Human Factors Plans & Reports - The AAMI Store

3y ago
107 Views
6 Downloads
7.77 MB
23 Pages
Last View : 18d ago
Last Download : 4m ago
Upload by : Averie Goad
Transcription

PREVIEW COPYThis is a preview edition of an AAMI guidance document and isintended to allow potential purchasers to evaluate the contentof the document before making a purchasing decision.For a complete copy of this AAMI document, contact AAMI at 1-877-249-8226 or visit www.aami.org.WritingHuman FactorsPlans & Reportsfor Medical Technology DevelopmentMichael WiklundLaura BirminghamStephanie Alpert Larsen

PREVIEW COPYThis is a preview edition of an AAMI guidance document and isintended to allow potential purchasers to evaluate the contentof the document before making a purchasing decision.For a complete copy of this AAMI document, contact AAMI at 1-877-249-8226 or visit www.aami.org.

WritingHuman FactorsPlans & Reportsfor Medical Technology DevelopmentPREVIEW MichaelCOPYWiklundLauraBirminghamThis is a preview edition of an AAMIguidancedocument and isStephanieAlpertLarsenintended to allow potential purchasers to evaluate thecontentof the document before making a purchasing decision.For a complete copy of this AAMI document, contact AAMI at 1-877-249-8226 or visit www.aami.org.

This publication is intended to be a helpful resource, and reflects theexpert advice and views of the authors. It is not to be construed as legalor regulatory advice.This publication was prepared by Michael Wiklund, Laura Birmingham,and Stephanie Alpert Larsen in their personal capacities and not asemployees of UL. The opinions in this book belong to the authors anddo not reflect the views of UL.PREVIEW COPY 2018 UL LLCThis is a preview edition of an AAMI guidanceand isReprinted documentwith permission.intended to allow potential purchasers to evaluate the contentof the document before making a purchasing decision.For a complete copy of this AAMI document, contact AAMI at 1-877-249-8226 or visit www.aami.org.Published byAAMI4301 N. Fairfax Drive, Suite 301Arlington, VA 22203-1633www.aami.org 2018 by the Association for the Advancement of Medical InstrumentationAll Rights ReservedPublication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document withoutthe prior written permission of the Association for the Advancement of Medical Instrumentation is strictly prohibited by law. It is illegalunder federal law (17 U.S.C. § 101, et seq.) to make copies of all or any part of this document (whether internally or externally) withoutthe prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, includingcivil and criminal penalties, and damages of 100,000 per offense. For permission regarding the use of all or any part of this document,complete the reprint request form at www.aami.org or contact AAMI at 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633.Phone: 1-703-525-4890; Fax: 1-703-525-1424.Printed in the United States of AmericaISBN 978-1-57020-689-4

Table of ContentsPageForeword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vAcknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ixAbout the Authors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiAbout UL-Wiklund . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiiiAdvisory Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvWho Could Use This Book . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviiDisclaimers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xixSECTION IChapter 1Chapter 2Chapter 3Chapter 4Chapter 5Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Human Factors Engineering Process Overview . . . . . . . . . . . . . . . . . . . . . . 3Hypothetical Intravenous Infusion Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . 7AssumptionsHypotheticalDesign’s11This is a aboutprevieweditionof anProgression . . . . . . . . . . . . . . .AAMI guidance documentand isUsefulTermsandDefinitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13intended to allow potential purchasers to evaluate the contentPREVIEW COPYSECTION IIChapter 6Chapter 7Chapter 8Chapter 9Chapter 10Chapter 11of the document before making a purchasing decision.Human Factors Engineering Project Plan . . . . . . . . . . . . . . . . . . . . . . . . . . 15For aUsabilitycompleteof this AAMI document, contactFormativeTest copyPlan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39 AAMI 1-877-249-8226orvisitwww.aami.org.Formative Usability Test Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61Summative Usability Test Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81Summative Usability Test Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117Human Factors Engineering Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155atFurther Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217 AAMITable of Contentsiii

