Six Sigma tympanostomy tube insertion: Achieving the highest safety levels during residency training

OBJECTIVE: To evaluate a protocol designed to avoid complications during tympanostomy tube insertion by residents. DESIGN: Ten-year consecutive cases series by a single surgeon supervising residents. SETTING: Tertiary children's hospital. PATIENTS: Children 6 weeks to 21 years. INTERVENTION: Residents followed a defined protocol for tube insertion. A resident operated until the tube was placed or he/she committed one major or two minor errors. MAIN OUTCOME MEASURES: Incidence of 1) major complications: profound sensorineural hearing loss (SNHL), injury to major vascular structures, or disruption of the ossicular chain; and 2) minor complications: tube loss into the middle ear, tympanic membrane tears, or tube occlusion by blood clot. RESULTS: There were no major complications in 10,000 tube insertions. Two children had unilateral profound SNHL; both were found to have Mondini malformations. Five tubes were recovered from the middle ear. Eight tympanic membrane tears healed with gelatin patches. Three tubes were occluded by blood clots. CONCLUSION: By following a defined protocol, major complications of a common operation can be reduced to the five-sigma level and minor complications minimized.