React Homecare
CC107 – Management of Medical Devices Policy and Procedure
1. Purpose
1.1 To set out how React Homecare will ensure the safe and effective management of medical devices in use at React Homecare.
1.2 This policy is dovetailed with the Managing Medical Devices (MHRA) document (2015) and should be available for staff to access.
1.3 To meet regulatory, legislative and best practice guidance and requirements.
1.4 To meet the legal requirements of the regulated activities that React Homecare is registered to provide:
The Care Act 2014
The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
Health and Social Care Act 2008 (Registration and Regulated Activities) (Amendment) Regulations 2015
Health and Safety at Work etc. Act 1974
The Medical Devices Regulations 2002
The Medical Devices (Amendment) Regulations 2012
Data Protection Act 2018
2. Scope
2.1 The following roles may be affected by this policy:
o Registered Manager
o Other management
o Care staff
2.2 The following service users may be affected by this policy:
o Service Users
2.3 The following stakeholders may be affected by this policy:
o Commissioners
o External health professionals
o Local Authority
o NHS
3. Objectives
3.1 To ensure that medical devices are properly maintained, clean and are used only for the purpose intended, by suitably trained and competent members of staff.
4. Policy
4.1 All staff whose role involves using medical devices are responsible for:
o Completing any training or competency required (and maintaining this knowledge) in relation to medical devices
o Not using any device which they have not been adequately trained to use or do not feel competent and confident to operate
o Using medical devices in a safe and effective manner in accordance with guidance and the manufacturer's intended use
o Reporting any concerns or defects relating to the safe use of medical devices to the Registered Manager
o Contributing to audits, risk assessments and service improvement
o Cleaning and decontaminating reusable devices and safely disposing of single-use devices
4.2 Suppliers of new medical devices to React Homecare will be expected to comply with the Medical Devices Directive (93/42/EEC). Assurance from the Registered Manager will be gained before first use.
4.3 Where devices are provided by other healthcare professionals for the care and support of Service Users, this policy remains applicable and all responsibilities of staff remain unchanged.
4.4 React Homecare will respond and fully comply to alerts and recalls via the MHRA. In addition, incidents or accidents relating to medical devices will be reported to the MHRA, with due regard for and in compliance with the Duty of Candour, where necessary.
5. Procedure
5.1 Service User Involvement with Medical Devices
At all times Service Users will be involved in their Care Planning which includes the introduction of medical devices or the use of existing ones. Competent and trained Care Workers must ensure that Service Users understand what the medical device is, how it is used and the rationale for its choice. Where they are unable to answer any queries, Care Workers will escalate to the appropriate healthcare professional for advice and support.
Service Users will be able to access information (e.g. manufacturers guidance, leaflets) to assist with understanding the purpose of the medical device and be provided the opportunity to ask questions and make informed decisions around their Care.
Where medical devices are assessed as needing to be introduced to Service Users who lack capacity to consent, staff must refer to the Mental Capacity Act (MCA) 2005 Policy and Procedure at React Homecare, and a multidisciplinary approach will be taken with the relevant health and social care professional overseeing their Care.
5.2 Purchasing and Supply of Medical Devices
Any purchasing of new medical devices must first be discussed with the Registered Manager. Where appropriate, advice and recommendations will be sought from a relevant healthcare professional (e.g. occupational therapist).
Before any new purchase, the Registered Manager will consider:
o Staff training requirements
o Familiarity of staff with the type of equipment
o Servicing requirements
o Cost benefits and quality of the product
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o Support available externally from other health and social care professionals
Medical equipment will not be purchased unless it is CE marked.
5.3 Each medical device will have a unique identifier. React Homecare must record the unique identifier in the Care Plan to aid servicing and maintenance checks as well as monitoring the age of the equipment. The equipment record will be subject to accuracy checks and audit.
Where device maintenance is not the responsibility of React Homecare, or due to the specialist nature of the products (such as hoists), local service agreements will be in place. Staff must refer to the Purchasing Policy and Procedure, and the Moving and Handling Policy and Procedure for further details.
Staff will not use any equipment that has not been serviced or calibrated in line with the manufacturer's instructions.
5.4
Maintenance of Medical Devices
Record Keeping
Records will be maintained to ensure that all medical devices used in the homes of Service Users can demonstrate a servicing history, are compliant with the manufacturer's instructions and that an appropriate risk assessment is in place.
Where maintenance records are required, these will be subject to a retention period in line with the Records Management Code of Practice and Retention Schedules and must be kept in a location that is secure. Records will be accessible for inspection upon request.
5.5 Regular Maintenance
Staff must carry out visual assessments on equipment or devices before use, in accordance with the manufacturer's instructions as well as following infection control principles and practices. Please refer to the Infection Control Policy and Procedure at React Homecare.
It is the responsibility of all staff to ensure that equipment is fit for use, performs as expected and is kept clean. All equipment must be stored safely after use.
