LNE/G-MED North America, Inc...LNE/G-MED North America, Inc. 8/30/2017 Do not distribute or reproduce without permission 3 [email protected] 1-301-495-0477 lne-america.com Agenda

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



Do not distribute or reproduce without permission

Sara Jafari, Ph.D., Medical Device Certification Project Manager, Active Medical Devices LNE/G-MED North America, Inc.



Agenda

Introduction

Usability

Usability and European Regulations and Standards

Overview of Usability Standards and the latest changes

Usability and Medical Device QMS

Conclusion



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



What is 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

Specified Users

Specified Goals

Usability

Efficiency

Satisfaction

Effectiveness

Usability

http://www.usabilitynet.org/tools/r_international.htm#9241-11





What is Medical Device Usability ?



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

https://intensivecareathome.com/

https://intensivecareathome.com/



Usability Engineering



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



European Medical Device Usability Requirements



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



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



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



Harmonized Standards & Official Journal of the European Union

https://ec.europa.eu/growth/single-market/european-sandards/harmonised-standards/medical-devices_en













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)



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



Overview of IEC 62366-1:2015



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



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



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



What is Usability Engineering Process



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



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



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)



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)




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




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




Added “Formative Evaluation” and “Summative Evaluation”

Removed “Frequently Used Functions”

Removed “Usability Verification”

Annexes Number of informative annexes reduced to 4.




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




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




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)



Usability and Medical Device Quality Management System



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)



Outcome/Documentation



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



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



For more information: LNE/Gmed Newsletter Medical Device Usability: Highlights of European Regulations and Standards

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LNE/G-MED North America, Inc...LNE/G-MED North America, Inc. 8/30/2017 Do not distribute or reproduce without permission 3 [email protected] 1-301-495-0477 lne-america.com Agenda