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| medical device risk assessment example: Medical Device Regulations Michael Cheng, World Health Organization, 2003-09-16 The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems. |
| medical device risk assessment example: Integrated Safety and Risk Assessment for Medical Devices and Combination Products Shayne C. Gad, 2020-02-24 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. |
| medical device risk assessment example: Registries for Evaluating Patient Outcomes Agency for Healthcare Research and Quality/AHRQ, 2014-04-01 This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. |
| medical device risk assessment example: Digital Conversion on the Way to Industry 4.0 Numan M. Durakbasa, M. Güneş Gençyılmaz, 2020-10-25 This book presents the proceedings from the International Symposium for Production Research 2020. The cross-disciplinary papers presented draw on research from academics and practitioners from industrial engineering, management engineering, operational research, and production/operational management. It explores topics including: · computer-aided manufacturing; Industry 4.0 applications; simulation and modeling big data and analytics; flexible manufacturing systems; decision analysis quality management industrial robotics in production systems information technologies in production management; and optimization techniques. Presenting real-life applications, case studies, and mathematical models, this book is of interest to researchers, academics, and practitioners in the field of production and operation engineering. |
| medical device risk assessment example: Medical Devices and the Public's Health Institute of Medicine, Board on Population Health and Public Health Practice, Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, 2011-11-25 Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework. |
| medical device risk assessment example: Rare Diseases and Orphan Products Institute of Medicine, Board on Health Sciences Policy, Committee on Accelerating Rare Diseases Research and Orphan Product Development, 2011-04-03 Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development. |
| medical device risk assessment example: Public Health Effectiveness of the FDA 510(k) Clearance Process Institute of Medicine, Board on Population Health and Public Health Practice, Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, 2010-10-04 The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop. |
| medical device risk assessment example: Pharmaceutical Applications Ponnadurai Ramasami, 2021-10-25 Based on The Virtual Conference on Chemistry and its Applications (VCCA-2020) - Research and Innovations in Chemical Sciences: Paving the Way Forward held in August 2020 and organized by the Computational Chemistry Group of the University of Mauritius. The chapters reflect a wide range of fundamental and applied research in the chemical sciences and interdisciplinary subjects. |
| medical device risk assessment example: Medical Devices World Health Organization, 2010 Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9 |
| medical device risk assessment example: ANSI/AAMI St79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities Aami, 2013-10-01 The AAMI recommended practice, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, is a breakthrough standard in terms of its scope. AAMI has updated ST79 with the release of ST79:2010/A4:2013. Of particular importance, A4:2013 provides four new figures demonstrating the wrapping of items for steam sterilization and adds an annex focused on Moisture assessment. As of Oct. 25, 2013, purchasers of ST79 will receive ANSI/AAMI ST79:2010 and A1:2010 and A2:2011 and A3:2012 and A4:2014 as a single consolidated document. Among other changes from the 2006 edition of ST79, this revised and expanded second edition of ST79 includes guidance on the use and application of Class 6 emulating indicators, a chemical monitoring device fairly new to the United States. Because ST79 essentially consolidates five AAMI steam sterilization standards (whose content was reviewed and updated to reflect current good practice prior to being incorporated into ST79), it truly is a comprehensive guideline for all steam sterilization activities in healthcare facilities, regardless of the size of the sterilizer or the size of the facility, and provides a resource for all healthcare personnel who use steam for sterilization. |
| medical device risk assessment example: Toxicity Testing in the 21st Century National Research Council, Division on Earth and Life Studies, Institute for Laboratory Animal Research, Board on Environmental Studies and Toxicology, Committee on Toxicity Testing and Assessment of Environmental Agents, 2007-10-05 Advances in molecular biology and toxicology are paving the way for major improvements in the evaluation of the hazards posed by the large number of chemicals found at low levels in the environment. The National Research Council was asked by the U.S. Environmental Protection Agency to review the state of the science and create a far-reaching vision for the future of toxicity testing. The book finds that developing, improving, and validating new laboratory tools based on recent scientific advances could significantly improve our ability to understand the hazards and risks posed by chemicals. This new knowledge would lead to much more informed environmental regulations and dramatically reduce the need for animal testing because the new tests would be based on human cells and cell components. Substantial scientific efforts and resources will be required to leverage these new technologies to realize the vision, but the result will be a more efficient, informative and less costly system for assessing the hazards posed by industrial chemicals and pesticides. |
