Evaluation of Ophthalmic Surgical Instrument Sterility Using Short-Cycle Sterilization for Sequential Same-Day Use.

PURPOSE: The common practice of short-cycle sterilization for ophthalmic surgical instrumentation has come under increased regulatory scrutiny. This study was undertaken to evaluate the efficacy of short-cycle sterilization processing for consecutive same-day cataract procedures.

DESIGN

Testing of specific sterilization processing methods by an independent medical device validation testing laboratory.

PARTICIPANTS

Phaco handpieces from 3 separate manufacturers were tested along with appropriate biologic indicators and controls using 2 common steam sterilizers.

METHODS

A STATIM 2000 sterilizer (SciCan, Canonsburg, PA) with the STATIM metal cassette, and an AMSCO Century V116 pre-vacuum sterilizer (STERIS, Mentor, OH) using a Case Medical SteriTite container (Case Medical, South Hackensack, NJ) rigid container were tested using phaco tips and handpieces from 3 different manufacturers. Biological indicators were inoculated with highly resistant Geobacillus stearothermophilus, and each sterility verification test was performed in triplicate. Both wrapped and contained loads were tested with full dry cycles and a 7-day storage time to simulate prolonged storage. In adherence with the manufacturers' instructions for use (IFU), short cycles (3.0-3.5-minute exposure times) for unwrapped and contained loads were also tested after only 1 minute of dry time to simulate use on a consecutive case. Additional studies were performed to demonstrate whether any moisture present in the load containing phaco handpieces postprocessing was sterile and would affect the sterility of the contents after a 3-minute transit/storage time. This approximated the upper limit of time needed to transfer a containment device to the operating room.

MAIN OUTCOME MEASURES: Presence or absence of microbial growth from cultured test samples.

RESULTS

All inoculated test samples from both sterilizers were negative for growth of the target organism whether the full dry phase was interrupted or not. Pipetted postprocessing moisture samples and swabs of the handpieces were also negative for growth after a 3-minute transit/storage time.

CONCLUSIONS

These studies support the use of unwrapped, short-cycle sterilization that adheres to the IFU of these 2 popular Food and Drug Administration-cleared sterilizers for sequential same-day cataract surgeries. A full drying phase is not necessary when the instruments are kept within the covered sterilizer containment device for prompt use on a sequential case.