Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices
Author: Bijan Elahi
Publsiher: Academic Press
Total Pages: 534
Release: 2021-11-11
Genre: Technology & Engineering
ISBN: 9780323918237

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Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. Includes new coverage of ISO 14971:2019, ISO/TR 24971 Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation

Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices
Author: Bijan Elahi
Publsiher: Academic Press
Total Pages: 424
Release: 2018-06-29
Genre: Technology & Engineering
ISBN: 9780128130995

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Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction. This book delivers not only theory, but also practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971—a requirement for all medical devices. This book outlines sensible, easily comprehensible, and state-of the-art methodologies that are rooted in current industry best practices. Opening chapters introduce the concept of risk, the legal basis for risk management, and the requirements for a compliant risk-management process. The next group of chapters discusses the connection between risk management and quality systems, usability engineering and biocompatibility. This book delves into the techniques of risk management, such as fault tree analysis and failure modes and effects analysis, and continues with risk estimation, risk control, and risk evaluation. Special topics such as software risk management, clinical investigations, and security are also discussed. The latter chapters address benefit-risk analysis, and production and postproduction monitoring. This book concludes with advice and wisdom for sensible, efficient, and successful safety risk management of medical devices. Teaches industry best practices on medical-device risk management in compliance with ISO 14971 Provides practical, easy-to-understand, and step-by-step instructions on how to perform hazard analysis and manage the risks of medical devices Offers a worked-out example applying the risk management process on a hypothetical device

Integrated Safety and Risk Assessment for Medical Devices and Combination Products

Integrated Safety and Risk Assessment for Medical Devices and Combination Products
Author: Shayne C. Gad
Publsiher: Springer Nature
Total Pages: 490
Release: 2020-02-24
Genre: Medical
ISBN: 9783030352417

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While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.

Managing Medical Devices within a Regulatory Framework

Managing Medical Devices within a Regulatory Framework
Author: Beth Ann Fiedler
Publsiher: Elsevier
Total Pages: 380
Release: 2016-09-10
Genre: Technology & Engineering
ISBN: 9780128041925

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Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle. This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements. Covers compliance with FDA and CE regulations, plus EU directives for service and maintenance of medical devices Provides operational and clinical practice recommendations in regard to regulatory changes for risk management Discusses best practices for equipment procurement and maintenance Provides guidance on dealing with the challenge of medical records management and compliance with patient confidentiality using information from medical devices

Safety of Electromedical Devices

Safety of Electromedical Devices
Author: Norbert Leitgeb
Publsiher: Springer Science & Business Media
Total Pages: 233
Release: 2010-05-06
Genre: Technology & Engineering
ISBN: 9783211996836

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Preface Development in the feld of medical technology has resulted in a manifold of medical devices enabling us to diagnose illnesses more reliably, treat them more effciently and compensate for handicaps more effectively. However, these improvements are also - sociated with safety risks. Today, patients are in contact with an increasing number of medical devices longer and more intensively then before. Applied parts are put into contact with the body, probes may be introduced into the body via natural or surgical orifces, and even whole devices may be implanted for many years. The application of devices is no longer restricted to medical locations only. Home use by lay people is increasing and involves even critical devices such as for dialysis, nerve and muscle stimulation and ventilation. In contrast to users’ patients are in a special situation. Their life could depend on the performance of a device, they might be unconscious, may have impaired reactions, or have been made insensitive to pain by medication, and hence they may be exposed to hazards without their awareness and protection by their own reaction. Therefore, medical devices must meet particularly stringent safety requirements. However, the question arises how safe is safe enough? The readiness to accept risks depends on a variety of accompanying circumstances. In fact, subjective risk p- ception varies among individuals and differs from country to country, and frequently only in rare cases it is in agreement with assessments of objective scientifc ana- ses.

