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Innovative Tools, Regulatory Bodies, and the Creative Surgeon
James S. Reilly, MD
Arch Otolaryngol Head Neck Surg. 2003;129:678.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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Dr Casler's article provides a valuable discussion of the rules and regulations that have modified oversight of surgical behavior over the last 25 years. Physicians are all under close scrutiny and must adhere to practicing otolaryngology as effectively, safely, and creatively as possible. This debate is an overview that is important for all of us.
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As busy surgeons and teachers, we need to be reminded often of the subtle distinctions between novel employment of medical devices and modifying or extending surgical techniques. The availability of newer tools for surgery and changes in our surgical techniques are modifications meant to improve outcomes while maintaining and enhancing patients' safety.
Who is best equipped to perform these tasks? Is it our local IRB or is it the FDA? Each has an increasing role to play, and surgeons must comply with these regulatory bodies to avoid . . . [Full Text of this Article]
Wilmington, Del
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