How to improve regulatory practices for refurbished medical devices.

Modern health-care facilities rely on medical devices and equipment. However, keeping up with the development of new technology is unfeasible for many health facilities, especially in low-resource settings. Thus, the demand for refurbished medical devices is increasing worldwide, especially in low- and middle-income countries. Refurbished medical devices are restored devices that are rebuilt to meet safety and performance requirements comparable to their condition when new, without changing the intended use of the original device. While new medical devices are controlled by well-established and stringent safety and quality regulations, a great variation in the regulations of refurbished medical devices exists across countries. Here we discuss the different regulations and practices specific to refurbished medical devices in countries of major markets. We also explore the opportunities and challenges for expanding the refurbished medical device market. Finally, we suggest that regulatory guidelines pertaining to the import, sale, labelling and use of a refurbished medical product are needed, and authorities should implement these guidelines to ensure a high quality and safety standard of refurbished devices.

Les établissements de soins de santé modernes dépendent d'équipements et dispositifs médicaux. Pour nombre de ces établissements, il est toutefois impossible de suivre l'évolution des nouvelles technologies, surtout dans les lieux manquant de ressources. La demande en dispositifs médicaux remis à neuf est donc en hausse partout dans le monde, en particulier dans les pays à revenu faible et intermédiaire. Il s'agit de dispositifs restaurés, remaniés pour répondre aux mêmes exigences de sécurité et de performances que lorsqu'ils sont neufs, sans que l'usage prévu du dispositif d'origine ne soit modifié. Alors que les dispositifs médicaux neufs sont soumis à des normes de qualité et de sécurité strictes et bien établies, leurs équivalents restaurés font l'objet de règles nettement plus variables d'un pays à l'autre. Dans le présent document, nous évoquons les différentes réglementations et pratiques spécifiques aux dispositifs médicaux remis à neuf dans les pays qui abritent les principaux marchés. Nous nous intéressons en outre aux opportunités et aux défis liés à un développement du marché des dispositifs médicaux remis à neuf. Enfin, nous suggérons l'adoption de lignes directrices réglementaires concernant l'importation, la vente, l'étiquetage et l'utilisation de tels dispositifs; ces lignes directrices sont à faire appliquer par les autorités afin de garantir les normes les plus élevées en matière de qualité et de sécurité.

Los centros sanitarios modernos dependen de dispositivos y equipos médicos. Sin embargo, mantenerse al día en el desarrollo de las nuevas tecnologías no es viable para muchos centros sanitarios, sobre todo en los de escasos recursos. Por este motivo, la demanda de dispositivos médicos renovados está aumentando en todo el mundo, especialmente en los países de ingresos bajos y medios. Los dispositivos médicos renovados son dispositivos restaurados que se reconstruyen para que cumplan unos requisitos de seguridad y rendimiento comparables a los que tenían cuando eran nuevos, sin cambiar el uso previsto del dispositivo original. Mientras que los dispositivos médicos nuevos están sujetos a reglamentos estrictos y bien establecidos en materia de seguridad y calidad, los reglamentos de los dispositivos médicos renovados varían mucho de un país a otro. En este artículo, se analizan los diferentes reglamentos y prácticas específicos de los dispositivos médicos renovados en los países de los principales mercados. También se exploran las oportunidades y los desafíos que plantea la expansión del mercado de dispositivos médicos renovados. Por último, se propone que se establezcan directrices reglamentarias relativas a la importación, venta, etiquetado y uso de los dispositivos médicos renovados y que las autoridades las apliquen para asegurar su calidad y seguridad.

Infection control in the bronchoscopy suite: effective reprocessing and disinfection of reusable bronchoscopes.

PURPOSE OF REVIEW: With advancements in technology, flexible bronchoscopes have become thinner in diameter and in need of more thorough reprocessing to prevent infection transmission than ever before. Many experienced bronchoscopists are not aware of the critical steps involved in effective bronchoscope reprocessing and we hope to bridge this gap by describing this process in detail. RECENT FINDINGS: Bronchoscope reprocessing includes several distinct steps (precleaning, leak testing, manual cleaning, visual inspection, terminal reprocessing, rinsing and drying). Each step is comprehensive and needs to be carried out systematically by trained personnel. Failure of any step can lead to serious downstream events such as outbreaks and pseudo-outbreaks. Some experts now recommend sterilization when feasible, although high-level disinfection remains the minimum standard. We also will review some literature on the utility of borescopes, automated endoscope reprocessors and disposable bronchoscopes. SUMMARY: Our article will focus on the most recent recommendations for effective reprocessing and disinfection of reusable bronchoscopes.

