Module - Regulatory Frameworks (HBI106)
Aim of this module
By the end of this module the Clinical Scientist in HSST will be able to analyse, synthesise and apply their knowledge and understanding of the regulatory framework within which medical technologies are safely and effectively managed in healthcare services.
The Clinical Scientist in HSST will understand and comply with the requirements of relevant reporting structures as established by organisations such as the Health and Safety Executive (HSE), the Environment Agencies, the Care Quality Commission (CQC), the Medicines and Healthcare products Regulatory Agency (MHRA) and equivalent organisations in terms of safe and effective use of healthcare technologies. They will also understand the governance of issues around medical device development and the use and role of standards, guidance and best practice in providing safe and effective clinical services that use medical technologies. The Clinical Scientist in HSST will understand reporting structures in relation to incidents involving the use of medical devices, including how to manage and investigate the root cause of such incidents.
The Clinical Scientist in HSST will also be expected to consistently demonstrate the attitudes and behaviours necessary for the role of a CCS leading safe Medical Physics services.
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:
Technical and Clinical Skills
By the end of this module the Clinical Scientist in HSST will be able to demonstrate a critical understanding of the regulatory framework for healthcare technology and its application to the performance and mastery of the following technical skills and will:
By the end of this module the Clinical Scientist in HSST will also be expected to evaluate their own response to both normal and complex situations. They should consistently demonstrate the professional attributes and insights required of a CCS working within the limits of professional competence, referring as appropriate to senior staff, and will demonstrate: