Sterility of reusable transrectal ultrasound transducer assemblies for prostate biopsy reprocessed according to food and drug administration guidelines--bacteriologic outcomes in a clinical setup

Abstract

Objectives: To test the effectiveness of the sterilization process of the transducer while applying the Food and Drug Administration recommendations on a routine basis in a high-volume clinical setup. In June 2006, the Food and Drug Administration issued a Public Health notification about reprocessing of the reusable ultrasound transducer assemblies used for transrectal biopsy of the prostate.

Methods: Transrectal ultrasound assembly components were systematically swabbed and cultured. The ultrasound gel and disinfectant fluid were also cultured.

Results: A total of 42 sets of cultures from 4 predetermined locations were obtained (n = 168). Bacterial growth was demonstrated in 2 sets of cultures, both from the transducer working channel (2 of 168, 1.19%): Streptococcus viridans from the distal orifice of the working channel and coagulase-negative staphylococcus from the proximal orifice. No bacterial growth was found in the gel samples or in the disinfectant fluid. No patient experienced a symptomatic urinary tract infection or sepsis, regardless of the culture results.

Conclusions: Processing transrectal ultrasound biopsy transducer assemblies using the Food and Drug Administration recommendations achieved sterility in 98.8% of the cultures tested and in 95.2% of the consecutive cycles of equipment preparations.