Medical Device Use Error

Author: Michael Wiklund
Publisher: CRC Press
ISBN: 1498705804
Format: PDF, ePub, Docs
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Medical Device Use Error: Root Cause Analysis offers practical guidance on how to methodically discover and explain the root cause of a use error—a mistake—that occurs when someone uses a medical device. Covering medical devices used in the home and those used in clinical environments, the book presents informative case studies about the use errors (mistakes) that people make when using a medical device, the potential consequences, and design-based preventions. Using clear illustrations and simple narrative explanations, the text: Covers the fundamentals and language of root cause analysis and regulators’ expectations regarding the thorough analysis of use errors Describes how to identify use errors, interview users about use errors, and fix user interface design flaws that could induce use errors Reinforces the application of best practices in human factors engineering, including conducting both formative and summative usability tests Medical Device Use Error: Root Cause Analysis delineates a systematic method of analyzing medical device use errors. The book provides a valuable reference to human factors specialists, product development professionals, and others committed to making medical devices as safe and effective as possible.

Medical Device Use Error

Author: Michael E. Wiklund
Publisher: CRC Press
ISBN: 9781498705790
Format: PDF, ePub, Mobi
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Root Cause Analysis of Use Error delineates a systematic method of analyzing medical device use errors. The book is to the specific needs of people developing medical devices, people studying to serve this role, and the folks responsible for evaluating device use error (including the regulators).

Usability Testing of Medical Devices Second Edition

Author: Michael E. Wiklund, P.E.
Publisher: CRC Press
ISBN: 1466595892
Format: PDF, ePub
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Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests. Since publication of the first edition, the FDA and other regulatory groups have modified their regulations and expectations regarding how medical device manufacturers should approach usability testing. Reflecting these changes, this Second Edition provides updated guidance to readers with an interest or direct role in conducting a usability test of a medical device or system. Key updates involve the 2011 FDA guidance on human factors engineering, requirements set forth by the third edition of IEC 60601 and closely related IEC 62366-1:2015, linking usability test tasks to risk analysis results, and analyzing root causes of use errors that occur during usability tests. Written by seasoned human factors specialists, Usability Testing of Medical Devices, Second Edition is an informative, practical, and up-to-date handbook for conducting usability tests of medical devices. The book helps ensure a smooth and painless development process—and thus, safe and effective medical devices.

Safe Medical Devices for Children

Author: Committee on Postmarket Surveillance of Pediatric Medical Devices
Publisher: National Academies Press
ISBN: 0309096316
Format: PDF, Mobi
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Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.

Advances in Human Factors and Ergonomics in Healthcare and Medical Devices

Author: Nancy J. Lightner
Publisher: Springer
ISBN: 3319943731
Format: PDF, ePub, Mobi
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This book shows how human factors and ergonomic principles have been transforming healthcare. It reports on the design of systems and devices to improve quality, safety, efficiency, and effectiveness in patient care, and discusses findings related to improving organizational outcomes in a healthcare setting, as well as approaches for analyzing and modeling those work aspects that are unique to healthcare. Based on the AHFE 2018 International Conference on Human Factors and Ergonomics in Healthcare and Medical Devices, held on July 21–25, 2018, in Orlando, Florida, USA, the book highlights the physical, cognitive and organizational aspects of human factors and ergonomic applications, presenting various perspectives, including those of clinicians, patients, health organizations, and insurance providers. The book is intended as a timely reference guide for researchers involved in the design of medical systems, healthcare professionals managing healthcare settings, as well as healthcare counselors and international health organizations.

Designing Safe User Interfaces

Author: Michael Wiklund
Publisher: CRC Press
ISBN: 9781138299177
Format: PDF, ePub, Mobi
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This work details 100 examples of how to design a user interface that guards against potentially harmful use errors. The examples cover myriad features concerning hardware, software, and documents with emphasis placed on medical devices. This analysis is timely considering the intense focus within multiple worldwide industries to increase the safety of products, tolls, machines and systems, including those used by professionals and laypersons. This intense focus arises from the revelation that preventable error is among the leading causes of death, in the same magnitude of heart disease and cancer. Each of the 100 examples will include a concise design guideline.

