Sterility of Reusable Transrectal Ultrasound Transducer Assemblies for Prostate Biopsy Reprocessed According to Food and Drug Administration Guidelines—Bacteriologic Outcomes in a Clinical Setup

• Published in: Urology (Ridgewood, N.J.) N.J.), 2011, Vol.77 (1), p.17-19
• Main Authors: Sabler, Itay M, Lazarovitch, Tsilia, Haifler, Miki, Lang, Erez, Shapira, Galina, Zelig, Sheli, Lindner, Arie, Zisman, Amnon
• Format: Article
• Language: English
• Subjects: Biological and medical sciences; Biopsy, Needle - methods; Birth control; Equipment Contamination; Equipment Reuse; Gynecology. Andrology. Obstetrics; Humans; Male; Medical sciences; Nephrology. Urinary tract diseases; Practice Guidelines as Topic; Prostate - diagnostic imaging; Prostate - pathology; Sterility. Assisted procreation; Sterilization; Ultrasonography, Interventional - instrumentation; United States; United States Food and Drug Administration; Urology
• ISSN: 0090-4295; 1527-9995
• DOI: 10.1016/j.urology.2010.06.069

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.