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

Beth Ann earned her doctorate in Public Affairs at the University of Central Florida. The author of books on innovative approaches to healthcare quality; Dr. Fiedler has also successfully completed quality-award winning management projects for the private sector and the US military. Her research includes policy analysis focused on healthcare quality and business development presented to U.S. Congressional representatives, medical, technology and business audiences in the US and abroad. She has published in several peer-reviewed journals, was named a Founder’s Fellow by the American Society for Public Administration in 2014 and was featured by the US National Center for Policy Analysis for “Ideas Changing the World” on Health Issues.