Device Risk Management and Governance 1 (SPE326)

20 credits

Aim of this module

Medical Device Management Strategy

To re-orientate the trainee with the history, principles and practice of a medical device management service within the healthcare environment. The module will then concentrate on a comprehensive review of prevailing guidance, regulation and policy from which medical device management strategies are developed. The trainee will revisit electromedical and risk management standards with emphasis on how standards are developed and revised.

Optimisation of Medical Device Effectiveness and Efficiency

The trainee will build on knowledge gained in the rotational element into the operation of a wide range of medical devices commonly used in the clinical environment. The trainee will comprehensively understand 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.

Equipment Acquisition, Acceptance Testing and Installation

The trainee will focus on medical device selection, procurement, acceptance testing and installation processes. The trainee will learn how to manage a medical device acquisition project. The trainee will understand the maintenance implications and clinical risks associated with the acquired devices to ensure patient safety.

Medical Device Information System

This module will enable the trainee to become an expert user of the institution’s medical device information system. In addition to using the system the trainee should be able to specify the features of a replacement system and ensure the existing system is robustly managed and updated.

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. Describe the key principles of medical equipment management, including standards and guidance.
  2. Discuss asset and maintenance record keeping and analyse asset and maintenance records.
  3. Work within project management methodologies.
  4. Discuss the process of specifying, designing, implementing, validating and verifying a novel clinical measurement, software or electronic design solution.
  5. Critically evaluate the risk management and governance framework for medical devices in healthcare.

Indicative Content

Equipment Management

  • The principles  of  operation  of  common  types  of    medical  equipment, including examples of diagnostic, therapeutic and life support devices
  • The benefits, limitations and risks associated with the use of these devices
  • Testing, normal/abnormal readings and artefacts in common applications
  • Test equipment  for  checking  the  function  and  calibration    of  medical equipment
  • The performance of medical devices in relation to alternative  models and relevant standards, using appropriate test equipment
  • Methods of evaluating medical equipment (including pre-purchase and old) in relation to clinical requirements, risks and costs
  • Calibration of diagnostic and therapeutic devices to appropriate accuracy, demonstrating traceability to national standards
  • Infection risks   and   control   procedures, sterilisation,  decontamination, protective equipment

Risk Management and Governance

  • National and international standards and guidance
  • Equipment compliance  with  the  requirements  of  the   Medical  Devices Directive (MDD)
  • The requirements of the MDD and the application of these and technical standards to the safety and performance of medical equipment
  • Device classifications
  • Investigation of adverse incidents involving medical equipment
    • root cause analysis
    • failure mode analysis
  • Statistical and risk analysis of repair and maintenance processes
  • Clinical governance framework
  • Current standards   and   compliance   in   the   healthcare   environment, including Standards for Better Health, NHS Litigation Authority

Project Management

  • Risk management
  • Team management (personnel and technical)
  • Project planning (resource and technical)
  • Education and training
  • Cost estimation
  • Project scheduling

Clinical Measurement

  • Detection of physiological signals and potential sources of interference
  • Normal ranges and abnormal results
  • Processing physiological signals
  • Safety issues relating to transducers and associated equipment
  • Sources of artefacts
  • Stimulation and evoked response techniques
  • Instrumentation and signal processing
  • Measurements in    organ    systems,    g.    cardiovascular,    respiratory, neurological, urological
  • Audiological and ophthalmological measurements
  • Ambulatory monitoring
  • Clinical validation and verification of developed systems

Medical Engineering Design

  • The design process and description of the problem to be solved
  • Standards and requirements
  • Prototyping and testing
  • Technical communication
  • Tools and charts
  • Project monitoring
  • Outcome evaluation