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LNE/G-MED North America, Inc Medical Device Usability: Highlights of European Regulations and the Latest Standards Do not distribute or reproduce without permission 1

Sara Jafari, Ph.D., Medical Device Certification Project Manager, Active Medical Devices LNE/G-MED North America, Inc. Do not distribute or reproduce without permission 2

Agenda Introduction Usability Usability and European Regulations and Standards Overview of Usability Standards and the latest changes Usability and Medical Device QMS Conclusion Do not distribute or reproduce without permission 3

Introduction 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. Do not distribute or reproduce without permission 4

What is Usability? Do not distribute or reproduce without permission 5

Usability 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 Satisfac tion Specified Users Usability Efficiency Specified Goals Effectiv eness Do not distribute or reproduce without permission 6

What is Medical Device Usability? Do not distribute or reproduce without permission 7

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 MD Of the Usability User : Characteristic Interface Of the that User facilitate Interface that facilitate Use Use In the Intended Use Environment 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 Do not distribute or reproduce without permission 8

Usability Engineering Do not distribute or reproduce without permission 9

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. user correct use user interface Device Use use environment Use error Source: FDA Guidance, Applying UE to medical devices, Feb 2016 Usability Engineering and Human Factors engineering are treated as synonymous Do not distribute or reproduce without permission 10

European Medical Device Usability Requirements Do not distribute or reproduce without permission 11

Medical Device Directive 93/42/ EEC 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) Do not distribute or reproduce without permission 12

Medical Device Directive 93/42/ EEC 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 Do not distribute or reproduce without permission 13

European Regulation (EU) 2017/745 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 Do not distribute or reproduce without permission 14

Harmonized Standards & Official Journal of the European Union https://ec.europa.eu/growth/single-market/european-sandards/harmonised-standards/medical-devices_en Do not distribute or reproduce without permission 15

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) Do not distribute or reproduce without permission 16

Usability Standards for Medical Devices IEC 62366/A1: 2014 IEC 62366-1:2015 & IEC 62366-2:2016 Withdrawn IEC 62366:2007 Withdrawn IEC 62366:2007 /Amd1:2014 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 Do not distribute or reproduce without permission 17

Overview of IEC 62366-1:2015 Do not distribute or reproduce without permission 18

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 Do not distribute or reproduce without permission 19

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 Do not distribute or reproduce without permission 20

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 Do not distribute or reproduce without permission 21

What is Usability Engineering Process Do not distribute or reproduce without permission 22

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 Do not distribute or reproduce without permission 23

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 Do not distribute or reproduce without permission 24

Usability engineering process (IEC 62366-1 : 2015) Risk Management ( ISO 14971:2007) 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 hazardrelated 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) Do not distribute or reproduce without permission 26

Usability engineering process (IEC 62366-1 : 2015) Risk Management ( ISO 14971:2007) 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 Do not distribute or reproduce without permission 27

IEC 62366-1:2015 changes comparing to EN 62366:2008 Do not distribute or reproduce without permission 28

User Interface of Unknown Provenance IEC 62366-1:2015 changes comparing to EN 62366:2008 EN 62366 : 2008 IEC 62366/A1: 2014 IEC 62366-1:2015 No reference to UOUP Annex K Annex C 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 Do not distribute or reproduce without permission 29

IEC 62366-1:2015 changes comparing to EN 62366:2008 Added Removed Removed Formative Evaluation and Summative Evaluation Frequently Used Functions Usability Verification Annexes Number of informative annexes reduced to 4. Do not distribute or reproduce without permission 30

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 Do not distribute or reproduce without permission 31

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 Do not distribute or reproduce without permission 32

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) Do not distribute or reproduce without permission 33

Usability and Medical Device Quality Management System Do not distribute or reproduce without permission 34

Usability & Medical device Quality Management System (EN ISO 13485:2016) 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 Do not distribute or reproduce without permission 35

Outcome/Documentation Do not distribute or reproduce without permission 36

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 Do not distribute or reproduce without permission 37

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 Do not distribute or reproduce without permission 38

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-europeanregulations-and-standards Do not distribute or reproduce without permission 39

Thank You! LNE / G-MED North America, Inc. lne-america.com contact@lne-america.com Do not distribute or reproduce without permission 40