Full-Cycle Steam Sterilization in Ophthalmic Surgery—The Effect of Wrapping Instruments

Abstract

To determine if wrapping instruments in conjunction with full-cycle steam sterilization affects the incidence of postoperative infection in patients undergoing ophthalmic surgery in a dedicated eye center. Retrospective, consecutive-case, comparative study. Two consecutive groups, each of approximately 19 000 ophthalmic surgical patients, were reviewed for postoperative infection. For both groups, the surgical instruments were sterilized using full-cycle, steam sterilization, with a single major difference. The instruments for the first group were sterilized with equipment located adjacent to the operating room and no wrapping of the instruments was used, whereas for the second group, the sterilization equipment was located at a central facility and the instruments were wrapped before being transported to the operating rooms. In the unwrapped sterilization group 17 presumed postoperative infections were identified, compared to 9 presumed infections in the wrapped sterilization group. Because the observed infection rates for each group were so low, this apparent difference is not statistically significant (P = .16). Similarly, differences found in the incidence of culture-positive cases of endophthalmitis (5 for unwrapped vs 3 for wrapped) were not statistically significant (P = .47). In a dedicated, high-volume eye facility, the incidence of presumed postoperative infection associated with unwrapped and wrapped full-cycle steam sterilization were shown to be identical within statistical error. This provides strong evidence that if eye surgical facilities carefully clean surgical instruments and follow the industry and manufacturer guidelines, they can, with confidence, use either of these 2 methods of sterilization. This study presents the first concrete data that corroborate the current position of The Joint Commission, American Academy of Ophthalmology (AAO) and American Society of Cataract and Refractive Surgery (ASCRS).