Battery Maintenance for Medical Devices

Transcription

1 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 Battery Maintenance for Medical Devices Page 1 of 7 Version 1.0 December 2015

2 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 Battery Maintenance for Medical Devices Page 2 of 7 Version 1.0 December 2015

3 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) Battery Maintenance for Medical Devices Page 3 of 7 Version 1.0 December 2015

4 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 Battery Maintenance for Medical Devices Page 4 of 7 Version 1.0 December 2015

5 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 batteries Charge/discharge/ check output/condition as appropriate in line with device manufacturer s instructions. Device with non- rechargeable batteries Batteries should be removed and replaced if damaged/ no longer have useable life in line with manufacturer s instructions. Battery Maintenance for Medical Devices Page 5 of 7 Version 1.0 December 2015

6 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 Battery Maintenance for Medical Devices Page 6 of 7 Version 1.0 December 2015

7 Standard Operating Procedure Details Unique Identifier for this SOP is State if SOP is New or Revised BCPFT-CLIN-POL New Policy Category Executive Director whose portfolio this SOP comes under Policy Lead/Author Job titles only Committee/Group Responsible for Approval of this SOP Month/year consultation process completed Clinical Deputy Chief Executive & Director of Resources Medical Devices Group Medical Devices Group April 2015 Month/year SOP was approved November 2015 Next review due December 2018 Disclosure Status Key words relating to this SOP B can be disclosed to patients and the public Battery check, battery replacement, charging batteries, battery function, chargers, connection cables, plugs, sockets, rechargeable batteries, non-rechargeable batteries Review and Amendment History Version Date Description of Change 1.0 Dec 2015 New Procedure established to supplement Medical Devices Policy Battery Maintenance for Medical Devices Page 7 of 7 Version 1.0 December 2015