3. NHSLA Criterion 2.7
• Standard 2: Competent & Capable Workforce
• Criterion 7: Medical Devices Training
• User training of permanent staff
– Identifying authorised staff
– Determining training required & frequency of updates
– Ensuring training needs are met
• Levels:
– Level 1: Documentation
– Level 2: Implementation
– Level 3: Monitoring
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4. 2. Revision & Update of Policy
• Policy Aim: Lifecycle Management
• Policy/ies:
– Medical device maintenance policy
– Medical device training policy
• Two options:
– If a policy already exists, review & make recommendations
– If a policy does not exist, we use our own policy template
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5. 4. Implementation of Training Records
• Training records for individual staff:
– Staff details: Name, location, role
– Medical device details: Medical devices within the area
– Devices on which they have had/are due/need training
• Options for implementation:
– Hard-copy forms held by Equipment Controllers
– Off-shelf IT products (e-learning)
– Additional module within biomedical database
– Bespoke TBS GB system specific to customer requirements
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6. 6. Implementation of Training & Centralised Records
• Planning
– Interim project support
– Other organisation in-house trainers/practice development staff
– Equipment Controllers/Ward Managers
• Advertising
– Staff Communications
– Intranet
– Posters in wards & departments
• Delivery
– Original Equipment Manufacturers
– Organisation in-house trainers
– Consultant trainers
• …
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7. 9. Attendance at Committee Meetings
• Active member of relevant committees
• Present results of training audits & reports
• Highlight key issues
• Receive feedback from other staff
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9. Steps to Compliance
1. Review of Systems
NHSLA Level 1 CQC
2. Revision & Update of Policy Outcome
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NHSLA Level 2
3. Review & Implementation of Maintenance Provisions
NHSLA Level 3
4. Implementation of Regular Audits & Reports
5. Attendance at Committee Meetings
NHSLA & CQC
6. Preparation of Evidence Folder
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10. 4. Implementation of Audits & Reports
• Regular organisation wide audit for all device types
• Introduction of ward audit
– Monitor compliance with policy
– Review effectiveness of device maintenance
• Against key performance indicators:
– Medical devices are commissioned and added to an inventory
before being put into use
– All staff are aware of the single-use symbol and that devices should
only be used once on a patient and then discarded
– Medical devices are on planned maintenance schedules and are in
date for service
– Medical devices are labelled appropriately when faults are identified
and the relevant department notified
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11. CQC
• Care Quality Commission (CQC)
• Essential Standards of Quality and Safety,
Regulation 16, Outcome 11
• Focused on the impact of the whole medical
device lifecycle management on the patient
• Provider Compliance Assessment
• Evidence Gathering
• Attendance at assessments or audits
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