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


METHODS
Simulated use, reprocessing, and testing of the catheters.


METHODS
Microbiology and virology department of a public health diagnostic laboratory.


METHODS
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.
Tessarolo
Francesco
F
Department of Materials Engineering and Industrial Technologies, University of Trento, Trento, Italy. tessaro@science.unitn.it
Caola
Iole
I
Caciagli
Patrizio
P
Guarrera
Giovanni M
GM
Nollo
Giandomenico
G
D003428:Cross Infection / Q000517:prevention & control; D004203:Disinfection; D022062:Electrophysiologic Techniques, Cardiac; D004594:Electrophysiology / Q000295:instrumentation*; D017743:Equipment Reuse / Q000191:economics; D004869:Equipment Safety / Q000191:economics; D006801:Humans; D006861:Hydrogen Peroxide; D007442:Intubation, Intratracheal / Q000295:instrumentation*; D013242:Sterilization / Q000379:methods / Q000592:standards*
D006861:Hydrogen Peroxide