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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.

journal_name

Urology

journal_title

Urology

authors

Sabler IM,Lazarovitch T,Haifler M,Lang E,Shapira G,Zelig S,Lindner A,Zisman A

doi

10.1016/j.urology.2010.06.069

subject

Has Abstract

pub_date

2011-01-01 00:00:00

pages

17-9

issue

1

eissn

0090-4295

issn

1527-9995

pii

S0090-4295(10)01527-X

journal_volume

77

pub_type

临床试验,杂志文章

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