Download book Managing Medical Devices Within a Regulatory Framework by David Yadin DJV, PDF3/18/2018
9780128041925
English 0128041927 Managing Medical Devices in a Dynamic Stakeholder Environment helps engineers to ensure proper maintenance of medical equipment for compliance and safety, anticipate problems with equipment and utilize funding wisely for such purchases. It also advises on how to make sure that devices are compliant with HIPAA, discusses legal issues surrounding device use, and the impact of device failures on patient safety. This contributed book contains perspectives from industry professionals and academics, and provides a comprehensive look at best practices for managing healthcare technology. It will assist you with navigating worldwide regulatory frameworks for new devices and current equipment. This book provides guidance on dealing with the challenge of medical records management and compliance with patient confidentiality using information from medical devices. It also covers interoperability between and among devices outside of healthcare and the dynamics of implementation of new devices to ensure patient safety. The authors bring forth relevant issues, challenges and demonstrate how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom line by demystifying 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, Managing Medical Devices within a Regulatory Framework, 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, Managing Medical Devices within a Regulatory Framework helps engineers ensure proper maintenance of medical equipment for compliance and safety, anticipate problems with equipment, and utilize funding wisely for purchases. The book also advises on how to make sure that devices are compliant with HIPAA, and discusses legal issues surrounding device use and the impact of device failures on patient safety. This contributed book contains perspectives from industry professionals and academics, and provides a comprehensive look at best practices for managing healthcare technology. It will assist you with navigating worldwide regulatory frameworks for new devices and current equipment. This book provides guidance on dealing with the challenge of medical records management and compliance with patient confidentiality using information from medical devices. It also covers interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The authors bring forth relevant issues and challenges and demonstrate how management can foster increased clinical and non-clinical relations to enhance patient outcomes. This strategy also will enhance bottom lines by demystifying 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 Managing Medical Devices Within a Regulatory Framework by David Yadin read DOC, FB2Francis, this book will deepen that understanding and provide a new perspective on his enduring legacy., For everyone who has been touched by the / story of St.Well researched. 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