A narrative review on current duodenoscope reprocessing techniques and novel developments.

Duodenoscopy-associated infections occur worldwide despite strict adherence to reprocessing standards. The exact scope of the problem remains unknown because a standardized sampling protocol and uniform sampling techniques are lacking. The currently available multi-society protocol for microbial culturing by the Centers for Disease Control and Prevention, the United States Food and Drug Administration (FDA) and the American Society for Microbiology, published in 2018 is too laborious for broad clinical implementation. A more practical sampling protocol would result in increased accessibility and widespread implementation. This will aid to reduce the prevalence of duodenoscope contamination. To reduce the risk of duodenoscopy-associated pathogen transmission the FDA advised four supplemental reprocessing measures. These measures include double high-level disinfection, microbiological culturing and quarantine, ethylene oxide gas sterilization and liquid chemical sterilization. When the supplemental measures were advised in 2015 data evaluating their efficacy were sparse. Over the past five years data regarding the supplemental measures have become available that place the efficacy of the supplemental measures into context. As expected the advised supplemental measures have resulted in increased costs and reprocessing time. Unfortunately, it has also become clear that the efficacy of the supplemental measures falls short and that duodenoscope contamination remains a problem. There is a lot of research into new reprocessing methods and technical applications trying to solve the problem of duodenoscope contamination. Several promising developments such as single-use duodenoscopes, electrolyzed acidic water, and vaporized hydrogen peroxide plasma are already applied in a clinical setting.

Applying heat and humidity using stove boiled water for decontamination of N95 respirators in low resource settings.

Global shortages of N95 respirators have led to an urgent need of N95 decontamination and reuse methods that are scientifically validated and available world-wide. Although several large scale decontamination methods have been proposed (hydrogen peroxide vapor, UV-C); many of them are not applicable in remote and low-resource settings. Heat with humidity has been demonstrated as a promising decontamination approach, but care must be taken when implementing this method at a grassroots level. Here we present a simple, scalable method to provide controlled humidity and temperature for individual N95 respirators which is easily applicable in low-resource settings. N95 respirators were subjected to moist heat (>50% relative humidity, 65-80°C temperature) for over 30 minutes by placing them in a sealed container immersed in water that had been brought to a rolling boil and removed from heat, and then allowing the containers to sit for over 45 minutes. Filtration efficiency of 0.3-4.99 µm incense particles remained above 97% after 5 treatment cycles across all particle size sub-ranges. This method was then repeated at a higher ambient temperature and humidity in Mumbai, using standard utensils commonly found in South Asia. Similar temperature and humidity profiles were achieved with no degradation in filtration efficiencies after 6 cycles. Higher temperatures (>70°C) and longer treatment times (>40 minutes) were obtained by insulating the outer vessel. We also showed that the same method can be applied for the decontamination of surgical masks. This simple yet reliable method can be performed even without electricity access using any heat source to boil water, from open-flame stoves to solar heating, and provides a low-cost route for N95 decontamination globally applicable in resource-constrained settings.

Adequate PPE Is Finally Within Reach.

The challenge now is ensuring distribution and proper use.

Performance and impact of disposable and reusable respirators for healthcare workers during pandemic respiratory disease: a rapid evidence review.

OBJECTIVES: To synthesise evidence concerning the range of filtering respirators suitable for patient care and guide the selection and use of different respirator types. DESIGN: Comparative analysis of international standards for respirators and rapid review of their performance and impact in healthcare. DATA SOURCES: Websites of international standards organisations, Medline and Embase, hand-searching of references and citations. STUDY SELECTION: Studies of healthcare workers (including students) using disposable or reusable respirators with a range of designs. We examined respirator performance, clinician adherence and performance, comfort and impact, and perceptions of use. RESULTS: We included standards from eight authorities across Europe, North and South America, Asia and Australasia and 39 research studies. There were four main findings. First, international standards for respirators apply across workplace settings and are broadly comparable across jurisdictions. Second, effective and safe respirator use depends on proper fitting and fit testing. Third, all respirator types carry a burden to the user of discomfort and interference with communication which may limit their safe use over long periods; studies suggest that they have little impact on specific clinical skills in the short term but there is limited evidence on the impact of prolonged wearing. Finally, some clinical activities, particularly chest compressions, reduce the performance of filtering facepiece respirators. CONCLUSION: A wide range of respirator types and models is available for use in patient care during respiratory pandemics. Careful consideration of performance and impact of respirators is needed to maximise protection of healthcare workers and minimise disruption to care.

