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Surrey and Sussex Healthcare NHS Trust
An Organisation-wide Policy for Medical Devices and
Equipment Training
Version 5
Status Ratified
Date Ratified Oct 2011
Name of Owner Medical Devices & Equipment Educator, Fortunate Mangaira
Name of Sponsor Group Medical Devices Group
Name of Ratifying Group Management Board for Quality and Risk Type of Procedural Document Policy
Policy Reference 0055
Date Issued Nov 2011
Review Date Nov 2014
Target Audience All Clinical Staff
Human Rights Statement The Trust incorporates and supports the human rights of the individual, as set out by the European Convention on Human Rights and the Human Rights Act 1998
EIA Status Completed
This policy is available on request in different formats and languages from the Policy Coordinator / PALS.
The latest approved version of this document supercedes all other versions. Upon receipt of the latest approved versions all other version should be destroyed, unless specifically stated that the previous version(s) are to remain extant. If in any doubt please contact the document owner or Policy Coordinator.
Page 2 of 28 Contents Page 1. Introduction 4 2. Purpose 4 3. Definitions 4 3.1 Medical Devices 4
3.2 Oracle Learning Management 4
3.3 National Learning Management System 4 3.4 National Health Service Litigation Authority (NHSLA) 5 3.5 Medicines and Healthcare Products Regulatory Agency 5
3.6 Care Quality Commission 5
3.7 End User 5
3.8 Competence 5
3.9 Adverse Incident 5
4. Duties 5
4.1 The Organisation 5
4.2 Medical Devices Group 6
4.3 Procurement 6
4.4 Manufacturers/ Suppliers 6
4.5 Electro Medical Engineering (EME) 7
4.6 Head of Education and Training 7
4.7 Medical Devices Educator 7
4.8 Departmental/ Ward Managers 8
4.9 Clinical Trainers 8
4.10 All Staff Using Medical Devices 9 4.11 Medical Devices Liaison Officer 9
5. Core Elements 9
5.1 Inventory of Diagnostic and Therapeutic Equipment 9
5.2 Medical Devices Training 10
5.2.1 Identification of training needs 10
5.2.2 Frequency of updates 10
5.2.3 Process for identifying staff authorised to use equipment 11
5.2.4 Clinical trainers 11
5.2.5 Specific training for particular devices 12
5.2.6 Induction of new staff 12
5.2.7 Temporary staff 12
5.2.8 Training for EME staff 13
5.2.9 Patients and Carers (End Users) 13 5.2.10 Procurement linked to training 14 5.3 Training Records 14 5.4 Auditing and reporting of device training 14
5.5 Reporting Adverse Incidents 14
5.5.1 Who should report adverse incidents? 15
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5.5.3 When to report 16
5.5.4 Reporting adverse incidents to the MHRA 16
5.5.5 How to report 16
5.6 Medical Devices Involved in Adverse Incidents 16 6. Consultation and Communication with Stakeholders 17
7. Approval and Ratification 17
8. Review and Revision 17
9. Dissemination and Implementation 17
10. Archiving 18
11. Monitoring Compliance 18
12. References 18
13. Associated Documents 18
Appendices
Appendix 1 - Procurement Checklist Appendix 2 - Risk Classification Matrix
Appendix 3 - Generic Template for Medical Device Competence Appendix 3.1 - Example of Competence
Appendix 4 - End User Agreement Form Appendix 5 - Adverse Incident Checklist Appendix 6 - Equality Impact Assessment
Change History
Version Date Author/Policy Lead Details of Change
1 unknown unknown unknown
2 Dec 2005 Medical Devices Educator. Linda Baker
General review and revision 3 Jan 2008 Medical Devices Educator.
Linda Baker
Periodic review and minor amendments
4 Jan 2010 Head of Education and Training. Obi Maduako
New policy template and minor amendments for NHSLA
5 Oct 2011 Medical Devices and Equipment Educator. Fortunate Mangaira
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1. Introduction
The use of medical devices is an essential part of the daily workings of the Trust. The Care Quality Commission (CQC) and National Health Service Litigation Authority (NHSLA) require Trusts to reduce risks associated with medical devices and equipment, in order to protect patients and staff from any harm. Training is integral to reducing that risk.
Surrey and Sussex Healthcare NHS Trust (SASH) has a commitment in ensuring staff are trained to use medical devices and equipment correctly and safely. This policy applies to all staff employed at Trust and includes permanent, temporary and volunteer staff that use medical devices and equipment.
