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.

Front Cover; Managing Medical Devices within a Regulatory Framework; Related titles; Managing Medical Devices within a Regulatory Framework; Copyright; Dedication; Contents; List of Contributors; Foreword; Preface; 1 -- Medical Device Development and Regulatory Overview; 1 -- Reframing Product Life Cycle for Medical Devices; 1.1 INTRODUCTION; 1.2 FDA TOTAL PRODUCT LIFE CYCLE; 1.2.1 CONCEPTION; 1.2.2 PROTOTYPE; 1.2.3 PRECLINICAL INVESTIGATION; 1.2.4 ADVANCED CLINICAL/POSTMARKETING STUDIES; 1.2.5 END OF LIFE; 1.3 EUROPEAN COMMISSION PRODUCT LIFE CYCLE; 1.4 SUMMARY; DEFINITIONS; REFERENCES.

RECOMMENDATIONS FOR ADDITIONAL READING2 -- Overview of Medical Device Clinical Trials; 2.1 INTRODUCTION; 2.2 MEDICAL DEVICE SUBMISSIONS OVERVIEW; 2.3 MEDICAL DEVICE CLINICAL TRIALS; 2.3.1 INVESTIGATIONAL DEVICE EXEMPTION; 2.3.2 CLINICAL TRIALS; 2.3.3 MANUFACTURING AND ADDITIONAL STANDARDS; 2.4 REGULATORY PROFILE OF THE US MEDICAL DEVICE BY CLASSIFICATION TYPE; 2.4.1 CLASS I MEDICAL DEVICES; 2.4.2 CLASS II MEDICAL DEVICES; 2.4.3 CLASS III MEDICAL DEVICES; 2.5 REGULATORY PROFILE OF THE EU MEDICAL DEVICE BY CLASSIFICATION TYPE; 2.6 SUMMARY; DEFINITIONS; REFERENCES.

RECOMMENDATIONS FOR ADDITIONAL RE…