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Sterility and Microbiological Assessment of Reused Single-Use Cardiac Electrophysiology Catheters

Published online by Cambridge University Press:  21 June 2016

Francesco Tessarolo ,
Iole Caola ,
Patrizio Caciagli ,
Giovanni M. Guarrera  and
Giandomenico Nollo
Francesco Tessarolo*
Affiliation:
Departments of Materials Engineering and Industrial Technologies, University of Trento, Azienda Provinciale per i Servizi Sanitari, Trento, Italy
Iole Caola
Affiliation:
Departments of Microbiology and Virology, Azienda Provinciale per i Servizi Sanitari, Trento, Italy
Patrizio Caciagli
Affiliation:
Departments of Microbiology and Virology, Azienda Provinciale per i Servizi Sanitari, Trento, Italy
Giovanni M. Guarrera
Affiliation:
Heathcare and Rehabilitation, Azienda Provinciale per i Servizi Sanitari, Trento, Italy
Giandomenico Nollo
Affiliation:
Physics, University of Trento, Azienda Provinciale per i Servizi Sanitari, Trento, Italy
*
Department of Materials Engineering and Industrial Technologies, University of Trento, Via Mesiano 77, 1-38050 Trento, Italy ([email protected])
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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.

Type
Original Articles
Information
Infection Control & Hospital Epidemiology , Volume 27 , Issue 12 , December 2006 , pp. 1385 - 1392
Copyright
Copyright © The Society for Healthcare Epidemiology of America 2006

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