Non-Sterile Gloves as a Source of Radiation-Tolerant Microorganisms.

Radiation methods are widely used for disinfection and sterilization applications. Microorganisms demonstrate known, variable tolerance levels to inactivation with lower doses of ionizing and non-ionizing radiation based on multiple mechanisms of resistance in their structures and nucleic acid repair mechanisms. The radiation dose required to ensure microbial inactivation during sterilization is typically based on the understanding and routine monitoring of the natural population and resistance of microorganisms on products exposed to radiation sterilization processes. This report describes the isolation of Roseomonas mucosa in a device manufacturing environment that was detected during routine device bioburden and dose verification monitoring. Sources of Gram-negative bacteria in the environment were investigated. Non-sterile examination gloves used during manufacturing were found to be a persistent source of R. mucosa and other microbial contaminants. The source of contamination was determined to be from the glove manufacturing process. Maintenance and routine microbiological controls during glove manufacturing, including water systems, are required to reduce the risks of gloves being a source of unexpected microbiological contamination.

US Soldiers' Individual and Unit-level Factors Associated with Perceptions of Disinformation in the Military Context.

INTRODUCTION: Although the US Government considers threats of misinformation, disinformation, and mal-information to rise to the level of terrorism, little is known about service members' experiences with disinformation in the military context. We examined soldiers' perceptions of disinformation impact on the Army and their units. We also investigated associations between disinformation perceptions and soldiers' sociodemographic characteristics, reported use of fact-checking, and perceptions of unit cohesion and readiness. METHODS: Active-duty soldiers (N = 19,465) across two large installations in the Southwest US completed an anonymous online survey. RESULTS: Sixty-six percent of soldiers agreed that disinformation has a negative impact on the Army. Thirty-three percent of soldiers perceived disinformation as a problem in their unit. Females were more likely to agree that disinformation has a negative impact on the Army and is a problem in their unit. Higher military rank was associated with lower odds of agreeing that disinformation is a problem in units. Most soldiers were confident about their ability to recognize disinformation (62%) and reported using fact-checking resources (53%), and these factors were most often endorsed by soldiers who agreed that disinformation is a problem for the Army and their unit. Soldiers' perceptions of unit cohesion and readiness were negatively associated with the perception that disinformation is a problem in their unit. CONCLUSION: While the majority of soldiers viewed disinformation as a problem across the Army, fewer perceived it as problematic within their units. Higher levels of reported fact-checking were most evident among those who perceived disinformation as a problem, suggesting that enhancing awareness of the problem of disinformation alone could help mitigate its deleterious impact. Perceptions of disinformation problems within units were associated with soldiers' perceptions of lower unit cohesion and readiness, highlighting misinformation, disinformation, and mal-information's impact on force readiness. Limitations and future directions are discussed.

Affinity and Inactivation of Bacterial Endotoxins for Medical Device Materials.

Endotoxins are high-molecular-weight complexes that contain lipopolysaccharide, protein, and phospholipid originating from the outer membrane of gram-negative bacteria. As gram-negative bacteria are naturally present in a variety of sources, endotoxins are commonly identified as contaminants in manufacturing environments. In industrial applications, endotoxin often is considered difficult to inactivate and to have a strong affinity with surfaces resulting from its hydrophobic chemical structure. This article describes the investigation of the true affinity of endotoxin, from various microbial sources in solution, for medical device material surfaces. In addition, endotoxin reduction was investigated with commonly used sterilization methods such as those based on ionizing radiation, dry and moist heat, and ethylene oxide sterilization. Endotoxin activity was found to be reduced following exposure to a range of sterilization modalities with the degree of activity reduction related to the source of endotoxin and the substrate material upon which it was present.

Validation of the Device Feature Approach for Reusable Medical Device Cleaning Evaluations.

