Device Complications: What Does the Surgeon Do?

Abstract

Program Description: Medical device failures are commonly associated with surgical complications. In late 1997, the US FDA (Food and Drug Administration) reported that it receives approximately 100,000 medical device reports a year, and the agency considers this number just the tip of the medical device problem iceberg. Any surgeon is very likely to experience this complication in his or her operative career. The Pediatric Otolaryngology and the Medical Devices and Drugs Committee decided to organize a miniseminar to provide guidelines to surgeons experiencing this complication and for surgeons wishing to be informed to device failures. The symposium will be divided into two major parts. In the first part, clinical cases associated with medical device failures will be presented. The impact of one of these cases based on a national survey of pediatric otolaryngologists will be highlighted. The second part will then include the medicolegal ramifications, disclosure to patients and families, and resources available for the surgeon to report and receive updates on device failures.

Educational Objectives: 1) Learn the role of the surgeon in disclosing device complications to patients and national reporting agencies. 2) Learn the medicolegal ramifications of a device failure to the surgeon. 3) Learn how an otolaryngologist can keep him or herself informed of device recalls or complications.