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Historical Perspective of Surgical Innovation
Pages 1-7
Punto di Riferimento
per Medici e Operatori Sanitari
per Medici e Operatori Sanitari
LIBRERIA STUDIUM
The SAGES Manual Ethics of Surgical Innovation
Stain, Pryor, Shadduck
Editore
Springer
Anno
2016
Pagine
280
ISBN
9783319276618
70,00 €
This text provides a comprehensive review of the ethical issues involved with the development, evaluation, and introduction of new treatments of gastrointestinal diseases. How several landmark surgical innovations were developed are described to show the challenges faced, and the ethical dilemmas these innovators dealt with. The challenges of dealing with regulatory issues, and how to work with industry partners, and investors when working on a new therapy is described. Once a new technology has been brought to the market, standards need to be developed regarding the training, credentialing and adoption of the new technology. There are insufficient standards of how to balance the desire to provide patients the latest therapy with the obligation that patients receive informed consent about the new technology, and the relationship that the physician may have had with product development. The book describes the national perspective of paying for new technology, and provides one insurance company’s approach to the introduction of innovative therapy.
The Sages Manual Ethics of Surgical Innovation will be a resource for surgeons, researchers and health policy personnel to understand the ethical issues related to the development, introduction and adoption of innovative therapies for gastrointestinal diseases. Although the context for discussion is the application of innovation to gastrointestinal disease, the ethical issues are applicable to any discussion of innovative medical or procedural therapies.
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Examples of Innovation by Surgeons: Percutaneous Endoscopic Gastrostomy and Its Ethical Implications
Pages 9-12
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Examples of Innovation by Surgeons: Endoscopic Variceal Ligation
Pages 13-24
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Examples of Surgical Innovation by Surgeons: Natural Orifice Transluminal Endoscopic Surgery
Pages 25-36
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Managing Conflict of Interest
Pages 37-48
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The FDA/CDRH Perspective on Device Innovation
Pages 49-60
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The FDA and Surgical Innovation
Pages 61-71
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Getting an Idea from Paper to Patient
Pages 73-80
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How and Why Work with an Industry Partner?
Pages 81-87
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Status and Impact of Evolving Medical Device Venture Capital Landscape on Innovation
Pages 89-110
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Corporate Perspective in Surgical Innovation Ethics: A Literature Review
Pages 111-128
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Innovations in Surgery: Responsibilities and Ethical Considerations
Pages 129-136
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Device Development for the Innovative Clinician: Intellectual Property and Regulatory Basics
Pages 137-145
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Training and Credentialing in New Technologies
Pages 147-157
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Informed Consent and Surgical Innovation
Pages 159-169
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Semantics and Patient Perceptions of New Technologies
Pages 171-178
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Tracking Outcomes of New Technologies
Pages 179-189
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Balancing the Surgeon’s Responsibility to Individuals and Society
Pages 191-211
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Paying for New Technology: Insurance Company Perspective
Pages 213-221
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Evolving Responsibility for SAGES-TAVAC
Pages 223-228
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Evolving Responsibility for SAGES: New Technology Guideline
Pages 229-238
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Training Physicians in Innovation
Pages 239-247
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Fundamentals of Medical Ethics
Pages 249-260
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The Use of Randomized Clinical Trials in the Evaluation of Innovative Therapy
Pages 261-272
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