Module information
Module details
- Title
- Device Risk Management and Governance 2
- Type
- Specialist
- Module code
- SPE327
- Credits
- 30
- Requirement
- Compulsory
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
Work-based components
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
- Critically discuss the use of medical devices in a complex clinical/electrical/network environment.
- Describe the range of materials encountered in the development of novel engineering solutions in medicine.
- Critically appraise the legislation and guidance that ensures safe working with non-ionising radiation.
- 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
Biomaterials
- 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
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.
Activities
Planned Maintenance and Repairs to Devices
- Illustrate the maintenance arrangements for all devices on the medical device information system, g. in-house maintained, on external service contract, loan devices, etc. Select one or two devices to follow this process through and undertake a limited range of planned maintenance and repair activities.
- Take responsibility for overseeing the delivery of a series of planned maintenance visits to a range of clinical areas, liaising with colleagues and reviewing work done following visits, and determining further actions if devices were unavailable or problems were Reflect on your experience in terms of implications for service delivery and patient care.
- Take responsibility for overseeing a range of equipment repairs as they progress through the workshop environment, giving the trainee experience of work allocation and job progress monitoring.
- Develop a range of policies and procedures relating to device maintenance, g. device decontamination.
- Shadow the quality manager to learn how to handle non-conforming product, document changes, internal audits and workmanship issues.
- Take responsibility for overseeing the calibration/verification of a range of workshop test equipment, as well as executing some device validation personally.
- Develop examples of risk-based planned maintenance supported by an appropriate engineering evidence base.
Patient Safety
- Investigate and describe the institutions approach to the handling of safety alerts, identifying who the issuing agencies are and the local responsible personnel.
- Review current safety alerts on the prevailing national distribution systems.
- Shadow personnel receiving and determining actions in relation to a number of safety Reflect and report on your experience in terms of the important considerations for staff and patient care.
- Review medical device incidents that have occurred in the institution over the past year and categorise them by cause, effect on service delivery, effect on patient care and implications for your future practice.
- Contribute to an incident investigation, gaining insight into national reporting requirements and root cause analysis.
- Contribute to the institution’s patient safety programme by reviewing medical devices incidents that have reoccurred with a view to establishing actions to prevent the incident in future.
Expertise in Medical Device Risk Management
- Describe the organisational approach to risk management and clinical governance
- Execute a range of medical device-related risk assessments
- Complete a project involving analysis of risk and proposal of solutions to mitigate, involving a clinical department
- Identify the process necessary to follow if a device is to be modified
Professional Advisory Services
- Attend a variety of groups relating to clinical management of medical devices and contribute to discussions relating to medical devices
- Shadow group chairs to gain experience of meeting organisation
- Contribute to clinical audit undertaking audits that involve devices
- Provide advice and comments to the organisation on new technologies, articulating the potential benefits
- Contribute to medical device-related research projects
- Remain abreast of professional best practice
- Provide strategic advice to the organisation, eg develop a five-year equipment replacement programme
- Provide technical reports on medical device issues as required