The need for systematic quality controls in implementing N95 reprocessing and sterilization.

BACKGROUND: Due to increased requirement for personal protective equipment during the coronavirus disease 2019 pandemic, many medical centres utilized sterilization systems approved under Food and Drug Administration Emergency Use Authorization for single-use N95 mask re-use. However, few studies have examined the real-world clinical challenges and the role of ongoing quality control measures in successful implementation. AIMS: To demonstrate successful implementation of quality control measures in mask reprocessing, and the importance of continued quality assurance. METHODS: A prospective quality improvement study was conducted at a tertiary care medical centre. In total, 982 3M 1860 masks and Kimberly-Clark Tecnol PFR95 masks worn by healthcare workers underwent sterilization using a vaporized hydrogen peroxide gas plasma-based reprocessing system. Post-processing qualitative fit testing (QFT) was performed on 265 masks. Mannequin testing at the National Institute for Occupational Safety and Health (NIOSH) laboratory was used to evaluate the impact of repeated sterilization on mask filtration efficacy and fit. A locally designed platform evaluated the filtration efficiency of clinically used and reprocessed masks. FINDINGS: In total, 255 N95 masks underwent QFT. Of these, 240 masks underwent post-processing analysis: 205 were 3M 1860 masks and 35 were PFR95 masks. Twenty-five (12.2%) of the 3M masks and 10 (28.5%) of the PFR95 masks failed post-processing QFT. Characteristics of the failed masks included mask deformation (N=3, all 3M masks), soiled masks (N=3), weakened elastic bands (N=5, three PFR95 masks), and concern about mask shrinkage (N=3, two 3M masks). NIOSH testing demonstrated that while filter efficiency remained >98% after two cycles, mask strap elasticity decreased by 5.6% after reprocessing. CONCLUSIONS: This study demonstrated successful quality control implementation for N95 mask disinfection, and highlights the importance of real-world clinical testing beyond laboratory conditions.

Assessment of disinfectant efficacy in reducing microbial growth.

The incidence of hospital- and community-acquired infections has been dramatically increased worldwide. Accordingly, hands hygiene and the use of disinfectants have been increased leading to the expansion in hand sanitizers production to meet public demand. This study was conducted to assess the efficiency of common disinfectants in the market of Riyadh, Saudi Arabia in inhibiting the microbial growth during the time of Coronavirus disease 2019 (COVID-19) pandemic. Five bacterial strains of commonly hospital-acquired infections (Pseudomonas aeruginosa, Escherichia coli, Salmonella enteritidis, Staphylococcus aureus, and Enterococcus faecalis) (ATCC reference strains and clinical isolates) were examined for their susceptibility against 18 disinfectants collected from the Saudi market. The tested 18 disinfectants were broadly clustered into different groups based on their active chemical composition as following: 12 products contained alcohol, 2 products had chlorhexidine, 3 products contained mixed concentration of alcohol/chlorhexidine and 1 product had a mixture of chlorhexidine/Hexamidine/Chlorocresol. By measuring the minimum inhibitory concentration (MIC) and the minimum bactericidal concentration (MBC), our results revealed that all the 18 disinfectants have reduced the microbial growth of all the tested strains. Generally, the MICs and the MBCs for the clinical strains are higher than those of the reference strains. Taken together, our findings showed that all tested products have high disinfectants' killing rate against microbes of different origins, which suggest the high quality of these disinfectants and the good surveillance practice by the local authorities in Saudi Arabia.

A new laser device for ultra-rapid and sustainable aerosol sterilization.

