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 Fenningkoh1. Reframing Product Life Cycle for Medical Devices, Beth Fiedler2. Overview of Medical Device Clinical Trials, Beth Fiedler, Michael Ferguson3. Review Regulatory Guidelines by Device Classification Type, Beth Fiedler4. Manufacturing/Distribution, Beth Fiedler5. Overview and Application in Clinical Engineering, Beth Fiedler6. Roles of Biocompatibility, Beth Fiedler7. Risk Management, Beth Fiedler, Abdullah Farid8. Sterility and Reusability, Beth Fiedler9. EU National Differences and Potential Impact on CE Marking, Beth Fiedler10. Understanding the Transitioning Regulatory EU Market, Beth Fiedler11. Evaluating new medical equipment purchases, Beth Fiedler12. Evaluating Reimbursement Strategies in the US, Beth Fiedler , Jeremiah Greathouse13. Healthcare Facility Users Legal Responsibilities and Risks, Marc Sanchez14. Clinical and Biomedical Engineering Evidence Strategy, Beth Fiedler15. Device Failure Tracking and Response to Manufacturing Recalls, Beth Fiedler16. Health Economics and Outcomes Research and Evidence Strategies, Michael Ferguson17. The Future of Health Technology Management, Beth Fiedler18. Challenges of New Technology: Securing Medical Devices and Their Software for HIPPA Compliance, Beth Fiedler19. Managing Smartphone and Tablet Applications, Beth Fiedler