PREVIEW COPYThis is a preview edition of an AAMI guidance document and isintended to allow potential purchasers to evaluate the contentof the document before making a purchasing decision.For a complete copy of this AAMI document, contact AAMI at 1-877-249-8226 or visit www.aami.org.ivWriting Human Factors Plans & Reports for Medical Technology Development AAMI

ForewordIt has been widely reported that preventable medical error byclinicians was the third leading cause of death in the UnitedStates in 2015, claiming over a quarter million people’slives that year and trailing only heart disease and cancer interms of lethality. These reports were based on a conclusionderived from a Johns Hopkins University School of Medicinestudy, published in The BMJ in May 2016.1 The study quotesProfessor of Surgery Martin Makary, stating, “ researchersexamined four separate studies that analyzed medical deathrate data from 2000 to 2008. Then, using hospital admissionrates from 2013, they extrapolated that, based on a total of35,416,020 hospitalizations, 251,454 deaths stemmed froma medical error, which the researchers say now translates to9.5% of all deaths each year in the U.S.” (Figure F-1)Evidently, the more researchers study the problem in theUnited States and recognize how many deaths have beenincorrectly categorized, the more the reported magnitude ofmedical error seems to increase. The magnitude of errorrelated deaths in the United States suggests that researcherswould discover the same situation in many other countries,with death rates varying to some extent because of thelevel of medical care provided and the types of medicaltechnology in use.The pressing question for human factors engineering(HFE) specialists is: How many medical errors are whathuman factors specialists call “use errors,” committed whileinteracting with medical technology (e.g., infusion pumps,dialysis machines, defibrillators, glucose meters, nebulizers,This troubling findingthe equallywidely reportedpenguidanceinjectors) thatinduced the anderror?isThe research tellsThisupdatedis a previeweditionof an AAMIdocumentfinding, publishedintendedin the rmmedicalerrorcovers such failuresto allow potential purchasers to evaluate the contentas misdiagnoses, wrong-site surgeries, surgical blunders,To Err Is Human: Building a Safer Health System in 1999,2of the document before making a purchasing decision.that between 44,000 and 98,000 people in the United Statesadministering medication to the wrong patient, and notdied in hospitals as the consequence of the same problem— responding to alarms in a timely manner. But, we do notFora completedocument,AAMIat are induced by userhealthcare providersmakingmistakes. copy of this AAMIknowthe degreecontactto which themistakesPREVIEW COPY 1-877-249-8226 or visit www.aami.org.Figure F-1. Medical death rate from 2000 to 2008. Source: National Center for Health Statistics, The BMJ.1 AAMIForewordv