The current COVID-19 pandemic has highlighted the importance of aerosol-based transmission of human pathogens; this therefore calls for novel medical devices which are able to sterilize contaminated aerosols. Here we describe a new laser device able to sterilize droplets containing either viruses or bacteria. Using engineered viral particles, we determined the 10,600 nm wavelength as the most efficient and exploitable laser source to be manufactured in a commercial device. Given the lack of existing working models to reproduce a human aerosol containing living microbial particles, we developed a new system mimicking human droplet formation and preserving bacterial and viral viability. This evidenced the efficacy of 10,600 nm laser light to kill two aerosol transmitted human pathogens, Legionella pneumophila and SARS-CoV-2. The minimal exposure time of <15 ms was required for the inactivation of over 99% pathogens in the aerosol; this is a key element in the design of a device that is safe and can be used in preventing inter-individual transmission. This represents a major advantage over existing devices, which mainly aim at either purifying incoming air by filters or sterilizing solid surfaces, which are not the major transmission routes for airborne communicable diseases.

Reusability of P3 Facial Filter in a Pandemic Emergency: A 3D Analysis of Filter Microstructure with X-ray Microtomography Images after Dry Heat and UV Sterilization Procedures.

OBJECTIVE: Our goal is to evaluate the effects of heat and ultraviolet (UV) irradiation on P3 facial respirator microstructure. INTERVENTION: P3 facial filters were exposed to dry heat and UV sterilization procedures. METHODS: P3 facial filter samples underwent a standardized sterilization process based on dry heat and UV irradiation techniques. We analyzed critical parameters of internal microstructure, such as fiber thickness and porosity, before and after sterilization, using 3D data obtained with synchrotron radiation-based X-ray computed microtomography (micro-CT). The analyzed filter has two inner layers called the "finer" and "coarser" layers. The "finer" layer consists of a dense fiber network, while the "coarser" layer has a less compact fiber network. RESULTS: Analysis of 3D images showed no statistically significant differences between the P3 filter of the controls and the dry heat/UV sterilized samples. In particular, averages fiber thickness in the finer layer of the control and the 60° dry heated and UV-irradiated sample groups was almost identical. Average fiber thickness for the coarser layer of the control and the 60° dry heated and UV-irradiated sample groups was very similar, measuring 19.33 µm (±0.47), 18.33 µm (±0.47), and 18.66 µm (±0.47), respectively. There was no substantial difference in maximum fiber thickness in the finer layers and coarser layers. For the control group samples, maximum thickness was on average 11.43 µm (±1.24) in the finer layer and 59.33 µm (±6.79) in the coarser layer. Similarly, the 60° dry heated group samples were thickened 12.2 µm (±0.21) in the finer layer and 57.33 µm (±1.24) in the coarser layer, while for the UV-irradiated group, the mean max thickness was 12.23 µm (±0.90) in the finer layer and 58.00 µm (±6.68) in the coarser layer. Theoretical porosity analysis resulted in 74% and 88% for the finer and coarser layers. The finer layers' theoretical porosity tended to decrease in dry heat and UV-irradiated samples compared with the respective control samples. CONCLUSIONS: Dry heat and UV sterilization processes do not substantially alter the morphometry of the P3 filter samples' internal microstructure, as studied with micro-CT. The current study suggests that safe P3 filter facepiece reusability is theoretically feasible and should be further investigated.

Supercritical CO2 sterilization: An effective treatment to reprocess FFP3 face masks and to reduce waste during COVID-19 pandemic.

The outbreak of COVID-19 pandemic unveiled an unprecedented scarcity of personal protective equipment (PPE) available in sanitary premises and for the population worldwide. This situation fostered the development of new strategies to reuse PPE that would ensure sterility and, simultaneously, preserve the filtering properties of the materials. In addition, the reuse of PPEs by reprocessing could reduce the environmental impact of the massive single-use and disposal of these materials. Conventional sterilization techniques such as steam or dry heat, ethylene oxide, and gamma irradiation may alter the functional properties of the PPEs and/or leave toxic residues. Supercritical CO2 (scCO2)-based sterilization is herein proposed as a safe, sustainable, and rapid sterilization method for contaminated face masks while preserving their performance. The functional (bacterial filtration efficiency, breathability, splash resistance, straps elasticity) properties of the processed FFP3 face masks were evaluated after 1 and 10 cycles of sterilization. Log-6 sterilization reduction levels were obtained for face masks contaminated with Bacillus pumilus endospores at mild operating conditions (CO2 at 39 °C and 100 bar for 30 min) and with low contents of H2O2 (150 ppm). Physicochemical properties of the FFP3 face masks remained unchanged after reprocessing and differences in efficacy were not observed neither in the filtration tests, following UNE-EN 14683, nor in the integrity of FFP3 filtration after the sterilization process. The herein presented method based on scCO2 technology is the first reported protocol achieving the reprocessing of FFP3 masks up to 10 cycles while preserving their functional properties.