Analysis of SteraMist ionized hydrogen peroxide technology in the sterilization of N95 respirators and other PPE.

The COVID-19 pandemic has led to widespread shortages of personal protective equipment (PPE) for healthcare workers, including of N95 masks (filtering facepiece respirators; FFRs). These masks are intended for single use but their sterilization and subsequent reuse has the potential to substantially mitigate shortages. Here we investigate PPE sterilization using ionized hydrogen peroxide (iHP), generated by SteraMist equipment (TOMI; Frederick, MD), in a sealed environment chamber. The efficacy of sterilization by iHP was assessed using bacterial spores in biological indicator assemblies. After one or more iHP treatments, five models of N95 masks from three manufacturers were assessed for retention of function based on their ability to form an airtight seal (measured using a quantitative fit test) and filter aerosolized particles. Filtration testing was performed at a university lab and at a National Institute for Occupational Safety and Health (NIOSH) pre-certification laboratory. The data demonstrate that N95 masks sterilized using SteraMist iHP technology retain filtration efficiency up to ten cycles, the maximum number tested to date. A typical iHP environment chamber with a volume of ~ 80 m3 can treat ~ 7000 masks and other items (e.g. other PPE, iPADs), making this an effective approach for a busy medical center.

Quantitative UV-C dose validation with photochromic indicators for informed N95 emergency decontamination.

With COVID-19 N95 shortages, frontline medical personnel are forced to reuse this disposable-but sophisticated-multilayer respirator. Widely used to decontaminate nonporous surfaces, UV-C light has demonstrated germicidal efficacy on porous, non-planar N95 respirators when all surfaces receive ≥1.0 J/cm2 dose. Of utmost importance across disciplines, translation of empirical evidence to implementation relies upon UV-C measurements frequently confounded by radiometer complexities. To enable rigorous on-respirator measurements, we introduce a photochromic indicator dose quantification technique for: (1) UV-C treatment design and (2) in-process UV-C dose validation. While addressing outstanding indicator limitations of qualitative readout and insufficient dynamic range, our methodology establishes that color-changing dosimetry can achieve the necessary accuracy (>90%), uncertainty (<10%), and UV-C specificity (>95%) required for UV-C dose measurements. In a measurement infeasible with radiometers, we observe a striking ~20× dose variation over N95s within one decontamination system. Furthermore, we adapt consumer electronics for accessible quantitative readout and use optical attenuators to extend indicator dynamic range >10× to quantify doses relevant for N95 decontamination. By transforming photochromic indicators into quantitative dosimeters, we illuminate critical considerations for both photochromic indicators themselves and UV-C decontamination processes.

COVID-19 Solutions Are Climate Solutions: Lessons From Reusable Gowns.

The COVID-19 pandemic has laid bare the inadequacy of the U.S. healthcare system to deliver timely and resilient care. According to the American Hospital Association, the pandemic has created a $202 billion loss across the healthcare industry, forcing health care systems to lay off workers and making hospitals scramble to minimize supply chain costs. However, as the demand for personal protective equipment (PPE) grows, hospitals have sacrificed sustainable solutions for disposable options that, although convenient, will exacerbate supply strains, financial burden, and waste. We advocate for reusable gowns as a means to lower health care costs, address climate change, and improve resilience while preserving the safety of health care workers. Reusable gowns' polyester material provides comparable capacity to reduce microbial cross-transmission and liquid penetration. In addition, previous hospitals have reported a 50% cost reduction in gown expenditures after adopting reusable gowns; given the current 2000% price increase in isolation gowns during COVID-19, reusable gown use will build both healthcare resilience and security from price fluctuations. Finally, with the United States' medical waste stream worsening, reusable isolation gowns show promising reductions in energy and water use, solid waste, and carbon footprint. The gowns are shown to withstand laundering 75-100 times in contrast to the single-use disposable gown. The circumstances of the pandemic forewarn the need to shift our single-use PPE practices to standardized reusable applications. Ultimately, sustainable forms of protective equipment can help us prepare for future crises that challenge the resilience of the healthcare system.

