Managing Medical Devices Within a Regulatory Framework

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