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Titre du document / Document title

Sterility and microbiological assessment of reused single-use cardiac electrophysiology catheters

Auteur(s) / Author(s)

TESSAROLO Francesco (1) ; CAOLA Iole (3) ; CACIAGLI Patrizio (3) ; GUARRERA Giovanni M. (4) ; NOLLO Giandomenico (2) ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

(1) Department of Materials Engineering and Industrial Technologies, University of Trento, Trento, ITALIE
(2) Department of Physics, University of Trento, Trento, ITALIE
(3) Department of Microbiology and Virology, Azienda Provinciale per i Servizi Sanitari, Trento, ITALIE
(4) Department of Heathcare and Rehabilitation, Azienda Provinciale per i Servizi Sanitari, Trento, ITALIE

Résumé / Abstract

OBJECTIVE. To assess the performance and limitations of a reprocessing protocol for nonlumen electrophysiology catheters by testing the sterility of reprocessed devices and defining the maximum number of reprocessing cycles sustainable by the device in hygienically safe conditions. DESIGN. Simulated use, reprocessing, and testing of the catheters. SETTING. Microbiology and virology department of a public health diagnostic laboratory. INTERVENTIONS. Seventy-three catheters were collected after clinical use on patients. The first group of devices was tested for sterility after 1 cycle of reprocessing. By the repetition of simulated use (blood inoculated with bacteria) and reprocessing (decontamination, cleaning, and hydrogen peroxide gas plasma sterilization), we obtained 39 sample devices reprocessed 2 times, 26 reprocessed 3 times, 28 reprocessed 4 times, 36 reprocessed 5 times, and 22 reprocessed 6 times. Devices were cultured for 28 days in trypticase soy broth. RESULTS. We tested 208 catheters with 6 cycles of reprocessing and 4 inoculated bacteria species. No devices tested positive for the inoculated strains until the fourth cycle of reprocessing. One of 35 catheters showed the growth of the inoculated strain Bacillus subtilis after 5 cycles of reprocessing, and 1 of 22 catheters showed growth of this organism 6 cycles. After the second reprocessing, 7 of 36 devices showed growth of gram-negative bacteria other than the strain inoculated. CONCLUSIONS. Reprocessing according to the reprocessing protocol was insufficient to guarantee device sterility after 5 reuses. Cleaning with enzymatic solution revealed good cleaning properties with efficient bioburden reduction. Storage intervals of longer than 24 hours during reprocessing should be avoided to limit contamination or bacterial overgrowth. Technical considerations suggest the introduction of reprocessing procedures only in hospitals with considerable workloads.

Revue / Journal Title

Infection control and hospital epidemiology    ISSN  0899-823X 

Source / Source

2006, vol. 27, no12, pp. 1385-1392 [8 page(s) (article)] (30 ref.)

Langue / Language

Anglais

Editeur / Publisher

University of Chicago Press, Chicago, IL, ETATS-UNIS  (1988) (Revue)

Mots-clés anglais / English Keywords

Bacteria

;

Bacillales

;

Bacillaceae

;

Public health

;

Catheter

;

Bacillus subtilis

;

Heart

;

Disposable

;

Sterility

;

Electrophysiology

;

Bacteriosis

;

Infection

;

Mots-clés français / French Keywords

Bactérie

;

Bacillales

;

Bacillaceae

;

Santé publique

;

Cathéter

;

Bacillus subtilis

;

Coeur

;

Usage unique

;

Stérilité

;

Electrophysiologie

;

Bactériose

;

Infection

;

Mots-clés espagnols / Spanish Keywords

Bacteria

;

Bacillales

;

Bacillaceae

;

Salud pública

;

Catéter

;

Bacillus subtilis

;

Corazón

;

Uso único

;

Esterilidad

;

Electrofisiología

;

Bacteriosis

;

Infección

;

Localisation / Location

INIST-CNRS, Cote INIST : 19430, 35400014516257.0160

Nº notice refdoc (ud4) : 18384666



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