| medical device risk assessment example: Model-Based Safety and Assessment Marc Zeller, Kai Höfig, 2020-09-03 This book constitutes the proceedings of the 7th International Symposium on Model-Based Safety and Assessment, IMBSA 2020, held in Lisbon, Portugal, in September 2020. The conference was held virtually due to the COVID-19 pandemic. The 15 revised full papers and 4 short papers presented were carefully reviewed and selected from 30 initial submissions. The papers are organized in topical sections on safety models and languages; state-space modeling; dependability analysis process; safety assessment in automotive domain; AI and safety assurance. |
| medical device risk assessment example: Benefit-Risk Assessment Methods in Medical Product Development Qi Jiang, Weili He, 2017-12-19 Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a common B–R framework and patient input into B–R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA’s Center for Devices and Radiological Health. The third section examines key elements of B–R evaluations in a product’s life cycle, such as uncertainty evaluation and quantification, quantifying patient B–R trade-off preferences, ways to identify subgroups with the best B–R profiles, and data sources used to assist B–R assessment. The fourth section equips practitioners with tools to conduct B–R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B–R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B–R evaluations. |
| medical device risk assessment example: Medical Devices , 2019 This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle. This document does not apply to: decisions on the use of a medical device in the context of any particular clinical procedure; or business risk management. This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels. Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place. NOTE Guidance on the application of this document can be found in ISO/TR 24971-- Scope, page 1. |
| medical device risk assessment example: Modern Methods of Clinical Investigation Institute of Medicine, Committee on Technological Innovation in Medicine, 1990-02-01 The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians. |
| medical device risk assessment example: Health Technology Assessment of Medical Devices World Health Organization, 2012-10-25 WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: * policy framework for health technology * medical device regulations * health technology assessment * health technology management * needs assessment of medical devices * medical device procurement * medical equipment donations * medical equipment inventory management * medical equipment maintenance * computerized maintenance management systems * medical device data * medical device nomenclature * medical devices by health-care setting * medical devices by clinical procedures * medical device innovation, research and development. These documents are intended for use by biomedical engineers, health managers, donors, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional or global levels. HTA is the systematic evaluation of properties, effects, and/or impacts of health technology. Its main purpose is to inform technology-related policy-making in health care, and thus improve the uptake of cost-effective new technologies and prevent the uptake of technologies that are of doubtful value for the health system. It is one of three complementary functions to ensure the appropriate introduction and use of health technology. The other two components are regulation, which is concerned with safety and efficacy, and assessment of all significant intended as well as unintended consequences of technology use; and management, which is concerned with the procurement and maintenance of the technology during its life-cycle. The performance of health systems is strengthened when the linkages and exchange among these elements are clearly differentiated but mutually supportive. This document integrates health technology assessment into the WHO framework for evidence-informed policy-making. Health systems are strengthened when HTA is integrated into the human and material resources, data, transparent decision- and policy-making, and linked to the overall vision of equity and accountability. Good governance can rely on health technology assessment to provide a policy approach that is accountable for its decisions to the population. |
| medical device risk assessment example: Maintenance Management for Medical Equipment , 1988-01-01 |
| medical device risk assessment example: The Medical Device Industry Norman F. Estrin, 1990-08-31 Practical information about the complexities of biomedical technology and regulation, and their implications for manufacturers and marketers of health care devices. Written primarily for those in the industry concerned about staying competitive in light of complex and fluctuating regulatory approach |
| medical device risk assessment example: WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices World Health Organization, 2017-05-09 The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either rely on or recognize the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms medical devices and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices. |
| medical device risk assessment example: Mutagenic Impurities Andrew Teasdale, 2022-02-15 Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control. |
| medical device risk assessment example: Handbook of Human Factors in Medical Device Design Matthew Bret Weinger, Michael E. Wiklund, Daryle Jean Gardner-Bonneau, 2010-12-13 Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance |
| medical device risk assessment example: Biocompatiblity Julian H. Braybrook, 1997-08-04 This book presents both an overview and forward assessment of medical device materials and test methods. Highlighting the complex problem of host responses and related issues which may restrict the accuracy and reliability of existing test methodology, the book provides an unbiased appraisal of the requirements for biocompatibility and the approaches that have been developed to evaluate it. |
