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

Foreword, Larry Fenningkoh 1. Reframing Product Life Cycle for Medical Devices, Beth Fiedler 2. Overview of Medical Device Clinical Trials, Beth Fiedler, Michael Ferguson 3. Review Regulatory Guidelines by Device Classification Type, Beth Fiedler 4. Manufacturing/Distribution, Beth Fiedler 5. Overview and Application in Clinical Engineering, Beth Fiedler 6. Roles of Biocompatibility, Beth Fiedler 7. Risk Management, Beth Fiedler, Abdullah Farid 8. Sterility and Reusability, Beth Fiedler 9. EU National Differences and Potential Impact on CE Marking, Beth Fiedler 10. Understanding the Transitioning Regulatory EU Market, Beth Fiedler 11. Evaluating new medical equipment purchases, Beth Fiedler 12. Evaluating Reimbursement Strategies in the US, Beth Fiedler , Jeremiah Greathouse 13. Healthcare Facility Users Legal Responsibilities and Risks, Marc Sanchez 14. Clinical and Biomedical Engineering Evidence Strategy, Beth Fiedler 15. Device Failure Tracking and Response to Manufacturing Recalls, Beth Fiedler 16. Health Economics and Outcomes Research and Evidence Strategies, Michael Ferguson 17. The Future of Health Technology Management, Beth Fiedler 18. Challenges of New Technology: Securing Medical Devices and Their Software for HIPPA Compliance, Beth Fiedler 19. Managing Smartphone and Tablet Applications, Beth Fiedler