Walter and Miller s Textbook of Radiotherapy E book

Author: R Paul Symonds
Publisher: Elsevier Health Sciences
ISBN: 0702046620
Format: PDF, ePub
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A comprehensive textbook of radiotherapy and related radiation physics and oncology for use by all those concerned with the uses of radiation and cytotoxic drugs in the treatment of patients with malignant disease. Walter & Miller's Textbook of Radiotherapy has become the core text for therapeutic radiography students and an important introductory text for trainee radiologists and clinical physicists. The book is divided into two parts: the first covers underlying principles of physics, and the second is a systematic review by tumour site concentrating on the role of radiotherapy in the treatment of malignant disease and setting its use in context with chemotherapy and surgery. The 7th edition continues the tradition of bringing the physics and clinical application of radiation for therapy together at entry level and is completely revised to take into account the huge technological advances in radiotherapy treatment since publication of the previous edition. *Imaging is now an essential part of radiotherapy, relevant for both the treatment and preparation of a patient's treatment. Radionuclide imaging and X-ray imaging have been expanded to MRI and PET, along with some use of ultrasound. *Treatment planning dose prediction - the basis and application of modern computational calculations are explained for modern treatment delivery systems. The role of the algorithm for dose prediction is central to ensure speedy and accurate calculations for treatment. *Quality Control *Quality Systems The book is supported by Evolve electronic resources: sample plans, additional diagnostic images and clinical photographs.

Risk Management Handbook for Health Care Organizations

Author: American Society for Healthcare Risk Management (ASHRM)
Publisher: John Wiley & Sons
ISBN: 0470443715
Format: PDF, Kindle
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This comprehensive textbook provides a complete introduction to risk management in health care. Risk Management Handbook, Student Edition, covers general risk management techniques; standards of health care risk management administration; federal, state and local laws; and methods for integrating patient safety and enterprise risk management into a comprehensive risk management program. The Student Edition is applicable to all health care settings including acute care hospital to hospice, and long term care. Written for students and those new to the topic, each chapter highlights key points and learning objectives, lists key terms, and offers questions for discussion. An instructor's supplement with cases and other material is also available.

Quality Improvement in Neonatal and Perinatal Medicine An Issue of Clinics in Perinatology E Book

Author: Alan R. Spitzer
Publisher: Elsevier Health Sciences
ISBN: 1455700533
Format: PDF, ePub
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This issue of Clinics in Perinatology, guest edited by Drs. Alan Spitzer and Dan Ellsbury, examines Quality Improvement in Neonatal and Perinatal Medicine. The first part of the issue addresses Tools of Quality Improvement and includes articles on The Quality Chasm in Neonatal and Perinatal Medicine; Evaluating the Medical Evidence; The Vermont Oxford Network Database; The Pediatrix Clinical Data Warehouse; Role of Regional Collaboratives: The California Perinatal Quality Care Collaborative Model; A Primer on Quality Improvement Methodology; Using Statistical Process Control Methodology; Human Factors in Quality Improvement, Random Safety Audits, Root Cause Analysis, and Failure Mode and Effects Analysis; Collaboration Between Obstetricians and Neonatologists: Perinatal Safety Programs and Improved Clinical Outcomes; and Pay for Performance: A Business Strategy for Quality Improvement in Neonatal-Perinatal Medicine. The second part of this issue addresses Specific Applications of Documented Quality Improvement Methodology in Neonatal and Perinatal Medicine and includes articles on Delivery Room Intervention-Improving the Outcome, Reducing Retinopathy of Prematurity, Improving Breast Milk Use During and After the NICU Stay, Decreasing Catheter Related Bloodstream Infection, and Decreasing Bronchopulmonary Dysplasia.

Clinical Engineering Handbook

Author: Ernesto Iadanza
Publisher: Elsevier
ISBN: 0080476570
Format: PDF, ePub, Docs
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As the biomedical engineering field expands throughout the world, clinical engineers play an evermore-important role as translators between the medical, engineering, and business professions. They influence procedure and policy at research facilities, universities, as well as private and government agencies including the Food and Drug Administration and the World Health Organization. The profession of clinical engineering continues to seek its place amidst the myriad of professionals that comprise the health care field. The Clinical Engineering Handbook meets a long felt need for a comprehensive book on all aspects of clinical engineering that is a suitable reference in hospitals, classrooms, workshops, and governmental and non-governmental organization. The Handbook’s thirteen sections address the following areas: Clinical Engineering; Models of Clinical Engineering Practice; Technology Management; Safety Education and Training; Design, Manufacture, and Evaluation and Control of Medical Devices; Utilization and Service of Medical Devices; Information Technology; and Professionalism and Ethics. The Clinical Engineering Handbook provides the reader with prospects for the future of clinical engineering as well as guidelines and standards for best practice around the world. From telemedicine and IT issues, to sanitation and disaster planning, it brings together all the important aspects of clinical engineering. Clinical Engineers are the safety and quality faciltators in all medical facilities The most definitive, comprehensive, and up-to-date book available on the subject of clinical engineering Over 170 contributions by leaders in the field of clinical engineering