Module information

Module details

Device Risk Management and Governance
Module code

Aim of this module

The aims of the rotation are to allow the trainee to gain experience of operating a wide range of medical devices and appreciation of their application in the clinical setting, and an insight into and practical experience of all elements of the medical device management life cycle, including device selection, commissioning, device maintenance, patient safety, training and condemnation. The trainee will also be introduced to the requirements for and use of a medical device information system and patient safety and device risk management. The trainee will gain an overview of the roles and responsibilities of a device risk management service and the local arrangements for service delivery and will be able to work effectively in the clinical setting assist them in choosing their future area of specialisation.

Work-based content


# Learning outcome Competency Action
# 1 Learning outcome 1,2 Competency

Operate a wide range of commonly encountered medical devices used in the organisation, ensuring coverage of diagnostic, monitoring and therapeutic equipment types.

Action View
# 2 Learning outcome 1,2 Competency

Electrically safety test a range of Class1 and Class 2 devices, of types B, BF and CF, including the testing of applied parts

Action View
# 3 Learning outcome 1,2 Competency

Access information sources to aid with the operation of devices, including manufacturer’s instructions for use, medical device workshop manuals, organisations medical device training resources

Action View
# 4 Learning outcome 3 Competency

Participate in the development and execution of a medical device procurement exercise

Action View
# 5 Learning outcome 3 Competency

Carry out acceptance tests, including commissioning devices into clinical use

Action View
# 6 Learning outcome 3 Competency

Medical device training:

  • Complete a competency-based training programme for a medical device
  • Shadow company representatives delivering equipment training to clinical users
  • Contribute to the delivery of training to support the use of a medical device in the clinical setting in conjunction with training officers in theorganisation
Action View
# 7 Learning outcome 3 Competency

Undertake planned maintenance on a range of medical devices and complete service records comprehensively and legibly

Action View
# 8 Learning outcome 3 Competency

Observe the process for device repair and observe medical devices being repaired

Action View
# 9 Learning outcome 3 Competency

Clean and decontaminate a medical device

Action View
# 10 Learning outcome 3 Competency

Participate in the removal of a medical device from service

Action View
# 11 Learning outcome 4 Competency

Participate in the actions on a safety alert from receipt into the organisation, through determination of actions, execution of work, monitoring of progress and closure

Action View
# 12 Learning outcome 4 Competency

Participate in the investigation of a medical device incident within the organisation

Action View
# 13 Learning outcome 5 Competency

Investigate and describe the organisational approach to medical device management and the management of the life cycle of medical devices

Action View
# 14 Learning outcome 5 Competency

Identify and navigate the standards that underpin or are used within the organisation’s medical device management strategy and associated service delivery

Action View
# 15 Learning outcome 6 Competency

Use the organisation’s medical device information system to:

  • recall inventory item details
  • log an equipment fault or service request
  • generate asset/maintenance reports, for an individual device or group of devices
  • generate key performance data
Action View
# 16 Learning outcome 7 Competency

Undertake a risk assessment on a piece of equipment or a service- related issue in accordance with ISO 14971 and local trust risk management policies and procedures

Action View


You must complete:

  • 1 case-based discussion(s)
  • 1 of the following DOPS/ OCEs:
Carry out a range of medical device life cycle procedures, including acceptance testing, planned maintenance, device verification and condemnation, including the use of patient simulators, test equipment and electro medical safety testers DOPS
Navigate the medical device information system, including production of simple asset detail and maintenance reports . DOPS
Access and interpret relevant medical device management standards that the healthcare institution have to work to DOPS
Complete a real or shadow change to an operating procedure used in medical device maintenance DOPS
Describe the key services of the medical device life cycle process and the prevailing standards healthcare organisations work to DOPS

