Effect of Cleaning on Sterilization Efficacy

The effect of salt and serum on the efficacy of low-temperature sterilization technologies has raised concern regarding the margin of safety of these technologies. Experiments have shown that salts have the greatest impact on protecting microorganisms from killing426, 469. However, other studies have suggested that these concerns may not be clinically relevant. One study evaluated the relative rate of removal of inorganic salts, organic soil, and microorganisms from medical devices to better understand the dynamics of the cleaning process426. These tests were conducted by inoculating Alfa soil (tissue-culture media and 10% fetal bovine serum) 469 containing 106 G. stearothermophilus spores onto the surface of a stainless-steel scalpel blade. After drying for 30 minutes at 35°C followed by 30 minutes at room temperature, the samples were placed in water at room temperature. The blades were removed at specified times, and the concentration of total protein and chloride ion was measured. The results showed that soaking in deionized water for 60 seconds resulted in a >95% release rate of chloride ion from NaCl solution in 20 seconds, Alfa soil in 30 seconds, and fetal bovine serum in 120 seconds. Thus, contact with water for short periods, even in the presence of protein, rapidly leads to dissolution of salt crystals and complete inactivation of spores by a low-temperature sterilization process (Table 10). Based on these experimental data, cleaning procedures would eliminate the detrimental effect of high salt content on a low-temperature sterilization process.

These articles ^{426, 469, 721} assessing low-temperature sterilization technology reinforce the importance of meticulous cleaning before sterilization. These data support the critical need for healthcare facilities to develop rigid protocols for cleaning contaminated objects before sterilization⁴⁷². Sterilization of instruments and medical devices is compromised if the process is not preceded by meticulous cleaning.

The cleaning of any narrow-lumen medical device used in patient care presents a major challenge to reprocessing areas. While attention has been focused on flexible endoscopes, cleaning issues related to other narrow-lumen medical devices such as sphinctertomes have been investigated⁹¹³. This study compared manual cleaning with that of automated cleaning with a narrow-lumen cleaner and found that only retro-flushing with the narrow lumen cleaner provided adequate cleaning of the three channels. If reprocessing was delayed for more than 24 hours, retro-flush cleaning was no longer effective and ETO sterilization failure was detected when devices were held for 7 days ⁹¹³. In another study involving simulated-use cleaning of laparoscopic devices, Alfa found that minimally the use of retro-flushing should be used during cleaning of non-ported laparoscopic devices⁹¹⁴.