2. Purpose
This policy identifies how the Trust meets its obligations regarding the use of medical devices. It outlines the procedures for medical devices training and the staff accountability for safe practice.
The policy will explain how the Trust as an organisation meets and complies with the Care Quality Commission outcome 11 of the Essential Standards of Quality and Safety regarding medical devices training and the NHS Litigation Authority Risk Management Standards. The aim of both of these is to lead to the reduction of risk and incidents related to medical device use, for patients, staff and other persons.
3. Definitions
Medical Devices (including equipment) can be defined as all products except medicines, used in healthcare for diagnosis, prevention, monitoring or treatment. This includes the alleviation, or compensation for an injury or handicap, the investigation, replacement or modification of the anatomy or of a physiological process, and the control of conception. Under the amended European
Commission Directive 2007 the term Medical Device now includes software products, and not only software required for the normal functioning of a device.
Oracle Learning Management (OLM) forms part of Electronic Staff Records
(ESR) and is used to record training, both completed and in progress and competences for permanent and temporary staff.
National Learning Management System (NLMS) is the e-learning application
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National Health Service Litigation Authority (NHSLA) administers the Clinical Negligence Scheme for Trusts (CNST) and thereby provides a means for NHS organisations to fund the cost of clinical negligence claims in England.
The NHSLA has a statutory duty to manage and raise the standards of risk management throughout the NHS. In order to achieve this, all NHS trusts are assessed every few years against a set of risk management standards which are based on those factors which give rise to the greatest number and cost of claims.
Medicines and Healthcare Products Regulatory Agency (MHRA) is the
agency charged with protecting and promoting public health and patient safety in relation to medical devices and the use of medicines. It does this by ensuring that the manufacture and use of medicines and medical devices meet appropriate standards of safety, quality, performance and effectiveness.
The MHRA:
Investigates adverse incidents involving medical devices.
Issues safety warnings.
Provides advice and guidance on safety and quality issues.
Acts as the UK Competent Authority, the regulator for the medical devices industry.
Care Quality Commission (CQC) is the independent regulator of all health and social care providers in England (from April 2010). It is responsible for ensuring healthcare providers maintain the quality and safety regulatory standards set out in the Health and Social Care Act 2008 (Regulations for Registration 2009).
End User is a person who uses a medical device for him/herself, as distinct from a professional user e.g. patients and/ or carers.
Competence is a specific range of skill, knowledge, or ability at a sufficient level to be able to perform effectively in an appropriate setting.
Adverse Incident is an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of patients, users or other persons.
4. Duties
4.1 The Organisation
The Trust Board has the overall responsibility for ensuring that medical devices risks are appropriately managed, or mitigated against, in order to maintain staff and patient safety Trust wide. The Board also has the responsibility for ensuring that sufficient resources are allocated for appropriate training and development.
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4.2 Medical Devices Group
They are responsible for:
Developing and maintaining a medical devices action plan.
Facilitating a rolling program of medical equipment investment.
Ascertaining and prioritising medical equipment needs on the basis of risk minimisation.
Advising the Trust on risk management issues in relation to medical devices.
Establishing clear lines of accountability in the procurement and maintenance of medical devices.
Ensuring that policies and procedures are in place to optimise staff training in the safe use of medical devices.
Monitoring the implementation of NPSA and MHRA guidance with regard to medical devices.
Ensuring that appropriate local and Trust wide action occurs in response to external device alerts/new guidance.
Reviewing significant incidents relating to the use of medical devices reported through the clinical incident pathway.
Establishing clear lines of accountability in the implementation of CQC regulation.
4.3 Procurement Department
Duties to include:
Liaising with the relevant department to ensure suitability of the purchased clinical items
Liaising with the Medical Devices Educator regarding training needs and standards for equipment purchases proposed; and for negotiating training requirements and resources from the manufacturer/ supplier within the scope of purchasing contracts.
4.4 Manufacturers/ Suppliers
Duties to include:
Conforming to the Trust training plans and agreed procedures
Communicating and liaising with the relevant clinical trainers for all medical devices training needs
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Providing relevant information related to medical devices, access to operating manuals (paper and electronic), and where available, access to a helpline for specific medical device as stipulated by the Medical Devices Regulations
Complying with National Patient Safety Agency (NPSA) guidelines where applicable
Providing training to the Trust clinical trainers at an appropriate level for them to be able to cascade training in their local areas
Delivering update training as agreed with the Trust
4.5 Electro Medical Engineering (EME)
Duties to include:
Holding the inventory of diagnostic and therapeutic equipment used in the Trust
Liaising and communicating with the Medical Devices Educator for any training needs identified as a result of equipment sent for repairs
4.6 Head of Education, Training and Development
Has the responsibility for ensuring that accurate and timely information pertaining to medical devices and equipment training is provided to the Medical Devices Group.
