Version: 4.0. Training Policy for Medical Devices. Name of Policy: Effective From: 24/10/2012

Transcription

1 Policy No: RM45 Version: 4.0 Name of Policy: Training Policy for Effective From: 24/10/2012 Date Ratified 07/08/2012 Ratified Management Group Review Date 01/08/2014 Sponsor Director of Estates and Facilities Expiry Date 06/08/2015 Withdrawn Date This policy supersedes all previous issues. Training Policy for v4

2 Version Control Version Release Author/Reviewer Ratified by/authorised by Date Changes (Please identify page no.) 1.0 March 2006 J Edwards Trust Policy Forum February November 2006 J Edwards Trust Policy Forum November /08/2009 J Edwards PQRS 17/07/ /10/2012 J Edwards MDMG 07/08/2012 Change risk assessment tool to comply with trust format of 4 colours rather than 3 Training Policy for v4 2

3 CONTENTS Page No. 1. Introduction Policy scope Aim of policy Duties - roles and responsibilities Definition of terms Training devices inventory Process for identifying which permanent staff are authorised to use equipment identified in the inventory Training Levels Process for determining the training required to use the equipment identified on the inventory and the frequency of updates required Process for identifying training needs for all permanent staff are met Training Equality and diversity Process for monitoring compliance with the policy Consultation and review of this policy Implementation of this policy References Associated documentation Appendices Appendix 1 Training Levels Appendix 2 Training And Re-Training Assessment Matrix Appendix 3 Risk Assessment Matrix Training Policy for v4 3

4 1. Introduction The development of this policy is based on the criterion specified within the Essential Standards of Quality & Safety and the NHSLA Risk Management Standards. It takes into account the principals highlighted in DB 2000 Equipped to care: the safe use of medical devices in the 21 st century, DB 2001 in practice: a guide for health and social care professionals, Managing MHRA (2006) and MHRA DB (2006) Single use medical devices: implications and consequences of reuse. The principle being to ensure practice within the Trust is such, to effectively minimise identified risks and promptly mitigate adverse consequences associated with the use of medical devices for patients, staff and others Recent advances in technology have led to increased use of medical devices and consequently we have seen a rise in the number of device related incidents. Human Factors have been identified as the key feature for the increase in incidents associated with devices. It is believed this is largely due to the wide range of devices now available. If training cannot match the speed at which technology advances there is scope for a large risk gap to open. 2. Policy scope This policy applies to all staff employed by Gateshead Health NHS Foundation Trust both professional and support workers who have access to, and are required to use medical devices within their role, this includes those personnel in training e.g. students. It also covers all medical devices used by staff for the delivery of treatment, care, diagnosis, monitoring etc. Although maintenance training is as important as user training this field is addressed in the Electronics operational policy The recommendations made in the policy are approved by the Chief Executive, although the implementation of the recommendations will be carried by qualified clinical staff who are responsible for the day to day care, support will be offered by other managers, technical staff and trainers etc, who have shared responsibility to ensure appropriate action is taken in response to the recommendations 3. Aim of policy This policy aims to ensure systems are in place to reduce the risks associated with the use of medical devices and related incidents by ensuring all clinical staff or users of medical devices are aware of their roles, responsibilities and accountabilities in relation to instruction and training. The Trust will; Ensure all who use medical devices in this organisation attend induction training and retain competency by accessing training and updates. Introduce competency training for all staff using high and Moderate risk devices throughout the trust Standardise medical devices Training Policy for v4 4

5 Ensure all users have access to training, retraining, updates and support to develop and maintain knowledge, skill and competency levels Maintain records of training 4. Duties Roles and Responsibilities Chief Executive Trust Board The Management Group (MDMG) Clinical Risk Manager Point of Care Coordinator Is responsible for ensuring that the Trust complies with all safety regulations and approved guidance via processes managed within the Trust to promote patient, staff and visitor safety. Is responsible for overseeing the delivery of education and training, to ensure compliance with regulations. The Trust board will also review the systems and processes for safe acquisition, storage and deployment of medical devices on an annual basis in line with the Care Quality Commissions Essential Standards of Safety & Quality Is responsible for ensuring policies, procedures and guidelines are in place which meet Trust and regulatory requirements. Members of the MDMG are responsible for feeding information back to their respective division (see group terms of reference, available on trust intranet.) Minutes of meetings can also be accessed via Device Links, Clinical Risk Manager, or Trust intranet. Is responsible for:- Ensuring departments have an identified medial devices link. Ensuring competency training is in place for medical devices in the trust. Developing a framework in which all users of a medical device will be assessed. Developing a network in which medical device information/ updates can be easily accessed (intranet site, , booklets). Centralise records of staff trained to use medical devices. Acting as a link with the medical devices group and departmental medical devices link. Providing induction training and medical devices awareness sessions. Is responsible for:- Ensuring departments have an identified a point of care link. Ensuring competency training is in place for point of care devices in the trust. Developing a framework in which all users of a point of care devices will be assessed. Developing a network in which point of care information/ updates can be easily accessed (intranet site, , booklets). Maintaining records of staff trained to use point of care devices. Acting as a link with the medical devices group and departmental point of care link. Providing training and clinical skills awareness sessions. Training Policy for v4 5

