Comparative evaluation of the microbicidal activity of low-temperature sterilization technologies to steam sterilization

2020 ◽  
Vol 41 (4) ◽  
pp. 391-395 ◽  
Author(s):  
William A. Rutala ◽  
Maria F. Gergen ◽  
Emily E. Sickbert-Bennett ◽  
David J. Weber
Keyword(s):  
Hydrogen Peroxide ◽  
Low Temperature ◽  
Failure Rate ◽  
Geobacillus Stearothermophilus ◽  
Steam Sterilization ◽  
Microbicidal Activity ◽  
Gas Plasma ◽  
Test Organisms ◽  
Margin Of Safety ◽  
Vancomycin Resistant

AbstractObjective:To compare the microbicidal activity of low-temperature sterilization technologies (vaporized hydrogen peroxide [VHP], ethylene oxide [ETO], and hydrogen peroxide gas plasma [HPGP]) to steam sterilization in the presence of salt and serum to simulate inadequate precleaning.Methods:Test carriers were inoculated with Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, vancomycin-resistant Enterococcus, Mycobacterium terrae, Bacillus atrophaeus spores, Geobacillus stearothermophilus spores, or Clostridiodes difficile spores in the presence of salt and serum and then subjected to 4 sterilization technologies: steam, ETO, VHP and HPGP.Results:Steam, ETO, and HPGP sterilization techniques were capable of inactivating the test organisms on stainless steel carriers with a failure rate of 0% (0 of 220), 1.9% (6 of 310), and 1.9% (5 of 270), respectively. The failure rate for VHP was 76.3% (206 of 270).Conclusion:Steam sterilization is the most effective and had the largest margin of safety, followed by ETO and HPGP, but VHP showed much less efficacy.

scholarly journals Comparative Evaluation of the Microbicidal Activity of Low-Temperature Sterilization Technologies to Steam Sterilization

2020 ◽  
Vol 41 (S1) ◽  
pp. s176-s177
Author(s):  
William Rutala ◽  
Maria Gergen ◽  
Emily Sickbert-Bennett ◽  
David Jay Weber
Keyword(s):  
Hydrogen Peroxide ◽  
Low Temperature ◽  
Failure Rate ◽  
Steam Sterilization ◽  
Healthcare Facilities ◽  
Microbicidal Activity ◽  
Gas Plasma ◽  
Surgical Devices ◽  
Significant Difference ◽  
Test Organisms

Background: Most medical and surgical devices used in healthcare facilities are made of materials that are sterilized by heat (ie, heat stable), primarily steam sterilization. Low-temperature sterilization methods developed for heat and moisture sensitive devices include ethylene oxide gas (ETO), hydrogen peroxide gas plasma (HPGP), vaporized hydrogen peroxide (VHP), and hydrogen peroxide plus ozone. This study is the first to evaluate the microbicidal activity of the FDA-cleared VHP sterilizer and other methods (Table 1) in the presence of salt and serum (10% FCS). Methods: Brushed stainless steel discs (test carriers) were inoculated with test microbes (Table 1) and subjected to 4 sterilization methods: steam, ETO, VHP and HPGP. Results: Steam sterilization killed all 5 vegetative and 3 spore-forming test organisms in the presence of salt and serum (Table 1). Similarly, the ETO and the HPGP sterilizers inactivated the test organisms with a failure rate of 1.9% for each (ie, 6 of 310 for ETO and 5 of 270 for HPGP). Although steam had no failures compared to both ETO and HPGP, which demonstrated some failures for vegetative bacteria, there was no significant difference comparing the failure rate of steam to either ETO (P > .05) or HPGP (P > .05). However, the VHP system tested failed to inactivate all the test organisms in 76.3% of the tests (206 of 270; P < .00001) (Table 1). Conclusions: This investigation demonstrated that steam sterilization was the most effective method, followed by ETO and HPGP and, lastly, VHP.Funding: NoneDisclosures: Dr. Rutala was a consultant to ASP (Advanced Sterilization Products)

Does blood on “dirty” instruments interfere with the effectiveness of sterilization technologies?

