Competency information

Details

Identify and navigate the standards that underpin or are used within the organisation’s medical device management strategy and associated service delivery.

Considerations

  • Existence of and ability to navigate key prevailing standards, including:
    • legal requirements, health and safety at work legislation
    • medical device elements of prevailing NHS standards, e.g. Care Quality Commission and NHS Litigation Authority
    • electromedical safety standards, IEC60601, part one, collaterals and family of particular part 2 standards
    • ISO 9001 quality management standards
    • risk management standards
    • best practice standards.
    • The philosophy, hierarchy of IEC 60601 and key differences from other standards, i.e. single fault condition. Understand how these standards are used by the practising clinical engineer.
    • The clinical governance framework and corporate objectives of the organisation.
    • Local healthcare environment and range of services offered by the institution and the existence of relevant policies and procedures.

Relevant learning outcomes

# Outcome
# 5 Outcome design training material to support the use of a medical device in the clinical setting