Exploration of Community Care Awareness about COVID-19 Sterilization.

BACKGROUND: COVID-19 affects millions of people worldwide so WHO declared the COVID-19 pandemic on 11 March 2020. Since the vaccine is in the early trial phase and until it proves its efficacy, the need of finding alternative methods, which can help to curb this pandemic is urgent, so its prevention depends on standard infection control measures. This study's aim is to assess the knowledge, awareness, and practice level of Taif population towards Corona Virus disease - 2019 (COVID-19) sterilization. METHODS: A cross sectional study was conducted on 504 participants by administering a well-structured questionnaire comprising three sections including demographics, knowledge, attitude, and practice among the general population in Taif governorate KSA, over a duration of three months from July until September 2020. The descriptive analysis was carried out for demographics and dependent variables using the statistical program for social sciences. The t-test was used to detect any relationship between knowledge and practice score percentage of the general population response with respect to their gender and level of education. A p-value of < 0.05 was considered statistically significant. RESULTS: A total of 504 respondents willingly participated in the survey, there is a highly significant difference in the knowledge score percentage in respondents aged between 41 - 60 years old in comparison to the age group < 20 - 40 years old also between urban residence in comparison to rural residence, and a highly significant difference in the knowledge and practice score percentage in post graduate respondents in comparison to undergraduate. In addition, there was a significant difference in the practice score percentage in respondents aged between 41 - 60 years old in comparison to age group < 20 - 40, and a highly significant difference was seen in the practice score percentage in respondents living in urban areas in comparison to rural areas. CONCLUSIONS: The suggestion of this study was that knowledge and practice gaps among population, especially in the young age group, had to be covered by holding training programs through workshops or to include courses in the curriculum of ministry of health.

Rapid SARS-CoV-2 Inactivation in a Simulated Hospital Room Using a Mobile and Autonomous Robot Emitting Ultraviolet-C Light.

The spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) since 2019 has made mask-wearing, physical distancing, hygiene, and disinfection complementary measures to control virus transmission. Especially for health facilities, we evaluated the efficacy of an UV-C autonomous robot to inactivate SARS-CoV-2 desiccated on potentially contaminated surfaces. ASSUM (autonomous sanitary sterilization ultraviolet machine) robot was used in an experimental box simulating a hospital intensive care unit room. Desiccated SARS-CoV-2 samples were exposed to UV-C in 2 independent runs of 5, 12, and 20 minutes. Residual virus was eluted from surfaces and viral titration was carried out in Vero E6 cells. ASSUM inactivated SARS-CoV-2 by ≥ 99.91% to ≥ 99.99% titer reduction with 12 minutes or longer of UV-C exposure and onwards and a minimum distance of 100cm between the device and the SARS-CoV-2 desiccated samples. This study demonstrates that ASSUM UV-C device is able to inactivate SARS-CoV-2 within a few minutes.

Multi-Scale Nanoarchitectured Fibrous Networks for High-Performance, Self-Sterilization, and Recyclable Face Masks.