Forewordinterface (UI) design flaws: defects at the points wherepeople interact with medical technology. In 2008, whendelivering the keynote speech at the annual Human Factorsand Ergonomics Society meeting, Peter Carstensen, theFood and Drug Administration’s (FDA’s) human factorsteam founder and leader, grossly estimated, based onadverse event reports, that 10% to 15% of medical errors—and potentially more—might have this root cause.Years later, our sense for the magnitude of deaths relatedspecifically to UI shortcomings, as compared to deathsgenerally caused by medical error, is not much better;but we can make the simplifying assumption that themagnitude of UI-related deaths is significant, perhaps inthe tens of thousands. Therefore, we and many other HFEspecialists believe that applying HFE to medical devices toimprove safety, and by extension effectiveness and usability,is a worthwhile pursuit. Of course, regulatory bodies havealready drawn this conclusion, dating back to 1996 when theU.S. government changed the Quality System Regulation,3calling for medical device developers to closely considerusers’ needs when designing a medical device and then toverify and validate that users’ needs have been met.(another term for HFE). This standard has been adoptedin the United States as ANSI/AAMI/IEC 62366-1:2015,Medical devices—Part 1: Application of usability engineering tomedical devices.Regulators’ actions and the moral imperative to make medicaltechnology safer have led to widespread adoption of HFE bycompanies that only now are gaining experience with thediscipline. This is where this book’s content can be helpful.As covered in the Introduction to follow, we intend thisbook’s content to give companies a head start on theimportant tasks of defining the elements of an HFE projectplan, planning and reporting the results of usability tests,and reporting HFE research results to the FDA in particular.Note that this book is less focused on helping companiesconform to 62366-1. Specific guidance for this standardis provided in the IEC Technical Information Report IECTR 62366-2:2016, Medical devices—Part 2: Guidance on theapplication of usability engineering to medical devices (adoptedin the United States as AAMI/IEC TIR62366-2:2016).Naturally, it is distressing that people receiving medicalcare can be hurt or killed by the same medical technologyintended to help them. It is also distressing to considerthe consequences for healthcare professionals and homecaregivers taking care of a dependent who are induced to errby a device with a flawed UI.Today, medical technology developers must apply HFEcomprehensively and demonstrate to regulators that devicesare unlikely to induce potentially harmful use errors.Specifically, those seekingor clearanceto marketThisapprovalis a previeweditionof an AAMI guidance document and iscertain types of Class II and III devices in the UnitedOver the courseof many yearsHFE practice and tointended to allow potential purchasersto evaluatetheofcontentStates must meet the FDA’s HFE guidance,4 which calls fordate,wehaveidentifiedUIshortcomingsof the document before making a purchasing decision. (i.e., flaws) inmanufacturers to submit an HFE report that summarizesall manner of medical technology, including large capitaltheir HFE approach and results. Those who intend toequipment (e.g., ventilators, computed tomography [CT]Forcountriesa completecopy of this AAMIdocument, contact AAMI atsell devices in many othermust demonstratescanners, heart-lung machines) down to hand-held devices 1-877-249-8226orvisitwww.aami.org.compliance with the International Electrotechnicalpurchased over-the-counter (e.g., glucose meters, penCommission (IEC) standard on usability engineeringinjectors, inhalers). The flaws have been as fundamentalPREVIEW COPYFigure F-2. People in every stage of life might need to use medical devices and should not be at risk of death dueto mistakes induced by the device’s user interface. Note that the products shown simply depict medical devices inuse and are not presented as flawed devices that caused use errors.viWriting Human Factors Plans & Reports for Medical Technology Development AAMI

as the assignment of system monitoring and calibrationfunctions to human operators—who are not particularlygood at performing tedious tasks perfectly and exactly ontime—instead of automating them. The flaws have beenas seemingly superficial and trivial as placing two pushbuttons too close together or labeling them with confusingterms. Fortunately, we discovered the flaws through HFEresearch and have worked with our clients to fix them.Just as fortunately, resolving them did not require magicor even a startling level of brilliance. Rather, it requireddiligence, the diligence to apply HFE in a quality-conscious,comprehensive manner throughout device development,which included taking time to perform activities such as aproper formative usability test of a prototype medical device.We hope this book’s content helps many of you do the same.Finally, we wish all readers success at integrating HFEinto their device development efforts, as we work in broadcollaboration to address the epidemic of medical errors.PREVIEW COPYThis is a preview edition of an AAMI guidance document and isintended to allow potential purchasers to evaluate the contentof the document before making a purchasing decision.For a complete copy of this AAMI document, contact AAMI at 1-877-249-8226 or visit www.aami.org. AAMIForewordvii

PREVIEW COPYThis is a preview edition of an AAMI guidance document and isintended to allow potential purchasers to evaluate the contentof the document before making a purchasing decision.For a complete copy of this AAMI document, contact AAMI at 1-877-249-8226 or visit www.aami.org.viiiWriting Human Factors Plans & Reports for Medical Technology Development AAMI