| medical device risk assessment example: The Changing Economics of Medical Technology Institute of Medicine, Committee on Technological Innovation in Medicine, 1991-02-01 Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€as well as the involvement of numerous government agenciesâ€affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public. |
| medical device risk assessment example: The Cambridge Handbook of Health Research Regulation Graeme Laurie, Edward Dove, Agomoni Ganguli-Mitra, Catriona McMillan, Emily Postan, Nayha Sethi, Annie Sorbie, 2021-06-09 The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues. |
| medical device risk assessment example: Safety Risk Management for Medical Devices Bijan Elahi, 2021-11-11 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 |
| medical device risk assessment example: Practical Approaches to Risk Minimisation for Medicinal Products World Health Organization, 2014 Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large. Previous reports from CIOMS I - VIII provided practical guidance in some essential components of risk management such as terminology and reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection. Beyond the detection, identification, and characterization of risk, risk minimization is used as an umbrella term for the prevention or mitigation of an undesirable outcome. Risk management always includes tools for routine risk minimization such as product information, the format depending on the jurisdiction, to inform the patient and the prescriber, all of which serve to prevent or mitigate adverse effects. Until this current CIOMS IX document, limited guidance has been available on how to determine which risks need additional risk minimization, select the appropriate tools, apply and implement such tools globally and locally, and measure if they are effective and valuable. Included in the report is a CIOMS framework for the evaluation of effectiveness of risk minimization, a discussion of future trends and developments, an annex specifically addressing vaccines, and examples from real life. |
| medical device risk assessment example: Risk Assessment Marvin Rausand, Stein Haugen, 2020-03-31 Introduces risk assessment with key theories, proven methods, and state-of-the-art applications Risk Assessment: Theory, Methods, and Applications remains one of the few textbooks to address current risk analysis and risk assessment with an emphasis on the possibility of sudden, major accidents across various areas of practice—from machinery and manufacturing processes to nuclear power plants and transportation systems. Updated to align with ISO 31000 and other amended standards, this all-new 2nd Edition discusses the main ideas and techniques for assessing risk today. The book begins with an introduction of risk analysis, assessment, and management, and includes a new section on the history of risk analysis. It covers hazards and threats, how to measure and evaluate risk, and risk management. It also adds new sections on risk governance and risk-informed decision making; combining accident theories and criteria for evaluating data sources; and subjective probabilities. The risk assessment process is covered, as are how to establish context; planning and preparing; and identification, analysis, and evaluation of risk. Risk Assessment also offers new coverage of safe job analysis and semi-quantitative methods, and it discusses barrier management and HRA methods for offshore application. Finally, it looks at dynamic risk analysis, security and life-cycle use of risk. Serves as a practical and modern guide to the current applications of risk analysis and assessment, supports key standards, and supplements legislation related to risk analysis Updated and revised to align with ISO 31000 Risk Management and other new standards and includes new chapters on security, dynamic risk analysis, as well as life-cycle use of risk analysis Provides in-depth coverage on hazard identification, methodologically outlining the steps for use of checklists, conducting preliminary hazard analysis, and job safety analysis Presents new coverage on the history of risk analysis, criteria for evaluating data sources, risk-informed decision making, subjective probabilities, semi-quantitative methods, and barrier management Contains more applications and examples, new and revised problems throughout, and detailed appendices that outline key terms and acronyms Supplemented with a book companion website containing Solutions to problems, presentation material and an Instructor Manual Risk Assessment: Theory, Methods, and Applications, Second Edition is ideal for courses on risk analysis/risk assessment and systems engineering at the upper-undergraduate and graduate levels. It is also an excellent reference and resource for engineers, researchers, consultants, and practitioners who carry out risk assessment techniques in their everyday work. |
| medical device risk assessment example: GAMP 5 Sion Wyn, 2008 GAMP 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500. This revolutionary Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management. |
| medical device risk assessment example: Adherence to Long-term Therapies Eduardo Sabaté, World Health Organization, 2003 This report is based on an exhaustive review of the published literature on the definitions, measurements, epidemiology, economics and interventions applied to nine chronic conditions and risk factors. |
