge. The organisation could be held responsible under
health and safety law and civil liability in the event that a patient or member of personnel
died or suffered personal injury or damage as a result of supplying an inappropriate
charging system.

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

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When should the procedure be applied?

When performing routine maintenance/service of battery powered medical devices.

How to carry out this procedure

Staff must always refer to the manufacturer’s instructions these should include:
 How to access the batteries
 How and when to charge
 How connections are marked to prevent incorrect fitting
 How to connect, disconnect and reconnect
 How to maintain and if necessary how to clean the connectors
 How to test the output of a battery or charger to ensure its performance is
adequate
 When to replace batteries
 Details of any fuses, overloads, circuit protection and what to do if any of these are
activated
 Guidance on battery replacement
 Battery voltage and capacity
 Battery type
 Time to charge batteries depending on conditions of use or storage
 Maintenance required including frequency for batteries, chargers, cables and
connectors

Battery Maintenance
It is essential to maintain battery function of medical devices, particularly devices that
are infrequently used such as Defibrillators. Planned preventive maintenance should
include inspections of:
 Batteries
 Chargers
 Connector cables
 Plugs
 Sockets

Staff must ensure that the correct batteries/chargers/connection cables etc. are always
retained with the device and as part of routine checks ensure the batteries are fully
charged and ready for use.

All devices with rechargeable batteries should be maintained and serviced in line with
the manufacturer’s instructions. This may require regular charging and discharging of
the battery and use of specialist test equipment to check the output and condition of the
battery or straightforward maintenance suitable for the end user to undertake.

To ensure rechargeable battery function and life is maintained all staff must:
 Charge batteries correctly in line with the device manufacturer’s instructions
 Use the correct charger
 Keep the terminals clean and free from debris

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 Check connector cables, plugs and sockets

Non-rechargeable batteries cannot be repaired if damaged, and should be replaced.

Batteries should also be removed and replaced in line with manufacturer’s instructions
when they no longer have any useable life. Repairs to the outer case of a rechargeable
battery may be possible in some circumstances, but should only be carried out by
appropriately trained personnel. This may involve the battery being returned to the
original manufacturer.

Chargers especially designed for non-rechargeable batteries are being marketed in the
UK. Users should be aware that this charging process could be hazardous, and the
recharged batteries have an extremely short shelf life. Batteries recharged in this way
are not generally suitable for use in medical devices because of their unreliability.

 When a device is not going to be used for a significant time, it may be beneficial to
remove the batteries from the device
 All batteries must be treated with care to avoid physical damage
 Batteries should be subjected to as little environmental stress as possible. This
includes storage or use outside the temperature range intended by the
manufacturer, e.g. storage in vehicles or unheated outdoor storage. Batteries,
wiring and connectors in medical devices which are left outdoors must be protected
from damp to avoid corrosion of the case, contacts, terminals or connections. High
ambient temperatures will reduce the capacity and life of the battery; low
temperatures will reduce the ability of most batteries to deliver their rated output
 Batteries should be stored in line with the manufacturer’s instructions
 Batteries in implantable medical devices, such as pacemakers, require no specific
maintenance other than voltage monitoring by the clinician in line with the
pacemaker manufacturer’s instructions, since they are sealed within the implant
 Freestanding chargers should be positioned to allow a free flow of air into and out
of the case venting or heat sinks. Chargers should not be covered or placed on
long pile carpets. During the operation of charging, the charger should be close
enough to the batteries and the mains socket to avoid strain on either of the leads.
All usage should be in line with the manufacturer’s instructions

Compatibility of Power Sources

Manufacturers of medical devices set the specification of the battery, charger, all leads
and connectors and the charging process, to ensure that the device operates correctly
during normal use. Manufacturers will also establish the detailed specification for
maintenance and future replacements.

Batteries, chargers or processes that do not meet the specification set by the
manufacturer can lead to incorrect operation or failure of the device. The user or others
may be put at risk of:
 Fire
 Shock
 Inhalation of fumes
 Inappropriate treatment (e.g. misadministration of intravenous fluids via an infusion
pump)

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 Malfunction of a device (e.g. patient hoist which does not operate as expected and
leads to injury).

For applications where the chargers, batteries and leads are constantly disconnected
and reconnected, it is essential that the plugs, leads and sockets have been designed to
cope with multiple uses. Where repair services replace cables, plugs and sockets, it
should be in line with the manufacturer’s instructions – the correct cable wiring
configuration and plug or socket should be used.

Incorrect output from a charger or an incomplete charging cycle could result in the
battery being undercharged. This may result in a reduced time of operation of the device
between charges. In other cases, incorrect output from the charger may result in
overcharging with consequent deterioration of the battery performance and of the
battery itself. The frequency with which batteries are charged depends on use.

If in a specific case it is deemed that it would be beneficial not to use the battery,
charger, connectors or charging process specified by the device manufacturer then a
risk assessment should be carried out. This should be documented to ensure that all
components within a system are compatible and can be used safely.

If a device fails in use after a part has been replaced with one that does not correspond
to the device manufacturer’s specification and this leads to the death or serious injury of
a patient / user, there is a greater likelihood of the organisation being held liable. This
liability is likely to be mitigated if a thorough, valid and documented risk assessment has
been carried out.

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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 Routine Maintenance/Service of Battery
Powered Devices.

Staff should refer to manufacturer’s instructions

for guidance

Inspect batteries, chargers, connectors, cables,

plugs and sockets ensuring all components
correspond with manufacturer's specifications.

If any of these do not correspond with

manufacturer’s specifications a risk assessment
is necessary.

Device with rechargeable Device with non- rechargeable

batteries batteries
Charge/discharge/ check Batteries should be removed and
output/condition as appropriate in replaced if damaged/ no longer
line with device manufacturer’s have useable life in line with
instructions. manufacturer’s instructions.

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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
 Define persons responsible for device management task, training and safe device
operation

Nominated Medical Device Leads (Clinical Groups) and Team Leaders in

Community Services
 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

 Take ownership and be responsible for the medical devices used in their areas
 Retain instruction manuals, technical instructions etc. relating to medical devices
and make them available to end users
 Identify a link person for coordination of medical devices issues in each area
 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

The Medical Physics and Clinical Engineering department

 Technical and clinical support of the equipment and staff during its life time

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-12-11

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

Battery check, battery replacement, charging
batteries, battery function, chargers, connection
Key words relating to this SOP
cables, plugs, sockets, rechargeable
batteries,‘non-rechargeable batteries

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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