The identification of worst-case device (or device set) features has been a well-established validation approach in many areas (e.g., terminal sterilization) for determining process effectiveness and requirements, including for reusable medical devices. A device feature approach for cleaning validations has many advantages, representing a more conservative approach compared with the alternative compendial method of testing the entirety of the device. By focusing on the device feature(s), the most challenging validation variables can be isolated to and studied at the most difficult-to-clean feature(s). The device feature approach can be used to develop a design feature database that can be used to design and validate device cleanliness. It can also be used to commensurately develop a quantitative cleaning classification system that will augment and innovate the effectiveness of the Spaulding classification for microbial risk reduction. The current study investigated this validation approach to verify the efficacy of device cleaning procedures and mitigate patient risk. This feature categorization approach will help to close the existing patient safety gap at the important interface between device manufacturers and healthcare facilities for the effective and reliable processing of reusable medical devices. A total of 56,000 flushes of the device features were conducted, highlighting the rigor associated with the validation. Generating information from design features as a critical control point for cleaning and microbiological quality will inform future digital transformation of the medical device industry and healthcare delivery, including automation.

Dry heat sterilization modelling for spacecraft applications.

AIMS: Inactivation processes using heat are widely used for disinfection and sterilization. Dry heat sterilization of spacecraft equipment has been the preferred microbial inactivation method as part of interplanetary travel protection strategies. An antimicrobial model, based on temperature and exposure time based on experimental data, was developed to provide reliable sterilization processes to be used for interplanetary applications. METHODS AND RESULTS: Bacillus atrophaeus spores, traditionally used to challenge dry heat sterilization processes, were tested over a range of temperatures in comparison with spores of Bacillus canaveralius that have been shown to have a higher heat resistance profile. D-value and Z-values were determined and used to develop a mathematical model for parametric sterilization applications. The impact of the presence of a contaminating soil, representative of Mars dust, was also tested to verify the practical application of the model to reduce the risk of microbial contamination in such environments. CONCLUSION: The sterilization model developed can be used as an intrinsic part of risk reduction strategies for interplanetary protection. SIGNIFICANCE AND IMPACT: Forward and backward planetary protection strategies to reduce the risks of microbial contamination during interplanetary exploration and research is an important consideration. The development of a modern sterilization model, with consideration of microorganisms identified with higher levels of heat resistance than traditionally deployed in terrestrial applications, allows for the consideration of optimal inactivation processes to define minimum criteria for engineering design. The ability to inactivate living microorganisms, as well as to degrade biomolecules, provides a reliable method to reduce the risk of known and potentially unknown contaminants in future applications.

Assessing Detergent Residuals for Reusable Device Cleaning Validations.

Cleaning chemistries are detergent-based formulations that are used during the processing of reusable medical devices. Manufacturers are responsible for demonstrating the safety of cleaning formulations when they are used during a device processing cycle, including the risk of device-associated cytotoxicity over the concentration ranges for recommended use and rinsing during cleaning. However, no regulation currently exists requiring manufacturers to demonstrate such safety. Although manufacturers' safety data sheets (SDSs) provide information on the safe use of chemicals for users, this information may not provide sufficient detail to determine the risks of residual chemicals on device surfaces. SDSs are not required to contain a comprehensive list of chemicals used, only those of risk to the user. They should be supplemented with information on the correct concentrations that should be used for cleaning, as well as instructions on the rinsing required to reduce the levels of chemicals to safe (nontoxic) levels prior to further processing. Supporting data, such as toxicity profiles or cytotoxicity data that support the instructions for use, would provide medical device manufacturers and healthcare personnel with the necessary information to make informed decisions about selection and correct use of detergents. In the current work, cytotoxicity profiles for eight commonly used cleaning formulations available internationally were studied. Although all of these products are indicated for use in the cleaning of reusable medical devices, results vary across the serial dilution curves and are not consistent among detergent types. The information presented here can be leveraged by both medical device manufacturers and processing department personnel to properly assess residual detergent risks during processing. This work also serves as a call to cleaning formulation manufacturers to provide this information for all chemistries.

Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality.

In the design, control, and regulation of the manufacturing and supply of microbiologically controlled devices (including sterile devices) and drug products (including cleaning, disinfection, and sterilization processing and/or aseptic process manufacturing), different terms and/or definitions are often used for similar processes or applications internationally. With product innovations (including combination products and cell-based therapy) and global regulatory influences, there is a growing need to harmonize these definitions. The objective of the Kilmer Regulatory Innovation microbiological quality and sterility assurance glossary is to clarify and harmonize the practical use of terms employed by the different parts of regulated healthcare product industries internationally and by regulators of the manufacturing and supply of microbiologically controlled healthcare products internationally. The glossary is expected to continue to evolve, and further industry, academic, and regulatory input is encouraged.

Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality.

In the design, control, and regulation of the manufacturing and supply of microbiologically controlled devices (including sterile devices) and drug products (including cleaning, disinfection, and sterilization processing and/or aseptic process manufacturing), different terms and/or definitions are often used internationally for similar processes or applications. With product innovations (including combination products and cell-based therapy) and global regulatory influences, there is a growing need to harmonize these definitions. The objective of the Kilmer Regulatory Innovation microbiological quality and sterility assurance glossary is to clarify and harmonize the practical use of terms employed by the different parts of regulated health care product industries internationally and by regulators of the manufacturing and supply of microbiologically controlled health care products internationally. The glossary is expected to continue to evolve; and further industry, academic, and regulatory input is encouraged.

Thermal Disinfection Validation: The Relationship Between A0 and Microbial Reduction.

Validating a thermal disinfection process for the processing of medical devices using moist heat via direct temperature monitoring is a conservative approach and has been established as the A0 method. Traditional use of disinfection challenge microorganisms and testing techniques, although widely used and applicable for chemical disinfection studies, do not provide as robust a challenge for testing the efficacy of a thermal disinfection process. Considerable research has been established in the literature to demonstrate the relationship between the thermal resistance of microorganisms to inactivation and the A0 method formula. The A0 method, therefore, should be used as the preferred method for validating a thermal disinfection process using moist heat.

Regulatory Approach for Transitioning from Gamma Ray to X-ray Radiation Sterilization.

When investing in X-ray irradiation facilities around the world, an opportunity exists for defining a regulatory framework for assessing the transition from current gamma irradiation processes. Historically, regulatory strategies for changing the radiation source for routine processing has consisted of repeating the majority, if not all, of the validation activities performed as part of an initial validation and associated submission. Although not a new concept, performing a risk assessment has the potential to be leveraged more fully by increasing the rigor of determining what is changing when product moves from a gamma to an X-ray irradiator, then determining how these differences may affect product characteristics. During these steps, differences can be identified and quantified between radiation sources and potential impacts, if any, to product quality can be elucidated. Based on these risk assessments, the level of action required, or not required, in terms of empirical product testing can be examined and a determination can be made regarding whether a substantial change has occurred.

Research: Dry Heat Processing of Single-Use Respirators and Surgical Masks.

The COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2, has challenged healthcare providers in maintaining the supply of critical personal protective equipment, including single-use respirators and surgical masks. Single-use respirators and surgical masks can reduce risks from the inhalation of airborne particles and microbial contamination. The recent high-volume demand for single-use respirators and surgical masks has resulted in many healthcare facilities considering processing to address critical shortages. The dry heat process of 80°C (176°F) for two hours (120 min) has been confirmed to be an appropriate method for single-use respirator and surgical mask processing.

Moist Heat Disinfection and Revisiting the A0 Concept.

Moist heat is employed in the medical device, pharmaceutical, and food processing industries to render products and goods safe for use and human consumption. Applications include its use to pasteurize a broad range of foods and beverages, the control of microbial contamination of blood products, and treatment of bone tissue transplants and vaccines. In the pharmaceutical industry, water heated to 65°C to 80°C is used to sanitize high-purity water systems. In healthcare, it has been employed for decades to disinfect patient care items ranging from bedpans to anesthesia equipment. There is a good understanding of the conditions necessary to achieve disinfection of microorganisms at temperatures ranging from 65°C to 100°C. Based on this information, the efficacy of moist heat processes at a range of exposure times and temperatures can be quantified based on mathematical models such as the A0 calculation. While the A0 concept is recognized within the European healthcare community, it has yet to be widely adopted within the United States. This article provides information regarding the A0 concept, a brief overview of the classification of thermal disinfection for use with healthcare applications within the United States, and recent data on reinvestigating the thermal disinfection of a selected panel of microorganisms and a mixed culture biofilm.

Effectiveness of the SYSTEM 1E Liquid Chemical Sterilant Processing System for reprocessing duodenoscopes.