Textbook of Patient Safety and Clinical Risk Management

Textbook of Patient Safety and Clinical Risk Management
Author: Liam Donaldson,Walter Ricciardi,Susan Sheridan,Riccardo Tartaglia
Publsiher: Springer Nature
Total Pages: 496
Release: 2020-12-14
Genre: Medical
ISBN: 9783030594039

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Implementing safety practices in healthcare saves lives and improves the quality of care: it is therefore vital to apply good clinical practices, such as the WHO surgical checklist, to adopt the most appropriate measures for the prevention of assistance-related risks, and to identify the potential ones using tools such as reporting & learning systems. The culture of safety in the care environment and of human factors influencing it should be developed from the beginning of medical studies and in the first years of professional practice, in order to have the maximum impact on clinicians' and nurses' behavior. Medical errors tend to vary with the level of proficiency and experience, and this must be taken into account in adverse events prevention. Human factors assume a decisive importance in resilient organizations, and an understanding of risk control and containment is fundamental for all medical and surgical specialties. This open access book offers recommendations and examples of how to improve patient safety by changing practices, introducing organizational and technological innovations, and creating effective, patient-centered, timely, efficient, and equitable care systems, in order to spread the quality and patient safety culture among the new generation of healthcare professionals, and is intended for residents and young professionals in different clinical specialties.

Health and Safety Risk Management

Health and Safety  Risk Management
Author: Tony Boyle
Publsiher: Routledge
Total Pages: 498
Release: 2019-01-16
Genre: Business & Economics
ISBN: 9780429790768

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Health and Safety: Risk Management is the clearest and most comprehensive book on risk management available today. This newly revised fifth edition takes into account new developments in legislation, standards and good practice. ISO 45001, the international health and safety management system standard, is given comprehensive treatment, and the latest ISO 9004 and ISO 19011 have also been addressed. The book is divided into four main parts. Part 1.1 begins with a basic introduction to the techniques of health and safety risk management and continues with a description of ISO 45001. Part 1.2 covers basic human factors including how the sense organs work and the psychology of the individual. Part 2.1 deals with more advanced techniques of risk management including advanced incident investigation, audit and risk assessment, and Part 2.2 covers a range of advanced human factors topics including human error and decision making. This authoritative treatment of health and safety risk management is essential reading for both students working towards degrees, diplomas and postgraduate or vocational qualifications, and experienced health and safety professionals, who will find it invaluable as a reference.

Medical Devices Application of Risk Management to Medical Devices

Medical Devices  Application of Risk Management to Medical Devices
Author: British Standards Institute Staff
Publsiher: Unknown
Total Pages: 50
Release: 2001-03
Genre: Electronic Book
ISBN: 0580370844

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Medical equipment, Medical instruments, Risk assessment, Risk analysis, Management, Hazards, Clinical investigation instruments, Safety measures

DESIGN CONTROLS RISK MANAGEMENT PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS

DESIGN CONTROLS  RISK MANAGEMENT   PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS
Author: Vernon Geckler
Publsiher: Wasatch Consulting Resources LLC
Total Pages: 441
Release: 2017-02-11
Genre: Electronic Book
ISBN: 9780692835418

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This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA & ISO 13485 design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in-depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading an existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 20-40 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.

Healthcare Hazard Control and Safety Management

Healthcare Hazard Control and Safety Management
Author: James T. Tweedy
Publsiher: CRC Press
Total Pages: 816
Release: 2005-06-24
Genre: Business & Economics
ISBN: 9781420025460

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Surpassing the standard set by the first edition, Healthcare Hazard Control and Safety Management, Second Edition presents expansive coverage for healthcare professionals serving in safety, occupational health, hazard materials management, quality improvement, and risk management positions. Comprehensive in scope, the book covers all major issues i

User Interface Requirements for Medical Devices

User Interface Requirements for Medical Devices
Author: Michael Wiklund,Erin Davis,Alexandria Trombley
Publsiher: CRC Press
Total Pages: 224
Release: 2021-11-17
Genre: Technology & Engineering
ISBN: 9781000471847