| medical device risk assessment example: Occupational Therapy Practice Framework: Domain and Process Aota, 2014 As occupational therapy celebrates its centennial in 2017, attention returns to the profession's founding belief in the value of therapeutic occupations as a way to remediate illness and maintain health. The founders emphasized the importance of establishing a therapeutic relationship with each client and designing an intervention plan based on the knowledge about a client's context and environment, values, goals, and needs. Using today's lexicon, the profession's founders proposed a vision for the profession that was occupation based, client centered, and evidence based--the vision articulated in the third edition of the Occupational Therapy Practice Framework: Domain and Process. The Framework is a must-have official document from the American Occupational Therapy Association. Intended for occupational therapy practitioners and students, other health care professionals, educators, researchers, payers, and consumers, the Framework summarizes the interrelated constructs that describe occupational therapy practice. In addition to the creation of a new preface to set the tone for the work, this new edition includes the following highlights: a redefinition of the overarching statement describing occupational therapy's domain; a new definition of clients that includes persons, groups, and populations; further delineation of the profession's relationship to organizations; inclusion of activity demands as part of the process; and even more up-to-date analysis and guidance for today's occupational therapy practitioners. Achieving health, well-being, and participation in life through engagement in occupation is the overarching statement that describes the domain and process of occupational therapy in the fullest sense. The Framework can provide the structure and guidance that practitioners can use to meet this important goal. |
| medical device risk assessment example: Avoidance of Failure , 1970 |
| medical device risk assessment example: Diagnostic and Statistical Manual of Mental Disorders (DSM-5) American Psychiatric Association, 2021-09-24 |
| medical device risk assessment example: Maintenance Management for Medical Equipment American Society for Healthcare Engineering, 1996-05-01 |
| medical device risk assessment example: Medical Devices and In Vitro Diagnostics Christian Baumgartner, Johann Harer, Jörg Schröttner, 2023-08-26 This updatable reference work gives a comprehensive overview of all relevant regulatory information and requirements for manufacturers and distributors around medical and in-vitro diagnostic devices in Europe. These individual requirements are presented in a practice-oriented manner, providing the reader with a concrete guide to implementation with main focus on the EU medical device regulations, such as MDR 2017/745 and IVD-R 2017/746, and the relevant standards, such as the ISO 13485, ISO 14971, among others. This book offers a good balance of expert knowledge, empirical values and practice-proven methods. Not only it provides readers with a quick overview about the most important requirements in the medical device sector, yet it shows concrete and proven ways in which these requirements can be implemented in practice. It addresses medical manufacturing companies, professionals in development, production, and quality assurance departments, and technical and medical students who are preparing themselves for a professional career in the medical technlogy industries. |
| medical device risk assessment example: Practical Aspects of Signal Detection in Pharmacovigilance Council for International Organizations of Medical Sciences (CIOMS), 2010 In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled. |
| medical device risk assessment example: DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS Vernon M. Geckler, 2017-02-11 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. |
| medical device risk assessment example: Medical Device Design Peter J. Ogrodnik, 2019-10-30 Medical Device Design: Innovation from Concept to Market, Second Edition provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones; this book fills that need. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace. This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design. - Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation - Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more - Presents additional content around software and biocompatibility concerns |
| medical device risk assessment example: Mastering Safety Risk Management for Medical and In Vitro Devices Jayet Moon, Arun Mathew, 2024-05-10 When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product’s life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR). |
| medical device risk assessment example: Clinical Engineering Handbook Joseph F. Dyro, 2004-08-27 As the biomedical engineering field expands throughout the world, clinical engineers play an ever more important role as the translator between the worlds of the medical, engineering, and business professionals. They influence procedure and policy at research facilities, universities and private and government agencies including the Food and Drug Administration and the World Health Organization. Clinical engineers were key players in calming the hysteria over electrical safety in the 1970s and Y2K at the turn of the century and continue to work for medical safety. This title brings together all the important aspects of Clinical Engineering. It provides the reader with prospects for the future of clinical engineering as well as guidelines and standards for best practice around the world. |
| medical device risk assessment example: Managing Medical Devices within a Regulatory Framework Beth Ann Fiedler, 2016-09-10 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 |
Application of Risk Management Principles for Medical Devices
Example: Benefit-Risk Analysis. Product Availability, Compliance, and Enforcement Decision: Human chorionic gonadotropin (hCG) device. Detection of hCG in urine to aid in early …
Medical device risk management using ISO 14971 - PharmOut
Recognised by regulatory authorities such as those in the United States, Europe, Canada, and Australia, ISO 14971 holds a prominent status in guiding risk management practices across …
Risk Assessment Applied to Medical Devices: Recent and proposed ...
