Risk analysis of Leksell Gamma Knife Model C with Automatic Positioning System

Purpose: This study was conducted to evaluate the decrease in risk from misadministration of the new Leksell Gamma Knife Model C with Automatic Positioning System compared with previous models. Methods and Materials: Elekta Instruments, A.B. of Stockholm has introduced a new computer-controlled Leksell Gamma Knife Model C which uses motor-driven trunnions; to reposition the patient between isocenters (shots) without human intervention. Previous models required the operators to manually set coordinates from a printed list, permitting opportunities for coordinate transposition, incorrect helmet size, incorrect treatment times, missing shots, or repeated shots. Results: A risk analysis was conducted between craniotomy involving hospital admission and outpatient Gamma Knife radiosurgery. A report of the Institute of Medicine of the National Academies dated November 29, 1999 estimated that medical errors kill between 44,000 and 98,000 people each year in the United States. Another report from the National Nosocomial Infections Surveillance System estimates that 2.1 million nosocomial infections occur annually in the United States in acute care hospitals alone, with 31 million total admissions. Conclusions: All medical procedures have attendant risks of morbidity and possibly mortality. Each patient should be counseled as to the risk of adverse effects as well as the likelihood of good results for alternative treatment strategies. This paper seeks to fill a gap in the existing medical literature, which has a paucity of data involving risk estimates for stereotactic radiosurgery. (C) 2002 Elsevier Science Inc.