6 Departmental Managers / Preceptors Link Or Trained Trainer Individual Staff Departmental managers are responsible for:- Identifying a medical devices link on their ward or dept. Ensuring training programmes are available to all staff within their area. Ensuring that staff do not use medical devices until they have been trained and deemed competent in its use unless working under direct supervision. This includes the induction of new staff, temporary and locum staff. Ensuring Skills/Training Matrices are completed and up to date. Ensuring local policies are completed for authorised users of medical devices and locum, bank and agency staff using medical devices. Supporting induction process of identifying medical device training needs of staff. Supporting staff during Personal Development Plans and appraisal in identifying medical device training needs and monitor the outcome. Ensuring all devices are risk assessed in their department. The medical devices link along with support of the Clinical Risk Manager are responsible for:- Ensuring the agreed framework /training process is in place for all medical devices within their area. Ensuring staff using medical devices within their area receive training prior to device use and have completed competency assessments. Ensure all medical devices training records, documents and files are kept up to date. Ensuring staff within their area attend updates and retraining Maintaining records of staff training and updates. Acting as a link to the Clinical Risk Manager, informing of any progress / problems within the area, and updates of staff. Ensuring supplementary material (Manufacturing training manuals, CD ROMS etc) is stored safely. Staff that use medical devices have an individual responsibility to:- Recognise their own limitations with regards to using specific medical devices. For ensuring they attend medical device awareness session Seek training on a device to ensure competency is achieved as stated in appendix 1 1. The device risk category (Appendix 3). 2. What the device is used for How to operate the device. 3. The device warning alarms. 4. The consumable used with the device. Training Policy for v4 6

7 5. Definition of Terms The term covers any healthcare product excluding drugs used for treatment, monitoring, prevention, diagnosis and alleviation of patient s illness, disease injury or disability. It also covers devices used for control of conception. 6. Training 6.1 Inventory Within the trust reusable medical devices are assigned an individual unique Asset No upon delivery into the trust. Details of the device asset, make, model, location, date of delivery, dates of maintenance etc are compiled and stored within the Trusts inventory data base Backtraq which is maintained by the Electronics department; this data base can be used to determine the whereabouts or use of devices trust wide. Each ward is required to formulate an inventory of the types of devices used within that area; this should mirror the trust wide inventory for that area, and will inform the basis of the locally developed policy for authorised users (template available via Clinical Risk Manager or via the Trust Intranet site RM 44). The local policy will identify to all staff the devices they are required to use and consequently formulate the contents of training packs and training needs analysis. The training needs analysis is developed when details of equipment types linked to each ward or dept are entered onto a standardised excel framework in addition to details of competency achievements of each staff member. Hence this will provide details for central recording of competent users and those requiring training. Disposable devices and other non electrical devices are managed through the supplies dept. The supplies dept record orders and deliveries which indicate ward usage. 6.2 Process for identifying which permanent staff are authorised to use equipment identified in the inventory Within the organisation there are differences to the extent individuals perform within the same profession, depending on their ward/department specialities. It is therefore necessary to have local policy for determining the potential /authorised users of specific medical devices. It is the responsibility of the Ward or Department Managers are to agree locally the level of authority attributed to each medical device used within their ward or department. This could be related to profession, grade or procedure the device is to be used. Each clinical area is then required to complete a local policy (RM 44 Local Policy for Authorised users of ) which indicates authorised users of specific devices within that ward or department. This gives an indication to all clinical personnel practicing on that ward/department which devices they can and cannot use or specific function they are authorised to Training Policy for v4 7