Outline. Part 1 Role of chemical characterization (ChemChar) and toxicological risk assessment (TRA) when evaluating medical device biocompatibility. Part 2 Advancing …
Medical Device White Paper Series Risk management for medical devices ...
The risk management process described in BS EN ISO 14971 [1] consists of several steps, as illustrated in Figure 1, which apply to the design, development and production of every medical …
Clinical investigations of biological safety assessment
There is thus a need for a biological risk assessment of the device. This assessment should include an evaluation of all relevant toxic endpoints according to the device’s nature and
Introduction to medical device risk management - Qualio
This guide is your introduction to implementing risk management with practical examples and with minimal technical jargon. This guide focuses primarily on risk from the design controls …
Factors to Consider Regarding Benefit-Risk in Medical Device …
An FDA benefit-risk assessment for medical device product availability, compliance, and enforcement decisions may be prompted by events—such as a recall, variance petition, new …
Risk Analysis in Design and Development of Medical Devices
Risk Evaluation – Harm. Once all the hazards have been identified, the harm associated with the hazard can be accessed. For example the risk posed by current leakage may have greater …
Guide for STP Trainees : Medical Device Risk Management and …
Outline the key elements of a medical device management strategy and the associated service delivery. Have awareness of the medical device lifecycle and present and explain one taken …
Risk Management for Medical Device Manufacturers - ASQ
with the concepts in ISO 14971, hands-on experience with risk tools (for example, fault tree analysis and failure mode and effects analysis), and knowledge of the applicable regulations …
Joanne Archambault, PhD 2015 ATA – Session ST-4
ISO 14971 standard Risk management process Sample medical device. Use of any medical device entails some degree of risk. Acceptability of this risk affected by stakeholder’s …
Toxicological Risk Assessment of Medical Devices: An Overview
estimate the true risks of a medical device, in line with ISO 14971 Medical Devices - Application of risk management to medical devices. These primary steps are: • Hazard Identification • …
Setting and Updating Probabilities in Medical Device Risk
ISO 14971:2019 is a process standard for risk management applicable to all medical devices. The process starts with a hazard – a potential source of harm. Unlike an FMEA, a hazard could …
MEDICAL DEVICE RISK MANAGEMENT - PPI
MEDICAL DEVICE RISK MANAGEMENT. This 3-day training course delivered worldwide provides a comprehensive coverage of topics that are needed for successful management of …
Case Studies in Successful Implementation of Effective Risk
• Regulatory Status (for the medical device being studied): The most common types of medical device studies include Investigational Device Exemption (IDE), Condition of Approval Post …
Improving medical device risk management
This white paper investigates some of the classic challenges of medical device risk management and demonstrates how using Siemens PLM Software’s solution significantly improves the …
Risk Management for Medical Devices - WSEAS
The results of this paper take into consideration the advances in device reliability, reduced preventive maintenance requirements, and internal device surveillance (self test) along with …
Risk Management Series - Part 6: Estimating Probability of
risk management in the medical device industry to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their …
Risk Basics for Medical Devices - Transcript - U.S. Food and Drug ...
You will start by determining risk during device design. From a practical standpoint, I can tell you the earlier you identify and understand a devices risk while designing the device the...
MEDICAL DEVICE THREAT MODELING - Toreon
Medical Device Security (MDS2) is a broadly used assessment template that requires architecture and data-flow diagrams; these diagrams are an excellent starting point for threat modeling.
Application of Risk Management Principles for Medical Devices
Example: Benefit-Risk Analysis. Product Availability, Compliance, and Enforcement Decision: Human chorionic gonadotropin (hCG) device. Detection of hCG in urine to aid in early detection of ...
Medical device risk management using ISO 14971 - PharmOut
Recognised by regulatory authorities such as those in the United States, Europe, Canada, and Australia, ISO 14971 holds a prominent status in guiding risk management practices across the global medical device industry.
Risk Assessment Applied to Medical Devices: Recent and proposed ...
Outline. Part 1 Role of chemical characterization (ChemChar) and toxicological risk assessment (TRA) when evaluating medical device biocompatibility. Part 2 Advancing analytical/toxicological risk assessment approaches/methods for medical device extractables.
Medical Device White Paper Series Risk management for medical devices ...
