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Human Factors Plans amp Reports The AAMI Store
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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. 1 877 249 8226 or visit www aami org,Human Factors. Plans Reports,for Medical Technology Development,PREVIEW Michael. COPYWiklund,This is a preview edition of an AAMI Birmingham. guidance document and is,Stephanie Alpert Larsen, 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. 1 877 249 8226 or visit www aami org, This publication is intended to be a helpful resource and reflects the. expert advice and views of the authors It is not to be construed as legal. or regulatory advice, This publication was prepared by Michael Wiklund Laura Birmingham. and Stephanie Alpert Larsen in their personal capacities and not as. employees of UL The opinions in this book belong to the authors and. do not reflect the views of UL,PREVIEW COPY,This is a preview edition of an AAMI guidance. Reprinted document,2018 UL LLC,with permission 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. Published by,1 877 249 8226 or visit www aami org,4301 N Fairfax Drive Suite 301.
Arlington VA 22203 1633,www aami org, 2018 by the Association for the Advancement of Medical Instrumentation. All Rights Reserved, Publication reproduction photocopying storage or transmission electronically or otherwise of all or any part of this document without. the prior written permission of the Association for the Advancement of Medical Instrumentation is strictly prohibited by law It is illegal. under federal law 17 U S C 101 et seq to make copies of all or any part of this document whether internally or externally without. the prior written permission of the Association for the Advancement of Medical Instrumentation Violators risk legal action including. civil 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 America. ISBN 978 1 57020 689 4,Table of Contents,Foreword v. Acknowledgments ix,About the Authors xi,About UL Wiklund xiii.
Advisory Panel xv,Who Could Use This Book xvii,Disclaimers xix. Chapter 1 Introduction 1,PREVIEW COPY, Chapter 2 Human Factors Engineering Process Overview 3. Chapter 3 Hypothetical Intravenous Infusion Pump 7. Chapter 4 Assumptions,This is a about,preview Hypothetical. edition Design s,of anProgression,AAMI guidance document 11 and is. Chapter 5 Useful Terms and Definitions, intended to allow potential purchasers to evaluate the content 13.
SECTION II of the document before making a purchasing decision. Chapter 6 Human Factors Engineering Project Plan 15. Chapter 7 For aUsability, Formative complete Test copy of this AAMI document contact. Plan 39 AAMI at,Chapter 8 1 877 249 8226 or visit www aami org. Formative Usability Test Report 61,Chapter 9 Summative Usability Test Plan 81. Chapter 10 Summative Usability Test Report 117,Chapter 11 Human Factors Engineering Report 155. Further Reading 215,References 217,AAMI Table of Contents iii.
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. 1 877 249 8226 or visit www aami org, iv Writing Human Factors Plans Reports for Medical Technology Development AAMI. It has been widely reported that preventable medical error by Evidently the more researchers study the problem in the. clinicians was the third leading cause of death in the United United States and recognize how many deaths have been. States in 2015 claiming over a quarter million people s incorrectly categorized the more the reported magnitude of. lives that year and trailing only heart disease and cancer in medical error seems to increase The magnitude of error. terms of lethality These reports were based on a conclusion related deaths in the United States suggests that researchers. derived from a Johns Hopkins University School of Medicine would discover the same situation in many other countries. study published in The BMJ in May 2016 1 The study quotes with death rates varying to some extent because of the. Professor of Surgery Martin Makary stating researchers level of medical care provided and the types of medical. examined four separate studies that analyzed medical death technology in use. rate data from 2000 to 2008 Then using hospital admission. rates from 2013 they extrapolated that based on a total of The pressing question for human factors engineering. 35 416 020 hospitalizations 251 454 deaths stemmed from HFE specialists is How many medical errors are what. a medical error which the researchers say now translates to human factors specialists call use errors committed while. PREVIEW COPY, 9 5 of all deaths each year in the U S Figure F 1 interacting with medical technology e g infusion pumps. dialysis machines defibrillators glucose meters nebulizers. This troubling finding,Thisupdated the equally,is a preview widely reported. edition penguidance,of an AAMI injectors that induced the and.
document error isThe research tells,finding publishedintended. in the Institute of Medicine s publication us that the broad term. to allow potential purchasers to evaluate the content medical error covers such failures. To Err Is Human Building a Safer Health System in 1999 2 as misdiagnoses wrong site surgeries surgical blunders. of the document before making a purchasing decision. that between 44 000 and 98 000 people in the United States administering medication to the wrong patient and not. died in hospitals as the consequence of the same problem responding to alarms in a timely manner But we do not. healthcare providersFor a complete,making mistakes copy of this AAMIknow document. the degreecontact AAMI,to which the at are induced by user. 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. AAMI Foreword v, interface UI design flaws defects at the points where another term for HFE This standard has been adopted.
