Background: Many state medical boards and legislatures are in the process of developing regulations that restrict procedures in the office setting with the intention of enhancing patient safety. The highest quality data in existence on office procedure adverse incidents have been collected by the state of Florida.
Objective: The objective was to determine and analyze the nature of surgical incidents in office-based settings using 3 years of Florida data from March 2000 to March 2003.
Methods: An incidence study with prospective data collection was performed. Individual reports that resulted in death or a hospital transfer were further investigated by determining the reporting physician's board certification status, hospital privilege status (excluding procedure specific operating room privileges), and office accreditation status.
Results: In 3 years there were 13 procedure-related deaths and 43 procedure-related complications that resulted in a hospital transfer. Seven of the 13 deaths involved elective cosmetic procedures, 5 of which were performed under general anesthesia and 2 of which were performed with intravenous sedation anesthesia. Forty-two percent of the offices reporting deaths and 50% of the offices reporting procedural incidents that resulted in a hospital transfer were accredited by an independent accreditation agency. Ninety-six percent of physicians reporting surgical incidents were board-certified, and all had hospital privileges.
Conclusions: Restrictions on office procedures for medically necessary procedures, such as requiring office accreditation, board certification, and hospital privileges, would have little effect on overall safety of surgical procedures. These data also show that the greatest danger to patients lies not with surgical procedures in office-based settings per se, but with cosmetic procedures that are performed in office-based settings, particularly when under general anesthesia. Our conclusions are dramatically different from those of a recent study, which claimed a 12-fold increased risk of death for procedures in the office setting.