Introduction to Device Risk Management and Governance

Module details

Title

Introduction to Device Risk Management and Governance

Type

Rotation

Module code

SPS105

Credits

10

Requirement

Compulsory

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.

Competencies

#	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
# 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
# 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 the organisation.	Action View

Assessments

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 details 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
Demonstrate the operation of a range of medical devices encountered in the typical clinical environment, explaining principles of operation and risk factors.	OCE
Demonstrate the key steps and information required to log a fault on the medical device information system	OCE
Describe the key features of the IEC 60601 family of standards and their use in Device Risk Management	OCE

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. Use 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:
   • identify the key elements involved in medical device procurement
   • acceptance test and commission a new medical device
   • design training material to support the use of a medical device in the clinical setting
   • perform planned maintenance on a range of medical devices
   • observe the device repair process
   • condemn a medical device.
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 organisation’s strategy for medical device management and service delivery arrangements for life-cycle management, including:
   • prevailing national standards for healthcare
   • legal/statutory requirements
   • electromedical safety standards
   • quality management standards
   • risk management standards
   • best practice standards
   • organisational polices, and procedures, together with medical device workshop-specific procedures.
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.

Learning outcomes

1. Work safely within the critical care and wider clinical environments.
2. Understand the basis of medical electronics and the medical device lifecycle.
3. Have the underpinning knowledge to gain useful practical experience within the context of the work based rotations.

Indicative content

Safety

• Health and safety legislation specific to critical care technology
• Risk assessment techniques
• Chemical safety: COSHH, hazards, storage, use and disposal
• Electrical safety: medical equipment, leakage currents, fault conditions, isolation and circuit protection; biological/physiological response to electric shock; treatment of electric shock; equipment testing
  • Mechanical safety: lifting gear; guards and operation of machine and hand tools, eye and ear protection; fumes, dusts, moving and handling
  • Biological safety: pathological and normal specimens; blood and other tissues; equipment contamination, cleaning, cross-contamination; handling procedures and protocols
  • Theatre safety: anaesthetic agents, explosion hazard, waste gas extraction, function checks, obstacles, sterility

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

Activities

• 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.