Learning outcomes

  1. Operate a wide range of medical devices used in the clinical environment, understanding their clinical applicability, associated risks and limitations.
  2. Operate standard workshop test equipment, specialist medical device test instrumentation, including electromedical safety testers. Using appropriate equipment to test a range of Class 1 and Class 2 equipment of types B, BF and CF, including some with applied parts. 
  3. Carry out the following device life cycle technical tasks:
    1. identify the key elements involved in a medical device procurement exercise
    2. acceptance test and commission a new medical device
    3. design of training material to support the use of a medical device in the clinical setting
    4. perform planned maintenance on a range of medical devices
    5. describe and observe the device repair process
    6. condemn a medical
  4. Identify sources of patient safety information and describe the key elements of processes to manage safety alerts and investigate patient incidents involving medical devices. 
  5. Identify and navigate the standards that underpin the organisations strategy for medical device management and service delivery arrangements for life cycle management including:
    1. prevailing national standards for healthcare
    2. legal/statutory requirements
    3. Electro-medical safety standards
    4. quality management standards
    5. risk management standards
    6. best practice standards
    7. organisational polices, and procedures, together with medical device workshop-specific
  6. Use the organisation’s medical device information system for device risk management activities, including the recording of key information relating to life -cycle service elements as well as the ability to retrieve essential asset-related information and reports.
  7. Perform a risk assessment on a piece of equipment or a service-related issue, showing an appreciation of local institutional risk management policies and procedures. 

Academic content (MSc in Clinical Science)

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. Discuss and evaluate the role of Clinical Engineering in innovation and service development. 
  2. Describe the legislation that underpins safe working within the radiation, workshop and clinical environements.  

Indicative content

Medical Device Life Cycle

  • Health Technology Assessment
  • Principles of project management
  • Quality systems and standards
    • ISO9000
    • EN13485
  • Equipment evaluation
  • Medical device life cycle
  • Medical Devices Directorate
  • Risk management principles applied to medical devices


Introduction to Radiation Physics

  • X-rays, electrons (betas), neutrons, alpha and other particles
  • Radioactivity units and relationships
  • X-ray production
  • Physical effects of radiation
  • Interaction processes with matter
  • Measurement and instrumentation
  • Biological effects of ionising radiation
  • Basic principles of imaging:
    • X-ray, computerised tomography (CT)
    • magnetic resonance (MR)
    • nuclear medicine
    • ultrasound (US)
  • Non-ionising radiations including ultraviolet (UV), radiofrequency (RF) and microwaves, lasers, infrared, magnetic fields and ultrasound
  • Radiation safety: dose limits; national and international organisations and recommendations; legislation; principles of protection, safe practice, monitoring and reporting applied to:
    • ionising radiation
    • UV, microwave, RF and magnetic fields, lasers and ultrasound

Clinical experiences

Important information

Clinical experiential learning is the range of activities trainees may undertake in order to gain the experience and evidence to demonstrate their achievement of module competencies and assessments. The list is not definitive or mandatory, but training officers should ensure, as best training practice, that trainees gain as many of these clinical experiences as possible. They should be included in training plans, and once undertaken they should support the completion of module assessments and competencies within the e-portfolio.


  • Operate a wide range of medical devices available in the Healthcare Institution, gaining an insight into their clinical utilisation in a variety of clinical settings
  • Participate in the following medical device life cycle elements:
    • discuss and evaluate the stages of managing a procurement project for medical devices This may include device specification, standing financial instructions (SFI), technical, clinical and financial evaluations
    • acceptance testing and commissioning
    • design of user training material for medical devices
    • planned maintenance of equipment in a clinical setting
    • repair of medical device
    • use of electromedical safety testers, specialist and general workshop test equipment
    • medical device condemnation
  • Critically appraise the use of a particular type of medical device in clinical practice This may include an evaluation of service records, incidents, training issues and standardisation
  • Follow the process associated with receipt, action and monitoring of national safety alerts to gain an insight into the role of Clinical Engineering in supporting patient safety
  • Interact with clinical users of the medical device management service, understanding the need to provide information relating to medical device management in an accessible format to clinical staff