Competency: 16

Details

Undertake a risk assessment on a piece of equipment or a service- related issue in accordance with ISO 14971 and local trust risk management policies and procedures

Considerations

• How to assess the value of existing and new techniques.
• Formal and informal techniques for the assessment of risk.
• Formal and informal techniques for the assessment of benefit.
• The principles of the technology used in the equipment under consideration.
• The clinical implications and use of the equipment under consideration.
• The measurement principles and limitations of test equipment used.
• Legislative and regulatory framework for equipment under consideration.
• Range and type of evaluation methods and how to match these to type and complexity of equipment under consideration.
• How to establish evaluation criteria relevant to equipment functionality, performance, intended use and clinical context.
• How and where to obtain expert advice.
• How to assess training implications of new and emerging techniques
• The type, range and level of detail of data required to enable a decision on safety and effectiveness of equipment.
• Peripheral issues affecting use and cost of equipment under consideration, including location, environment, consumables, risks and training requirements.
• The healthcare context of the relevant area of clinical medicine.
• Clinical risks associated with the use of equipment.
• To an appropriate level, the anatomy, physiology and disease processes or deficits in the relevant area of clinical medicine.
• Individual level of authority and competence.
• The role, capabilities and limitations of medical equipment in the clinical environment and the contexts in which it is used.
• Common causes of equipment failure and misuse.
• Technical, safety and regulatory guidance and obligations with respect to medical facilities (electrical installations, emergency power requirements, piped gas and suction supplies, decontamination requirements, ancillary services, etc).

Relevant learning outcomes