Reconciling human health with the environment while struggling against the COVID-19 pandemic through improved face mask eco-design.

Surgical masks have become critical for protecting human health against the COVID-19 pandemic, even though their environmental burden is a matter of ongoing debate. This study aimed at shedding light on the environmental impacts of single-use (i.e., MD-Type I) versus reusable (i.e., MD-Type IIR) face masks via a comparative life cycle assessment with a cradle-to-grave system boundary. We adopted a two-level analysis using the ReCiPe (H) method, considering both midpoint and endpoint categories. The results showed that reusable face masks created fewer impacts for most midpoint categories. At the endpoint level, reusable face masks were superior to single-use masks, producing scores of 16.16 and 84.20 MPt, respectively. The main environmental impacts of single-use masks were linked to raw material consumption, energy requirements and waste disposal, while the use phase and raw material consumption made the most significant contribution for reusable type. However, our results showed that lower environmental impacts of reusable face masks strongly depend on the use phase since reusable face masks lost their superior performance when the hand wash scenario was tested. Improvement of mask eco-design emerged as another key factor such as using more sustainable raw materials and designing better waste disposal scenarios could significantly lower the environmental impacts.

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.

Elastomeric Respirators for COVID-19 and the Next Respiratory Virus Pandemic: Essential Design Elements.

Respiratory viruses are transmitted via respiratory particles that are emitted when people breath, speak, cough, or sneeze. These particles span the size spectrum from visible droplets to airborne particles of hundreds of nanometers. Barrier face coverings ("cloth masks") and surgical masks are loose-fitting and provide limited protection from airborne particles since air passes around the edges of the mask as well as through the filtering material. Respirators, which fit tightly to the face, provide more effective respiratory protection. Although healthcare workers have relied primarily on disposable filtering facepiece respirators (such as N95) during the COVID-19 pandemic, reusable elastomeric respirators have significant potential advantages for the COVID-19 and future respiratory virus pandemics. However, currently available elastomeric respirators were not designed primarily for healthcare or pandemic use and require further development to improve their suitability for this application. The authors believe that the development, implementation, and stockpiling of improved elastomeric respirators should be an international public health priority.

The properties of hot household hygroscopic materials and their potential use for non-medical facemask decontamination.

The widespread use of facemasks throughout the population is recommended by the WHO to reduce transmission of the SARS-CoV-2 virus. As some regions of the world are facing mask shortages, reuse may be necessary. However, used masks are considered as a potential hazard that may spread and transmit disease if they are not decontaminated correctly and systematically before reuse. As a result, the inappropriate decontamination practices that are commonly witnessed in the general public are challenging management of the epidemic at a large scale. To achieve public acceptance and implementation, decontamination procedures need to be low-cost and simple. We propose the use of hot hygroscopic materials to decontaminate non-medical facemasks in household settings. We report on the inactivation of a viral load on a facial mask exposed to hot hygroscopic materials for 15 minutes. As opposed to recent academic studies whereby decontamination is achieved by maintaining heat and humidity above a given value, a more flexible procedure is proposed here using a slow decaying pattern, which is both effective and easier to implement, suggesting straightforward public deployment and hence reliable implementation by the population.

Effectiveness of oolong tea and simethicone solution for lens cleansing during colonoscopy: A double-blinded randomized study.