The impact of extreme reuse and extended wear conditions on protection provided by a surgical-style N95 filtering facepiece respirator.

Most respirators employed in health care settings, and often in first responder and industrial settings, are intended for single-use: the user dons the respirator, performs a work activity, and then doffs and discards the respirator. However, in the current COVID-19 pandemic, in the presence of persistent shortages of personal protective equipment, extended use and reuse of filtering facepiece respirators are routinely contemplated by many health care organizations. Further, there is considerable current effort to understand the effect of sterilization on the possibility of reuse, and some investigations of performance have been conducted. While the ability of such a respirator to continue to provide effective protection after repeated sanitization cycles is a critical component of implementing its reuse, of equal importance is an understanding of the impact that reusing the respirator multiple times in a day while performing work tasks, and even extending its wear over multiple days, has on the workplace protective performance. In this study, we subjected a stockpiled quantitatively fitted surgical style N95 filtering facepiece respirator device to extreme reuse and extended wear conditions (up to 19 uses over a duration of 5 days) and measured its protective performance at regular intervals, including simulated workplace protection factor measurements using total inward leakage. With this respirator, it was shown to be possible to maintain protection corresponding to an assigned protection factor greater than 10 under extreme usage conditions provided an individual is properly trained in the use of, and expertly fitted in, the respirator. Other factors such as hygiene and strap breakage are likely to place limits on reuse.

N95 mask reuse in a major urban hospital: COVID-19 response process and procedure.

BACKGROUND: The shortage of single-use N95 respirator masks (NRMs) during the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has prompted consideration of NRM recycling to extend limited stocks by healthcare providers and facilities. AIM: To assess potential reuse via autoclaving of NRMs worn daily in a major urban Canadian hospital. METHODS: NRM reusability was assessed following collection from volunteer staff after 2-8 h use, sterilization by autoclaving and PortaCount fit testing. A workflow was developed for reprocessing hundreds of NRMs daily. FINDINGS: Used NRMs passed fit testing after autoclaving once, with 86% passing a second reuse/autoclave cycle. A separate cohort of used masks pre-warmed before autoclaving passed fit testing. To recycle 200-1000 NRMs daily, procedures for collection, sterilization and re-distribution were developed to minimize particle aerosolization risk during NRM handling, to reject NRM showing obvious wear, and to promote adoption by staff. NRM recovery ranged from 49% to 80% across 12 collection cycles. CONCLUSION: Reuse of NRMs is feasible in major hospitals and other healthcare facilities. In sharp contrast to studies of unused NRMs passing fit testing after 10 autoclave cycles, we show that daily wear substantially reduces NRM fit, limiting reuse to a single cycle, but still increasing NRM stocks by ∼66%. Such reuse requires development of a comprehensive plan that includes communication across staffing levels, from front-line workers to hospital administration, to increase the collection, acceptance of and adherence to sterilization processes for NRM recovery.

Ultraviolet germicidal irradiation for filtering facepiece respirators disinfection to facilitate reuse during COVID-19 pandemic: A review.

BACKGROUND: To review the effect of ultraviolet germicidal irradiation (UVGI) as a disinfection method for filtering facepiece respirators (FFRs) to facilitate reuse during COVID-19 pandemic. METHODS: Systematic review of the research concerning UVGI for FFRs disinfection to facilitate reuse (also termed limited reuse) during respiratory infectious diseases where aerosol transmission is considered possible. RESULTS: UVGI is one possible method for respiratory disinfection to facilitate the reuse of dwindling supplies. Appropriate dose UVGI exposition could provide enough energy to effectively decontaminate respiratory viral agents and maintain respirator's integrity for reuse. There was not currently sufficient research evidence on the effect of UVGI to inactivate coronaviruses SARS-CoV-2, and the practical application of UVGI is still unclear. . CONCLUSION: Appropriate dose UVGI exposition could provide enough energy to effectively decontaminate respiratory viral agents and maintain respirator's integrity for reuse. Further evidence concerning UVGI as a decontamination technique specifically for SARS-CoV-2 isneeded.

