Medical Device Management Strategy

Competencies

#	Learning outcome	Competency	Action
# 1	Learning outcome 1	Competency Undertake a comprehensive review of the institution’s medical device management policy against the prevailing national standards and professional best practice	Action View
# 2	Learning outcome 1	Competency Outline the key elements of a medical device management strategy and the associated service delivery	Action View
# 3	Learning outcome 2	Competency Navigate and interpret the IEC 60601 electromedical family of standards, including collateral, particular and performance standards	Action View
# 4	Learning outcome 1,2	Competency Navigate and interpret the healthcare-related risk management standards, including consideration of at least the following specific examples of medical device risks encountered	Action View

Assessments

You must complete:

• 1 case-based discussion(s)
• 1 of the following DOPS/ OCEs:

Undertake a review of the Institutions approach to Device Risk Management, identifying key features of the Medical Device Management policy, governance controls and local arrangements for device life cycle management	DOPS
Navigate the IEC 60601 1 standard and associated collateral and particular standards.	DOPS
Conduct a medical device related risk assessment	DOPS
Clean and decontaminate a reusable medical device d	DOPS
Describe to clinical staff the reasons for control of medical devices and how this is achieved.	OCE
Develop a practical application for a device management protocol in relation to a particular equipment type you're familiar with using information extracted from the standards. Present the protocol to colleagues	OCE
Present findings of a risk assessment to clinical colleagues including recommendations to mitigate risk	OCE

Learning outcomes

1. Review an Institution’s medical device management policy against the prevailing national standards and professional best practice
2. Interpret and recommend application of relevant national standards relating to medical device management and assessment of risks
3. Apply policies associated with decontamination of medical devices to daily work practice