Device Risk Management

Details

Title

Device Risk Management

Type

Stage One

Module code

HPE305

Requirement

Compulsory

Module objective

By the end of this module the Clinical Scientist in HSST will be able to analyse and synthesise their understanding of device risk management. The Clinical Scientist in HSST will be expected to apply their knowledge to identify, quantify and reduce risk associated with medical device usage. The Clinical Scientist in HSST will also be expected to evaluate their own response to both normal and complex situations using the professional attributes and insights required of a Consultant Clinical Scientist.

Knowledge and understanding

By the end of this module the Clinical Scientist in HSST will be able to analyse, synthesise and critically apply their expert knowledge with respect to medical equipment management including: 

• medical device risk management knowledge and engineering principles to minimise the risks associated with device acquisition and utilisation.

Technical and clinical skills

By the end of this module the Clinical Scientist in HSST will be able to demonstrate  a critical understanding of current research and its application to the performance and mastery of the following technical skills and will:

• identify prevailing medical device-related risks within the institution.
• develop medical device risk management strategies for the institution.
• develop a policy for the organisation to help manage  risk.
• perform a range of complex medical device- or service-related risk assessments.
• advise on practical risk management actions in medical device risk management  and governance.
• authorise modifications to medical devices having analysed associated risks.

By the end of this module the Clinical Scientist in HSST will be expected to evaluate their own response to both normal and complex situations demonstrating the professional attributes and insights required of a Consultant Clinical Scientist working within the limits of professional competence referring as appropriate to senior staff and will:

• critically appraise the utilisation of medical devices via an awareness of their use within the institutions specialities, i.e. a thorough appreciation of the range of clinical services provided and the context in which they are delivered.

Attitudes and behaviours

By the end of this module the Clinical Scientist in HSST will be expected to evaluate their own response to both normal and complex situations demonstrating the professional attributes and insights required of a Consultant Clinical Scientist working within the limits of professional competence referring as appropriate to senior staff and will:

• behave in accordance with Good Scientific Practice.
• establish and influence the culture of health and safety in the workplace promoting patient safety work in accordance with data protection and ethical guidelines.
• promote the importance of medical device risk management .
• ensure the integrity and security of data responding appropriately to issues as they arise.