AcknowledgmentsThe authors thank the following individuals for theirsupport during the book-writing process.mission to make the world a safer place. Special thanks goto Upayan Sengupta, Anil N. Patel, and Hiroshi Yamaki(retired from UL).Thanks to our families and friends Michael Wiklund thanks his wife, Amy, for her generoussupport during the book-writing effort. Laura Birmingham thanks her family and friends fortheir advice and feedback throughout the developmentof this book, and her parents, in particular, for theirencouragement and support over the years.Thanks to Gil Molho Gil Molho, an industrial designer based in Eindhoven,NL, enthusiastically embraced the task of interpreting andexpanding upon Jonathan Kendler’s hypothetical infusionpump design and then creating a 3-D model—the sourceof the IV infusion pump illustrations within the book.to Shannon HostePREVIEWThanksCOPY Stephanie Alpert Larsen thanks her husband, David, andher parents for their never-ending love and support. The authors express their appreciation to Shannon Hoste,This is a preview edition of an AAMIMSSE,guidancedocumentand andis comments onMSM, RACfor her reviewThanks to our colleaguesatUL-Wiklundintended to allow potential purchasersto evaluatethe contentour book.Shannon Hosteis a human factors engineerleadingthe Humandecision.Factors Premarket Evaluation Teamof theinformaldocumenta purchasing Our HFE colleagues offerededitorialbeforesupport makingandof the Food and Drug Administration’s (FDA’s) Centerhad a helping hand in the development of UL-Wiklund’sfor Devices andRadiologicalHealthFor a uponcompletecopyofthethisAAMI document,contactAAMIat (CDRH). Prior towork product templateswhich webasedplansjoiningtheFDAinJanuary2015,Shannon spent 18 years 1-877-249-8226or visit www.aami.org.and reports presented in this book.Special thanksin the medical device industry as a device developmentgo to Jonathan Kendler, Allison Strochlic, Jon Tilliss,engineer and R&D manager. Over this time she hasAndrea Dwyer, Erin Davis, Rachel Aronchick, Echo Kirk,worked within and directed project teams in all phasesand Cory Costantino, colleagues who have been with theof product development from front-end research toteam for many years and helped shape our HFE practice.postmarket support, as well as architecting new productdevelopment processes, including the incorporation of Jonathan Kendler provided extraordinary visual designhuman factors and usability into the product developmentsupport (including multiple book illustrations), andlifecycle. Shannon has a BS in mechanical engineering,both designed and coordinated the 3-D modeling of thean MS in cognitive systems engineering, and an MS inhypothetical intravenous (IV) infusion pump that servesmanagement. Generously, the FDA granted her requestas the focus of our sample work products.to review and comment on our book, but required her to UL senior managers “green lighted” our proposal toprovide this support while off duty and working on a peershare sample HFE work products that otherwise could beto-peer basis in an unofficial capacity. Neither the FDAviewed as the organization’s intellectual property and notnor the U.S. government has officially sanctioned thesuitable for release. They understood the value to industrybook’s content, and the FDA has neither recognized norof sharing our property and the potential it had toendorsed the book.improve healthcare quality, which is consistent with UL’s AAMIAcknowledgmentsix

AcknowledgmentsThanks to AAMI Melissa Coates, special projects editor, welcomed ourproposal to write this book and provided helpful projectmanagement and manuscript editing support. Steve Campbell, chief operating officer, also encouragedthe book-writing project and got us off to a rapid start onthe project by streamlining the approval process.PREVIEW COPYThis is a preview edition of an AAMI guidance document and isintended to allow potential purchasers to evaluate the contentof the document before making a purchasing decision.For a complete copy of this AAMI document, contact AAMI at 1-877-249-8226 or visit www.aami.org.xWriting Human Factors Plans & Reports for Medical Technology Development AAMI