Airborne particulate matter (PM) pollutants, especially with nanoscale size, have caused serious public health issues. The global demand for high-performance and recyclable face masks is increasing dramatically, especially during the COVID-19 pandemic. However, present masks suffer from low-efficiency interception of PM0.3 /pathogen, limited air permeability, and incapacity to reuse and recycle. Here, multi-scale nanoarchitectured nanofiber/carbon nanotube (NF/CNT) networks are constructed by a needleless-electrospinning/spraying-netting strategy, enabling well-dispersed CNT networks (diameter ≈ 25 nm) welded on charged nanofibrous scaffolds (diameter > 100 nm) layer by layer. The optimized NF/CNT networks possess a fluffy structure with narrow-distribution small pores (size ≈ 400 nm), "free molecular flow" behavior, and electrostatic adsorption property, thereby exhibiting high filtration efficiency (>99.994% PM0.3 removal) and low resistance (<0.05% atmosphere pressure). Furthermore, they demonstrate reliable and ultra-fast photothermal-driven self-sterilization (>99.986% in 5 min) under 1 sun and electrothermal-driven self-sterilization (>99.9999% in 2 min) in sunless scenes owing to their unique nanoarchitecture. Most importantly, the abandoned NF/CNT filters can be fully recycled as high-performance solar vapor generators to desalinate seawater (3.56 L m-2 d-1 ). This work offers a fascinating solution to reduce disease transmission, resource consumption, and environmental burdens.

Standard for the Quantification of a Sterilization Effect Using an Artificial Intelligence Disinfection Robot.

Recent outbreaks and the worldwide spread of COVID-19 have challenged mankind with unprecedented difficulties. The introduction of autonomous disinfection robots appears to be indispensable as consistent sterilization is in desperate demand under limited manpower. In this study, we developed an autonomous navigation robot capable of recognizing objects and locations with a high probability of contamination and capable of providing quantified sterilization effects. In order to quantify the 99.9% sterilization effect of various bacterial strains, as representative contaminants with robots operated under different modules, the operating parameters of the moving speed, distance between the sample and the robot, and the radiation angle were determined. We anticipate that the sterilization effect data we obtained with our disinfection robot, to the best of our knowledge, for the first time, will serve as a type of stepping stone, leading to practical applications at various sites requiring disinfection.

Investigation of SARS-CoV-2 inactivation using UV-C LEDs in public environments via ray-tracing simulation.

This paper proposes an investigating SARS-CoV-2 inactivation on surfaces with UV-C LED irradiation using our in-house-developed ray-tracing simulator. The results are benchmarked with experiments and Zemax OpticStudio commercial software simulation to demonstrate our simulator's easy accessibility and high reliability. The tool can input the radiant profile of the flexible LED source and accurately yield the irradiance distribution emitted from an LED-based system in 3D environments. The UV-C operating space can be divided into the safe, buffer, and germicidal zones for setting up a UV-C LED system. Based on the published measurement data, the level of SARS-CoV-2 inactivation has been defined as a function of UV-C irradiation. A realistic case of public space, i.e., a food court in Singapore, has been numerically investigated to demonstrate the relative impact of environmental UV-C attenuation on the SARS-CoV-2 inactivation. We optimise a specific UV-C LED germicidal system and its corresponding exposure time according to the simulation results. These ray-tracing-based simulations provide a useful guideline for safe deployment and efficient design for germicidal UV-C LED technology.

Transparent Air Filters with Active Thermal Sterilization.

The worldwide proliferation of COVID-19 poses the urgent need for sterilizable and transparent air filters to inhibit virus transmission while retaining ease of communication. Here, we introduce copper nanowires to fabricate transparent and self-sterilizable air filters. Copper nanowire air filter (CNAF) allowed visible light penetration, thereby can exhibit facial expressions, helpful for better communication. CNAF effectively captured particulate matter (PM) by mechanical and electrostatic filtration mechanisms. The temperature of CNAF could be controlled by Joule-heating up to 100 °C with thermal stability. CNAF successfully inhibited the growth of E. coli because of the oligodynamic effect of copper. With heat sterilization, the antibacterial efficiency against G. anodireducens was greatly improved up to 99.3% within 10 min. CNAF showed high reusability with stable filtration efficiency and thermal antibacterial efficacy after five repeated uses. Our result suggests an alternative form of active antimicrobial air filter in preparation for the current and future pandemic situations.

