Managing Medical Devices within a Regulatory Framework
- 1st Edition - September 10, 2016
- Imprint: Elsevier
- Editor: Beth Ann Fiedler
- Language: English
- Paperback ISBN:9 7 8 - 0 - 1 2 - 8 0 4 1 7 9 - 6
- eBook ISBN:9 7 8 - 0 - 1 2 - 8 0 4 1 9 2 - 5
Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide… Read more
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Request a sales quoteManaging 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
Biomedical Engineers, Clinical Engineers, Clinicians, Medical Device Developers, Management in Medical Device Hospital Departments
- Related titles
- Dedication
- List of Contributors
- Foreword
- Preface
- Section 1. Medical Device Development and Regulatory Overview
- Chapter 1. Reframing Product Life Cycle for Medical Devices
- 1.1. Introduction
- 1.2. FDA Total Product Life Cycle
- 1.3. European Commission Product Life Cycle
- 1.4. Summary
- Definitions
- Chapter 2. Overview of Medical Device Clinical Trials
- 2.1. Introduction
- 2.2. Medical Device Submissions Overview
- 2.3. Medical Device Clinical Trials
- 2.4. Regulatory Profile of the US Medical Device by Classification Type
- 2.5. Regulatory Profile of the EU Medical Device by Classification Type
- 2.6. Summary
- Definitions
- Chapter 3. Review Regulatory Guidelines by Device Classification Type
- 3.1. Introduction
- 3.2. Basic Overview of the Premarket Notification 510(k)
- 3.3. Premarket Approval Application Regulatory Path
- 3.4. Medical Device Class I
- 3.5. Medical Device Class II
- 3.6. Medical Device Class III
- 3.7. Summary
- Definitions
- Chapter 4. Manufacturing/Distribution Considerations
- 4.1. Introduction
- 4.2. US Preclinical Stage
- 4.3. US Postmarket Stage
- 4.4. European Union CE Marking: Premarketing Stage
- 4.5. EU Postmarket Stage
- 4.6. Summary
- Definitions
- Chapter 1. Reframing Product Life Cycle for Medical Devices
- Section 2. Defining and Meeting Regulatory Challenges in Clinical Engineering
- Chapter 5. Defining and Meeting Regulatory Challenges in Clinical Engineering
- 5.1. Introduction
- 5.2. Biocompatibility
- 5.3. Risk Management
- 5.4. Sterility and Reusability
- 5.5. Summary
- Definitions
- Chapter 6. Role of Biocompatibility
- 6.1. Introduction
- 6.2. Biocompatibility
- 6.3. US Major Biocompatibility Guidance
- 6.4. Discussion and Recommendations
- 6.5. Summary
- Definitions
- Chapter 7. Risk Management
- 7.1. Introduction
- 7.2. The Upside of Interdisciplinary Collaborative Partnerships
- 7.3. Managing Risk in Healthcare Technology
- 7.4. Health Information Technology Management in Action
- 7.5. Summary
- Definitions
- Chapter 8. Sterility and Reusability
- 8.1. Introduction
- 8.2. Sterilization Guidance and Legislation for Medical Device Developers
- 8.3. Sterilization Guidance and Legislation for Manufacturing
- 8.4. Sterilization Guidance and Legislation for Hospitals
- 8.5. Discussion and Summary
- Definitions
- Chapter 5. Defining and Meeting Regulatory Challenges in Clinical Engineering
- Section 3. European Markets
- Chapter 9. European Union National Differences and Potential Impact on CE Marking
- 9.1. Introduction
- 9.2. Germany
- 9.3. United Kingdom
- 9.4. France
- 9.5. Italy
- 9.6. Discussion and Conclusions
- Definitions
- Chapter 10. Understanding the Transitioning Regulatory EU Market
- 10.1. Introduction
- 10.2. Clinical Trial Regulation
- 10.3. Summary
- Chapter 9. European Union National Differences and Potential Impact on CE Marking
- Section 4. Equipment Acquisition, Integration and Maintenance
- Chapter 11. Evaluating New Medical Devices Purchases
- 11.1. Introduction
- 11.2. Medical Device Regulation General Overview
- 11.3. Evidence-Based Medicine
- 11.4. End User Purchasing Stakeholders
- 11.5. Clinical Evidence Strategies
- 11.6. Comparative Technologies
- 11.7. Medical Device Integration into Existing Workflows
- 11.8. Summary
- Definitions
- Chapter 12. Evaluating Reimbursement Strategies in the US
- 12.1. Introduction
- 12.2. Business of Medical Technology
- 12.3. Medical Device Identification and Regulatory Overview
- 12.4. Three Types of User Payment Methods
- 12.5. Discussion
- 12.6. Summary
- Definitions
- Chapter 13. Healthcare Facility Users’ Legal Responsibilities and Risks
- 13.1. Introduction
- 13.2. Premarket Approval in the US
- 13.3. Postmarket Surveillance: Good Manufacturing Practices
- 13.4. Device User Facilities: Postmarketing Regulatory Obligations
- 13.5. Special Regulatory Application for Device User Facilities
- 13.6. Comparison and Discussion of Obligatory Regulation in the US and EU
- 13.7. Summary
- Definitions
- Chapter 11. Evaluating New Medical Devices Purchases
- Section 5. Data Management, Patient Safety, and Efficacy
- Chapter 14. Clinical and Biomedical Engineering Evidence Strategy
- 14.1. Introduction
- 14.2. Important Overview for Medical Device Manufacturers: Complaints and Risk
- 14.3. Health Technology Basics
- 14.4. Clinical Development of Medical Devices
- 14.5. Discussion
- 14.6. Summary
- Definitions
- Chapter 15. Device Failure Tracking and Response to Manufacturing Recalls
- 15.1. Introduction
- 15.2. Regulation Definitions and Overview
- 15.3. Summary
- Definitions
- Chapter 16. Health Economics Outcomes Research and Evidence Strategies
- 16.1. Introduction
- 16.2. Health Economics for Medical Devices
- 16.3. Value Assessment Process
- 16.4. Clinical and Outcomes Data
- 16.5. Types of Economic Evaluation
- 16.6. Other Health Economics Proxy Measures
- 16.7. Dissemination Strategies and Tools for Health Economic Evidence
- 16.8. Conclusion
- Definitions
- Chapter 14. Clinical and Biomedical Engineering Evidence Strategy
- Section 6. Future of Healthcare
- Chapter 17. The Future of Health Technology Management
- 17.1. Introduction
- 17.2. Emerging Technologies: Seeing the Future Now
- 17.3. Planning Medical Device Development
- 17.4. Summary
- Definitions
- Chapter 18. Challenges of New Technology: Securing Medical Devices and Their Software for HIPPA Compliance
- 18.1. Introduction
- 18.2. Regulation
- 18.3. Challenges of Securing New Technology
- 18.4. Alert Mechanisms and Agency Resources
- 18.5. Compliance Solutions
- 18.6. Summary
- Definitions
- Acronyms
- Chapter 19. Managing Smartphone and Tablet Applications
- 19.1. Introduction
- 19.2. Regulations
- 19.3. Managing Digital Technology: The Device is Right
- 19.4. Summary
- Definitions
- Chapter 17. The Future of Health Technology Management
- Index
- Edition: 1
- Published: September 10, 2016
- Imprint: Elsevier
- No. of pages: 380
- Language: English
- Paperback ISBN: 9780128041796
- eBook ISBN: 9780128041925
BF
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.
Affiliations and expertise
Independent Author, Researcher, USARead Managing Medical Devices within a Regulatory Framework on ScienceDirect