Document Detail


Sterility of reusable transrectal ultrasound transducer assemblies for prostate biopsy reprocessed according to food and drug administration guidelines--bacteriologic outcomes in a clinical setup.
MedLine Citation:
PMID:  21195820     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Itay M Sabler; Tsilia Lazarovitch; Miki Haifler; Erez Lang; Galina Shapira; Sheli Zelig; Arie Lindner; Amnon Zisman
Publication Detail:
Type:  Clinical Trial; Journal Article    
Journal Detail:
Title:  Urology     Volume:  77     ISSN:  1527-9995     ISO Abbreviation:  Urology     Publication Date:  2011 Jan 
Date Detail:
Created Date:  2011-01-03     Completed Date:  2011-01-31     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0366151     Medline TA:  Urology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  17-9     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 Elsevier Inc. All rights reserved.
Affiliation:
Department of Urology, Assaf Harofeh Medical Center Affiliated with Tel-Aviv University Sackler Faculty of Medicine, Zerifin, Israel.
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MeSH Terms
Descriptor/Qualifier:
Biopsy, Needle / methods
Equipment Contamination*
Equipment Reuse
Humans
Male
Practice Guidelines as Topic
Prostate / pathology*,  ultrasonography
Sterilization*
Ultrasonography, Interventional / instrumentation*
United States
United States Food and Drug Administration
Comments/Corrections
Comment In:
Urology. 2011 Jan;77(1):19-20; author reply 20   [PMID:  21195821 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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