4.7 Medical Devices Educator
Duties to include:
Developing relevant policies and documents associated with medical devices training
Developing, planning, implementing and evaluating a training framework to co-ordinate medical devices training across the Trust
Identifying competences required by staff to use medical devices correctly and safely in accordance with manufacturers’ published guidelines
Collaborating with others to identify staff training needs, ensuring that training occurs and monitoring effectiveness
Ensuring that clinical trainers are trained to a sufficient level to be able to cascade training to other staff
Liaising with procurement to ensure that relevant training requirements are negotiated from manufacturers/ suppliers
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Liaising with manufacturers/ suppliers for the provision of training, guidelines or other information as required
4.8 Departmental/ Ward Managers
Duties to include:
Identifying staff that require medical devices training in accordance with this policy
Ensuring staff using medical devices are trained to do so prior to use and have had relevant updates
Ensuring new staff are trained to use medical devices as part of their induction
Ensuring that temporary staff required to use medical devices can do so in a safe and effective manner
Ensuring that any medical devices training undertaken by their ward staff is recorded on OLM in a timely manner
Ensuring the allocation of a medical device link professional for their clinical area who will receive relevant training to cascade medical devices training for that clinical area and allowing them sufficient time to do so
Ensuring staff have easy access to user manuals for all equipment, and utilise this for training if appropriate for the level of risk of the medical device according to the Trust Risk Classification System
Cooperate with the medical devices educator in ensuring the delivery of medical devices training
Ensuring the medical devices folder is accessible to all staff using medical devices
Ensuring that staff understand their responsibility for this policy and provide the policy in alternative languages or formats if required.
4.9 Clinical Trainers
They include medical device link professionals, Practice Development Nurses (PDN), Clinical Nurse Specialist and other trained staff.
Duties to include:
Attending relevant training to enable cascading of medical devices training to other staff
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Ensuring that any training they deliver is recorded onto OLM in a timely manner or that training registers are handed in to the Education and Training Department for uploading onto OLM.
Liaising and communicating with the medical devices educator for support as required
Ensuring the medical devices folder is up to date and liaising with the medical devices educator for information
4.10 All Staff Using Medical Devices
This includes permanent, temporary, fixed-term contract and volunteer staff that are expected to use medical devices.
Duties to include:
Familiarising themselves with the device manufacturer’s written
instructions or guidance and requesting alternative languages or formats if required
Receiving adequate training in accordance with this policy prior to using any medical devices and completing relevant competences
Not using a medical device if unable to affirm the above 2 points positively
Using a medical devices for its intended purpose
Ensuring that the device is free from any obvious defect before use
Reporting adverse incidents or near misses involving medical devices using appropriate procedures
Reporting defective devices to EME via agreed procedure
4.11 Medical Devices Liaison Officer
NHS trusts and primary care trusts in England have all designated a member of staff as their medical device liaison officer (MDLO) (CAS Liaison Officer at this Trust). The primary role of the MDLO is to encourage effective and
comprehensive adverse incident reporting through encouragement and training of healthcare and support staff and medical device users.They will encourage, promote and coordinate adverse incident reporting, manage the dissemination of medical device alerts and provide feedback.
5. Core Elements
5.1 Inventory of Diagnostic and Therapeutic Equipment
An inventory of diagnostic and therapeutic equipment used in the Trust is held, stored and kept up to date by the EME department.
Page 10 of 28 A medical devices information file is also available in each clinical area
containing a local inventory. This identifies the staff authorised to use the medical devices in that area and training requirements according to the risk classification. A further inventory will be kept on the Trust intranet on the Education and
Training page to make it accessible to all staff. It will identify the medical devices risk levels and staff authorised to use medical devices. It will be maintained and updated by the medical devices educator.
5.2 Medical Devices Training
Training is a key element in medical device safety.Healthcare professionals working for the organisation, as employees or contractors, have a professional duty to ensure their own skills and training are appropriate and remain up to date. A significant number of adverse incidents involving medical devices are caused by training deficits. NHSLA Risk Management Standards require hospitals to reduce the risk associated with the use of medical devices by implementing systems to ensure staff are trained to use medical devices safely and appropriately. This is also recognised and promoted by the National Patient Safety Agency and MHRA.
