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LNE/G-MED North America, Inc
Medical Device Usability: Highlights of European Regulations
and the Latest Standards
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Sara Jafari, Ph.D., Medical Device Certification Project Manager, Active Medical Devices LNE/G-MED North America, Inc.
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Agenda
Introduction
Usability
Usability and European Regulations and Standards
Overview of Usability Standards and the latest changes
Usability and Medical Device QMS
Conclusion
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Medical errors are one of the causes of mortality in hospitals
Up to 98000 death annually in US attributed to medical errors
Poor user interface design of medical devices lead to errors result in harm or death
administration of incorrect medication or dose
incorrect interpretation of data
incorrect device setting for therapy
Systematic and careful design of the user interface can reduce the likelihood of use/user error and improve the safety of medical devices.
Introduction
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What is Usability?
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Usability (ISO 9241-11: Ergonomics of Human System Interaction, Guidance on Usability ): The extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency and satisfaction in a specified context of use
Special Context of Use
Specified Users
Specified Goals
Usability
Efficiency
Satisfaction
Effectiveness
Usability
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What is Medical Device Usability ?
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Medical device Usability Standards:
focus on usability as it relates to safety of the user interface of a medical device in development
MD Usability : Characteristic
Of the User Interface that facilitate Use
MD Usability : Characteristic Of the User
Interface that facilitate
Use
to perceive information presented
by the User Interface
to understand and make decision based on
that information
to interact with the medical
device to achieve
specified goals In the
Intended Use Environment
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Usability Engineering
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Usability Engineering The application of knowledge about human behavior, abilities, limitations, and other characteristics to the design of medical devices including software, systems, tasks to achieve adequate usability.
Usability Engineering and Human Factors engineering are treated as synonymous
Source: FDA Guidance , “Applying UE to medical devices”, Feb 2016
Device Use
correct use user
user interface
use environment
Use error
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European Medical Device Usability Requirements
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Annex I, Essential Requirements
ER 1— The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons….this shall include:
reducing, as far as possible, the risk of use error due to the
ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety)
consideration of the technical knowledge, experience,
education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users)
Medical Device Directive 93/42/ EEC
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Annex I, Essential Requirements
ER 9.2— Devices must be designed and manufactured in such a way as to remove or minimize…— the risk of injury, in connection with physical features ….appropriate ergonomic features
ER 10.2 — Devices with a measuring function: The measurement, monitoring and display scale must be designed in line with ergonomic principles, taking account of the intended purpose of the device
ER 13.1 — each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users
ER 2, ER 3, ER 6, ER 11.4.1, ER 12.8 and ER 12.9
Medical Device Directive 93/42/ EEC
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ANNEX I, General Requirements
GR 5: In eliminating or reducing risks related to use error, the manufacturer shall:(a) reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety)
GR 14.2: Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible: (a) the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features
GR 14.6: Any measurement, monitoring or display scale shall be designed and manufactured in line with ergonomic principles, taking account of the intended purpose, users and the environmental conditions in which the devices are intended to be used
European Regulation (EU) 2017/745
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Harmonized Standards & Official Journal of the European Union
https://ec.europa.eu/growth/single-market/european-sandards/harmonised-standards/medical-devices_en
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Usability Standard for Medical Device Markets in EU
EN 62366:2008 Medical devices -Application of Usability Engineering to Medical Devices :
A process based standard for analysis, design, verification and validation of usability through the development cycle of the medical devices as it relates to their safety
Adopted from the international standard, IEC 62366 :2007 (withdrawn)
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Usability Standards for Medical Devices
IEC 62366/A1: 2014 IEC 62366-1:2015 & IEC 62366-2:2016
Medical Electrical Equipment:
IEC 60601-1-6: 2010 (Usability Standard EN 60601-1-6:2010) collateral standard reference EN 62366
Withdrawn IEC
62366:2007
Withdrawn IEC
62366:2007/Amd1:2014
IEC 62366-1:2015 & IEC 62366-
2:2016
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Overview of IEC 62366-1:2015
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IEC 62366-1:2015 (Part 1)
“Application of usability engineering to medical devices”
Focusing on the usability engineering as a design and development
process for the medical device user interface to identify and reduce the possibility of use errors and use associated risks
Streamline the Usability Engineering process Strength the link with ISO 14971:2007
This part of the standard targets
only the safety-related part of the usability of medical devices
Not harmonized yet Recognized by the FDA as of August 2015
in replacement of IEC 62366:2007
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IEC 62366-1:2015, Overview
1. Body of Standard • Scope • Normative References • Terms and Definitions • Principles • Usability Engineering Process
2. Informative annexes • A : General Guidance and rationale • B : Examples • D : Types of MD use and examples • E : Reference to essential principles
3. Normative annex C : UOUP
Usability Engineering process allows the manufacturer to assess and mitigate risk associated with correct use and use errors, i.e., normal use
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IEC/TR 62366-2:2016 (Part 2)
efficient ways to implement elements required by IEC 62366-1: 2015
does not contain any requirements
intended to be read in conjunction with
IEC 62366-1:2015
“How” document
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What is Usability Engineering Process
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Usability Engineering Process
Provide safety for the patient, user and others related to usability
Mitigates risks caused by usability problems associated with correct use and use errors