8 use. This policy should confirm all medical devices within the local area, therefore duplicating details held on the Trust-wide inventory Backtraq system. All staff must be informed locally of their responsibilities, and levels of authority to use specific devices. Staff working within the area must stay within the remit of agreed local policy unless deviation is approved by a Service Managers or equivalent. While consideration for the authority to use specific devices is agreed locally, so should the level of training Training Levels Level One Training Level one training is that received at Corporate Induction Training sessions, it will be related to current best practice and legislation (see appendix 1). It is the theory behind safe use of devices. Level one training is also included in first year Student Nurse Induction Programme to the Trust and junior Doctors induction. Level Two Training Level two training sessions are practical sessions, facilitated by a trained competent user, (These training sessions are to cover requirements listed in appendix 1). It is a chance to receive hands on practical training for specific devices. Level Three Training Level three training is the competence assessment stage of training. The trainee demonstrates their level of competence to the assessor (see appendix 1). Only when a member of staff is able to demonstrate acceptable level of competence can they then use the devices in practice unsupervised. 6.3 Process for determining the training required to use the equipment identified on the inventory and the frequency of updates required New Employees:- To the Trust will during their induction period, with the support of a preceptor, work through the medical devices competencies specific to their area, ward or department. Competency forms will identify trained/further training required. Competency forms are available via the trust intranet, Point of Care Team or Clinical Risk Manager. Attainment of previous competency must be presented in an acceptable format (signed competency document) during the induction period if they are to be considered to be transferable from one clinical area to another. Will during Personal Development Planning with support of a Manager identify how training will be achieved, i.e. locally via trained competent colleagues, Clinical Risk Manager, Manufacturing Representatives or other Trust Professionals. Training Policy for v4 8

9 With department managers will discuss time scales of training and competency achievement. Will attend Trust wide induction training, in which the medical devices session will give an overview of the safe use medical devices, and sign post topics requiring training. Attendance will be closely monitored within the electronic OD & Training database. Once training and competency are complete, the re-training matrix should be completed to indicate a retraining schedule (see appendix 1 & 2) Will require a copy of the Local Policies to offer an indication of the level at which they will be expected to use specific devices. Training and competency must be demonstrated to the expected level. Will require a copy of What Do I Need to Know booklet, Available via Trust Intranet. Are to have access to all training manuals, documents, CDROMS and intranet web page. Are responsible for ensuring they only use medical devices under direct supervision until competency assessed. Are responsible for keeping a personal record of training needs, and achievements which can be presented as requested by departmental manager, a copy must be forwarded to the Clinical Risk Manager or entered on to the electronic excel training data base by the ward medical device link. Existing Staff:- Are responsible for keeping up to date with training in relation to medical devices. All documentation required is available via trust intranet or the Clinical Risk Manager. Training needs will be identified during competency assessments, which are required for all Moderate and high risk devices used in the ward or department. Must be aware of local policies which direct them to their level of operation for specific medical devices within the area of employment. Will identify during Personal Development Plans or Contact Appraisal individual training needs with a ward/department manager, and discuss how and when these are to be achieved e.g. via competent colleagues (locally), Point of Care, Clinical Risk Manager, Manufacturing representatives of other Trust Professionals. Will attend updates or re-training for the use of pertinent medical devices. Attendance must be recorded locally and within the ward excel database. Must be able to demonstrate competency for all medical devices used, if staff are to work unsupervised. Must have documentation to show training / achievement of competency. Must attend training for any new devices, software updates or revised models, prior to initial use. Re-training matrix to be completed after all competency achievements and an indication of next training update (Appendix 2). Training Policy for v4 9

