Details

Title Device Acquisition and Acceptance
Type Stage One
Code HPE302
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 medical device selection, procurement, acceptance testing and installation processes and the maintenance implications and clinical risks associated with the acquired devices to ensure patient safety. The Clinical Scientist in HSST will be expected to apply their knowledge in the clinical setting and demonstrate the ability to manage a medical device acquisition project and 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 device management including: 

  • the application of engineering principles and practice to the evaluation and selection of medical devices, including an awareness of  the  clinical  requirements and associated risks.

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: 

  • write and evaluate a clinical specification as part of an equipment acquisition process, incorporating any technical standards and regulatory  compliance.
  • develop evaluation criteria against which to test candidate  devices.
  • develop and assess responses to pre-tender  questionnaires.
  • arrange equipment trials to ensure devices meet clinical need and evaluate against established criteria.
  • evaluate commercially available equipment against clinical  requirements.
  • contribute to business case development and write a case for medical device acquisition encompassing  key requirements.
  • apply project planning methodologies to assist in the procurement and installation process.
  • perform the installation process, including specifying all necessary acceptance tests and commissioning processes.
  • determine the ongoing maintenance arrangements for the device and associated life cycle issues.
  • handle rejected items that fail acceptance testing.

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:

  • show respect and behave in accordance with Good Scientific Practice.
  • establish and influence the culture of health and safety in the workplace.
  • have a clear focus on effective patient centred service delivery, minimising risk and promoting patient safety.

Specialties

Code Title Action
HPE3-1-20 Clinical Biomedical Engineering [v1] View