Managing Medical Devices within a Regulatory Framework

Managing Medical Devices within a Regulatory Framework

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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.
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Product details

  • Paperback | 380 pages
  • 191 x 235 x 22.86mm | 790g
  • United States
  • English
  • 012804179X
  • 9780128041796

Table of contents

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
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About Beth Ann Fiedler

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.
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