Decontamination interventions for the reuse of surgical mask personal protective equipment: a systematic review.

BACKGROUND: The high demand for personal protective equipment during the novel coronavirus outbreak has prompted the need to develop strategies to conserve supply. Little is known regarding decontamination interventions to allow for surgical mask reuse. AIM: To identify and synthesize data from original research evaluating interventions to decontaminate surgical masks for the purpose of reuse. METHODS: MEDLINE, Embase, CENTRAL, Global Health, the WHO COVID-19 database, Google Scholar, DisasterLit, preprint servers, and prominent journals from inception to April 8th, 2020, were searched for prospective original research on decontamination interventions for surgical masks. Citation screening was conducted independently in duplicate. Study characteristics, interventions, and outcomes were extracted from included studies by two independent reviewers. Outcomes of interest included impact of decontamination interventions on surgical mask performance and germicidal effects. FINDINGS: Seven studies met eligibility criteria: one evaluated the effects of heat and chemical interventions applied after mask use on mask performance, and six evaluated interventions applied prior to mask use to enhance antimicrobial properties and/or mask performance. Mask performance and germicidal effects were evaluated with heterogeneous test conditions. Safety outcomes were infrequently evaluated. Mask performance was best preserved with dry heat decontamination. Good germicidal effects were observed in salt-, N-halamine-, and nanoparticle-coated masks. CONCLUSION: There is limited evidence on the safety or efficacy of surgical mask decontamination. Given the heterogeneous methods used in studies to date, we are unable to draw conclusions on the most efficacious and safe intervention for decontaminating surgical masks.

Reuse of syringes for therapeutic injections in Pakistan: rethinking determinants.

BACKGROUND: Frequent reuse of syringes during medical injections is fuelling epidemics of human immunodeficiency virus and hepatitis C virus infections in many low- and middle-income countries including Pakistan. AIMS: To explore specific factors related to syringe reuse during therapeutic injections. METHODS: We randomly surveyed 319 healthcare providers from 2 socioeconomically diverse districts in Pakistan, along with 625 of their patients. RESULTS: Providers see 12-25 patients per day, and provide 7-14 therapeutic injections or intravenous drips. Comparing daily stocks with injections provided, we estimated that 38% of providers (Rawalpindi: 14%, Tando Allah Yar: 44%) likely reuse syringes 2 or 3 times. Rural location and longer duration of practice predict a higher likelihood of reuse. Physicians and non-physicians were equally likely to reuse. Most patients were unaware when a syringe had been reused. CONCLUSIONS: High rate of syringe reuse is driven by high injection demand by patients, to which providers comply. Patients are generally unaware of the harm of injections with syringe reuse or that reuse happens. Our findings suggest that patient focused approaches may help reduce syringe reuse.

An Environmental Analysis of Reusable and Disposable Surgical Gowns.

Surgical gowns help protect patients from exposure to microorganisms and serve as personal protective equipment for perioperative staff members. Medical textiles, including surgical gowns, are available as reusable and disposable products. Health care facility administrators and leaders who endeavor to use environmentally sustainable practices require current data for decision making. This study analyzed all activities from the extraction of fossil materials from the earth to the end-of-life disposal of reusable and disposable surgical gowns. The researchers included calculations for laundry and wastewater treatment operations and compared the environmental effects of the two surgical gown systems. The study results showed that selection of reusable gowns rather than disposable gowns reduced natural resource energy consumption (64%), greenhouse gas emissions (66%), blue water consumption (83%), and solid waste generation (84%). Perioperative nurses can use this information to assist facility leaders as they make informed decisions related to gown system selection.

Patient Notification Events Due to Syringe Reuse and Mishandling of Injectable Medications by Health Care Personnel-United States, 2012-2018: Summary and Recommended Actions for Prevention and Response.