Helps manufacturer to
discover hazards and hazardous situations related to the user interface
design and implement measures to control the risks related to the user interface
evaluate the risk control measures
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Risk Management and Usability:
Application of Risk management to medical devices (ISO 14971:2007, EN ISO 14971:2012) is normatively referenced in IEC 62366-1:2015, EN 62366:2008 and is essential for its application
Risk management: decision making process to determine acceptable risks
Usability Engineering: design and development process, evaluate the usability and mitigate the use errors that could results in risks for medical devices
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Intended medical indication, Patient population, part of body, user profile, use environment , operating principle
Prepare Use Specification (5.1)
Usability engineering process (IEC 62366-1 : 2015) Risk Management ( ISO 14971:2007)
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Intended medical indication, Patient population, part of body, user profile, use environment , operating principle
Prepare Use Specification (5.1)
Intended Use (4.2)
Analysis/Interface Specifications
Identify user interface characteristics related to safety and potential use errors (5.2) Identify known or foreseeable hazards and hazardous situations (5.3) Identify and describe hazard-related use scenarios (5.4) Select the hazard-related use scenarios for summative evaluation (5.5) Establish User Interface Specification (5.6)
Identify characteristics
related to safety (4.2)
Identify hazards and
sequences of events
leading to hazardous
situation(4.3, 4.4)
Usability engineering process (IEC 62366-1 : 2015) Risk Management ( ISO 14971:2007)
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Interface design and Formative evaluation
Establish User Interface evaluation Plan (5.7) Perform user interface design, implementation and formative evaluation(5.8)
summative evaluation Perform summative evaluation of the usability of the user interface (5.9)
No improvement necessary
Evaluation of residual risk
(6.4) evaluate overall
residual risk acceptability ,
complete RM report and
Review production and
post marker information
Usability engineering process (IEC 62366-1 : 2015) Risk Management ( ISO 14971:2007)
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IEC 62366-1:2015 changes comparing to EN 62366:2008
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IEC 62366-1:2015 changes comparing to EN 62366:2008
User Interface of Unknown Provenance (UOUP)
Ex. interface of a previously designed medical device for which records of the user interface process are not available
Documentation of use specifications and main service functions
Post-production information Review
Risk management file review
Review of accompanying documents
EN 62366 : 2008 IEC 62366/A1: 2014 IEC 62366-1:2015
No reference to UOUP Annex K Annex C
User Interface of Unknown Provenance
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IEC 62366-1:2015 changes comparing to EN 62366:2008
Added “Formative Evaluation” and “Summative Evaluation”
Removed “Frequently Used Functions”
Removed “Usability Verification”
Annexes Number of informative annexes reduced to 4.
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IEC 62366-1:2015 changes comparing to EN 62366:2008
Cl. 4.1.1: General requirements for personal competency regarding usability engineering activities is added
Cl. 4.1.2: Specification of requirements of risk control related to user interface design: a 3-level approach as required by EN ISO 14971:2007
Cl. 4.3: Specification of elements tailoring the usability engineering effort such as complexity of user interface and use specification, severity of the harm, extend or complexity of use specification and presence of User Interface of Unknown Provenance
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IEC 62366-1:2015 changes comparing to EN 62366:2008
Cl. 5.2: Clarification of requirements to identify user interface characteristics related to safety and use errors
Cl. 5.3: Specification of elements to consider during the identification of hazardous situation such as use specification, existing user interface and use errors
Cl. 5.4 & 5.5: Identification of use scenarios that could lead to harm and considering them during summative evaluation
Cl 5.6: Clarification of user interface specification requirements: consideration hazard related scenarios, determination of the necessity of accompanying documents and training
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IEC 62366-1:2015 changes comparing to EN 62366:2008
Cl. 5.7: Specification of user interface evaluation plan (objectives and methods of any planned formative and summative evaluation) and documentation of usability test parameters (users, environment, documentation, training)
Cl. 5.8 & 5.9: Evaluation of user interface: design, implementation and formative evaluation (iteratively during design and development process to explore unanticipated use errors), summative evaluation (at the end of user interface development, part of verification and validation of the overall medical device design to conclude that User Interface can be used safely)
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Usability and Medical Device Quality Management System
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Cl. 7.3.3 a : Usability and safety requirements according to the intended use shall be determined and recorded as an input for design and development
Cl. 7.3.9 : Significant of the change to usability for medical devices and its intended use shall be determined as part of control of design & development changes
Usability & Medical device Quality Management System
(EN ISO 13485:2016)
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Outcome/Documentation
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Outcome/Documentation
EN 62366:2008, IEC 62366-1:2015:
all aspects of Usability Engineering process should be documented in a Usability Engineering File
Usability Engineering File: an independent file
part of risk management file
part of product design file
contain pointers and references to all required documents
The Usability Engineering File enables efficient auditing of the design and development process
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Conclusion
European Usability Harmonized Standard
EN 62366: 2008
International Usability Standard also recognized by FDA:
IEC 62366-1:2015 & IEC 62366-2:2016
Inadequate medical device usability causes use error which can result to harm or death
Adequate usability could be achieved through Usability Engineering process
Usability activities should be conducted throughout all phases of design and development of medical devices
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For more information: LNE/Gmed Newsletter Medical Device Usability: Highlights of European Regulations and Standards
https://lne-america.com/library/news/medical-device-usability-highlights-of-european-regulations-and-standards
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LNE / G-MED North America, Inc.
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Thank You!