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)

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.

Impact of an Oil-Based Lubricant on the Effectiveness of the Sterilization Processes

2008 ◽  
Vol 29 (1) ◽  
pp. 69-72 ◽  
Author(s):  
William A. Rutala ◽  
Maria F. Gergen ◽  
David J. Weber
Keyword(s):  
Standard Test ◽  
Surgical Instruments ◽  
Hydraulic Fluid ◽  
Geobacillus Stearothermophilus ◽  
Bacillus Atrophaeus ◽  
Vancomycin Resistant Enterococci ◽  
Colony Forming Units ◽  
Vancomycin Resistant ◽  
Sterilization Process ◽  
Clinically Relevant Bacteria

Surgical instruments, including hinged instruments, were inoculated with test microorganisms (ie, methicillin-resistantStaphylococcus aureus,approximately 2 × 106colony-forming units [cfu];Pseudomonas aeruginosa,approximately 3 x 106cfu;Escherichia coli,approximately 2 × 105cfu; vancomycin-resistant enterococci, 1 × 105cfu;Geobacillus stearothermophilusspores, 2 × 105cfu or more; orBacillus atrophaeusspores, 9 × 104cfu or more), coated with an oil-based lubricant (hydraulic fluid), subjected to a sterilization process, and then samples from the instruments were cultured. We found that the oil-based lubricant did not alter the effectiveness of the sterilization process because high numbers of clinically relevant bacteria and standard test spores (which are relatively resistant to the sterilization process) were inactivated.

Characteristics, Protection and Functional Design of Three-Layer Laminate for Medical Footwear

Tekstilec ◽  
2020 ◽  
Vol 63 (4) ◽  
pp. 256-262
Author(s):  
Beti Rogina-Car ◽  
◽  
Stana Kovačević ◽  
Irena Šabarić ◽  
◽  
...  
Keyword(s):  
Working Conditions ◽  
Protective Clothing ◽  
Barrier Properties ◽  
Functional Design ◽  
Geobacillus Stearothermophilus ◽  
Bacillus Atrophaeus ◽  
Bacterial Endospores ◽  
Sterilization Process

The aim of this paper is to determine the influence of the washing and sterilization process in real hospital conditions on the microbial barrier properties of textile laminate used in medicine for protective clothing. The paper focuses on the functional design of three-layer laminate for medical footwear in surgery and in rooms where aseptic working conditions are required. The permeability and durability of the microbial barrier were determined after 0, 10 and 20 washing and sterilization procedures according to previously developed meth¬ods. Bacterial endospores of apathogenic species of the genera Geobacillus stearothermophilus and Bacillus atrophaeus were used. A functional design of the protective shoe cover was proposed. The results showed an extremely effective microbial barrier and the durability of the sample after 0, 10 and 20 washing and sterilization procedures, and over a period of one, two and three months.

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)

scholarly journals Influence of Washing and Sterilization on Properties of Polyurethane Coated Fabrics Used in Surgery and for Wrapping Sterile Items

Polymers ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 642
Author(s):  
Beti Rogina-Car ◽  
Stana Kovačević ◽  
Suzana Đorđević ◽  
Dragan Đorđević
Keyword(s):  
Mechanical Damage ◽  
Physical And Mechanical Properties ◽  
Ftir Analysis ◽  
Geobacillus Stearothermophilus ◽  
Bacillus Atrophaeus ◽  
Genus Bacillus ◽  
Medical Textiles ◽  
Bacterial Endospores ◽  
Sterilization Process ◽  
Coated Fabrics

The objective of this work was to determine the influence of washing and sterilization under real hospital conditions on properties of microbial barrier offered by polyurethane coated fabrics used in surgery and for wrapping sterile items. Emphasis was put on the change of surface polyurethane coating by using FTIR analysis. The permeability and durability of the microbial barrier were determined after 0, 10, and 20 washing and sterilization procedures according to previously developed methods. Bacterial endospores of the apathogenic species of the genus Bacillus Geobacillus stearothermophilus and Bacillus atrophaeus were used. Mechanical damage to medical textiles in the washing and sterilization process was determined according to standard HRN EN ISO 13914-1:2008 and associated with changes in physical and mechanical properties. Chemical changes of PU coatings were determined using FTIR analysis. The results showed an exceptionally efficient microbial barrier and its durability in all samples after 0, 10 and 20 washing and sterilization procedures and for a period of one, two and three months.