OBJECTIVES: To summarize patient notifications resulting from unsafe injection practices by health care personnel in the United States and describe recommended actions for prevention and response. PATIENTS AND METHODS: We examined records of events involving communications to groups of patients, conducted from January 1, 2012, through December 31, 2018, in which bloodborne pathogen testing was recommended or offered because of potential exposure to unsafe injection practices by health care personnel in the United States. Information compiled included: health care setting(s), type of unsafe injection practice(s), number of patients notified, number of outbreak-associated infections, and whether evidence suggesting bloodborne pathogen transmission prompted the notification. We compared these numbers with a similar review conducted from January 1, 2001, through December 31, 2011. RESULTS: From 2012 through 2018, more than 66,748 patients were notified as part of 38 patient notification events. Twenty-one involved exposures in non-hospital settings. Twenty-five involved syringe and/or needle reuse in the context of routine patient care; 11 involved drug tampering by a health care provider. The majority of events (n=25) were prompted by identification of unsafe injection practices alone, absent any documented infections at the time of notification. Outbreak-associated hepatitis B virus and/or hepatitis C virus infections were documented for 11 of the events; 8 involved patient-to-patient transmission, and 3 involved provider-to-patient transmission. CONCLUSIONS: Since 2001, nearly 200,000 patients in the United States were notified about potential exposure to blood-contaminated medications or injection equipment. Facility leadership has an obligation to ensure adherence to safe injection practices and to respond properly if unsafe injection practices are identified.

The Effect on Fit of Multiple Consecutive Donning and Doffing of N95 Filtering Facepiece Respirators.

BACKGROUND: N95 filtering facepiece respirators (FFRs) are widely used in healthcare to reduce transmission of airborne infectious diseases. These respirators are generally described as single use or limited reuse devices, but cost and operational issues mean that they may be donned and doffed multiple times. There is scant research on the effect of this practice on adequacy of fit. OBJECTIVE: The purpose of this study was to measure the effect on respirator fit of multiple donning and doffing of N95 FFRs. METHODS: This was an experiment in which 16 women and 9 men employed by the National Institute for Occupational Health (NIOH), Johannesburg, donned their same N95 FFR six times. All 25 were trained in the correct wearing of the devices before the experiment. Four models of respirators were used: the six who did not use respirators at work (novice subjects) were issued a 3M 1860 FFR and the others used their currently supplied one. During the experiment subjects donned their respirators under the supervision of the tester. Quantitative fit testing was done in the NIOH Occupational Hygiene laboratory after each donning according to the OSHA-Accepted Fit Test Protocol using the TSI PortaCount Pro+ Model 8038 Respirator Fit Tester. During the test, fit was measured after each of seven exercises and then an overall fit factor was computed. Only individuals who achieved an initial overall fit factor of ≥100 were allowed to continue participation in the study. Median overall fit factors were calculated for the 25 subjects for each donning and changes across them was examined using Wilcoxon rank sum tests. Men and women and frequent and infrequent users were compared across the six tests. Infrequent use was defined as subjects who wore respirators ≤ once per week, and novice subjects. RESULTS: Two subjects (8%) had an overall fit factor <100 at fit Test 2, 6 (24%) at Test 3, and 8 (32%) at Tests 4, 5, and 6. Thirteen respirator users (52%) achieved ≥100 throughout the fit testing, so 12 had at least one failure at either Tests 2-6. Five of the 12 subjects with at least one failure showed persistent failures on all subsequent donnings. Six subjects out of 12 (50%) who failed a fit test achieved an overall fit factor >100 at a subsequent test. There was a significant difference between the median first and sixth overall fit factors (195 versus 150; P = 0.0271), but not between the second and sixth (161 versus 150; P = 0.3584). Men and women had similar overall fit factors, but infrequent users had larger average overall fit factors than frequent users after all six donnings. CONCLUSION: Forty-eight percent of study subjects failed at least one fit test after re-donning an N95 FFR. The fit test data suggest that donning practices probably accounted for the fit test failures. The 50% of subjects who produced overall fit factors ≥100 after a test of <100 supports this contention.

A comprehensive literature-based equation to compare cost-effectiveness of a flexible ureteroscopy program with single-use versus reusable devices.