2021 ◽  
pp. 1-3
Author(s):  
William A. Rutala ◽  
Maria F. Gergen ◽  
David J. Weber
Keyword(s):  
Hydrogen Peroxide ◽  
Ethylene Oxide ◽  
Steam Sterilization ◽  
Gas Plasma ◽  
Margin Of Safety

Abstract We evaluated the robustness of sterilization technologies when spores and bacteria were placed on “dirty” instruments and overlaid with blood. The results illustrate that steam sterilization is the most effective sterilization technology with the largest margin of safety, followed by ethylene oxide and hydrogen peroxide gas plasma.

scholarly journals Does Blood on “Dirty” Instruments Interfere With the Effectiveness of Sterilization Technologies?

2020 ◽  
Vol 41 (S1) ◽  
pp. s194-s195
Author(s):  
William Rutala ◽  
Maria Gergen ◽  
David Jay Weber
Keyword(s):  
Disease Transmission ◽  
Surgical Instruments ◽  
Healthcare Personnel ◽  
Geobacillus Stearothermophilus ◽  
Surgical Instrument ◽  
Steam Sterilization ◽  
Bacillus Atrophaeus ◽  
Gas Plasma ◽  
Test Organisms ◽  
Sterilization Process

Background: Surgical instruments that enter sterile tissue should be sterile because microbial contamination could result in disease transmission. Despite careful surgical instrument reprocessing, surgeons and other healthcare personnel (HCP) describe cases in which surgical instruments have been contaminated with organic material (eg, blood). Although most of these cases are observed before the instrument reaches the patient, in some cases the contaminated instrument contaminates the sterile field, or rarely, the patient. In this study, we evaluated the robustness of sterilization technologies when spores and bacteria mixed with blood were placed on dirty (uncleaned) instruments. Methods: Dirty surgical instruments were inoculated with 1.5105 to 4.1107 spores or vegetative bacteria (MRSA, VRE or Mycobacterium terrae) in the presence or absence of blood. The spores used were most resistant to the sterilization process tested (eg, Geobacillus stearothermophilus for steam and HPGP and Bacillus atrophaeus for ETO). Once the inoculum dried, the instruments were placed in a peel pouch and sterilized by steam sterilization, ethylene oxide (ETO), or hydrogen peroxide gas plasma (HPGP). These experiments are not representative of practice or manufacturer’s recommendations because cleaning must always precede sterilization. Results: Steam sterilization killed all the G. stearothermophilus spores and M. terrae when inoculated onto dirty instruments in the presence or absence of blood (Table 1). ETO failed to inactivate all test spores (B. atrophaeus) when inoculated onto dirty instruments (60% failure) and dirty instruments with blood (90% failure). ETO did kill the vegetative bacteria (MRSA, VRE) under the same 2 test conditions (ie, dirty instruments with and without blood). The failure rates for HPGP for G. stearothermophilus spores and MRSA were 60% and 40%, respectively, when mixed with blood on a dirty instrument. Conclusions:This investigation demonstrated that steam sterilization is the most robust sterilization process and is effective even when instruments were not cleaned and the test organisms (G. stearothermophilus spores and MRSA) were mixed with blood. The low-temperature sterilization technologies tested (ie, ETO, HPGP) failed to inactivate the test spores but ETO did kill the test bacteria (ie, MRSA, VRE). These findings should assist HCP to assess the risk of infection to patients when potentially contaminated surgical instruments enter the sterile field or are unintentionally used on patients during surgery. Our data also demonstrate the importance of thorough cleaning prior to sterilization.Funding: NoneDisclosures: Dr. Rutala was a consultant to ASP (Advanced Sterilization Products)

scholarly journals How to Sterilize 3D Printed Objects for Surgical Use? An Evaluation of the Volumetric Deformation of 3D-Printed Genioplasty Guide in PLA and PETG after Sterilization by Low-Temperature Hydrogen Peroxide Gas Plasma