5.2.1 Identification of Training Needs
The training required for all medical devices is identified according to the Trust risk classification system for medical devices. This has been developed based on the NPSA Healthcare Risk Assessment Guidelines (2007).
This includes a traffic light colour coding system, see below:
RED Do not use, unless you have received training, completed relevant competencies and familiarised yourself with the user manual for this device
YELLOW Seek training or instructions for use from a trained member of staff and consult user manual
GREEN Continue as normal using your own professional judgement, orutilise user manual
5.2.2 Frequency of Updates
The underpinning principles of maintaining and updating competence are:
The importance of the recognition of the individual’s professional accountability for recognising learning deficits and requirements for updating
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Maintaining levels of expertise among those who use devices less frequently
Recommendations from the manufacturer
Change of device or software upgrade
Staff continual professional development
Criteria for method of update will be linked to the traffic light system for identifying training for each medical device, and then as follows:
High risk (red): Trainer-led training. Self assessment of competency every 3 years
Moderate risk (yellow): Competency self assessment every 5 years Low risk (green): Update as required or if equipment changes
Competency assessments will be developed using an agreed Trust wide framework and will be available on the intranet.
5.2.3 Process for identifying which staff are authorised to use medical devices
Any staff that are deemed competent to use certain equipment are authorised to use that equipment.
Managers will:
Identify which staff need to be trained for which item of equipment, according to clinical need and designation.
Use the risk classification system and the training framework to identify what medical device training is required
Liaise with the local medical device link professional as necessary, or other person as appropriate
Ensure staff have easy access to user manuals for all equipment, either in hard copy or electronic form (or alternative formats if required), and utilise this for training if appropriate for the level of risk classification of the device
Identify and implement other forms of training as required
Ensure device users are released to attend training where appropriate Device users will take accountability for their own professional updating, whether formal or informal.
Page 12 of 28 Other grades of medical staff and therapists will retain local records of training
required and accessed.
5.2.4 Clinical Trainers
Professional users need to understand how the manufacturer intends the device/ equipment to be used, and how it works normally, to be able to use it effectively and safely. Where relevant, clinical trainers should:
Be aware of differences between models, compatibility with other products and any contraindications or limitations on use
Be able to fit accessories and to be aware of how they may increase or limit the use of the device
Be able to use any controls appropriately
Understand any displays, indicators, alarms, etc.
Be aware of requirements for maintenance and decontamination, including cleaning, in accordance with the manufacturer’s and relevant local
procedures
Be able to show end users how to use the device
Be aware of known pitfalls, including those identified in safety advice from the MHRA, manufacturers and other relevant bodies
Be able to recognise device defects or when a device is not working properly and know what to do
Understand the importance of reporting device-related adverse incidents appropriately
5.2.5 Specific training for particular devices
Specific training on particular medical devices should be based on the manufacturer’s instructions and recommendations and provided by the manufacturer where possible.
5.2.6 Induction of new staff
All new staff who are expected to use medical devices should receive training as part of their induction. This will be carried out by the medical devices link
professional or other trained person, and relevant competences completed. Staff required to administer drugs intravenously will also receive generic infusion pump training when they attend the Intravenous Additives (IV) Course. This includes medical devices training.
5.2.7 Temporary Staff
Bank, agency and other temporary contracted staff who are expected to use medical devices should know how to do so correctly and safely.
Page 13 of 28 Temporary staff are required to sign statements confirming that they have
received and understood written and/or oral instructions where applicable or that they know how to use the medical device. They can keep a copy to produce on request. As a minimum standard, temporary staff are expected to familiarise themselves with the manufacturer’s user manual.
5.2.8 Training for EME staff
Staff carrying out maintenance, repair, and/or decontamination will require additional technical information or training.Individuals providing repair and maintenance services need to be adequately trained and appropriately qualified. This applies to directly employed staff, contracted services or others.
The EME Manager is responsible for ensuring that their staff are adequately trained.
5.2.9 Patients and carers (End Users)
End usersneed to understand the intended use and normal functioning of the device in order to use it effectively and safely. Where relevant, training should cover:
Any limitations on use
How to fit accessories and to be aware of how they may increase or limit the use of the device
How to use any controls appropriately
The meaning of any displays, indicators, alarms etc., and how to respond to them
Requirements for maintenance and decontamination, including cleaning
Recognising when the device is not working properly and know what to do about it
Any known pitfalls in the use of the device, including those identified in safety advice from the MHRA, manufacturers and other relevant bodies
The importance of reporting device-related adverse incidents to the Trust and/or MHRA as appropriate and how to do so
Training should also be supported by written instructions. Some users or carers with particular disabilities or medical conditions may need additional instructions or training. For example, people who are visually impaired may not be able to easily read some forms of written information.
