The new edition also offers guidance on navigating the changes in the EU medical approval process. Readers using the new edition will find new chapters on risk management for suppliers, residual risk and risk management review.
Medical equipment, Medical instruments, Risk assessment, Risk analysis, Management, Hazards, Clinical investigation instruments, Safety measures, Diagnosis medical. 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.
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. Risk management is the identification, evaluation, and prioritization of risks followed by coordinated and economical application of resources to minimize, monitor, and control the probability or impact of unfortunate events or to maximize the realization of opportunities.
The purpose of risk management is not to eliminate all risks. It is to minimize the potential negative consequence of risks. By working with risk managers, employees can make smart risk decisions to improve the chance of reward. This book provides information and explanations that can be used to develop precautionary measures that can reduce identified risks.
Reducing risks can prevent injuries, illnesses, and property damage caused by workplace accidents. Preventing these accidents can save money while improving the safety of employees while at work. Buy this book now. 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.
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.
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.
HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.
Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.
From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations.
This handbook provides the most up to date resource currently available for interpreting and understanding design controls. 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.
In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble.
The first edition of Handbook of Human Factors and Ergonomics in Health Care and Patient Safety took the medical and ergonomics communities by storm with in-depth coverage of human factors and ergonomics research, concepts, theories, models, methods, and interventions and how they can be applied in health care. Other books focus on particular human factors and ergonomics issues such as human error or design of medical devices or a specific application such as emergency medicine.
This book draws on both areas to provide a compendium of human factors and ergonomics issues relevant to health care and patient safety. The second edition takes a more practical approach with coverage of methods, interventions, and applications and a greater range of domains such as medication safety, surgery, anesthesia, and infection prevention.
New topics include: work schedules error recovery telemedicine workflow analysis simulation health information technology development and design patient safety management Reflecting developments and advances in the five years since the first edition, the book explores medical technology and telemedicine and puts a special emphasis on the contributions of human factors and ergonomics to the improvement of patient safety and quality of care.
In order to take patient safety to the next level, collaboration between human factors professionals and health care providers must occur. This book brings both groups closer to achieving that goal.
Risk management principles are effectively utilized in many areas of business and government, including finance, insurance, occupational safety, and public health, and by agencies regulating these industries. If risk reduction is not required, completeness of risk control applies. The results of this risk evaluation shall be recorded in the risk management file. Risk Control 6. This verification shall be recorded in the risk management file.
The effectiveness of the risk control measures shall be verified and the results shall be recorded in the risk management file. The results of this evaluation shall be recorded in the risk management file. For residual risks that are judged acceptable, the manufacturer shall decide which residual risks to disclose and what information is necessary to include in the accompanying documents in order to disclose those residual risks.
If the medical benefits outweigh the residual risk, then the risk can be accepted. The results of this review shall be recorded in the risk management file. The results of this activity shall be recorded in the risk management file. Evaluation of Residual Risk 7. Evaluation of Residual Risk After all risk control measures have been implemented and verified, the manufacturer shall decide if the overall residual risk posed by the medical device is acceptable using the criteria defined in the risk management plan.
Evaluation of Residual Risk If the overall residual risk is not judged acceptable using the criteria established in the risk management plan, the manufacturer may gather and review data and literature to determine if the medical benefits of the intended use outweigh the overall residual risk.
If this evidence supports the conclusion that the medical benefits outweigh the overall residual risk, then the overall residual risk can be judged acceptable. Evaluation of Residual Risk Otherwise, the overall residual risk remains unacceptable.
For an overall residual risk that is judged acceptable, the manufacturer shall decide which information is necessary to include in the accompanying documents in order to disclose the overall residual risk. Risk Management Report 8. Risk Management Report Prior to release for commercial distribution of the medical device, the manufacturer shall carry out a review of the risk management process. This review shall at least ensure that: - the risk management plan has been appropriately implemented; - the overall residual risk is acceptable; - appropriate methods are in place to obtain relevant production and post-production information.
Risk Management Report The results of this review shall be recorded as the risk management report and included in the risk management file.
The responsibility for review should be assigned in the risk management plan to persons having the appropriate authority. Production and Post- Production Information The manufacturer shall establish, document and maintain a system to collect and review information about the medical device or similar devices in the production and the post-production phases. When establishing a system to collect and review information about the medical device, the manufacturer should consider among other things: 9.
Production and Post- Production Information a the mechanisms by which information generated by the operator, the user, or those accountable for the installation, use and maintenance of the medical device is collected and processed; or b new or revised standards.
Production and Post- Production Information The system should also collect and review publicly available information about similar medical devices on the market. Production and Post- Production Information If any of the above conditions occur: 1 the impact on previously implemented risk management activities shall be evaluated and shall be fed back as an input to the risk management process, and 9. Production and Post- Production Information If any of the above conditions occur: 2 a review of the risk management file for the medical device shall be conducted; if there is a potential that the residual risk s or its acceptability has changed, the impact on previously implemented risk control measures shall be evaluated.
ISO specifies a process for a manufacturer to identify the hazards associated with medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
Open navigation menu. Close suggestions Search Search. User Settings. Skip carousel. Carousel Previous. Carousel Next. What is Scribd? Explore Ebooks. Bestsellers Editors' Picks All Ebooks. Explore Audiobooks. Bestsellers Editors' Picks All audiobooks. Explore Magazines. Editors' Picks All magazines. Risk management is the identification, evaluation, and prioritization of risks followed by coordinated and economical application of resources to minimize, monitor, and control the probability or impact of unfortunate events or to maximize the realization of opportunities.
The purpose of risk management is not to eliminate all risks. It is. 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. 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. HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.
Offering you a much broader, higher-level picture than other books in this field, this book helps. This handbook provides the most up to date resource currently available for interpreting and understanding design controls.
The first edition of Handbook of Human Factors and Ergonomics in Health Care and Patient Safety took the medical and ergonomics communities by storm with in-depth coverage of human factors and ergonomics research, concepts, theories, models, methods, and interventions and how they can be applied in health care.
Other books.
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