Device Risk Management and Governance 1

Module details

Title

Device Risk Management and Governance 1

Type

Specialist

Module code

SPE326

Credits

20

Requirement

Compulsory

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.

Submodules

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

Activities

Medical Device Management Strategy

• Review of the institution’s medical device management policy and service delivery, illustrating services provided and responsibilities of different professional groups within the organisation, and demonstrating how policies are interlinked. Reflect on the outcomes of this review in terms of the impact of policy on service delivery, on patient care and experience and on your own future practice.
• Identify and analyse prevailing national recommendations and best practice relating to medical device management within the UK. Consider their application to your own future practice and the impact on patient care. 
• Identify the local polices relating to decontamination of reusable medical devices and review their application in respect of at least two items of reusable medical devices. 
• Become familiar with policies for the handling of loan devices introduced into the institution and gain an understanding of the prevailing national arrangements for indemnity insurance. 
• Start to develop a detailed understanding of the IEC60601 electromedical safety standard To learn to navigate 60601-1 and associated collateral standards, particularly part 2 standards, and be aware of part 3 performance standards.

Optimisation of Medical Device Effectiveness and Efficiency

• The trainee will gain expertise in operating a diverse range of medical devices, ensuring the clinical application is understood, together with the engineering principles that underpin device This will require the trainee to understand and explain to others how to effectively and safely configure and use the device. This will include gaining a detailed understanding of associated risks, device limitations, alarm capabilities, etc.
• Similarly, the trainee will learn to select and utilise specialist test equipment, specifically including electromedical safety testers, understanding the need for calibrated devices. 
• Develop training material contextualised for the audience, which may include patients, professional users and practitioners involved in device maintenance. 
• Undertake a number risk assessments related to the utilisation of medical devices in complex clinical environments (e.g. theatres, intensive care), enabling the trainee to begin to offer professional advice on the use of devices in particular clinical settings.
• Gain an awareness of local quality management systems and begin to contribute to internal audit programmes. 
• Gain experience of a practical medical device prescribing issues and the development of specific guidance. 

Equipment Acquisition, Acceptance Testing and Installation

• Interdisciplinary working with clinical colleagues to develop a device specification, covering clinical and technical elements relating to the replacement of medical devices/systems in the healthcare environment
• Work as part of the team established to select the medical devices, gaining an insight into the organisation’s business planning, procurement and financial processes This will involve project management skills to establish a project plan and timeline, and communication with all stakeholders throughout the project
• Contribute to the device acquisition process by designing and implementing the means to assess and evaluate devices against the specification produced This may well encompass a workshop evaluation of devices as well as evaluation in the clinical setting, and summarising of results into a technical report to inform the selection process Increasingly the life cycle costing, including clinical consumable usage, will be required
• Evaluate a pre-purchase questionnaire from a supplier to inform the selection process
• Gain experience of arranging a trial of a medical device in a clinical setting, ensuring appropriate tests are undertaken prior to using devices on patients and that necessary indemnity insurance is in place
• Undertake acceptance testing of the selected equipment, liaising with training staff and equipment users about device introduction into service, including necessary risk management and housekeeping requirements
• Assess the planned maintenance requirements of a newly acquired device, including necessary technical training needs, test equipment requirements and routine maintenance procedures
• Contribute to a complex installation of a medical device system, possibly involving IT elements to understand safety testing issues and the need for clarification of management responsibilities between IT services and medical engineering. 

Medical Device Information System

• Utilise, extract, analyse and interpret data from the medical device information system in support of all equipment management activities.
• Critically appraise the organisation’s categorisation of medical devices. 
• Produce reports on:
  • equipment holding, categorised by type and value
  • replacement date reports
  • maintenance achieved and items overdue maintenance
  • additionally, key performance indicator reports can be developed showing activity levels, maintenance achieved/not achieved, turn-around times, staff performance, financial information, etc