Microbiological, microstructure, and material science examinations of reprocessed Combitubes after multiple reuse.
Reprocessing (repeated cleaning, disinfection, and sterilization) and reuse of single-use medical devices has been performed safely with some devices. The aim of our study was to analyze whether reprocessing of the Combitubes (Kendall-Sheridan, Argyll, NY) airway device, used for emergency endotracheal intubation and difficult airway management, is possible and can be performed appropriately and safely. Microbiological, microstructure, and material science examinations were performed with unused, as well as multiple reused and reprocessed Combitubes. The reprocessing procedure consisted of a cleaning, a disinfection, a final inspection, and a sterilization. Microbiological examinations of multiple reused and reprocessed Combitubes found no test organisms in quantitative cultures. A microbial reduction between four and five log levels compared with nonreprocessed tubes was found. Microstructure analysis for the examination of topographical alterations and changes in the chemical composition of the surface demonstrated nonsignificant alterations between new and reprocessed medical devices. In material science examinations, cuff burst pressures were not different between unused and multiple reprocessed Combitubes. The results of all examinations proved that the decontamination process is adequately effective, and that no significant superficial alterations are generated by the multiple reuse and reprocessing of the Combitubes. To assure uniformly good results, a quality management system must be established and only validated methods should be used.


CONCLUSIONS
Reprocessing of single-use medical devices offers the opportunity of significant savings and is already performed with some devices. Microbiological, microstructure, and material science examinations proved that reprocessing of multiple reused Combitubes (Kendall-Sheridan, Argyll, NY), mainly used for emergency airway management, is possible and safe.
Lipp
M D
MD
Clinic of Anesthesiology, University Hospital Mainz, Germany. lipp@mail.uni-mainz.de
Jaehnichen
G
G
Golecki
N
N
Fecht
G
G
Reichl
R
R
Heeg
P
P
D015169:Colony Count, Microbial; D004203:Disinfection; D019544:Equipment Failure Analysis; D017743:Equipment Reuse; D007442:Intubation, Intratracheal / Q000295:instrumentation*; D008422:Materials Testing; D013499:Surface Properties