people interact with medical technology In 2008 when in the United States as ANSI AAMI IEC 62366 1 2015. delivering the keynote speech at the annual Human Factors Medical devices Part 1 Application of usability engineering to. and Ergonomics Society meeting Peter Carstensen the medical devices. Food and Drug Administration s FDA s human factors. team founder and leader grossly estimated based on Regulators actions and the moral imperative to make medical. adverse event reports that 10 to 15 of medical errors technology safer have led to widespread adoption of HFE by. and potentially more might have this root cause companies that only now are gaining experience with the. discipline This is where this book s content can be helpful. Years later our sense for the magnitude of deaths related. specifically to UI shortcomings as compared to deaths As covered in the Introduction to follow we intend this. generally caused by medical error is not much better book s content to give companies a head start on the. but we can make the simplifying assumption that the important tasks of defining the elements of an HFE project. magnitude of UI related deaths is significant perhaps in plan planning and reporting the results of usability tests. the tens of thousands Therefore we and many other HFE and reporting HFE research results to the FDA in particular. specialists believe that applying HFE to medical devices to Note that this book is less focused on helping companies. improve safety and by extension effectiveness and usability conform to 62366 1 Specific guidance for this standard. is a worthwhile pursuit Of course regulatory bodies have is provided in the IEC Technical Information Report IEC. already drawn this conclusion dating back to 1996 when the TR 62366 2 2016 Medical devices Part 2 Guidance on the. U S government changed the Quality System Regulation 3 application of usability engineering to medical devices adopted. calling for medical device developers to closely consider in the United States as AAMI IEC TIR62366 2 2016. users needs when designing a medical device and then to. Naturally it is distressing that people receiving medical. verify and validate that users needs have been met. care can be hurt or killed by the same medical technology. Today medical technology developers must apply HFE intended to help them It is also distressing to consider. PREVIEW COPY, comprehensively and demonstrate to regulators that devices. are unlikely to induce potentially harmful use errors. the consequences for healthcare professionals and home. caregivers taking care of a dependent who are induced to err. Specifically those seeking by a device with a flawed UI. Thisapproval or clearance,is a preview to market,edition of an AAMI guidance document and is. certain types of Class II and III devices in the United. intended to allow potential purchasers to evaluate. Over the course theofcontent,of many years HFE practice and to. States must meet the FDA s HFE guidance 4 which calls for. of the document before making a purchasing decision i e flaws in. manufacturers to submit an HFE report that summarizes. date we have identified UI shortcomings, all manner of medical technology including large capital. their HFE approach and results Those who intend to. equipment e g ventilators computed tomography CT,Forcountries.
sell devices in many other a complete copy of this AAMI. must demonstrate document contact AAMI at, scanners heart lung machines down to hand held devices. 1 877 249 8226, compliance with the International Electrotechnical or visit www aami org. purchased over the counter e g glucose meters pen,Commission IEC standard on usability engineering. injectors inhalers The flaws have been as fundamental. Figure F 2 People in every stage of life might need to use medical devices and should not be at risk of death due. to mistakes induced by the device s user interface Note that the products shown simply depict medical devices in. use and are not presented as flawed devices that caused use errors. vi Writing Human Factors Plans Reports for Medical Technology Development AAMI. as the assignment of system monitoring and calibration. functions to human operators who are not particularly. good at performing tedious tasks perfectly and exactly on. time instead of automating them The flaws have been. as seemingly superficial and trivial as placing two push. buttons too close together or labeling them with confusing. terms Fortunately we discovered the flaws through HFE. research and have worked with our clients to fix them. Just as fortunately resolving them did not require magic. or even a startling level of brilliance Rather it required. diligence the diligence to apply HFE in a quality conscious. comprehensive manner throughout device development. which included taking time to perform activities such as a. proper 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 HFE. into their device development efforts as we work in broad. collaboration to address the epidemic of medical errors. 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. 1 877 249 8226 or visit www aami org,AAMI Foreword vii.
