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Author: Leslie A. Geddes
Publisher: Springer
ISBN:
Category : Medical
Languages : en
Pages : 264
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Book Description
This publication explores accidents that occur through the use of medical devices, providing critical information for attorneys, expert witnesses, clinical engineers, nurses, physicians, manufacturers, and designers of new medical devices. Each chapter follows the same format: a presentation of basic principles of a device or procedure, followed by accidents that take place through misuse or malfunction. Case studies and examples throughout the text illustrate and enliven the distinctive purpose of this singular resource.
Author: Leslie A. Geddes
Publisher: Springer
ISBN:
Category : Medical
Languages : en
Pages : 264
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Book Description
This publication explores accidents that occur through the use of medical devices, providing critical information for attorneys, expert witnesses, clinical engineers, nurses, physicians, manufacturers, and designers of new medical devices. Each chapter follows the same format: a presentation of basic principles of a device or procedure, followed by accidents that take place through misuse or malfunction. Case studies and examples throughout the text illustrate and enliven the distinctive purpose of this singular resource.
Author: Bertil Jacobson
Publisher: Elsevier Health Sciences
ISBN: 0443102597
Category : Medical
Languages : en
Pages : 388
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Book Description
Patient safety is important to all health professionals, but fatal accidents occur with medical devices every year. This is the first book for people who use medical equipment, rather than for engineers or technicians. It will help personnel within healthcare to avoid accidents by bridging the gap between the design principles and the user. The book encourages safe use of a wide range of equipment, from simple thermometers and blood-pressure cuffs to complex equipment such as pacemakers, ventilators and patient monitors. Simple explanations of basic medical devices Case histories of real-life accidents to highlight risk areas Clear, attractive illustrations "Tips" boxes identify particular problems "Basic Facts" boxes supply fundamental information needed by all readers "Technology" boxes provide more-advanced explanations for interested or experienced readers
Author: Tieyu Li
Publisher:
ISBN:
Category :
Languages : en
Pages : 103
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Book Description
The goal of medical device industry is to provide patients and healthcare professionals effective, reliable, safe and affordable products. However, due to the dynamic and competitive operation and business environment, most manufacturers did not always attain this goal. It is a challenge to balance the demands of meeting government regulations and containing production costs, in an effort to produce the most effective, reliable and safest medical devices. The increasing complexity on product structures, production process and usage context make this task even more formidable. The increase in serious adverse events has outpaced industry growth by 8 % since 2001[1], which reflects the insufficiency of traditional quality control measures. The disastrous consequences of quality hazards usually have profound impact on customers, manufacturers, and communities. Therefore, it is imperative to look for a better way to achieve effective quality control in medical device industry. The purpose of the thesis is to compare the traditional quality control measures, which are now widely adopted in quality systems of medical device industry for designing and development, process control and non-conformance handling, with the approach of Systems Theoretic Accident Model and Process (STAMP) based System-Theoretic Process Analysis (STPA) method. Through the case study on real quality issue in manufacturing control, this work analyzes the current states of complex manufacturing process controls that are designed by utilizing traditional principles and tools, and demonstrates the improvement after the STPA techniques was applied to the same cases. The advantages of STPA technique is to model the process to system control structure without oversimplifying any possible influencing factors, and then examine the links an interaction among these factors to reveal what constraints need to be installed and are followed to ensure that the system performs in safe zone and deliver the expected outcomes. This approach can effectively reveal hidden defects and dangers in system that the traditional measures are not able to detect, and thus is very helpful to the high-stake industry such as medical device manufacturing to prevent potential serious adverse events and protect patients from injuries caused by accidents of quality hazards.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309038472
Category : Medical
Languages : en
Pages : 203
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Book Description
In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.
Author: G.R Higson
Publisher: CRC Press
ISBN: 1420033980
Category : Medical
Languages : en
Pages : 278
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Book Description
Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241564040
Category : Medical
Languages : en
Pages : 147
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Book Description
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
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309162068
Category : Medical
Languages : en
Pages : 132
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Book Description
The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants.
Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 14
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Book Description
Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 72
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Book Description
Author: Ronda Hughes
Publisher: Department of Health and Human Services
ISBN:
Category : Medical
Languages : en
Pages : 592
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Book Description
"Nurses play a vital role in improving the safety and quality of patient car -- not only in the hospital or ambulatory treatment facility, but also of community-based care and the care performed by family members. Nurses need know what proven techniques and interventions they can use to enhance patient outcomes. To address this need, the Agency for Healthcare Research and Quality (AHRQ), with additional funding from the Robert Wood Johnson Foundation, has prepared this comprehensive, 1,400-page, handbook for nurses on patient safety and quality -- Patient Safety and Quality: An Evidence-Based Handbook for Nurses. (AHRQ Publication No. 08-0043)." - online AHRQ blurb, http://www.ahrq.gov/qual/nurseshdbk/