About the AuthorsStephanie Alpert Larsen (left), Laura Birmingham(center), and Michael Wiklund (right).PREVIEW COPYFDA provided the guide to the Human Factors EngineeringMichael WiklundThis is a preview edition of an AAMIguidance document and isCommittee at AAMI, which used it as a basis for writingintendedallow potentialpurchasers to evaluate the contentMichael has workedin the HFEtoprofessionfor more thanANSI/AAMI HE74:2001, Human factors design process fordocument before makinga purchasingdecision.became the basis for the30 years as a consultantofandtheeducator.medicaldevices. HE74 ultimatelycurrent standard of the International ElectrotechnicalHe received his master’s degree in engineering MIat62366-1:2015, adoptedCommission(IEC)on the topic(IEC(specializing in HFE) from Tufts University, where he has 1-877-249-8226orvisitwww.aami.org.in the United States as ANSI/AAMI/IEC 62366-1:2015).subsequently taught UI design for three decades. He hasa professional engineering license and is a board-certifiedIn 2005, Michael cofounded Wiklund Research & Design,human factors professional.Inc. with the goal of providing comprehensive HFE servicesHe joined the profession in the mi

Writing Human Factors Plans & Reports for Medical Technology Development pReVIeW COpY This is a preview edition of an AAMI guidance document and is intended to allow potential purchasers to evaluate the content of the document before making a purchasing decision. For a complete copy of this AAMI document contact AAMI at 1- 77-2-22 or visit www.aami.org. PREVIEW COPY This is a preview edition .

Related Documents:

May 02, 2018 · D. Program Evaluation ͟The organization has provided a description of the framework for how each program will be evaluated. The framework should include all the elements below: ͟The evaluation methods are cost-effective for the organization ͟Quantitative and qualitative data is being collected (at Basics tier, data collection must have begun)

Silat is a combative art of self-defense and survival rooted from Matay archipelago. It was traced at thé early of Langkasuka Kingdom (2nd century CE) till thé reign of Melaka (Malaysia) Sultanate era (13th century). Silat has now evolved to become part of social culture and tradition with thé appearance of a fine physical and spiritual .

On an exceptional basis, Member States may request UNESCO to provide thé candidates with access to thé platform so they can complète thé form by themselves. Thèse requests must be addressed to esd rize unesco. or by 15 A ril 2021 UNESCO will provide thé nomineewith accessto thé platform via their émail address.

̶The leading indicator of employee engagement is based on the quality of the relationship between employee and supervisor Empower your managers! ̶Help them understand the impact on the organization ̶Share important changes, plan options, tasks, and deadlines ̶Provide key messages and talking points ̶Prepare them to answer employee questions

Dr. Sunita Bharatwal** Dr. Pawan Garga*** Abstract Customer satisfaction is derived from thè functionalities and values, a product or Service can provide. The current study aims to segregate thè dimensions of ordine Service quality and gather insights on its impact on web shopping. The trends of purchases have

Chính Văn.- Còn đức Thế tôn thì tuệ giác cực kỳ trong sạch 8: hiện hành bất nhị 9, đạt đến vô tướng 10, đứng vào chỗ đứng của các đức Thế tôn 11, thể hiện tính bình đẳng của các Ngài, đến chỗ không còn chướng ngại 12, giáo pháp không thể khuynh đảo, tâm thức không bị cản trở, cái được

Food outlets which focused on food quality, Service quality, environment and price factors, are thè valuable factors for food outlets to increase thè satisfaction level of customers and it will create a positive impact through word ofmouth. Keyword : Customer satisfaction, food quality, Service quality, physical environment off ood outlets .

MARCH 1973/FIFTY CENTS o 1 u ar CC,, tonics INCLUDING Electronics World UNDERSTANDING NEW FM TUNER SPECS CRYSTALS FOR CB BUILD: 1;: .Á Low Cóst Digital Clock ','Thé Light.Probé *Stage Lighting for thé Amateur s. Po ROCK\ MUSIC AND NOISE POLLUTION HOW WE HEAR THE WAY WE DO TEST REPORTS: - Dynacó FM -51 . ti Whárfedale W60E Speaker System' .