Title Device Optimisation
Type Stage One
Code HPE304
Requirement Compulsory

Module objective

By the end of this the module Clinical Scientist in HSST will be able to analyse, synthesise, evaluate and apply their knowledge with respect to the operation of a wide range of medical devices commonly used in the clinical environment and the use and limitations of specialist equipment in a variety of clinical settings and will begin to understand certification and accreditation standards that apply to clinical services, e.g. ISO 9001 quality management system. Clinical Scientists in HSST will be expected to reflect on the challenges of applying research to practice in relation to these procedures and suggest improvements, building on a  critique  of available evidence.

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:

  • underlying engineering principles of operation of key medical devices and associated risks.
  • the application of scientific and engineering principles and practice to the safe and effective clinical utilisation of equipment.
  • indications/contraindications to the use of equipment and/or assessment/measurement techniques.
  • evolving knowledge of the clinical settings in which medical devices are  utilised
  • role and influence of the consultant healthcare s cientist in identifying new technologies and facilitating adoption for organisational efficiency and patient benefit.
  • sources of information that will aid development of indications/contraindications including manufacturer’s technical documentation, national safety documents, etc.
  • a range of medical devices spanning factors that can interfere with or confound measurements or readings and actions to  mitigate.
  • electromagnetic interference issues in the healthcare  environment.
  • how to collate information from a variety of sources to enable an engineering assessment of device appropriateness and continuing suitability. Sources of information will include manufacturer device obsolescence,  national  patient safety recommendations, Medicines and Healthcare Products  Regulatory Agency (MHRA) device alerts, Royal College recommendations, scientific journals, local audit, new technologies and patient  feedback.
  • the design and execution to audits and measurements/data  collection  to establish device efficacy to inform/confirm  device suitability.
  • the role of the healthcare scientist in medical device prescribing,  including.
    • suitability of the particular product for the environment it is to be used in (e.g. home care requirements may require alternative alarm  settings).
    • user training requirements and development of abridged  guidance.
    • arrangements for handling routine maintenance and reporting faults, if the device is to leave the organisations premises.
    • arrangements to handle queries and incidents.
    • plans for ongoing provision of consumables.
  • device return or replacement Information.
  • governance standards and policies.
  • networking and inter-operability standards.
  • network architecture.
  • IEC80001.
  • risks and issues relating to wireless networking, Bluetooth,  etc.
  • national clinical service standards.
  • current national clinical service standards to ensure device  management  services evolve to effectively support clinical department.

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 operational guidelines to assist operators use equipment optimally.
  • write procedures to assist in device maintenance/quality  assurance.
  • write technical reports to identify and explain safety and performance issues encountered with devices.
  • perform risk assessments, evaluate the output and ensure the necessary steps are taken to minimise risk.

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


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