10 All devices used within the Trust require a risk assessment to determine the potential level of risk patients and staff are exposed to using such equipment. Risk assessment outcomes can be concluded using the Trust s medical devices risk assessment tool (Appendix 3) The following categories demonstrate the possible outcomes HIGH RISK DEVICE Any device which if misused or fails during use Score could cause direct harm to the patient and/or MODERATE RISK DEVICE Score 8-12 LOW RISK score 6-4 VERY LOW RISK Score 1-3 LOW RISK DEVICE user which could potentially result in death Any device which if misused or fails during use could potentially result in temporary adverse consequences for the patient and/or user An information providing device, if the produced information not acted upon or is misinterpreted could have serious adverse consequences For the purposes of medical devices 'low risk' and' very low risk' are to be regarded in the same way i.e. a score of 1-6 covers any device that if used incorrectly or fails during use would be unlikely to have a serious consequence devices falling into a high or moderate category should not be used unless the user has been trained and assessed as competent, or unless the user is working under direct supervision of a competent user. The Electronics Department / Laboratory Point of Care Support Team and Device Clinical Risk Manager are available to assistance in the risk assessment of medical devices. Department managers are responsible for ensuring all medical devices in their area are risk assessed and identified as high and moderate or low risk. On completion of a risk assessment the device must be labelled if appropriate according to the risk assessment outcome, stickers (as below) are available from the medical equipment library. High risk device! Competency must be assessed Moderate Risk device Is Competency Assessed Low risk device refer to user manual The outcome of risk assessments must be held locally on each ward and replicated on the training matrix to demonstrate this process had been achieved. This data and can be used as a reference point for staff working within that area to determine the level of training required; i.e. all staff using devices with a high or moderate risk outcome must attend training and subsequently be able to demonstrate competency prior to using the device unsupervised. Low risk devices do not warrant competency assessment however staff should self assess competency following a review of the manufacturers literature. loaned from one clinical area to another must be reassessed upon receipt to ensure the outcome is the same. There is the possibility the same Training Policy for v4 10

11 device may have different risk outcomes when assessed within different medical specialism s. Users of medical devices are responsible for ensuring they are able to risk assess the device they use. 6.4 Process for ensuring that the identified training needs of all permanent staff are met All staff using medical devices must complete competency assessments for any high or moderate risk medical devices they use in their employment; should the practitioner maintain the level of competency with continued regular use of the device a self assessment will indicate retraining is addressed or competency maintained All questioning sections of competency/self assessment forms must be answered fully for competency to be achieved or continued All staff must be able to fully demonstration safe use of the device. Competency documents are available via Trust Intranet, Point of Care Team or Clinical Risk Manager. Full knowledge of training points (see section 7) relevant to the level of device use must be expressed. This information is available in operator manuals or Trust training booklets and should be discussed at all training sessions. Each member of staff is responsible for completing competency assessments, holding a copy of their achievements and informing the ward/dept medical devices link to upload the data onto the ward excel database. Ward managers and medical device links are to ensure ward files indicating staff training needs and level of competence are up to date (Skills/Training Matrix), this data must also be uploaded onto the wards excel database The Clinical Risk Manager will access training data from the local excel database to determine Trust wide training needs and support this accordingly. All clinical areas have access to Trust intranet, operator manuals, training booklets and competencies. All staff must be aware of how to access this data Attendance for Induction and update training is to be monitored and followed up as required. The excel training database will allow the identification of those members of staff requiring training and those who have attended. Review of Personal Development Plans and Contact Appraisals between staff and managers, will identify training needs and/or achievement or completion of induction packages. Audits will check training and competency level in all clinical areas, audits undertaken by Clinical Risk Manager and Device Links. Training records must be available and complete prior to usage of new equipment in patient areas. Training Policy for v4 11

12 New or updated devices or implementation of updated software versions to devices must not be released for use until training has been initiated within relevant clinical areas. Training needs may be identified following investigation of Incident Reports relating to the use of medical devices. Competency Assessments Competency assessments must be undertaken on all moderate and high risk devices. The assessment is to be preformed and documented using trust medical devices competency assessment forms. Self Assessment Self assessments can be used for low risk devices or for staff that have successfully completed previous competency assessments and have continued to maintain that level of competency by continued regular use of the device. The assessment is to be preformed and documented using trust medical devices self assessment forms. If staff are unable to complete all the questions correctly during self assessment, then training must be accessed with a subsequent competency assessment carried out to demonstrate effective training, understanding and improved level of competency. Training via Manufacturer s Representative All new high & moderate devices to the trust are to have competency training packages provided by the device manufacturers which are to be agreed by the medical device procurement group. The manufacturer s representative is to link with supplies, the Clinical Risk Manager or the Specialist Service Manager link to approve assessment criteria, (see pre purchase questionnaire). Point Of Care Training for point of care devices i.e. blood glucose monitoring, urine meter, blood gas machines and INR monitoring is provided and monitored by the Point of Care Team. Defibrillators Training for automated external defibrillators, is provided by, the resuscitation officer and basic life support cascade trainers. Training for manual & semi automated defibrillators is provided by the resuscitation officer. Low Risk This applies to all devices which have been assessed as low risk. Although competency based assessment is not required for these devices, each area is responsible for ensuring training is accessed. Retraining As technology and software advances there is a need to keep up to date therefore as new devices or software are introduced, training or update retraining are required, devices that are used infrequently also need refresher retraining sessions (see Appendix 2 retraining matrix). Training Policy for v4 12