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. 1 877 249 8226 or visit www aami org, viii Writing Human Factors Plans Reports for Medical Technology Development AAMI. Acknowledgments, The authors thank the following individuals for their mission to make the world a safer place Special thanks go. support during the book writing process to Upayan Sengupta Anil N Patel and Hiroshi Yamaki. retired from UL,Thanks to our families and friends. Thanks to Gil Molho, Michael Wiklund thanks his wife Amy for her generous.
support during the book writing effort Gil Molho an industrial designer based in Eindhoven. NL enthusiastically embraced the task of interpreting and. Laura Birmingham thanks her family and friends for expanding upon Jonathan Kendler s hypothetical infusion. their advice and feedback throughout the development pump design and then creating a 3 D model the source. of this book and her parents in particular for their of the IV infusion pump illustrations within the book. encouragement and support over the years,PREVIEWThanks. COPY to Shannon Hoste, Stephanie Alpert Larsen thanks her husband David and. her parents for their never ending love and support. The authors express their appreciation to Shannon Hoste. This is a preview edition of an AAMIMSSE guidance document. MSM RAC and and,for her review is comments on,Thanks to our colleagues at UL Wiklund. intended to allow potential purchasers to evaluate. our book the content,Shannon Hoste is a human factors engineer. of theinformal,Our HFE colleagues offered document.
editorialbefore,support making,and a purchasing,leading the Humandecision. Factors Premarket Evaluation Team, of the Food and Drug Administration s FDA s Center. had a helping hand in the development of UL Wiklund s. For a upon,complete copy ofthethis for Devices and. AAMI document Radiological,contact AAMI Health,at CDRH Prior to. work product templates which we based plans,1 877 249 8226 joining the.
or visit www aami org FDA in January 2015 Shannon spent 18 years. and reports presented in this book Special thanks, in the medical device industry as a device development. go to Jonathan Kendler Allison Strochlic Jon Tilliss. engineer and R D manager Over this time she has, Andrea Dwyer Erin Davis Rachel Aronchick Echo Kirk. worked within and directed project teams in all phases. and Cory Costantino colleagues who have been with the. team for many years and helped shape our HFE practice of product development from front end research to. postmarket support as well as architecting new product. Jonathan Kendler provided extraordinary visual design development processes including the incorporation of. support including multiple book illustrations and human factors and usability into the product development. both designed and coordinated the 3 D modeling of the lifecycle Shannon has a BS in mechanical engineering. hypothetical intravenous IV infusion pump that serves an MS in cognitive systems engineering and an MS in. as the focus of our sample work products management Generously the FDA granted her request. to review and comment on our book but required her to. UL senior managers green lighted our proposal to provide this support while off duty and working on a peer. share sample HFE work products that otherwise could be to peer basis in an unofficial capacity Neither the FDA. viewed as the organization s intellectual property and not nor the U S government has officially sanctioned the. suitable for release They understood the value to industry book s content and the FDA has neither recognized nor. of sharing our property and the potential it had to endorsed the book. improve healthcare quality which is consistent with UL s. AAMI Acknowledgments ix,Acknowledgments,Thanks to AAMI. Melissa Coates special projects editor welcomed our. proposal to write this book and provided helpful project. management and manuscript editing support, Steve Campbell chief operating officer also encouraged. the book writing project and got us off to a rapid start on. the project by streamlining the approval process,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. 1 877 249 8226 or visit www aami org, x Writing Human Factors Plans Reports for Medical Technology Development AAMI. About the Authors,Stephanie Alpert Larsen left Laura Birmingham. center and Michael Wiklund right,PREVIEW COPY, Michael Wiklund FDA provided the guide to the Human Factors Engineering. This is a preview edition of an AAMI guidance document and is. Committee at AAMI which used it as a basis for writing. Michael has workedintended,in the HFEto allow potential. profession purchasers to evaluate the content, for more than ANSI AAMI HE74 2001 Human factors design process for.
30 years as a consultantof,andthe document before making. educator a purchasing,medical decision became the basis for the. devices HE74 ultimately, He received his master s degree in engineering design current standard of the International Electrotechnical. For a complete copy of this, specializing in HFE from Tufts University where he has AAMI document. Commission contact,on the topic at62366 1 2015 adopted.