PURPOSE: To critically review all literature concerning the cost-effectiveness of flexible ureteroscopy comparing single-use with reusable scopes. MATERIALS AND METHODS: A systematic online literature review was performed in PubMed, Embase and Google Scholar databases. All factors potentially affecting surgical costs or clinical outcomes were considered. Prospective assessments, case control and case series studies were included. RESULTS: 741 studies were found. Of those, 18 were duplicated and 77 were not related to urology procedures. Of the remaining 646 studies, 59 were considered of relevance and selected for further analysis. Stone free and complication rates were similar between single-use and reusable scopes. Operative time was in average 20% shorter with digital scopes, single-use or not. Reusable digital scopes seem to last longer than optic ones, though scope longevity is very variable worldwide. New scopes usually last four times more than refurbished ones and single-use ureterorenoscopes have good resilience throughout long cases. Longer scope longevity is achieved with Cidex and if a dedicated nurse takes care of the sterilization process. The main surgical factors that negatively impact device longevity are lower pole pathologies, large stone burden and non-use of a ureteral access sheath. We have built a comprehensive fi nancial costeffective decision model to fl exible ureteroscope acquisition. CONCLUSIONS: The cost-effectiveness of a fl exible ureteroscopy program is dependent of several aspects. We have developed a equation to allow a literature-based and adaptable decision model to every interested stakeholder. Disposable devices are already a reality and will progressively become the standard as manufacturing price falls.

Injection practices in 2011-2015: a review using data from the demographic and health surveys (DHS).

BACKGROUND: Reuse of injection devices to give healthcare injections decreased from 39.8 to 5.5% between 2000 and 2010, but trends since 2011 have not been described. We reviewed results of Demographic and Health Surveys (DHS) to describe injection practices worldwide from 2011 to 2015. METHODS: We searched the DHS Internet site for data published on injection practices conducted in countries from 2011 to 2015, extracted information on frequency (number of healthcare injections per person in the last 12 months) and safety (proportion of syringes and needles taken from a new, unopened package). We compared gender groups and WHO regions in terms of frequency and safety. For countries with data available, we compared injection practices 2004-2010 and 2011-2015. RESULTS: Since 2011, 40 of 92 countries (43%) that conducted DHS surveys reported on injection practices. On average, the frequency of injection was 1.64 per person per year (from 3.84 in WHO Eastern Mediterranean region to 1.18 in WHO African region). Among those, 96.1% of injections reportedly used new injection devices (from 90.2% in the WHO Eastern Mediterranean region to 98.8% in the WHO Western Pacific region). On average, women received more injections per year (1.85) than men (1.41). Among 16 (40%) countries with data in 2004-2010 and 2011-2015, 69% improved in terms of safety. The annual number of unsafe injections reduced in 81% of countries. In Pakistan, the number of unsafe injections was the highest and did not decrease between 2006 and 2012. CONCLUSIONS: Injection practices have continued to improve in most countries worldwide, although the Eastern Mediterranean region in particular still faces unsafe practices that are not improving. Further efforts are needed to eliminate unsafe injection practices in health care settings, including through the use of reuse-prevention devices. Despite some limitations, DHS is an easily available method to measure progress over time.

A comprehensive literature-based equation to compare cost-effectiveness of a flexible ureteroscopy program with single-use versus reusable devices

ABSTRACT Purpose to critically review all literature concerning the cost-effectiveness of flexible ureteroscopy comparing single-use with reusable scopes. Materials and Methods A systematic online literature review was performed in PubMed, Embase and Google Scholar databases. All factors potentially affecting surgical costs or clinical outcomes were considered. Prospective assessments, case control and case series studies were included. Results 741 studies were found. Of those, 18 were duplicated and 77 were not related to urology procedures. Of the remaining 646 studies, 59 were considered of relevance and selected for further analysis. Stone free and complication rates were similar between single-use and reusable scopes. Operative time was in average 20% shorter with digital scopes, single-use or not. Reusable digital scopes seem to last longer than optic ones, though scope longevity is very variable worldwide. New scopes usually last four times more than refurbished ones and single-use ureterorenoscopes have good resilience throughout long cases. Longer scope longevity is achieved with Cidex and if a dedicated nurse takes care of the sterilization process. The main surgical factors that negatively impact device longevity are lower pole pathologies, large stone burden and non-use of a ureteral access sheath. We have built a comprehensive financial cost-effective decision model to flexible ureteroscope acquisition. Conclusions The cost-effectiveness of a flexible ureteroscopy program is dependent of several aspects. We have developed a equation to allow a literature-based and adaptable decision model to every interested stakeholder. Disposable devices are already a reality and will progressively become the standard as manufacturing price falls.