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Ann Thorac Surg 2002;74:1899-1900
© 2002 The Society of Thoracic Surgeons

Editorial

Building a "better" mousetrap

L.Henry Edmunds, Jr, MDa*

a Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA

* Address reprint requests to Dr Edmunds, Editor, The Annals of Thoracic Surgery, 5000 Ravdin Court, Hospital of the University of Pennsylvania, 3400 Spruce St, Philadelphia, PA 19104-4283, USA.
e-mail: ats@uphs.upenn.edu

The first 20% of the full text of this article appears below.

Over the ages human mousers strive to build "better" mousetraps, but none approach the performance of the family cat, so the search continues. Similarly cardiothoracic surgeons and their industrial partners continually search for better ways to improve the safety and efficacy of operations and perioperative care. Change implies progress, but neither change nor progress is a synonym for "better." New technology is progress, but is it better? That is the question.

The ongoing revolution for minimizing the surgical incision has prompted an explosion in new technology, which includes but is not limited to new devices, systems, machines, equipment, instruments, monitors, blood and tissue contact surfaces and implantable materials designed for improving care and outcomes of patients. Most new technology is developed by industry in cooperation with one or more surgeons, who either initiated the "idea" or who were recruited during development or the introductory phase of a marketing campaign. These "surgical partners" assist the company in obtaining Food and Drug Administration (FDA) approval, carry out initial animal or human evaluations and frequently have a financial relationship with the company.

There are several problems with this system. Surgeon-partners often have an intellectual attachment to the new technology and may have a financial stake and, therefore, are not sufficiently detached to objectively evaluate indications for use, efficacy and safety of a new device, procedure or system except possibly under FDA mandated protocols. All new devices and most new technology require FDA premarket approval; however, manufacturers provide all data that are reviewed by the FDA and rigorous, independent, objective evaluation is usually not done before the data are submitted. The FDA posts summaries of safety and efficacy information of approved products on their website, . . . [Full Text of this Article]






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