The responsible organisation may also need to supply its own information to explain any additional administrative arrangements e.g. contact details for maintenance, consumables or spare parts.
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5.2.10 Procurement linked to training
The procurement process must include a needs analysis of training where possible, to be provided by the supplier for implementation and ongoing training. Where large numbers of devices are being purchased e.g. infusion pumps, the EME and/or Purchasing Department will advise standardisation with the rest of the Trust to support an organisational approach to making such informed decisions.
5.3 Training Records
Medical devices training will be recorded on OLM. This should be done in a timely manner so that training can be captured in any reports that are run.
Staff who receive training and complete competences must ensure that their manager or trainer retains a copy of the competence to enable them to record it on OLM.
Users of equipment will be asked to sign statements confirming that they have received and understood written and/or oral instructions where formal competences are not used.
Paper records will be kept locally and supplied by the manager on request.
Medical staff and therapists will retain local records of training required and accessed.
5.4 Auditing and reporting of device training
Regular reports will be generated from OLM which will summarise overall
organisational uptake of training and highlight deficiencies. Action plans will then be developed by the medical devices and equipment educator and implemented as appropriate.
5.5 Reporting adverse incidents
An adverse incident is an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device users (including patients) or other persons. Information from adverse incident reporting indicates that the factors that have the greatest impact on the safety of devices involve the instructions issued by the manufacturer, their availability and clarity.
Other key safety factors include the design, the quality of training in the appropriate uses of devices and how well they are maintained and prepared. The causes of incidents may include:
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Poor training
Problems arising from the design or manufacturing process
Inappropriate local modifications or adjustments
Inadequate maintenance
Inadequate or inappropriate repairs or replacement parts
Unsuitable storage or use conditions
Inadequate end of life or scrapping information
5.5.1 Who should report adverse incidents?
Anyone working in the Trust may submit an adverse incident report. Reporters should, however, familiarise themselves with the Trust incident reporting procedures and risk management systems. Reports made within the Trust will be forwarded to the MHRA by the CAS Liaison Officer as appropriate. Adverse incident reports can also be made directly to the MHRA by anyone – clinicians, healthcare professionals, carers, patients and members of the public. Any reports that are made directly to the MHRA by a member of staff must be copied to the CAS Liaison Officer on this e-mail: sabs@sash.nhs.uk for recording on the Trust database.
5.5.2 What is reported?
Any adverse incident involving a device or its instructions for use (including user/device interface problems) will be reported to the MHRA, especially if the incident has led to or, were it to occur again, could lead to:
death, life-threatening illness or injury
deterioration in health or permanent impairment of body structure or function
the necessity for medical or surgical intervention (including implant revision)
hospitalisation or prolongation of existing hospitalisation
unreliable test results and associated risk of misdiagnosis or inappropriate treatment
foetal distress, foetal death, congenital abnormality or birth defect
ongoing faults that successive service/maintenance visits have failed to rectify.
This includes the reporting of potential problems. Other minor safety or quality problems will also be reported as these can help demonstrate trends or highlight inadequate manufacturing or supply systems.
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be reported because:
the error may be partly (or wholly) due to deficiencies in the design of the device or instructions for use
they may prompt promulgation of advice or device design improvements that will help prevent repetition of mistakes.
5.5.3 When to report
Incidents should be reported as soon as possible, usually within 24 hours. Serious incidents should be reported to the MHRA by the fastest means available.
5.5.4 Reporting an adverse incident to the MHRA
The principal aim of the MHRA is to safeguard the public’s health. They do this by making sure that medical devices work properly and are acceptably safe. They respond promptly when new concerns come to light, and ensure that sound evidence underpins all their decisions. Whilst no product is completely free of risk, we can work constructively with medical device manufacturers and device users to ensure that these risks are minimised and they can take regulatory action if required.
The MHRA greatly values the significant and positive efforts made by medical devices liaison officers (CAS Liaison Officer at this Trust) and all other health and social care professionals to ensure that medical device related adverse incidents are reported promptly to their Adverse Incident Centre. This has ensured that a number of important public health issues have been identified early and dealt with appropriately.
5.5.5 How to report
Local report - complete an all purpose report form as soon as possible. Report to the MHRA - this can be done online via the MHRA website, by telephone, email or post. Telephone reports must always be followed up by a written (online or email) confirmation. Forms may be downloaded from the MHRA website and then completed electronically or may be printed and sent by post. Copies of e-mails and forms must also be sent to the CAS liaison officer on this e-mail: sabs@sash.nhs.uk for recording on the Trust database.
