Device Risk Management and Governance 2 (SPE327)

30 credits

Aim of this module

Planned Maintenance and Repairs to Devices

The trainee will learn how to develop, organise and monitor planned maintenance programmes, including the use of risk-based methodologies. Additionally the trainee will learn to manage and oversee the equipment repair processes within the medical engineering workshop and clinical settings.

Patient Safety

The aim of this module is for the trainee to understand how safety alerts are received into the organisation, distributed, acted on and monitored to ensure all necessary safety-related actions have been taken.

Expertise in Medical Device Risk Management

The module will develop the trainee’s ability to proactively identify, quantify and reduce risk associated with medical device usage 

Professional Advisory Services

The module will develop the trainee’s ability to advise the institution on professional and technical issues relating to medical device management and governance and will be aware of medical device research and emerging technologies to ensure the institution is able to adopt innovative devices in a timely manner 

Important information

The academic parts of this module will be detailed and communicated to you by your university. Please contact them if you have questions regarding this module and its assessments. The module titles in your MSc may not be exactly identical to the work-based modules shown in the e-portfolio. Your modules will be aligned, however, to ensure that your academic and work-based learning are complimentary.

Learning Outcomes

  1. Critically discuss the use of medical devices in a complex clinical/electrical/network environment.
  2. Describe the range of materials encountered in the development of novel engineering solutions in medicine.
  3. Critically appraise the legislation and guidance that ensures safe working with non-ionising radiation.
  4. Discuss the issues around managing medical devices in complex clinical environments, e.g. neonatal intensive care, renal dialysis.

Indicative Content

Non-Ionising Radiation

  • Sources – physical properties, interactions with matter, biological effects, measurement, applications and safety of:
    • UV
    • intense light sources
    • lasers
    • infrared
    • microwaves
    • RF
    • electric and magnetic fields
    • ultrasound
  • The clinical measurements that use non-ionising radiation, for example:
    • red/infrared light to measure O2 content in blood
    • infrared to measure microvascular circulation
    • UV to measure skin sensitivity
    • Doppler ultrasound
  • Relevant guidelines, documents and standard operating procedures for safe practice with regard to the use of non-ionising radiation in the clinical environment
  • Electromedical (EM) interactions between implanted devices and the MRI environment
  • Safety issues and exposure limitations relevant to different patient groups
  • Rationale behind safety standards

IT and Networking

  • Networking and the network environment
  • Connecting medical devices to the hospital network
  • System management, configuration control and software release
  • Interoperability, DICOM RT, HL7 and messaging standards
  • Links to hospital administration systems
  • Legislative framework for IT, data protection
  • Regulatory standards including IEC601 and the Medical Devices Directive as applied to software
  • Equipment management database systems
  • Device tracking systems

Electrical Infrastructure and the Clinical Environment

  • The standards for electrical infrastructure for medical devices
  • Sources of EM interference, including mobile communication devices
  • Device interactions in complex clinical environments
  • The wireless patient environment

Specialist Clinical Environments

  • Theatres
  • Intensive care/high dependency
  • Neonatal intensive care
  • Renal dialysis, including:
    • renal anatomy, physiology and pathology
    • dialysis techniques and technology
    • monitoring performance
    • water treatment
    • psychological and social implications of renal replacement therapy


  • Properties of cells, organs, tissues, tissue repair; tissue substitutes
  • Biocompatibility, biotolerance, biodegradation
  • Tissue integration, wear
  • Materials for implantation: composites, polymers
  • Synthetic organs
  • Testing of materials, methods, standards, legislation