Competency information

Details

Participate in the development and execution of a medical device procurement exercise

Considerations

  • Processes for device procurement including:
    • identification of clinical need, user requirements and device application
    • development of a device or system specification
    • evaluation criteria
    • life cycle costing, including device, accessories and maintenanceinformation
    • device evaluation by clinical users and technical staff
    • identification of future maintenance requirements
    • review of pre-purchase questionnaire responses
    • disposal arrangements, including the Waste Electrical & Electronic Equipment directive
    • tender evaluation and final selection
    • device procurement.
  • Awareness of:
    • the legislative and regulatory framework covering the supply, installation and maintenance of medical equipment
    • product liability and health and safety legislation.
  • Access to Medicines and Healthcare Products Regulatory Agency (MHRA) and other published sources of evaluation and assessment information.

Relevant learning outcomes

# Outcome
# 3 Outcome Carry out the following device life cycle technical tasks:
  1. identify the key elements involved in a medical device procurement exercise