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This book is a practical guide for individuals responsible for creating products that are safe, effective, usable, and satisfying in the hands of the intended users. The contents are intended to reduce the number of use errors involving medical devices that have led to injuries and deaths. The book presents the strong connection between user interface requirements and risk management for medical devices and instructs readers how to develop specific requirements that are sufficiently comprehensive and detailed to produce good results – a user-friendly product that is likely to be used correctly. The book’s tutorial content is complemented by many real-world examples of user interface requirements, including ones pertaining to an inhaler, automated external defibrillator, medical robot, and mobile app that a patient might use to manage her diabetes. The book is intended for people representing a variety of product development disciplines who have responsibility for producing safe, effective, usable, and satisfying medical devices, including those who are studying or working in human factors engineering, psychology, mechanical engineering, biomedical engineering, systems engineering, software programming, technical writing, industrial design, graphic design, and regulatory affairs.

Medical Device Cybersecurity for Engineers and Manufacturers

Medical Device Cybersecurity for Engineers and Manufacturers
Author: Axel Wirth,Christopher Gates,Jason Smith
Publsiher: Artech House
Total Pages: 270
Release: 2020-08-31
Genre: Computers
ISBN: 9781630818166

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Cybersecurity for medical devices is no longer optional. We must not allow sensationalism or headlines to drive the discussion… Nevertheless, we must proceed with urgency. In the end, this is about preventing patient harm and preserving patient trust. A comprehensive guide to medical device secure lifecycle management, this is a book for engineers, managers, and regulatory specialists. Readers gain insight into the security aspects of every phase of the product lifecycle, including concept, design, implementation, supply chain, manufacturing, postmarket surveillance, maintenance, updates, and end of life. Learn how to mitigate or completely avoid common cybersecurity vulnerabilities introduced during development and production. Grow your awareness of cybersecurity development topics ranging from high-level concepts to practical solutions and tools. Get insight into emerging regulatory and customer expectations. Uncover how to minimize schedule impacts and accelerate time-to-market while still accomplishing the main goal: reducing patient and business exposure to cybersecurity risks. Medical Device Cybersecurity for Engineers and Manufacturers is designed to help all stakeholders lead the charge to a better medical device security posture and improve the resilience of our medical device ecosystem.

Usability Testing of Medical Devices

Usability Testing of Medical Devices
Author: Michael E. Wiklund P.E.,Jonathan Kendler,Allison Y. Strochlic
Publsiher: CRC Press
Total Pages: 477
Release: 2015-12-23
Genre: Medical
ISBN: 9781466595897

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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 h

The Role of Human Factors in Home Health Care

The Role of Human Factors in Home Health Care
Author: National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Human-Systems Integration,Committee on the Role of Human Factors in Home Health Care
Publsiher: National Academies Press
Total Pages: 322
Release: 2010-11-14
Genre: Medical
ISBN: 9780309156295

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The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research--the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.

Systems Software and Services Process Improvement

Systems  Software and Services Process Improvement
Author: Xabier Larrucea,Izaskun Santamaria,Rory V. O'Connor,Richard Messnarz
Publsiher: Springer
Total Pages: 668
Release: 2018-08-22
Genre: Business & Economics
ISBN: 9783319979250

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This volume constitutes the refereed proceedings of the 25th European Conference on Systems, Software and Services Process Improvement, EuroSPI conference, held in Bilbao, Spain, in September 2018. The 56 revised full papers presented were carefully reviewed and selected from 95 submissions. They are organized in topical sections on SPI context and agility, SPI and safety testing, SPI and management issues, SPI and assessment, SPI and safety critical, gamifySPI, SPI in industry 4.0, best practices in implementing traceability, good and bad practices in improvement, safety and security, experiences with agile and lean, standards and assessment models,team skills and diversity strategies, SPI in medical device industry, empowering the future infrastructure.