5.6 Medical devices involved in adverse incidents
Medical devices that have been involved in an incident shouldbe quarantined. An all purpose form should be completed as soon as possible and the EME Department informed.
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should notbe:
discarded
repaired
returned to the manufacturer
All material evidence, i.e. devices/parts removed, replaced or withdrawn from use following an incident, instructions for use, records of use, repair and maintenance records, packaging materials, or other means of batch identification mustbe:
clearly identified and labelled
stored securely
Evidence should not be interfered with in any way except for safety reasons or to prevent its loss. Where appropriate, a record should be made of all readings, settings and positions of switches, valves, dials, gauges and indicators, together with any photographic evidence and eyewitness reports.
6. Consultation and Communication with Stakeholders
This policy was developed by the Medical Devices Educator in consultation with the Medical Devices Group and clinicians input was sought.
7. Approval and Ratification
This policy will be approved by the Medical Devices Group and ratified by the Management Board for Quality and Risk after relevant feedback from the Stakeholders..
8. Review and Revision
This policy will be reviewed in accordance with the Trust Policy on Management and Development of Procedural Documents; the standard length of time for review is three years.
However, organisational and/or legislative changes may prompt the need for earlier revision.
9. Dissemination and Implementation
The Trust process for dissemination of policies will be followed as described in the Organisation Wide Policy for the Management and Development of
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Posting on the dedicated Policies and Procedures page of the Intranet
Notification to all staff of the new policy on the next available E-Bulletin
At training
10. Archiving
This policy will be held in the Trust Database, known as the library, and archived in line with the arrangements in the Organisation Wide Policy for the
Management and Development of Procedural Documents.
Working copies will be available on request from the policy co-ordinator by contacting the dedicated mailbox trustpolicies@sash.nhs.uk.
11. Monitoring Compliance
Compliance will be monitored by the Medical Device Educator. Any deficits identified and action plans will be communicated to the Medical Devices Group as they arise.
The Medical Devices Group will receive quarterly reports from the Medical Devices Educator which will include:
Training uptake and deficits
The overall effectiveness of the medical devices training programme
Any pertinent incidents relating to medical device use
12. References
MHRA DB2006 (05) - Managing Medical Devices MHRA DB2003 (02) - Infusion Systems
NPSA - Healthcare Risk Made Easy (2007)
MHRA DB2011 (01) - Reporting Adverse Incidents and Disseminating Medical Device Alerts
MHRA - Devices in Practice: a guide for professionals in health and social care (2008)
13. Associated Documents
Statutory and Mandatory Training Policy Management of Medical Devices Policy Induction Policy
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Appendix 1:
Procurement Checklist
The Device
i. What functions must the device perform?
Consider its fitness and suitability for purpose. If the device is being purchased for a specific individual, consider if his/her clinical or physical condition contra-indicates its use
ii. What similar devices do we already have? Keep range of any type of device limited
iii. What is the evidence for the choice of this device?
Consider whether any research on effectiveness has been carried out iv. How easy is the device to use and maintain?
Previous experience, feedback from users v. What is the life expectancy of the device?
vi. Does it have multi-functionality, i.e. can it replace several not just one device
vii. Is a single-use or a multiple-use device most appropriate? viii. Has the device a CE marking?
ix. What accessories are necessary for the intended function of the device? Consider whether they are easy to obtain and compatible with existing device
x. Where is the device to be used?
Consider location, e.g. health centre, care home or user’s home xi. Are infection control or decontamination processes required and are
facilities available?
Consider whether any infection control or decontamination measures are needed
xii. Where can unbiased information on the range of available devices be obtained?
Consult documents, e.g. Centre for Evidence-based Purchasing, Guidelines and Audit, Implementation Network (GAIN), Disabled Living Foundation reports, consult National Association of Equipment Providers, servicing contractors, hospital supplies departments, hospital specialists,
Page 20 of 28 seek advice from colleagues, professional, associations, experts in the
field Costs
i. What is the cost of the device and installation, if applicable? ii. What maintenance is required and what is the cost?
iii. Are maintenance and servicing costs included in the price? iv. What are the purchase, lease and finance options?
v. Is servicing insurance cover available and at what cost? vi. What is the cost of consumables?
vii. Does the device represent value for money? viii. What is the cost of disposal?
