Back Module: S-CE-S1-3

Healthcare Technology Management

Module information

Module details

Title
Healthcare Technology Management
Type
Specialist
Module code
S-CE-S1-3
Credits
10
Phase
2
Requirement
Compulsory

Aim of this module

This module provides experience of the role of the Clinical Engineer in the medical device lifecycle. This module will introduce legislative and best practice requirements, quality management, device risk management and system thinking abilities to support provision of a safe and effective healthcare technology management system.

Work-based content

Training activities

# Learning outcome Training activity Type Action
# 1 Learning outcome 1,2,3 Training activities

Present the impact of a change to an element of healthcare technology management service provision on patient outcomes and stakeholders

 Type DTA Action View
# 2 Learning outcome 1,2,6,8 Training activities

Develop a clinical specification for the procurement of a medical device in collaboration with key stakeholders and evaluate supplier responses, including Pre-Acquisition Questionnaires.

 Type DTA Action View
# 3 Learning outcome 4,5,8 Training activities

Organise and carry out an equipment evaluation with clinical users for a medical device procurement, ensuring appropriate indemnity arrangements have been made. Report on the findings of the evaluation.

 Type DTA Action View
# 4 Learning outcome 1,2,5,6 Training activities

Provide information and training to a patient and healthcare professional in the safe and effective use of a medical device.

 Type DTA Action View
# 5 Learning outcome 4,5,7,8 Training activities

Plan, perform, analyse and report on electrical safety, essential performance and calibration of different electrical classes and types of general medical devices.

 Type DTA Action View
# 6 Learning outcome 3,4,5 Training activities

Plan the introduction of a non-conforming medical device into research or clinical use.

 Type DTA Action View
# 7 Learning outcome 3,4,5 Training activities

Undertake complex medical device or service-related risk assessments in accordance with ISO 14971.

 Type ETA Action View
# 8 Learning outcome 3,4,5 Training activities

Draft a report to review the adherence to the relevant digital clinical safety standards for an installation and integration of a new medical device within the Trust’s network.

 Type DTA Action View
# 9 Learning outcome 1,2,5,6 Training activities

Investigate adverse events/incidents involving medical devices:

  • Draft a report of findings and make recommendations for remedial and corrective actions
  • Identify the correct incident reporting mechanisms and distribution routes for both the incident and the resulting actions, both internal and external to the organisation
 Type ETA Action View
# 10 Learning outcome 1,2,3,4,5 Training activities

Review a National Patient Safety Alert and/or Field Safety Notice. Facilitate the dissemination and implementation of the alert/notice across the Trust, working with the Medical Device Safety Officer and relevant stakeholders.

 Type DTA Action View
# 11 Learning outcome 2,7 Training activities

Plan and perform an audit of a departmental policy or process, and make recommendations for actions

 Type DTA Action View

Assessments

Complete 2 Case-Based Discussions

Complete 2 DOPS or OCEs

Direct Observation of Practical Skills Titles

  • Present an incident investigation report to a clinical stakeholder, and describe the findings and recommendations.
  • Present a safety alert and required local action plan to address it to a multidisciplinary team meeting.
  • Perform routine maintenance or calibration on a medical device.
  • Plan and perform an electrical safety test, and draw correct conclusions from the results.
  • Assess the requirements for verification of the essential performance and safety, and the planned maintenance activities of a medical device.

Observed Clinical Event Titles

  • Gather information as part of an adverse incident investigation from another healthcare professional.
  • Explain complex device information to other stakeholders/healthcare professionals.
  • Deliver training, contextualised for the audience, on device maintenance.
  • Present advice on the risks associated with the use of a medical device to a multidisciplinary team meeting.

Learning outcomes

# Learning outcome
1

Plan and manage the stages of the healthcare technology management lifecycle.
2

Apply and adapt communication skills to effectively provide and gather information to and from stakeholders.
3

Apply risk management strategies to the management of healthcare technology to ensure the safety of patients and healthcare professionals.
4

Appraise and apply legislative frameworks for healthcare technology management.
5

Practice in accordance with organisational policy for healthcare technology management.
6

Practice in accordance with organisational and national systems for patient safety and incident reporting.
7

Apply the relevant quality management standards to practice.
8

Identify and assess the essential performance and basic safety of healthcare technology.

Clinical experiences

Clinical experiences help you to develop insight into your practice and a greater understanding of your specialty’s impact on patient care. Clinical experiences should be included in your training plan and you may be asked to help organise your experiences. Reflections and observations from your experiences may help you to advance your practice and can be used to develop evidence to demonstrate your awareness and appreciation of your specialty.

Activities

  1. Visit a stakeholder service and equipment management service to appreciate the impact of the equipment management/lifecycle on service and use of the medical device within that service.
  2. Attend a clinical appointment where a device is used for clinical measurement.
  3. Attend a clinic where a medical device is prescribed for patient use.
  4. Visit a service with an established quality management system to appreciate the impact on service delivery and benefit to patient safety.
  5. Attend a corporate level medical device meeting to appreciate the management, governance and safety of medical devices within the organisation.

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

On successful completion of this module the trainee will be able to:

  1. Critically appraise the essential functions and responsibilities of a healthcare technology management unit including the tertiary and community health sectors.
  2. Critically appraise the regulation and guidance governing the management of technology within the healthcare setting.
  3. Identify, evaluate and support business developments in healthcare technology within a healthcare institution.

Indicative content

  • The role of health care technology management in the health care system.
  • Definition of the medical device.
  • The medical equipment lifecycle.
  • Asset management.
  • Concepts in systems analysis.
  • Concepts in risk management.
  • Concepts in clinical governance.
  • Quality management systems.
  • Medical device regulation and applicable standards.
  • Legal considerations in healthcare technology management.
  • Evaluating design for patient safety.
  • Clinical investigations and modifications.
  • Principles of clinical measurement.
  • Signal analysis for physiological signals.
  • Business planning, finance and cost benefit analysis.
  • Networking medical devices.

Module assigned to

Specialties

Specialty code Specialty title Action
Specialty code SPE3-4-27 Specialty title Clinical Engineering [2027] Action View
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