Disinfection and Sterilization in Health Care Facilities: An Overview and Current Issues.

All invasive procedures involve contact by a medical device or surgical instrument with a patient's sterile tissue or mucous membranes. The level of disinfection is dependent on the intended use of the object: critical, semicritical, or noncritical. New issues and practices can affect the risk of infection associated with devices and surfaces. Endoscopes continue to represent a nosocomial hazard. The contaminated surface environment in hospital rooms is important in the transmission of health care-associated pathogens. Thoroughness of cleaning must be monitored and no-touch room decontamination technology should be. In general, emerging pathogens are susceptible to currently available disinfectants.

Can sterilization of disposable face masks be an alternative for imported face masks? A nationwide field study including 19 sterilization departments and 471 imported brand types during COVID-19 shortages.

BACKGROUND: Face masks, also referred to as half masks, are essential to protect healthcare professionals working in close contact with patients with COVID-19-related symptoms. Because of the Corona material shortages, healthcare institutions sought an approach to reuse face masks or to purchase new, imported masks. The filter quality of these masks remained unclear. Therefore, the aim of this study was to assess the quality of sterilized and imported FFP2/KN95 face masks. METHODS: A 48-minute steam sterilization process of single-use FFP2/KN95 face masks with a 15 minute holding time at 121°C was developed, validated and implemented in the Central Sterilization Departments (CSSD) of 19 different hospitals. Masks sterilized by steam and H2O2 plasma as well as new, imported masks were tested for particle filtration efficiency (PFE) and pressure drop in a custom-made test setup. RESULTS: The results of 84 masks tested on the PFE dry particle test setup showed differences of 2.3±2% (mean±SD). Test data showed that the mean PFE values of 444 sterilized FFP2 face masks from the 19 CSSDs were 90±11% (mean±SD), and those of 474 new, imported KN95/FFP2 face masks were 83±16% (mean±SD). Differences in PFE of masks received from different sterilization departments were found. CONCLUSION: Face masks can be reprocessed with 121 °C steam or H2O2 plasma sterilization with a minimal reduction in PFE. PFE comparison between filter material of sterilized masks and new, imported masks indicates that the filter material of most reprocessed masks of high quality brands can outperform new, imported face masks of unknown brands. Although the PFE of tested face masks from different sterilization departments remained efficient, using different types of sterilization equipment, can result in different PFE outcomes.

A life cycle assessment of reprocessing face masks during the Covid-19 pandemic.

The Covid-19 pandemic led to threatening shortages in healthcare of medical products such as face masks. Due to this major impact on our healthcare society an initiative was conducted between March and July 2020 for reprocessing of face masks from 19 different hospitals. This exceptional opportunity was used to study the costs impact and the carbon footprint of reprocessed face masks relative to new disposable face masks. The aim of this study is to conduct a Life Cycle Assessment (LCA) to assess and compare the climate change impact of disposed versus reprocessed face masks. In total 18.166 high quality medical FFP2 face masks were reprocessed through steam sterilization between March and July 2020. Greenhouse gas emissions during production, transport, sterilization and end-of-life processes were assessed. The background life cycle inventory data were retrieved from the ecoinvent database. The life cycle impact assessment method ReCiPe was used to translate emissions into climate change impact. The cost analysis is based on actual sterilization as well as associated costs compared to the prices of new disposable face masks. A Monte Carlo sampling was used to propagate the uncertainty of different inputs to the LCA results. The carbon footprint appears to be 58% lower for face masks which were reused for five times compared to new face masks which were used for one time only. The sensitivity analysis indicated that the loading capacity of the autoclave and rejection rate of face masks has a large influence on the carbon footprint. The estimated cost price of a reprocessed mask was €1.40 against €1.55. The Life Cycle Assessment demonstrates that reprocessed FFP2 face masks from a circular economy perspective have a lower climate change impact on the carbon footprint than new face masks. For policymakers it is important to realize that the carbon footprint of medical products such as face masks may be reduced by means of circular economy strategies. This study demonstrated a lower climate change impact and lower costs when reprocessing and reusing disposable face masks for five times. Therefore, this study may serve as an inspiration for investigating reprocessing of other medical products that may become scarce. Finally, this study advocates that circular design engineering principles should be taken into account when designing medical devices. This will lead to more sustainable products that have a lower carbon footprint and may be manufactured at lower costs.

