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

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)

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

Infection Control and Hospital Epidemiology ◽

10.1017/ice.2020.2 ◽

2020 ◽

Vol 41 (4) ◽

pp. 391-395 ◽

Cited By ~ 2

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.

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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

The Open Dentistry Journal ◽

10.2174/1874210601913010410 ◽

2019 ◽

Vol 13 (1) ◽

pp. 410-417 ◽

Cited By ~ 8

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.

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

Infection Control and Hospital Epidemiology ◽

10.1017/ice.2020.122 ◽

2020 ◽

Vol 41 (8) ◽

pp. 999-1000

Author(s):

Randal Eveland

Keyword(s):

Low Temperature ◽

Comparative Evaluation ◽

Steam Sterilization ◽

Microbicidal Activity

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Adverse Events with Low Temperature Hydrogen Peroxide Gas Plasma Sterilisation Reported by Certified Sterilisation Service Technicians and Certified Sterilisation Specialists in Japan

Iryou kikigaku (The Japanese journal of medical instrumentation) ◽

10.4286/jjmi.83.28 ◽

2013 ◽

Vol 83 (1) ◽

pp. 28-33 ◽

Cited By ~ 2

Author(s):

Rika Yoshida ◽

Hiroyoshi Kobayashi

Keyword(s):

Hydrogen Peroxide ◽

Low Temperature ◽

Adverse Events ◽

Gas Plasma

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Evaluation of Multiple (3-Cycle) Decontamination Processing for Filtering Facepiece Respirators

Journal of Engineered Fibers and Fabrics ◽

10.1177/155892501000500405 ◽

2010 ◽

Vol 5 (4) ◽

pp. 155892501000500 ◽

Cited By ~ 29

Author(s):

Michael S. Bergman ◽

Dennis J. Viscusi ◽

Brian K. Heimbuch ◽

Joseph D. Wander ◽

Anthony R. Sambol ◽

...

Keyword(s):

Hydrogen Peroxide ◽

Occupational Safety ◽

Control Method ◽

Influenza Pandemic ◽

Treatment Method ◽

Physical Damage ◽

Airflow Resistance ◽

Laboratory Performance ◽

Healthcare Facilities ◽

Gas Plasma

Disposable N95 filtering facepiece respirators (FFRs) certified by the National Institute for Occupational Safety and Health (NIOSH) are widely used by healthcare workers to reduce exposures to infectious biological aerosols. There is currently major concern among public health officials about a possible shortage of N95 FFRs during an influenza pandemic. Decontamination and reuse of FFRs is a possible strategy for extending FFR supplies in an emergency; however, the NIOSH respirator certification process does not currently include provisions for decontamination and reuse. Recent studies have investigated the laboratory performance (filter aerosol penetration and filter airflow resistance) and physical integrity of FFRs following one-cycle (1X) processing of various decontamination treatments. The studies found that a single application of some methods did not adversely affect laboratory performance. In the event that healthcare facilities experience dramatic shortages of FFR supplies, multiple decontamination processing may become necessary. This study investigates three-cycle (3X) processing of eight different methods: ultraviolet germicidal irradiation, ethylene oxide, hydrogen peroxide gas plasma, hydrogen peroxide vapor, microwave-oven-generated steam, bleach, liquid hydrogen peroxide, and moist heat incubation (pasteurization). A four-hour 3X submersion of FFR in deionized water was performed for comparison (control). Following 3X treatment by each decontamination and control method, FFRs were evaluated for changes in physical appearance, odor, and laboratory filtration performance. Only the hydrogen peroxide gas plasma treatment resulted in mean penetration levels > 5% for four of the six FFR models; FFRs treated by the seven other methods and the control samples had expected levels of filter aerosol penetration (< 5%) and filter airflow resistance. Physical damage varied by treatment method. Further research is still needed before any specific decontamination methods can be recommended.

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

Infection Control and Hospital Epidemiology ◽

10.1017/ice.2021.202 ◽

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.

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

Infection Control and Hospital Epidemiology ◽

10.1086/502572 ◽

2005 ◽

Vol 26 (5) ◽

pp. 486-489 ◽

Cited By ~ 31

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.

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