The risk management process described in BS EN ISO 14971 [1] consists of several steps, as illustrated in Figure 1, which apply to the design, development and production of every medical device. The distinct process steps are numbered from 1 to 6 and discussed in detail in this paper. It is important to recognize
Clinical investigations of biological safety assessment
There is thus a need for a biological risk assessment of the device. This assessment should include an evaluation of all relevant toxic endpoints according to the device’s nature and
Introduction to medical device risk management - Qualio
This guide is your introduction to implementing risk management with practical examples and with minimal technical jargon. This guide focuses primarily on risk from the design controls perspective, but can be applied to your entire QMS with some minor tweaks. Kelly Stanton. Director of Quality, Qualio. Risk management terminology.
Factors to Consider Regarding Benefit-Risk in Medical Device …
An FDA benefit-risk assessment for medical device product availability, compliance, and enforcement decisions may be prompted by events—such as a recall, variance petition, new safety ...
Risk Analysis in Design and Development of Medical Devices
Risk Evaluation – Harm. Once all the hazards have been identified, the harm associated with the hazard can be accessed. For example the risk posed by current leakage may have greater consequences for a device used in intensive care that for a device used in a diagnostic laboratory.
Guide for STP Trainees : Medical Device Risk Management and …
Outline the key elements of a medical device management strategy and the associated service delivery. Have awareness of the medical device lifecycle and present and explain one taken from local documentation or other literature, Awareness of ISO 55000 and the NHSSC blueprint.
Risk Management for Medical Device Manufacturers - ASQ
with the concepts in ISO 14971, hands-on experience with risk tools (for example, fault tree analysis and failure mode and effects analysis), and knowledge of the applicable regulations that apply to their products and to risk (for example, 21 CFR 809, 21 CFR 820, and the EU Medical Device Regulation [MDR] and/or the In Vitro Diagnostic Regulation
Joanne Archambault, PhD 2015 ATA – Session ST-4
ISO 14971 standard Risk management process Sample medical device. Use of any medical device entails some degree of risk. Acceptability of this risk affected by stakeholder’s perception of this risk: Cultural background, educational level. Patient’s health condition.
Toxicological Risk Assessment of Medical Devices: An Overview
estimate the true risks of a medical device, in line with ISO 14971 Medical Devices - Application of risk management to medical devices. These primary steps are: • Hazard Identification • Hazard Characterization • Exposure Assessment • Risk Characterization ISO 10993-17 does not prescriptively define a procedure to complete these four ...
Setting and Updating Probabilities in Medical Device Risk
ISO 14971:2019 is a process standard for risk management applicable to all medical devices. The process starts with a hazard – a potential source of harm. Unlike an FMEA, a hazard could occur in either a normal or fault condition. An FMEA analyzes failures in a single fault condition.
MEDICAL DEVICE RISK MANAGEMENT - PPI
MEDICAL DEVICE RISK MANAGEMENT. This 3-day training course delivered worldwide provides a comprehensive coverage of topics that are needed for successful management of safety risks of medical devices in conformance with the international standard ISO 14971.
Case Studies in Successful Implementation of Effective Risk
• Regulatory Status (for the medical device being studied): The most common types of medical device studies include Investigational Device Exemption (IDE), Condition of Approval Post Approval Study (COA), and Post Market Study (PMS). • Medical Device Risk: Product and/or procedure • Therapeutic Indication: Patient population
Improving medical device risk management
This white paper investigates some of the classic challenges of medical device risk management and demonstrates how using Siemens PLM Software’s solution significantly improves the process.
Risk Management for Medical Devices - WSEAS
The results of this paper take into consideration the advances in device reliability, reduced preventive maintenance requirements, and internal device surveillance (self test) along with changes in standards. Key-Words: - criticality prioritization, medical devices, models, maintenance requirements, risk, software. 1.
Risk Management Series - Part 6: Estimating Probability of
risk management in the medical device industry to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their devices; and, as an added benefit, to maintain compliance with risk management standards.
Risk Basics for Medical Devices - Transcript - U.S. Food and Drug ...
You will start by determining risk during device design. From a practical standpoint, I can tell you the earlier you identify and understand a devices risk while designing the device the...
MEDICAL DEVICE THREAT MODELING - Toreon
Medical Device Security (MDS2) is a broadly used assessment template that requires architecture and data-flow diagrams; these diagrams are an excellent starting point for threat modeling.
