Bioburden reduction of four decontamination and cleaning protocols for reprocessing single-use cardiac electrophysiology catheters

Decontamination and cleaning protocols are critical in reprocessing medical device. Protocols should be designed to remove biological debris, reduce bioburden and minimize the risk for health professionals. These issues are of utmost importance when reprocessing of single-use-only labeled devices is considered. This study evaluates the efficiency in reducing bioburden of four protocols for decontaminating and cleaning electrophysiology single-use catheters. The proximal portion of sixty cardiac catheters was soiled in vitro by human blood spiked with Bacillus subtilis or Pseudomonas aeruginosa. Contaminated devices were treated according to one of the following experimental protocols: i) chlorine solution followed by enzymatic solution; ii) enzymatic solution followed by chlorine solution; iii) polyphenolic emulsion; iv) polyphenolic emulsion followed by enzymatic solution. Untreated device were considered as positive controls. Bacterial bioburden was quantified by enumerating colony forming units. Device sterility was checked by broth-enrichment and prolonged incubation time. Chlorine based protocols showed higher biocide properties (>2.6-3.8 log reduction) than polyphenolic based protocols (1.9-3.2 log reduction), irrespectively from bacterial strain and amount. A further reduction was related to the enzymatic treatment. To maximize the bactericidal efficiency and also guarantee an effective cleaning, the protocol should provide at first the cleaning phase by the enzymatic detergent, followed by treatment with the chlorine releasing solution. Since this protocol does not realize an immediate decontamination of the device, adequate safety measures for health professionals should be introduced. Wherever these risks cannot be reduced, polyphenols based protocols with immediate device decontamination after use should be considered.