Assessment of Residual Moisture and Maintenance of Sterility in Surgical Instrument Sets after Sterilization

2015 ◽  
Vol 36 (8) ◽  
pp. 990-992 ◽  
Author(s):  
Camille Fayard ◽  
Christophe Lambert ◽  
Catherine Guimier-Pingault ◽  
Marion Levast ◽  
Raphaelle Germi
Keyword(s):  
Laboratory Study ◽  
Infect Control Hosp ◽  
Surgical Instruments ◽  
Residual Water ◽  
Small Laboratory ◽  
Surgical Instrument ◽  
Steam Sterilization ◽  
Residual Moisture

AbstractGood sterilization practices include discarding items containing residual moisture after steam sterilization. In this small laboratory study, however, the presence of residual water did not appear to compromise the sterility of surgical instruments in 2 commonly used types of packaging during routine storage after steam sterilization.Infect Control Hosp Epidemiol 2015;36(8):990–992

scholarly journals Sensors in the Autoclave-Modelling and Implementation of the IoT Steam Sterilization Procedure Counter

Sensors ◽  
2021 ◽  
Vol 21 (2) ◽  
pp. 510
Author(s):  
Lukas Boehler ◽  
Mateusz Daniol ◽  
Ryszard Sroka ◽  
Dominik Osinski ◽  
Anton Keller
Keyword(s):  
The Body ◽  
Surgical Instruments ◽  
Sensor System ◽  
Temperature Profiles ◽  
Measured Temperature ◽  
Steam Sterilization ◽  
Automated Evaluation ◽  
Normative Requirements ◽  
Thermal Simulations ◽  
The Relationship

Surgical procedures involve major risks, as pathogens can enter the body unhindered. To prevent this, most surgical instruments and implants are sterilized. However, ensuring that this process is carried out safely and according to the normative requirements is not a trivial task. This study aims to develop a sensor system that can automatically detect successful steam sterilization on the basis of the measured temperature profiles. This can be achieved only when the relationship between the temperature on the surface of the tool and the temperature at the measurement point inside the tool is known. To find this relationship, the thermodynamic model of the system has been developed. Simulated results of thermal simulations were compared with the acquired temperature profiles to verify the correctness of the model. Simulated temperature profiles are in accordance with the measured temperature profiles, thus the developed model can be used in the process of further development of the system as well as for the development of algorithms for automated evaluation of the sterilization process. Although the developed sensor system proved that the detection of sterilization cycles can be automated, further studies that address the possibility of optimization of the system in terms of geometrical dimensions, used materials, and processing algorithms will be of significant importance for the potential commercialization of the presented solution.

Management of surgical instruments with radio frequency identification tags

2016 ◽  
Vol 29 (2) ◽  
pp. 236-247 ◽  
Author(s):  
Kaori Kusuda ◽  
Kazuhiko Yamashita ◽  
Akiko Ohnishi ◽  
Kiyohito Tanaka ◽  
Masaru Komino ◽  
...  
Keyword(s):  
Radio Frequency ◽  
Radio Frequency Identification ◽  
Management System ◽  
Surgical Instruments ◽  
Rfid Tags ◽  
Surgical Instrument ◽  
Content Type ◽  
History Of ◽  
Frequency Identification ◽  
Identification Tags

Purpose – To prevent malpractices, medical staff has adopted inventory time-outs and/or checklists. Accurate inventory and maintenance of surgical instruments decreases the risk of operating room miscounting and malfunction. In our previous study, an individual management of surgical instruments was accomplished using Radio Frequency Identification (RFID) tags. The purpose of this paper is to evaluate a new management method of RFID-tagged instruments. Design/methodology/approach – The management system of RFID-tagged surgical instruments was used for 27 months in clinical areas. In total, 13 study participants assembled surgical trays in the central sterile supply department. Findings – While using the management system, trays were assembled 94 times. During this period, no assembly errors occurred. An instrument malfunction had occurred after the 19th, 56th, and 73th uses, no malfunction caused by the RFID tags, and usage history had been recorded. Additionally, the time it took to assemble surgical trays was recorded, and the long-term usability of the management system was evaluated. Originality/value – The system could record the number of uses and the defective history of each surgical instrument. In addition, the history of the frequency of instruments being transferred from one tray to another was recorded. The results suggest that our system can be used to manage instruments safely. Additionally, the management system was acquired of the learning effect and the usability on daily maintenance. This finding suggests that the management system examined here ensures surgical instrument and tray assembly quality.

Challenges to Validation Of a Complex Nonsterile Medical Device Tray

2014 ◽  
Vol 48 (4) ◽  
pp. 306-311
Author(s):  
Daniel Prince ◽  
Jozef Mastej ◽  
Isabel Hoverman ◽  
Raja Chatterjee ◽  
Diana Easton ◽  
...  
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Biological Indicators ◽  
Careful Attention ◽  
Geobacillus Stearothermophilus ◽  
Steam Sterilization ◽  
Worst Case

Validation by steam sterilization of reusable medical devices requires careful attention to many parameters that directly influence whether or not complete sterilization occurs. Complex implant/instrument tray systems have a variety of configurations and components. Geobacillus stearothermophilus biological indicators (BIs) are used in overkill cycles to to simulate worst case conditions and are intended to provide substantial sterilization assurance. Survival of G. stearothermophilus spores was linked to steam access and size of load in the chamber. By a small and reproducible margin, it was determined that placement of the trays in a rigid container into minimally loaded chambers were more difficult to completely sterilize than maximally loaded chambers.

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