Michelle J. Alfa

Comparison of Ion Plasma, Vaporized Hydrogen Peroxide, and 100% Ethylene Oxide Sterilizers to the 12/88 Ethylene Oxide Gas Sterilizer

OBJECTIVE The performance of a standard gas sterilizer, which uses a mixture of 12% ethylene oxide (EtO) and 88% chlorofluorocarbon as the sterilizing gas (12/88), was compared to selected gas, ion plasma, and vaporized hydrogen peroxide (H2O2) sterilizers that do not use chlorofluorocarbons. The effect of serum and salt on sterilizer performance was evaluated. DESIGN Test carriers (porcelain and stainless steel penicylinders, or 125-cm lengths of plastic tubing [internal diameter of 3.2 mm]) were inoculated with Escherichia coli, Enterococcus faecalis, Pseudomonas aeruginosa, Mycobacterium chelonei, Bacillus stearothermophilus spores, Bacillus subtilis spores, and Bacillus circulans spores and then subjected to sterilization using 12/88, 100% EtO, ion plasma, or vaporized H2O2. The bacterial inoculum was prepared with and without 10% serum and 0.65% salt, and the residual bacterial load after sterilization as determined using viable counts. RESULTS All of the sterilizers tested effected a six-log10 reduction of the bacterial inoculum on penicylinders, unless 10% serum and 0.65% salt were present, in which case the 100% EtO, vaporized H2O2, and ion plasma sterilizers were not as effective as the 12/88 sterilizer. None of the sterilizers could eradicate 10(6) CFU of all of the bacteria in 10% serum and 0.65% salt when inoculated inside a narrow lumen. CONCLUSIONS The margin of safety for the 100% EtO, vaporized H2O2, and ion plasma sterilizers is less than that of the 12/88 sterilizer. The inability of all sterilizers, including the 12/88, to kill organisms in narrow lumens reliably when serum and salt were present raises concern about the current practice of gas sterilization of flexible endoscopes.

A survey of reprocessing methods, residual viable bioburden, and soil levels in patient-ready endoscopic retrograde choliangiopancreatography duodenoscopes used in Canadian centers.

OBJECTIVES To obtain information about current reprocessing practices and to obtain samples from the biopsy channel to quantitate soil levels and bioburden in patient-ready flexible duodenoscopes used for endoscopic retrograde choliangiopancreatography (ERCP). DESIGN Participating centers were sent a questionnaire and a kit for on-site collection of samples from the biopsy channel of the duodenoscope. SETTING Thirty-seven hospitals from across Canada participated. The only criterion was that they currently used and reprocessed flexible duodenoscopes for ERCP procedures. METHODS The questionnaire obtained information on reprocessing practices. The kit included a detailed instruction booklet outlining sample collection and all of the tubes, sterile water, and brushes needed for it. Samples were collected on-site from all ERCP scopes in each center on Monday morning and shipped by overnight courier on ice to the research center. Each sample was assayed by routine microbiologic methods for total viable count and protein, blood, carbohydrate, and endotoxin levels. RESULTS Microbial overgrowth was present in 7% of 119 scope samples. Cleaning appeared to be reasonably well done in most of the centers, and 43% of the centers were in total compliance with basic national guidelines. The data from the scope samples indicated that there was significantly greater buildup of protein, carbohydrate, and endotoxin associated with ERCP scopes from centers using glutaraldehyde, compared with those using peracetic acid. Carbohydrate was the soil component detected most frequently and in the highest concentration in scope channels. CONCLUSIONS Although cleaning was generally well done, areas for improvement included ensuring the availability of written reprocessing protocols, immersion of scopes during manual cleaning, use of adequate fluid volume for rinsing, adequate drying of scopes prior to storage, and the separation of ERCP valves from scopes during storage.

Bacterial killing ability of 10% ethylene oxide plus 90% hydrochlorofluorocarbon sterilizing gas.

OBJECTIVES To use a serum and salt challenge in narrow-lumen carriers to evaluate a 10% ethylene oxide plus 90% hydrochlorofluorocarbon (EO-HCFC) sterilant mixture in a retrofitted 12/88 sterilizer as an alternative to the banned chlorofluorocarbon-ethylene oxide (EO) sterilant mixture. DESIGN An EO-HCFC sterilizing gas mixture in a retrofitted 12/88 sterilizer was compared to 100% ethylene oxide (100% EO) sterilizing gas to determine its relative ability to kill seven different bacteria (Escherichia coli, Pseudomonas aeruginosa, Enterococcus faecalis, Bacillus subtilis spores, Bacillus stearothermophilus spores, Bacillus circulans spores, and Mycobacterium chelonei) in the presence or absence of a combined 10% serum and 0.65% salt challenge using both penicylinders (PC) and long narrow-lumen (LU) carriers. RESULTS The EO-HCFC sterilant mixture (96% sterile carriers) was equivalent to the 100% EO sterilant (98% sterile carriers) for killing vegetative organisms, as well as spore suspensions, on the 27 PC and 27 LU carriers in the absence of serum and salt. In the presence of serum and salt, the EO-HCFC sterilant mixture was markedly better than the 100% EO sterilant at reducing the bacterial load on the 63 PC carriers (95% vs 62% sterile PC carriers, respectively), whereas both sterilizers were equivalent for the 63 LU carriers (49% vs 40% sterile LU carriers, respectively). Of the seven test organisms, E faecalis, B subtilis, B stearothermophilus, and B circulans were the most difficult to kill for both PC and LU carriers when serum and salt were present. CONCLUSIONS The data presented in this report indicate that the EO-HCFC sterilant mixture is an effective alternative for gas sterilization. Indeed, the efficiency of bacterial killing for the EO-HCFC sterilant mixture was similar to that achieved by the 12/88 EO-CFC sterilant mixture.

Evaluation of the ability of different detergents and disinfectants to remove and kill organisms in traditional biofilm

BACKGROUND The objective of this study was to assess the ability of different detergent and disinfectant combinations to eradicate bacteria in traditional biofilm. METHODS Enterococcus faecalis and Pseudomonas aeruginosa were used to develop biofilm over 8 days. The biofilm on each minimum biofilm eradication concentration peg contained 8 log10 colony forming units (CFU)/cm2 of both bacteria. The detergents evaluated were as follows: Prolystica Enzymatic 2X, Prolystica Neutral 2X, Neodisher, and Endozime Bio-Clean. The disinfectants evaluated were as follows: glutaraldehyde, accelerated hydrogen peroxide, and ortho-phthalaldehyde. Biofilm removal was evaluated using viable count, protein and carbohydrate quantitation, and scanning electron microscopy. RESULTS Only Prolystica Enzymatic 2X and Endozime Bio-Clean killed both E faecalis (3.90 log10 CFU/mL reduction) and P aeruginosa (3.96 log10 CFU/mL reduction) in suspension. None of the detergents tested could provide >1 log10 CFU/cm2 reduction for bacteria within biofilm. Any combination of detergent and high-level disinfectant reduced the level of both E faecalis and P aeruginosa within biofilm by 3-5 log10 CFU/cm2. Although the combination of Endozime Bio-Clean and glutaraldehyde provided a 6 log10 reduction, it could not eliminate both bacteria within biofilm. CONCLUSIONS Our data indicate that if biofilm accumulates in flexible endoscope channels during repeated rounds of reprocessing, then neither the detergent nor high-level disinfectant will provide the expected level of bacterial removal or killing.