Training
i. Are special clinical and technical training requirements necessary?
ii. Are initial and updating training programmes provided by the manufacturer and have these been validated?
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Appendix 2:
Risk Classification Matrix
Likelihood Consequence 1 Rare 2 Unlikely 3 Possible 4 Likely 5 Almost Certain 1 Negligible 1 2 3 4 5 2 Minor 2 4 6 8 10 3 Moderate 3 6 9 12 15 4 Major 4 8 12 16 20 5 Catastrophic 5 10 15 20 25 Risk Levels 1-3 Low Risk 4-9 Moderate Risk 10-25 High Risk Training Required
Proceed with caution- seek training from a trained member of staff and utilise user manual.
Update training every 5 years.
STOP! Do not use this medical device unless you have had competence based training. Utilise user manual.
Update training every 3 years
Continue as normal, using your professional judgement and/or utilise user manual.
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Assessment of Medical Device Competence
Full Name Department
Role Date
Medical Device Risk Category
This form is a self-assessment tool, but the practitioner is required to discuss the rationale for each action and demonstrate competency in the practical application of these skills as applicable.
Achieved?
Below are the skills required for safe and effective use of the medical device. You must be able to answer “yes” to all the statements before considering yourself to be competent. Please note that users must refer to the user manual as responsibility for safe use
remains with them. Yes No
1 2 3 4 5 6 7 8 9 10 11 12 Signature of Practitioner
Action Plan Competent to use device
Needs more training and/or reassessment Name of Trainer/
Assessor Signature
N.B.Details of your competence will need to be recorded electronically in your personal record by the trainer/ Manager. This competency assessment is valid for a maximum of 3 years, after which further training may be needed and re-assessment is required. Staff that use this infusion device infrequently or do not feel competent must seek further training and re-assessment.
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Assessment of Medical Device Competence
Full Name Department
Role Date
Medical Device McKinley T34 Ambulatory
Syringe Pump Risk Category
HIGH RISK
This form is a self-assessment tool, but the practitioner is required to discuss the rationale for each action and demonstrate competency in the practical application of these skills as applicable.
Achieved?
Below are the skills required for safe and effective use of the medical device. You must be able to answer “yes” to all the statements before considering yourself to be competent. Please note that users must refer to the user manual as responsibility for safe use
remains with them. Yes No
1 Explain the initial checks required to ensure that the pump is ready and safe to use
2 Explain the functions of all the soft keys and the external features of the pump
3 Demonstrate the correct method for commencing an infusion and explain the importance of confirming the correctsyringe size and brand during set up 4 Explain the rationale for setting the rate first before priming the administration set
5 Demonstrate how to activate/deactivate the keypad lock and the rationale
6 Discuss functions that remain active when the keypad is locked
7 Demonstrate how to check the battery level and explain how long a battery lasts
8 Explain/demonstrate how to change the battery mid-infusion
9 Explain the purpose of the lock box and demonstrate how to use it correctly
10 Demonstrate how to change the syringe without altering the rate
11 Explain how to safely change an infusion line, ensuring that the rate is maintained
12 Name three alarms and how to correct them
13 Explain what action to take in the event of a device failure alarm
14 Explain the procedure for reporting adverse incidents
15 Demonstrate how to correctly dismantle the infusion system on completion
Signature of Practitioner
Action Plan Competent to use device Needs more training and/or reassessment Name of Trainer/
Assessor Signature
N.B.Details of your competence will need to be recorded electronically in your personal record by the trainer/ Manager. This competency assessment is valid for a maximum of 3 years, after which further training may be needed and re-assessment is required. Staff that use this infusiondevice infrequently or do not feel competent must seek further training and re-assessment.
Page 24 of 28
Appendix 4:
End User Agreement Form for Medical Devices
Name and Model of Device Date
The following information has been explained to the patient and/or
carer to ensure safe and correct use of the medical device Yes No 1 The reasons for using the device
2 Initial checks prior to use 3 How to operate it
4 The meaning of any displays, indicators and alarms, and how to respond to them
5 Potential problems and how to rectify them 6 Storage
7 Maintenance and cleaning 8 Who to contact if any problems 9 Written instructions for use
Patient/Carer Statement:
I have understood the information given to me and I feel confident to use the medical device correctly and safely
Patient/Carer Name Signature
Trainer comments
Trainer Name Role
Department Signature
Affix patient label here Patient Name: D.O.B:
Page 25 of 28
Appendix 5: Adverse Incident Checklist
i. Check and take steps necessary for the wellbeing of the patient ii. Take device(s) involved out of action, together with other material
evidence, e.g. packaging if available. Label the affected device. If this is not possible the state of the device at the time of incident should be recorded
iii. Record:
date and time of the incident
device settings if relevant
details of incident (how it happened and any outcomes for the person affected)
details of device affected and any others (type, make, model and serial numbers)
details of any error message or failures
iv. Report incident to relevant manager and complete an incident form as soon as possible
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Appendix 6: Equality Impact Assessment
Names of assessors carrying out the screening procedure (min of 2- author / manager and staff member / patient representative)
Suzanne Richardson – Manual Handling
Sally Knight- Equality & Engagement
Name of lead author /manager & contact number
Fortunate
Mangaira x 6592 1. Name of the strategy / policy / proposal /
service function
An Organisation-wide Policy for Medical Devices and Equipment Training
Date last reviewed or created & version number.
