Regulatory Frameworks (HBI106)

Module Objective

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.

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:

  • The requirements of the professional, regulatory and statutory bodies in the area of healthcare technology.
  • The HSE’s role with respect to the Management of Health and Safety at Work Regulations and other relevant legislation.
  • The statutory requirements related to ionising radiations, or equivalent legislation relevant to the Clinical Scientist in HSST’s area of practice.
  • Activity of ISO, IEC and other bodies in generation of standards that can be applied in healthcare settings (such as ISO9000, ISO17025, ISO 15189 and the IEC60601 family of standards) and the role of accreditation bodies that confirm compliance with standards.
  • The governance of medical devices in a specific healthcare organisation, and the value and development of standards, guidance and best practice as developed by professional bodies.

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:

  • Influence the development of  policy, regulation and standards.
  • Implement standards and demonstrate compliance.
  • Evaluate how effectively regulation and standards are implemented within an organisation.
  • Manage the reporting of non-compliance with standards and investigation of incidents that breach statutory requirements (including root cause analysis).
  • Generate auditable records of compliance with regulation and standards.

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:

  • The ability to appreciate the regulatory framework within which decisions are made.
  • An interest in influencing the formulation of policy, standards and guidance.