13 7. Training Training records and preceding training history will be identified within archived training matrix With an aim to ensure patient safety is promoted and maintained at a high level, adverse incidents will be monitored to determine the likely contribution of use error or human factors to an incident, in addition the level of competence held by the user at the time of the incident needs to be investigated. Healthcare professionals are individually accountable for their practice, as part of their continuing professional development they have a responsibility to ensure they gain the knowledge and skills required to use medical devices safely. All users of medical devices require training and subsequently need to demonstrate competency of use prior to using devices unsupervised. Training should consist of the following points; competency should also demonstrate knowledge and understanding of these points:- How to choose the correct device required for the task, assessment of the patients needs and abilities Which consumables/ components are used or required for the device How to risk assess devices using a risk assessment tool (see appendix 1) How does the manufacturer intend the device works Suitability of the device working in conjunction with other devices How is the device decontaminated/ cleaned How should the device be stored Any pre use checks Any pre use calibrations/ how to set up the device How to look for signs of wear and tear How to recognise if the device has a service history How to recognise faults, any common faults What to do if there is a fault or mistake How do I monitor the patient while the device is in use, importance of observing the patient How to report an incident When will re-training be required Aware of the level of authorisation to use the device If the device is multifunctional awareness of which functions are relevant to each person's role How to obtain assistance in the use of devices Operators of diagnostic equipment who are unable to interpret device produced results must forward them to a competent member of staff for interpretation; this should be done within an agreed specified time according to procedure protocols. Generic medical devices used throughout the Trust will have trust wide training packages developed by either teams of competent medical device links/users or via the manufacturer and the Clinical Risk Manager. Specialist medical devices used within specific areas may require training packages developed by competent users of that area if not available presently. Training Policy for v4 13

14 Training packages are designed to support training and are not in place of training. They can be accessed via the Trust s medical devices intranet site.. 8. Equality and diversity The Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds. This policy has been appropriately assessed. 9. Process for monitoring compliance to this policy Standard / process / issue Departmental managers are responsible for ensuring all records are maintained and training needs are covered in Personal Development Plans, Contact appraisal and Induction interviews Staff performing medical device assessments should ensure all documentation is complete, and forwarded accordingly for recording Incident forms related to all medical devices will be monitored by the Clinical Risk Manager This will form the basis of a report delivered at Management Group meetings All locally used medical devices must be risk assessed to determine the level of training required The Clinical Risk Manager will monitor records of staff for medical devices awareness & update sessions. Monitoring and audit Method By Committee Frequency A random sample months of 50% of the wards & departments will Clinical Risk Management be audited on an Manager Group annual rolling programme to demonstrate the process has occurred in that area Spot check of wards will ensure all documentation is up to date. Each ward will be checked within an 18 month period This report will form the basis of a standing agenda item at the Management Group on a 2 monthly basis Spot check of wards will ensure all documentation is up to date. Each ward will be checked within an 18 month period Each Ward & Dept will forward an updated Excel matrix of training to Clinical Risk Manager Clinical Risk Manager Clinical Risk Manager Clinical Risk Manager/ Ward Manager Clinical Risk Manager/ Ward Manager Management Group Management Group Management Group Management Group months 2 months months months Training Policy for v4 14

15 Standard / process / issue Excel training matrix will assist in producing annual reports demonstrating level of training and competency required and /or achieved for individual members of staff. This will emulate the inventory held locally for identified authorised users and will therefore form the basis of training needs analysis. Reports will also indicate the uptake of re-training All staff have access to training aids, documentation and support. Every ward will be audited to ensure they have identified authorised users of all reusable medical devices used within that area, and that levels of training are consequently decided in relation to this as set out in local policy RM 44 Monitoring and audit Method By Committee Frequency A random sample 12 months of 50% of the wards & departments will Clinical Risk Management be audited on an Manager/ Group annual rolling Ward Manager programme to demonstrate the process has occurred in that area Spot check of wards will ensure all documentation is up to date. Each ward will be checked within an 18 month period Spot check of wards will ensure all documentation is up to date. Each ward will be checked within an 18 month period Clinical Risk Manager/ Ward Manager Clinical Risk Manager/ Ward Manager Management Group Management Group months months 10. Consultation and review of this policy This policy has been reviewed in consultation with Risk Management & Management Group Membership 11. Implementation of policy (including raising awareness) device policies have been developed with an aim to guide and support all staff who directly or indirectly interface with medical devices within their role of employment to ensure safe and effective procurement, use and management of medical devices; and therefore safeguard public health. We need to ensure the Trust has systems in place that meet appropriate safety, quality and efficiency standards. The overall systems believed to be worthy of attaining of theses standards are described within the updated policies and encompass risk identification, management & monitoring. Policy development will continue to grow in a bid to remain up to date with achievable best practice and legislation. Clinical staff will be informed accordingly. Training Policy for v4 15

16 In recognition of the aims of policies clinical staff need to appreciate their responsibilities in embedding the systems within their individual role/practice, ward or department. Following ratification of the policies they will become available to all clinical staff via the Trust Intranet. The Clinical Risk Manager will access all wards and departments to ensure an up to date record of all current medical device links is available. This will ensure the correct members of each ward teams are receiving necessary communication and support. The Clinical Risk Manager will liaise with ward and department managers and requested access to any up and coming team meetings etc. If this is not an option the Clinical Risk Manager shall coordinate a meeting with the ward manager and medical devices link directly. Meetings will be arranged to highlight and discuss changes to the policies, while simultaneously instilling individual roles and responsibilities. The format of the meetings shall be that of an informative presentation followed by and informal discussion which should facilitate opinion, concerns etc from clinical staff. Individual wards will have the opportunity to view their audit results relating to policy compliance, this should give a basis to channel support. The outcomes of these sessions/meetings aim to determine a combined ward/dept and clinical risk manager action plan for the implementation of required changes. Following the development of ward action plans a further review will be planned to determine the effectiveness of the policy this will take the form of a repeat audit and provision for staff to feedback, all ward and department links will be requested to assist in the audits. 12. References NHS Litigation Authority Risk Management Standards for Acute Trusts Care Quality Commission Essential Standards of Quality & Safety DB 2000 Equipped to care: the safe use of medical devices in the 21st century DB 2001 in practice: a guide for health and social care professionals Managing MHRA (2006) MHRA DB (2006) Single use medical devices: implications and consequences of Reuse 13. Associated documentation OP 31Operational Policy For Engineering & Library RM30 Policy For The Procurement Management And Use Of Strategy RM 44 Local Policy for Authorised users of RM 46 Local policy for training required by Locum, Bank & Agency Staff Training Policy for v4 16

17 Appendix 1 MEDICAL DEVICES TRAINING Training to use medical devices safely reduces the risks of harm to your patients, self and colleagues. Level 1 Training = Local Mandatory Training, or Induction Training Level one training will cover issues surrounding the safety of medical devices focusing on:- All Healthcare Professionals and Support Workers responsibilities Risk Management, we can control risk by training staff well, having clear procedures and a maintaining safe environments). Incident reporting promotes learning from our failures with early recognition of poor practices, and mistakes, with feedback on performance, and decisive intervention. External agencies such as NHS Litigation Authority, National Patient Safety Agency, Medicines & Healthcare products Regulatory Agency, Care Quality Commission generate indisputable partnerships, share good practice and feedback on performance. Standardisation of equipment within the trust allows standardised training with the ability to develop strategies for accessing good practice and research value shared through education and training. Level 2 Training = Practical Sessions, facilitated by a trained competent user. Level 2 training involves being shown and informed of the following training points, which should also hold viable for demonstrating competency. Access to the actual device is required at this level of training, How to choose the correct medical devices if there are a number of makes & models in circulation. How to risk assess the device. Does the medical device fit with the patient s needs and abilities? Emphasis made to the importance of using a device the way the manufacturer intended and not just making do with a device because it is the only one there. How does the device work, ensure this is fully understood by the learner. The learner should question - will the next person on shift be aware of how to use the device. The availability of the components required for use with the medical device. Suitability of device working in conjunction with another device. How the device is decontaminated. How the device is stored. The pre-use checks. Pre use calibrations. Signs to look for wear and tear. Does the device have service history. How to recognise faults. What to do if there is a fault or mistake. When re-training will be required. Training must also cover all criteria requested on the competency forms. Level 3 Training = the stage where the user demonstrates competency to the assessor The trainee or user under assessment must demonstrate they can use the device safely and are aware of the risks associated with its use. Knowledge of the above points in level 2 training. Training Policy for v4 17