V5 October 2011 2. Who is the strategy / policy / proposal / service function aimed at?
All clinical staff permanent/temporary and voluntary that use medical devices and equipment.
3. What are the main aims and objectives?
This policy identifies how the Trust meets its obligations regarding the use of medical devices. It outlines the procedures for medical devices training and the staff accountability for safe practice.
4. Consider & list what data / information you have regarding the use of the strategy / policy / proposal / service function by diverse groups?
Workforce diversity data
5. Is the strategy / policy / proposal / service function relevant to any of the protected characteristics or human rights below?
If YES please indicate if the relevance is LOW, MEDIUM or HIGH Low
The policy may not be relevant to the Equality General Duty* as stated by law
Little or no evidence is available that different groups may be affected differently
Little or no concern raised by the communities or the public about the policy etc when they are consulted – (recorded opinions, not lack of interest)
Medium
The policy may berelevant to parts of the Equality General Duty* in the policy etc regarding differential impact
There may be some evidence suggesting different groups are affected differently
There may be some concern by communities and the public about the policy
Page 27 of 28
High
There will be relevance to all or a major part of the General Equality Duty* in the policy regarding differential impact.
There will be substantial evidence, data and information that there will be a significant impact on different groups
There will be significant concern by the communities and relevant partners on the potential impact on implementation of the policy etc.
Protected Characteristics Patient, their
carer or family
Staff
Age NO NO
Disability YES low YES low
a Physical YES low YES low
b Learning disability YES low YES low
c Sensory impairment, Hearing,
sight
YES low YES low
d Speech or communication difficulty YES low YES low
e Mental ill health NO NO
f People with HIV / AIDS NO NO
g Head injury, cognitive loss NO NO
h Other NO NO
Gender Reassignment NO NO
Race/ Ethnic Communities / groups YES low YES low
Religion or belief NO NO
Sex (male female) NO NO
Sexual Orientation
(Bisexual, Gay, heterosexual, Lesbian)
NO NO
Marriage & Civil Partnership NO NO
Pregnancy & Maternity NO NO
Human Rights NO NO
6. What aspects of the strategy / policy / proposal / service function are of particular relevance to the equality strands?
Training to staff, if they had any particular disabilities or
communication problems would they also be provided with the additional training/ instructions? You state in policy you do this for family and carers. Also need to be able to provide the policy / instructions in alternative languages and formats if requested
7. Does the strategy / policy / proposal / service function relate to an area where there are known inequalities? If so which and how?
Page 28 of 28 8. Please identify what evidence you have used / referred to in carrying out
this assessment.
See q4
9. If you identify LOW relevance only can you introduce any minor changes to the strategy / policy / proposal / service function which will reduce potential adverse impacts at this stage? If so please identify here.
Add in to the policy the requirement to provide instruction and training in alternative languages and formats if required.
10. Please indicate if a Full Equality Impact Assessment is recommended.
(required for all where there is MEDIUM & HIGH
relevance)
NO
11. If you are not recommending a Full Equality Impact assessment please explain why.
The policy follows national guidelines and is unlikely to have negative impact on protected groups
12. Signature of author / manager Date of completion and submission
Please send completed form to sally.knight@sash.nhs.uk
Human Rights
1 the right to life
2 the right not to be tortured or treated in an inhuman or degrading way 3 the right to be free from slavery or forced labour
4 the right to liberty 5 the right to a fair trial
6 the right to no punishment without law
7 the right to respect for private and family life home and correspondence
8 the right to freedom of thought, conscience and religion 9 the right to freedom of expression
10 the right to freedom of assembly and association 11 the right to marry and found a family
12 the right not to be discriminated against
13 the right to peaceful enjoyment of possessions 14 the right to an education
