FROM THE PREFACE

The field of medical devices represents one of the most advanced technological areas in the United States. In 1991, over 12 million Americans had at least one medical device; fixation devices had the highest incidence, followed by contact lens use and lens implants and, lastly, artificial joints. The public has come to expect that medical devices will alleviate maladies and/or conditions that were not treatable fifty years ago.

It is hard to believe that the first pacemaker was invented in the 1950s, the first artificial heart valve in 1952, and the first artificial hip replacement was performed in 1954. In 1992, the medical device industry exported a total of $6.9 billion, while the country imported a total of $3.9 billion, representing a $3.0 billion trade surplus.

Medical devices are among the most regulated products in the world. The FDA maintains a constant vigil over medical device manufacturers and importers; even medical device definitions are subject to official scrutiny. Title 21 of the Code of Federal Regulations publishes these definitions, but the definitions are spread over several medical specialty areas and are, thus, difficult to find. This book attempts to bring a measure of order by providing an alphabetical listing of officially defined devices.