1 877 249 8226, subsequently taught UI design for three decades He has or visit www aami org. in the United States as ANSI AAMI IEC 62366 1 2015. a professional engineering license and is a board certified In 2005 Michael cofounded Wiklund Research Design. human factors professional Inc with the goal of providing comprehensive HFE services. He joined the profession in the mid 1980s a time when to industry medical device manufacturers in particular. microprocessor technology started to change the In the ensuing years the firm has provided user research. fundamental nature of medical technologies Originally UI development and usability testing services to more than. trained to make machines safe and user friendly his early 100 clients based in multiple countries In 2012 UL acquired. work was focused on knobs and dials but soon transitioned Wiklund R D to expand the renowned safety organization s. to making software UIs more comprehensible to users portfolio of advisory services Now as general manager of. Today he helps optimize the design of hardware software HFE at UL Michael manages the work of HFE specialists. and hybrid devices as well as instructional media such as based in multiple countries while still serving as a technical. quick reference guides user manuals and online resources contributor on special projects. In 1997 the Food and Drug Administration FDA engaged Michael s other books include Usability in Practice editor. Michael to write a guide to applying HFE in medical device Medical Device and Equipment Design Designing Usability. development in a manner that was consistent with the into Medical Products co author and Handbook of. then new guidance of the agency on the topic Later the Human Factors in Medical Device Design co editor. AAMI About the Authors xi,About the Authors, He has published more than 70 articles in Medical Device Stephanie Alpert Larsen. Diagnostic Industry MD DI magazine that promote the. application of HFE in medical device development and Stephanie received BA degrees in both mathematics and. provide practical tips He has been an invited speaker at psychology from Binghamton University and received an. multiple professional conferences and universities where he MS in human factors engineering and ergonomics from. has described HFE as an imperative in the medical industry Virginia Polytechnic Institute and State University She has. and a path toward ensuring device safety and commercial worked in the field for four years. success owing to its effectiveness usability and appeal Stephanie serves as a senior human factors specialist at. He has served as a voting member of the AAMI Human UL Wiklund In this role she participates in a wide range of. Factors Engineering Committee for over 20 years He the HFE consulting group s activities including conducting. has also served on the Human Factors Committee of the user research task analyses and known problems analyses. IEC and as chair of the Industrial Designers Society of analyzing use related risks evaluating preliminary UI. America Medical Section designs and conducting various types of usability tests e g. formative summative comparison benchmark, Laura Birmingham Her HFE portfolio includes many combination products. including prefilled syringes pen injectors auto injectors. Laura received her BS degree in engineering psychology from. and inhalers It also includes web and smartphone, Tufts University and has worked in the field for six years. applications as well as computerized systems that process. Laura serves as a managing human factors specialist at UL various medical samples Stephanie s usability testing work. Wiklund In this role she participates in a wide range of the has involved a large variety of users including children. HFE consulting group s activities including conducting user adolescents adults and seniors clinicians and laypersons. research performing known problems analyses analyzing people with impairments associated with the medical. use related risks evaluating preliminary UI designs and condition addressed by the device being tested and people. conducting various types of usability tests e g formative with limited education and low literacy. PREVIEW COPY, summative comparison Laura s responsibilities extend.
to working with clients to determine project requirements. This is toa HFE,defining technical approaches preview edition. activities of an AAMI guidance document and is,and general. project management intended to allow potential purchasers to evaluate the content. of the document before making a purchasing decision. Laura s HFE portfolio includes a wide range of therapeutic. and diagnostic devices such as dialysis machines patient. monitoring devices insulin a complete copy of this AAMI document contact. a computer controlled AAMI at,1 877 249 8226, prosthetic limb and left ventricular assist devices She has or visit www aami org. also worked on a wide variety of combination products. including pen injectors inhalation systems and inhalers. and auto injectors These and many more medical, technologies have included UIs of various forms including. hardware software and documentation, Laura has been a lead author of each type of work product.
discussed and exemplified in this book, xii Writing Human Factors Plans Reports for Medical Technology Development AAMI. About UL Wiklund, This book is based on HFE documents developed and UL Wiklund is UL s HFE practice created when UL. refined over many years of HFE practice at UL Wiklund acquired Wiklund Research Design in 2012 The HFE. as well as essential inputs received from members of the practice concentrates on helping medical technology. book writing project s advisors developers bring safe effective usable and satisfying. devices to market through the comprehensive application. UL formerly named Underwriters of HFE However it often applies its expertise to help. Laboratories is a global independent develop other kinds of technology including consumer. safety science company with more than products commercial and industrial products and. a century of expertise innovating safety enterprise software applications. solutions from the public adoption of, 2018 UL LLC electricity in the past century to helping. Reprinted with permission,medical technology developers bring safe. and effective devices to market, UL s mission guides everything the organization does PREVIEW COPY.
UL conscientiously advances safety science through careful. This is a preview edition of an AAMI guidance document and is. research and investigation applies its efforts to prevent or. reduce loss of life intended,and property to,andallow potential. promotes safe livingpurchasers to evaluate the content. and working environments of the,for alldocument,people 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,ca 1971 UL LLC ca 1968 UL LLC. William Henry Merrill founded UL in 1894 to conduct product safety. tests on behalf of insurance underwriters The UL certification mark. quickly became a trusted symbol of product safety In the more than. 120 years since its founding UL has certified the safety of over one. billion products and driven the creation of innumerable safety. standards Photos reprinted with permission,AAMI About UL Wiklund xiii.

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