2019 ◽  
Vol 13 (1) ◽  
pp. 410-417 ◽  
Author(s):  
Olivier Oth ◽  
César Dauchot ◽  
Maria Orellana ◽  
Régine Glineur
Keyword(s):  
Hydrogen Peroxide ◽  
Low Temperature ◽  
Rapid Development ◽  
Clinical Use ◽  
Steam Sterilization ◽  
Plasma Technique ◽  
Gas Plasma ◽  
Cutting Guides ◽  
3D Printed ◽  
Morphological Differences

Introduction: In the present time, there is rapid development in the application of 3D printing technology in surgery. One of the challenges encountered by the surgeon is the sterilization of these 3D-printed objects for use in the operating room. Materials and Methods: Forty-two identical cutting guides used for genioplasty were 3D-printed: twenty-one in Polylactic acid (PLA) and twenty-one in Polyethylene terephthalate glycol (PETG). The guides were CT scanned after printing. They were then sterilized with the low-temperature hydrogen peroxide gas plasma technique (Sterrad®). A CT scan of the guides was also performed at T1 (after printing) and T2 (after sterilization). A software (Cloudcompare ®) was then used to accurately compare the volume of each guide at T0 (the initial computer-aided designed guide) vs T1 and T1 vs T2. Statistical analysis was then performed. Results: Although there are differences that are statistically significant for each series between T0 and T2 and T1 and T2 for both PLA and PETG, this had no impact on the clinical use of sterilized objects using hydrogen peroxide sterilization technique because these morphological differences were minimal at less than 0.2mm. Conclusion: Morphological deformations induced by the hydrogen peroxide sterilization are sub-millimeter and acceptable for surgical use. The hydrogen peroxide sterilization is, therefore, an alternative to avoid the deformation of 3D-printed objects made from PLA and PETG during conventional steam sterilization (autoclave). To the best of our knowledge, this is the first study regarding the morphologic deformation of 3D-printed objects in PLA and PETG after sterilization for medical use.

A Comparative Study of Ethylene Oxide Gas, Hydrogen Peroxide Gas Plasma, and Low-Temperature Steam Formaldehyde Sterilization

2005 ◽  
Vol 26 (5) ◽  
pp. 486-489 ◽  
Author(s):  
Keiji Kanemitsu ◽  
Takayuki Imasaka ◽  
Shiho Ishikawa ◽  
Hiroyuki Kunishima ◽  
Hideo Harigae ◽  
...  
Keyword(s):  
Hydrogen Peroxide ◽  
Low Temperature ◽  
Ethylene Oxide ◽  
Bacillus Stearothermophilus ◽  
Biological Indicator ◽  
Environmental Concerns ◽  
Gas Plasma ◽  
Complex Shapes ◽  
Multiple Trials ◽  
Ethylene Oxide Gas

AbstractObjective:To compare the efficacies of ethylene oxide gas (EOG), hydrogen peroxide gas plasma (PLASMA), and low-temperature steam formaldehyde (LTSF) sterilization methods.Methods:The efficacies of EOG, PLASMA, and LTSF sterilization were tested using metal and plastic plates, common medical instruments, and three process challenge devices with narrow lumens. All items were contaminated with Bacillus stearothermophilus spores or used a standard biological indicator.Results:EOG and LTSF demonstrated effective killing of B. stearothermophilus spores, with or without serum, on plates, on instruments, and in process challenge devices. PLASMA failed to adequately sterilize materials on multiple trials in several experiments, including two of three plates, two of three instruments, and all process challenge devices.Conclusions:Our results suggest that PLASMA sterilization may be unsuccessful under certain conditions, particularly when used for items with complex shapes and narrow lumens. Alternatively, LTSF sterilization demonstrates excellent efficacy and is comparable to EOG sterilization. LTSF could potentially act as a substitute if EOG becomes unavailable due to environmental concerns.

Comparison of low-temperature hydrogen peroxide gas plasma sterilization for endoscopes using various Sterrad™ models

2005 ◽  
Vol 59 (4) ◽  
pp. 280-285 ◽  
Author(s):  
J. Okpara-Hofmann ◽  
M. Knoll ◽  
M. Dürr ◽  
B. Schmitt ◽  
M. Borneff-Lipp
Keyword(s):  
Hydrogen Peroxide ◽  
Low Temperature ◽  
Plasma Sterilization ◽  
Gas Plasma
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