title: 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: OBJECTIVE
  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.
authors.affiliation: Department of Urology, Assaf Harofeh Medical Center Affiliated with Tel-Aviv University Sackler Faculty of Medicine, Zerifin, Israel.
authors.forename: Itay M
authors.initials: IM
authors.lastname: Sabler
authors.forename: Tsilia
authors.initials: T
authors.lastname: Lazarovitch
authors.forename: Miki
authors.initials: M
authors.lastname: Haifler
authors.forename: Erez
authors.initials: E
authors.lastname: Lang
authors.forename: Galina
authors.initials: G
authors.lastname: Shapira
authors.forename: Sheli
authors.initials: S
authors.lastname: Zelig
authors.forename: Arie
authors.initials: A
authors.lastname: Lindner
authors.forename: Amnon
authors.initials: A
authors.lastname: Zisman
mesh_terms: D001707:Biopsy, Needle / Q000379:methods; D004866:Equipment Contamination; D017743:Equipment Reuse; D006801:Humans; D008297:Male; D017410:Practice Guidelines as Topic; D011467:Prostate / Q000000981:diagnostic imaging / Q000473:pathology*; D013242:Sterilization; D018084:Ultrasonography, Interventional / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration