OTA 2006 Posters


Scientific Poster #111 Injury Prevention

The Use of Six Sigma Methodology in Orthopaedic Trauma Systems and Patient Care
Gil R. Ortega, MD, MPH1 (n);
Sudeep Taksali, MD2 (n);
Michael R. Baumgaertner, MD2 (n);
1University of Texas Southwestern Medical Center, Department of Orthopaedic Surgery, Dallas, Texas, USA;
2Yale University Department of Orthopaedics, New Haven, Connecticut, USA


Introduction: Six Sigma is a leadership and management method that focuses on error prevention, problem recognition, problem and issue solving, and managed change. Six Sigma utilizes a systematic method for perfecting the output of an organization by improving the quality of the system. The Sigma represents the standard deviation or the measure of variation in a process. The Six represents 6 standard deviations that produce an error or defect rate with a specific target of 3.4 errors/defects per million opportunities. To date, only a handful of health care organizations and hospitals have committed to the Six Sigma approach of improving business and medical processes. In health care, the use of statistics has traditionally been used in a retrospective analysis of production values, but not in developing new models of production for future use.

Purpose: The purpose of this study is to demonstrate whether Six Sigma methodology may be used in the evaluation and improvement of defects in orthopaedic trauma systems and patient care.

Methods: Through the use of Six Sigma methodology, we used the DMAIC (Define, Measure, Analyze, Improve, and Control) model to gain a quantitative and qualitative perspective relating to defects in three separate orthopaedic trauma settings. First, we studied prospectively the efficacy of digital trauma setting anteroposterior (AP) pelvic radiographs. Second, the Six Sigma DMAIC was used in our prospective, randomized comparison of direct, cellular versus indirect, pager communication between intraoperative orthopaedic surgeons and orthopaedic floor nurses. Third, we compared the standard use of intraoperative fluoroscopy versus a MicroOptical® head-mounted, monocular viewer, which displays the fluoroscopic images in front of the user's eye anytime fluoroscopy imaging is used, in order to try to measure and improve the use of intraoperative fluoroscopy.

Results: In reviewing 75 trauma setting AP radiographs, we discovered that the three most common defects for having an unacceptable radiograph were over or under film penetration (82%), radiographic obstruction (70%), and visibility of anatomic landmarks (62%). A positive correlation (100%) was found between missed diagnosis and unacceptable films.

After 60 communication trials, indirect pager communication allowed a 27% and 33% error rate with patient problem and surgeon solution communications, respectively, while there were no communication errors with direct, cellular Bluetooth earpiece communication. Cellular Bluetooth communications showed statistically significant improvements in mean time intervals in response time (Cell = 11 s, Page = 211 s), correct patient identification (Cell = 5 s, Page = 172 s), patient problem and solution time (Cell = 13 s, Page = 189 s), and total communication time (Cell = 32 s, Page = 250 s) (s=seconds, all P <0.001). Intraoperative case interruptions increased with indirect page communication (10 page vs. 0 cell).

Using the DMAIC, we found when performing orthopaedic procedures requiring standard fluoroscopic examination, a few defects occurred such as monitor obstruction, leaving surgical field attention to view the monitor, head/neck and body strain, and radiation turn exposure. When using the MicroOptical® device, we demonstrated improvements by decreasing radiation turn exposure, decreasing body straining, and decreasing the need to leave the attention of the operative field.

Conclusion/Significance: Our studies demonstrate that Six Sigma methodology may be used in the evaluation of defects in orthopaedic trauma systems and patient care. In addition, the Six Sigma DMAIC offers clear and user-friendly methods that allow quality system improvements and the ability to perfect orthopaedic trauma system output.


If noted, the author indicates something of value received. The codes are identified as a-research or institutional support; b-miscellaneous funding; c-royalties; d-stock options; e-consultant or employee; n-no conflicts disclosed, and *disclosure not available at time of printing.
· The FDA has not cleared this drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an "off label" use). · · FDA information not available at time of printing.