Usability Engineering in Medical Devices

Approvals

• Compass Health Al SOP: Usability Engineering
• Tenzin Yangzom, Head of QA/RA, Author, 02 Jan 2024
• James Baskin, COO, Approver, 02 Jan 2024
• Rushabh Gudka, Head of Product, Approver, 02 Jan 2024

Revision History

• Version 1.0, Date 3-Jan-2024, Description Initial Release

Introduction

• Purpose: To instruct and systematize the assignment of responsibilities for evaluating Compass Health's medical devices' usability, focusing on safety
• Goal: Minimize use errors and associated risks.
• Compliance: Meant to meet IEC 62366-1:2015, ISO 14971:2019 guidelines for medical devices

Scope

• Applies to the analysis, specification, design, verification, and validation of usability features for Compass Health-developed products

Applicable Standards

• IEC 62366-1:2015 Medical Devices – Application of usability engineering
• ISO 14971:2019 Medical Devices-Application of risk management to medical devices

Reference Documents

• SOP: Competence & Training (QMS-SOP-0005)
• SOP: Risk Management (QMS-SOP-0013)
• SOP: Complaint Handling (QMS-SOP-0026)
• SOP: Device Recall and Advisory Notices (QMS-SOP-0028)
• SOP: Medical Device Reporting/ Mandatory Problem Reporting (QMS-SOP-0029)
• SOP: Corrective and Preventative Action (QMS-SOP-0031)

Acronyms and Definitions

• MDD: Directive for Medical Devices
• UEP: Usability Engineering Process; related to user interface analysis, design strengths, weaknesses, and unanticipated errors in user interaction
• Abnormal Use: Conscious, intentional actions that violate normal use, and are out of scope for reasonable user interface risk control.
• Accompanying Documentation: Materials accompanying a medical device that includes use instructions for its installation, use, and maintenance
• Correct Use: Normal use without errors
• Effectiveness: Accuracy and completeness of users achieving their goals during use
• Efficiency: Effectiveness in relation to resources expended
• Expected Service Life: Specified duration a medical device can safely remain functional, maintaining essential performance and safety
• Formative Evaluation: Iterative evaluation of user interface design to expose strengths, weaknesses, and unanticipated use errors, before summative
• Hazard: Potential source of harm, for which use scenarios are described, and possible link to use errors.
• Hazard Related Use Scenario: Use scenario that could lead to a hazardous situation or harm
• Intended Use: Intended purpose of a product, service, or process as per manufacturer specifications
• Manufacturer: Natural or legal person responsible for designing, manufacturing, and labeling a device
• Medical Device: Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent, calibrator, software, material or other related article, designed by a manufacturer for human use.

Usability Test, Use Environment, Use Scenario, Use Specification

• Various methods related to user testing and analysis
• Use environment variables (location, lighting, user population/profile, etc.) and the user interaction specific details
• Use scenario: Sequence of tasks by a user interacting with a medical device under certain conditions (Use environment)
• Use specification: Details on intended medical use (indicated medical use, specific populations, etc.)
• User Interface Specification: Comprehensive description of a medical device's user interface components and prospective user actions

User, User Group, User Interface Evaluation, User Profile

• Person operating or handling the medical device (like a patient, clinician, installer)
• Subset of users sharing common traits like age, culture, expertise, and type of interaction
• Process for evaluating user interactions using methods to measure effectiveness, efficiency, and user satisfaction
• Summary of user mental, physical, and demographic traits

Validation, Process Roles, Quality Assurance, Product Manager, Project Team Members

• Confirmation of meeting usability requirements
• Specific roles and responsibilities:
  • Planning verification/validation, product monitoring, etc.
  • Managing all usability engineering issues
  • Completing required templates
  • Assigning usability engineering tasks to members of the project team
  • Presenting summaries of the project to management
  • Advise management on issues, as appropriately

Usability Engineering Process, Residual Risk/Risk Control

• General requirements for maintaining and enhancing usability
• Reviewing and managing residual risks related to the user interface

Information for Safety

• Using safety information to control risks during any use of a medical device, in compliance to a medical device risk management file
• Including user instructions, markings, monitored variables

User Interface Specification, Hazard-Related Use Scenarios

• Details of the user interface specification that are generated through user interactions with the device.
• Identifying reasonably foreseeable hazard-related use scenarios associated with hazards involved.

Usability Validation, Establish User Interface Evaluation Plan

• Evaluation and validation of usability
• Steps designed to specifically validate and evaluate the usability of the product use, including plan preparation

User Interface Design, Implementation, and Formative Evaluation

• User interface design and implementation
• Specific results and findings from formative evaluation
• Any changes/updates based on post-market surveillance

Perform Summative Evaluation, User Interface of Unknown Provenance

• Summative evaluation of the user interface's overall usability.
• Evaluating a device whose user interface was not properly documented during usability engineering
• Details when the process doesn't conform, or does not need to conform, to the rest of the IEC 62366 user interface requirements.

Accompanying Documents

• Information related to intended use, documentation of the device description, its operating principles, characteristics, etc.
• Training and materials, provided as required, to support safe and effective use.

This quiz covers the principles and guidelines outlined in the SOP for usability engineering specific to Compass Health's medical devices. It focuses on the assignment of responsibilities, compliance with IEC 62366-1:2015 and ISO 14971:2019 standards, and aims to minimize use errors and associated risks.