Do not distribute or reproduce without permission 1 8/30/2017 [email protected]1-301-495-0477 lne-america.com LNE/G-MED North America, Inc Medical Device Usability: Highlights of European Regulations and the Latest Standards Do not distribute or reproduce without permission
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Do not distribute or reproduce without permission 1 8/30/2017
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
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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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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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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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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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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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)
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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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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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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