Implementation of an Elastomeric Mask Program as a Strategy to Eliminate Disposable N95 Mask Use and Resterilization: Results from a Large Academic Medical Center.

BACKGROUND: The COVD-19 global pandemic has placed a large demand on personal protective equipment for healthcare workers. N-95 respirators, required to perform aerosolizing procedures, are in short supply and have increased significantly in cost. The lack of a clear end to the pandemic requires hospitals to create a long-term, cost effective solution to the N95 shortage. We initially used previously described methods to reuse and resterilize N95 masks; however, we found they did not solve the issues related to just-in-time fit-testing and cost. STUDY DESIGN: We initiated a program with the aim to reduce our dependence on N95 masks by initiating a phased program to acquire industrial style elastomeric P100 masks as a substitute for reuse and resterilization of disposable N95s. We created an allocation strategy based on availability of the masks, as well as an operational plan to fit test, educate, and disinfect the masks. RESULTS: Within 1 month, we were able to reduce the number of N95s needed by our network by 95%. We also found that the cost was, conservatively, 10 times less per month than purchasing disposable N95s, and the cost benefit increases the longer they are needed. CONCLUSIONS: Establishment of an elastomeric mask program is feasible and less expensive than programs focused on reusing and disinfecting disposable N95 masks. A well thought out elastomeric distribution and disinfection program does not pose greater operational challenges than an N95 reuse and resterilization program. In addition, elastomeric masks can be stored for future surges and should be considered an essential part of all healthcare facilities' supply of personal protective equipment. Implementation of the program has eliminated our dependence on disposable N95s to maintain normal operations during the global pandemic.

Reducing Setup and Turnover Times in the OR With an Innovative Sterilization Container: Implications for the COVID-19 Era Military Medicine.

INTRODUCTION: The global 2019 coronavirus pandemic (COVID-19) is setting unprecedented demands on the nation and the military and surgical services. Surgical demands include a large backlog of surgical cases, strain on available resources, and the need for additional measures to prevent exposure. The purpose of this project was to evaluate the feasibility, duration, adverse events, and potential gains associated with using a Turbett Sterilization Pod (TSP) for total joint replacements. MATERIALS AND METHODS: A multidisciplinary team used the Plan-Do-Study-Act model to guide this project. A time-motion study was completed in the operating room (OR) to measure the average time required to set up surgical instrumentation for total joint replacement cases that required 12 or more instrument trays. We compared the amount of time it took to complete the setting up of instrumentation using the traditional method versus the TSP method. The traditional method consisted of unwrapping each surgical tray, checking for holes in the blue wrapper, and placing the tray on the back table. In the case of the TSP, the door of the pod was opened, and the instrument trays were transferred directly to the back table. We measured the time the staff took to perform the task using each of these methods. RESULTS: When compared to the traditional method, the use of the TSP resulted in improved turnover time, decreased room setup time, reduced environmental waste, and eliminated both the effect of damage to wrappers and the time previously spent wrapping surgical trays. CONCLUSION: The TSP minimizes the time needed by the staff to set up an OR suite for a total joint replacement, therefore permitting them to focus more on direct patient care. This time improvement suggests that all surgical specialties, including those requiring greater than 12 traditional instrument sets, may experience reduced turnover time between cases. The use of the TSP is one means to help rectify the OR backlog brought on by COVID-19.