SUDs were deliberately contaminated with the suspension of approximately 106 CFU (colony formation units) / ml of spores. Quantified, standardized and diluted in sheep are sterile debug. The contaminated inoculum was inserted into the current internal spaces of the devices. The instruments were then left for 80 minutes on a lined and covered surface with impermeable sterile drapes, retaining contact with the contaminated inoculum. The choice of this micro-organism was justified as this is the usual biological indicator to monitor sterilization cycles through ethylene oxide, the method for the experiments was chosen for its high diffuseness and compatibility with thermo materials.
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The re-usable instruments have been subject to the same contamination process, with the exception of Geobacillus stearothermophilus, as this is the standard micro-organism in the biological indicators to monitor the sterilization cycles of autoclave steam, the type of sterilization recommended for devices Stainless steel.
Then, dried the instruments, contaminated with tap water to drink for about 30 minutes to them moist. Gradually, enzyme detergent made on each device, first in an ultrasonic cleaner with pulsatile water jet; after this washing has been completed with manual cleaning, as required in the test protocol described below, prepared for reprocessing, both for single use and reusable devices.
The test protocol stages were: unloading of reusable laparoscopic devices; wetting the material by immersing in tap water for 30 minutes, diving the parts in an enzymatic detergent solution, as guided by the manufacturer, washing the instruments in ultrasonic washer with pulsatile water jet specifically for canulas and instruments cleaning, extra hand cleaning on each piece with 2 mm diameter brushes (internal washing of Veress needles, stem and Electromagnetic Pruning System), and sensitive brushes for washing the parts of the active part of the forces; rack and pinion, discussion and other niches and recesses of all pieces; flushing the material with the help of a high pressure water gun, focused on the internal structure of the instrument; final rinse with sterile distilled water; support the devices in baskets lined with white drapes for a few minutes to facilitate drying and inspection for blood residues; dried with compressed air and with soft medical compression; rigorous inspection for the cleanliness and integrity of devices with the aid of a more intense lens to direct image; the re-launch of the “reusable” forces; the individual packaging of devices in a double package of surgical grade paper, adding a multi-parameter chemical class (class 5) into the package; SUDs sterilization by ethylene oxide gas, and autologous with saturated steam under pressure with pre-vacuum for reusable instruments; forward sterile samples for the sterility test.
It should be noted that, prior to the experiments, the microbiological analytical methodologies were collected by the laboratory technical staff, using the following steps:
((STEP 1) samples of each of the devices single-use and reusable, subject to CFU counts per unit of material (CFU / material) after microbial contamination, after cleaning and sterilization procedure
(STEP 2). The recovery of materials in both phases was confirmed, confirming that the instrument complied with the instrument, and the consequent challenge to the sterilization phase, providing continuity for the experiments. Such validation of the method was a positive control and aimed to ensure that micro-organisms were tested in devices to challenge sterilization.
The sterilization tests were experiments to verify the recovery of test micro-organisms in an average culture, in which they had previously proliferated. The contaminated devices, after cleaning and sterilization, were exploited directly in soybean casein culture media, which were considered suitable for the recovery of a potential micro-organism of testing that survives the reprocessing methods. The growth period was 14 days, with daily readings on the turbidity of the cultural media, and the incubation of Bacillus atrophaeus at 37 ° C and Geobacillus stearothermophilus at 56 ° C.
With the SUDs, the tests were negative. Under laminar flow, all materials were broken using sterile pliers so that the samples could be fully immersed in the cultural medium. The comparison group tools were directly dismantled and immersed in the cultural medium.
The microbiological culture results of video-surgical-laparoscopic devices marketed as single use devices and reusable devices, following the contamination challenge, cleaning and sterilization are presented.
According to Outcomes, no bacterial growth of Bacillus atrophaeus or Geobacillus stearothermophilus was recovered in the respective samples of the experimental group nor in the comparative one.
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