18 Appendix 2 MEDICAL DEVICES TRAINING AND RE-TRAINING ASSESSMENT MATRIX 2012 Are you authorised to use this device? (Check your local policy) No You should not use this device unless directly supervised Yes What is the risk assessment outcome of this device? High Risk Moderate Risk Low Risk You must access competency based training and complete a competency document prior to using this device unsupervised You must access competency based training and complete a competency document prior to using this device unsupervised You must complete a self assessment competency document once you have read the manufacturer guidance on this device You must be able to produce evidence of your level of competence and your competency training/ assessment If you have been absent from my usual work place 3-6 months, on your return you need to self assess In clinical practice how often do you use this device (on average)? I have been absent from my usual place of work 6-12 months or longer On your return you need a competency assessment Daily / weekly Monthly 2-3 times / year Less than twice / year UNLESS a new device is introduced to your ward or department from a different manufacturer, or there is a software update or model upgrade your re-training /assessment guide is as follows Competency training or self assess for high, medium or low risk devices every 2-3 years Competency training for high risk devices, competency training or self assess for medium risk devices & self assess for low risk devices every 18 months- 2 years Competency training every 1 year 18 months for high or medium risk devices and self assess for low risk devices Competency training every 6 months -1 year for high or medium risk devices and self assess for low risk devices Training Policy for v4 18

19 The above are the maximum retraining targets if you feel you need training more frequently then remember it is your responsibility to seek this, no one will be judged if they need more training. Patient and user safety is our ultimate goal. If new devices are introduced to your ward or department from a different manufacturer, or there is software updates or model upgrades re -training and competency assessment must be carried out prior to device use. Guidelines for re-training competency and self assessment with medical devices If you take a break from your usual job due to long term sickness, maternity leave or secondment etc, hence limited or no use of medical devices, you are to ensure you hold the same level of competency on return to using the devices. If you have been absent from your usual post for 3-6 months you must complete a self assessment on your return (if your absence time added to the time of your last assessment takes you over the matrix time for re-training you must take part in a competency based assessment). If you have been absent for 6-12 months or longer you are to have a competency based assessment carried out on return to your ward/dept. If you have successfully completed competency assessments for high and moderate risk devices and have maintained this level of competency by continuing regular use (i.e. daily or weekly) your next retaining assessment may be in the form of a self assessment. If you have achieved an initial accepted level of competency but had had limited opportunity to maintain this level due to infrequent use (i.e. 2-3 times a year or less), you are required to undertake a competency assessment at the point of retraining assessment Training related to risk categories High risk devices training is to be delivered via a trained trainer, manufacturing representative or medical devices clinical risk manager (if appropriate). Moderate risk devices - training delivered via trained trainers, manufacturing representatives or medical devices clinical risk manager (if appropriate). Low risk devices training delivered via CD ROMS, instruction manuals or trained trainers each dept is responsible for ensuring training is available for low risk devices. Competency assessment is not required following training (for low risk devices only). If at any time you feel you need training or you feel you do not hold the required level of competency even after training you need to seek further training. Remember you are responsible for the care you give and is not safe care if you do not have training or understand the training given. Training Policy for v4 19

20 Likelihood Appendix 3 MEDICAL DEVICES RISK ASSESSMENT MATRIX This matrix should be used to assess the risk category of a medical device. It assumes:- The device is safe to use at commencement of treatment, diagnosis etc The practitioner possesses the required competency to use the medical device safely and effectively Consequence 1 Negligible No obvious harm injury 2 Minor Non permanent harm (up to 1 month medical treatment) 3 Moderate/ serious Significant/ semipermanent harm (up to 1 yr medical treatment) 4 Major Permanent harm 5 Catastrophic Single or multiple deaths 1 Rare 1:1000,000 2 Unlikely 1:10,000 3 Possible 1: Likely 1:100 5 Almost Certain 1: Risk 1-6 Low Risk 8-12 Moderate Risk High Risk All staff using devices with a high or moderate risk outcome must attend training and subsequently be able to demonstrate competency prior to using the device unsupervised. Low risk devices do not warrant competency assessment however staff should self assess competency following a review of the manufacturers literature. Training Policy for v4 20