BACKGROUND: A troubling number of health care-acquired infection outbreaks and transmission events, some involving highly resistant microbial pathogens and resulting in serious patient outcomes, have been traced to reusable, high-level disinfected duodenoscopes in the United States. The Food and Drug Administration (FDA) requested a study be conducted to verify liquid chemical sterilization efficacy of SYSTEM 1E(®) Liquid Chemical Sterilant Processing System (STERIS Corporation, Mentor, OH) with varied duodenoscope designs under especially arduous conditions. Here, we describe the system's performance under worst case SYSTEM 1E(®) processing conditions. METHODS: The test protocol challenged the system's performance by running a fractional cycle to evaluate reduction of recoverable test spores from heavily contaminated endoscopes, including all channels and each distal tip, under worst case SYSTEM 1E(®) processing conditions. RESULTS: All devices were successfully liquid chemically sterilized, showing greater than a 6 log10 reduction of Geobacillus stearothermophilus spores at every inoculation site of each duodenoscope tested, in less than half the exposure time of the standard cycle. CONCLUSIONS: The successful outcome of the additional efficacy testing reported here indicates that the SYSTEM 1E(®) is an effective low-temperature liquid chemical sterilization method for duodenoscopes and other critical and semicritical devices. It offers a fast, safe, convenient processing alternative while providing the assurance of a system expressly tested and cleared to achieve liquid chemical sterilization of specific validated duodenoscope models.

Mechanism of Sporicidal Activity for the Synergistic Combination of Peracetic Acid and Hydrogen Peroxide.

There is still great interest in controlling bacterial endospores. The use of chemical disinfectants and, notably, oxidizing agents to sterilize medical devices is increasing. With this in mind, hydrogen peroxide (H2O2) and peracetic acid (PAA) have been used in combination, but until now there has been no explanation for the observed increase in sporicidal activity. This study provides information on the mechanism of synergistic interaction of PAA and H2O2 against bacterial spores. We performed investigations of the efficacies of different combinations, including pretreatments with the two oxidizers, against wild-type spores and a range of spore mutants deficient in the spore coat or small acid-soluble spore proteins. The concentrations of the two biocides were also measured in the reaction vessels, enabling the assessment of any shift from H2O2 to PAA formation. This study confirmed the synergistic activity of the combination of H2O2 and PAA. However, we observed that the sporicidal activity of the combination is largely due to PAA and not H2O2. Furthermore, we observed that the synergistic combination was based on H2O2 compromising the spore coat, which was the main spore resistance factor, likely allowing better penetration of PAA and resulting in the increased sporicidal activity.

Superbugs on Duodenoscopes: the Challenge of Cleaning and Disinfection of Reusable Devices.

Inadequate flexible endoscope reprocessing has been associated with infection outbreaks, most recently caused by carbapenem-resistant Enterobacteriaceae. Lapses in essential device reprocessing steps such as cleaning, disinfection/sterilization, and storage have been reported, but some outbreaks have occurred despite claimed adherence to established guidelines. Recommended changes in these guidelines include the use of sterilization instead of high-level disinfection or the use of routine microbial culturing to monitor efficacy of reprocessing. This review describes the current standards for endoscope reprocessing, associated outbreaks, and the complexities associated with both microbiological culture and sterilization approaches to mitigating the risk of infection associated with endoscopy.

Biochemical and microbial contamination of surgical devices: a quantitative analysis.

Reusable devices are required to be safety processed prior to patient use, including cleaning and disinfection and sterilization. In developing and testing cleaning processes, it is important to understand the levels of soils typically present on devices after surgical use. Previous soil investigations have focused on microbial contamination levels; less is known about biochemical contamination. In this study, microbial and biochemical contamination on a range of surgical instrumentation after patient use were investigated. Analysis included bacteria levels, total organic carbon, protein, and hemoglobin. The highest levels of soil contamination were caused by protein, in contrast with bacteria levels being a minor component of instrument soiling. This study provides a better understanding of the microbial and biochemical levels of soils that are typically present in used surgical devices. These levels can be used to develop artificial test soils for testing cleaning efficacy under laboratory conditions and to further evaluate patient risks from inadequate cleaning.