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Florida study proves that office-based plastic surgery is risky business

March 27, 2008

Office surgery incidents: what seven years of Florida data show us.  

Coldiron BM, Healy C, Bene NI.Dermatol Surg. 2008 Mar;34(3):285-91; discussion 291-2. Epub 2007 Dec 20.

Patient safety in ambulatory surgery centers (ASCs) has received increasing attention, and the Joint Commission's National Patient Safety Goals now include specific requirements for ASCs. This study summarizes the types and severity of adverse events occurring in ASCs in Florida, gathered using that state's mandatory reporting system. The majority of deaths and hospital transfers occurred in patients undergoing cosmetic procedures, incidents that are generally considered never events. A previous AHRQ WebM&M commentary and perspective discuss the issues pertaining to improving safety in outpatient surgery, which remains a largely unregulated area.

BACKGROUND: In the wake of increased media attention focusing on human error in medicine, numerous state medical boards and legislatures have drafted, and are continuing to draft, regulations aimed at protecting patients undergoing procedures in the office setting. These regulations will have a considerable impact on patient access to medically necessary procedures, and any regulations should be based on good data. This report summarizes 7 years of prospective data from the state of Florida, the best data available on office surgery incidents.

OBJECTIVE: The objective was to determine the nature and incidence of hospital transfers and deaths resulting from office procedures.

METHODS: This study is a compilation of mandatory reporting by Florida physicians to a central agency of all in-office adverse incidents resulting in death, serious injury, or hospital transfer in the State of Florida from March 2000 to March 2007. Telephone and internet follow-up was conducted to determine reporting physician board certification, hospital privileges, and office accreditation.

RESULTS: In 7 years there were 31 deaths and 143 procedure-related complications and hospital transfers. Liposuction and liposuction with abdominoplasty or another cosmetic procedure resulted in 24 complications and 8 deaths. Of the offices reporting adverse incidents, 38.5% were accredited by an independent accrediting agency, 92.5% of the physicians were board-certified, and 96.6% had hospital privileges. A total of 58% (18/31) of the deaths and 61% (87/143) of the complications were associated with nonmedically necessary (cosmetic) procedures. A total of 78% (14/18) of these deaths were in ASA Class 1 patients. Plastic surgeons were responsible for 48% of all deaths (83% of cosmetic surgery deaths) and for 52% of all hospital transfers (83% of cosmetic surgery complications and hospital transfers).

CONCLUSION: Plastic surgeons were responsible for an inordinate number of deaths and hospital transfers. Requiring physician board certification and physician hospital privileges would not seem to increase safety, because most physicians already have these credentials, and physicians without these credentials were not responsible for a disproportionate share of incidents. These data do not show an emergent hazard to patients from medically necessary office surgery. Liposuction under general anesthesia deserves continued scrutiny because deaths due to this procedure continue to occur and this procedure can be performed with dilute local anesthesia, with which no deaths were reported. Mandatory reporting of office incidents should be strongly supported, as well as reporting of incidents that occur after surgery in the hospital outpatient department and ambulatory surgery center. These data should be available for analysis after protecting patient confidentiality. A national debate needs to occur to determine how many deaths and injuries are acceptable from cosmetic procedures performed under general and intravenous anesthesia.