5.6
Loan of Medical Devices
It is acknowledged that medical devices may be loaned from healthcare professionals or be in use by Service Users upon commencement of the Care service.
React Homecare will record these devices within the Service User's Care Plan and have access to guidance and instructions. At the point of assessment or when Care needs change, the Registered Manager will consider any training needs and access resources before confirming and commencing the package of Care. Staff will report any concerns or defects with the device to the Registered Manager and the supplying healthcare professional.
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All medical devices must be returned to the supplier when they are no longer required in a clean, decontaminated condition. Staff will keep records of this action in the Service User's file.
5.7
Incident/Accident Reporting
All incidents involving medical devices must be reported through the reporting process at React Homecare. It is the responsibility of any member of staff who finds a problem with a medical device to report it.
It is a requirement that medical device incidents such as the following, are reported to the MHRA via the yellow card scheme, or directly via https://www.gov.uk/report-problem-medicine-medical-device:
o A medicine causes side effects
o Someone is injured (or almost injured) by a medical device, either because its labelling or instructions are not clear, it is broken or has been misused
o A patient's treatment is interrupted because of a faulty device
o Someone receives the wrong diagnosis because of a medical device
o A medicine does not work properly
o A medicine is of a poor quality
o You think a medicine or medical device is fake or counterfeit
5.8 Faulty equipment must be immediately removed from use and alternative equipment sourced. The item will be clearly labelled and dated to advise colleagues that the device must not be used until servicing and maintenance is complete and it is safe to reuse the equipment, or the item has been condemned.
A record must be made in the Service User's daily record and the Care Plan updated. React Homecare will ensure that any Care Workers visiting the Service User are aware of the issues.
5.9
Device Alteration
Medical equipment must be used in accordance with the manufacturer’s instructions.
No alterations or adaptation of use of medical equipment can be made without the permission of the manufacturer in accordance with BS EN ISO 14155:2011.
5.10 Cleaning and Decontamination
Where possible, single-use items will be used to support the Service User. Reusable medical devices must always be decontaminated according to the manufacturer’s instructions and in accordance with guidance from the Infection Control Policy and its procedures.
Reusable medical devices must be decontaminated after use and before use on another Service User.
5.11
Training and Education
Medical devices must only be used by trained staff who have received training on the products and are deemed to be competent in their use.
Training requirements and competency assessments will be identified by the Registered Manager at induction, reviewed during supervisions and discussed
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as part of the yearly appraisal. Staff are expected to discuss the need for training at all other times if they feel they do not have sufficient knowledge to complete the task safely.
A Training Needs Analysis must be completed in order to determine the need for training provision. The frequency will be determined in accordance with the manufacturer’s instructions and as agreed by React Homecare Ltd and the Registered Manager.
All records of training will be available upon request for inspection.
Staff are expected to attend arranged training and achieve competency assessments as set by React Homecare. Persistent failings to attend or achieve will result in disciplinary action or capability management by the Registered Manager
5.12
Medical Device Alerts
Receipt of safety alerts, emergency alerts, drug alerts and medical device alerts will be responded to in a timely manner and staff will refer to the Distribution of Safety Alert Broadcasts, Rapid Response Reporting and Safety Notices Policy and Procedure for consistent management.
6. Definitions
6.1 Medical Device
o A medical device is any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article; intended by the manufacturer to be used alone or in combination for human beings, for the purpose of:
Diagnosis, prevention, monitoring and treatment of disease or disability
Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
Investigation, replacement or modification of the anatomy, or of a physiological process
Control of conception
6.2 Adverse Incident
An adverse incident is an event which gives rise to, or has the potential to produce, unexpected or unwanted effects involving the safety or wellbeing of Service Users or others
7. Key Facts – Professionals
Professionals providing this service should be aware of the following:
Medical devices play a key role in healthcare and are vital for diagnosis, therapy, monitoring, rehabilitation and Care delivery
Effective management of devices is necessary to ensure delivery of highquality care that includes minimising the risks of adverse events
Maintenance, servicing and day-to-day care of medical devices is everyone's responsibility
Good record keeping is essential for the safe management of medical devices
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8. Key Facts – People affected by the Service
People affected by this service should be aware of the following:
Staff will be fully trained and competent to support you with any medical device in use
Staff are responsible for ensuring that your medical device remains fit for purpose, clean, serviced and well-maintained
You are encouraged to discuss any concerns in relation to this policy with the Registered Manager
9. Outstanding Practice
To be ‘outstanding’ in this policy area you could provide evidence that:
Staff have completed medical devices training (as located in the further reading section of this policy)
The Registered Manager completes thematic audits and has the MHRA checklist for medical devices. Findings are discussed with staff and changes embedded in practice
A lead role has been assigned as a medical device champion to oversee the management and best practice of device usage within React Homecare
Medical devices are discussed at health and safety meetings
Date Policy Reviewed
27th December 2019
6th January 2021
15th November 2024`
Signature of Reviewer
D Woolley
D Woolley
C Ellis