BACKGROUND AND AIMS: water is an imperfect agent for lens cleansing during endoscopy due to its incompetence to clean hydrophobic dirt, whereas amphiphilic surfactants have the potential to overcome the limitation of water. The trial was aimed to evaluate the cleansing effectiveness of 2 typical surfactants (simethicone solution and oolong tea) for colonoscopic lens. METHODS: Oolong tea (O-), low concentration simethicone solution (S1-), high concentration simethicone solution (S2-) and distilled water (D-) were used as washing solutions for colonoscopic lens. Study I: The tip of the colonoscope was immersed in lard oil in order to simulate the blur, and photographs were taken toward a standard colonoscopy image in-vitro pre- and post- each cleansing procedure. The blurred areas of each image were quantified and compared. Study II: 395 consecutive patients who were due to colonoscopy examination were enrolled and randomized into O-, S2-, D-group. The volume of washing solution used and cleansing level during the examination procedure, adenoma and polyp detected per colonoscopy, insertion time and withdraw time were analyzed. RESULTS: Study I: There were no differences in 4 groups for the blurred areas on images before lens cleansing. The blurred areas after lens cleansing were significantly smaller in 3 groups (O- 8.47 ±â€Š20.91 vs S1- 13.06 ±â€Š10.71 vs S2- 6.76 ±â€Š8.49 vs D- 38.24 ±â€Š29.69, P < .05) than water. The decline range of blurred areas after lens cleansing in oolong tea, low concentration simethicone solution, high concentration simethicone solution groups were significantly higher than that in distilled water group (O- 87.35 ±â€Š20.81 vs S1- 78.12 ±â€Š19.24 vs S2- 89.57 ±â€Š8.50 vs D- 53.39 ±â€Š28.45, P < .05). Study II: The volume of washing solution used in S2-group was significantly smaller than that in O-group and D-group. The cleansing level of the colonoscopic lens of O-group was significantly superior than that of S2-group and D-group. CONCLUSIONS: The in-vitro test showed oolong tea and simethicone solution can effectively cleans the colonoscopic lens. The clinical trial demonstrated that oolong tea instead of water is effective to provide better visualization during colonoscopy.Registration: Chictr.org.cn No: ChiCTR1900025606.

Comparación de los desenlaces clínicos con cuatro técnicas de apendicetomía laparoscópica tras la implementación de políticas de reúso de dispositivos médicos / Comparison of clinical outcomes with four laparoscopic appendectomy techniques after implementation of medical devices reuse policy

Resumen Objetivo: En este estudio se comparan los desenlaces clínicos de cuatro técnicas de apendicectomía laparoscópica utilizadas en una institución colombiana para el manejo de la apendicitis aguda tras la adopción de políticas de reúso y reprocesamiento de dispositivos médicos para la Región de las Américas (2014). Materiales y Método: Mediante el análisis de varianza de una vía (ANOVA) y la prueba de Kruskal Wallis, se compararon las tasas de infección de sitio operatorio (ISO), reoperación no planeada, readmisión y mortalidad (en los primeros 30 días del postoperatorio) de las siguientes técnicas: Técnica 1: Ligadura del muñón apendicular con endonudo y disección del mesenterio apendicular con electrocoagulación bipolar convencional; Técnica 2: Clipaje del muñón con endoclip de polímero y disección del mesenterio con electrocoagulación bipolar convencional; Técnica 3: Clipaje del muñón con endoclip de polímero y disección del mesenterio con electrocoagulación monopolar; Técnica 4: Clipaje del muñón y disección roma y ligadura del mesenterio con endoclip de polímero. Resultados: Se incluyeron 551 pacientes. No se encontraron diferencias en los ANOVAs en cuanto a las características demográficas de los pacientes por cada técnica. Los desenlaces globales fueron: ISO (5,44%), reoperación no planeada (3,08%), readmisión (15,97%) y mortalidad (0,18%). Se encontraron diferencias significativas (p < 0,05) en estos desenlaces explicados por mayores tasas de ISO y reoperación con la Técnica-1. Conclusiones: Los desenlaces globales de la apendicectomía laparoscópica tras la adopción de políticas de reúso de dispositivos médicos se encuentran dentro de los aceptados globalmente cuando se utilizan las Técnicas 2-3-4 en poblaciones equivalentes de pacientes con apendicitis aguda. En este contexto, nuestros resultados invitan a utilizar con precaución la Técnica-1.

Aim: The present study sought to compare the clinical outcomes between four operative techniques for laparoscopic appendectomy in a Colombian institution, following the adoption of reuse and reprocessing policies for medical devices in the Region of Americas (2014). Materials and Methods: One-way analysis of variance (ANOVA) and Kruskal Wallis tests were used to compare the rates of Surgical Site Infection (SSI), unplanned reoperation, readmission and mortality (confined to 30 days after surgery) of these operative techniques: Technique 1: Ligature of appendiceal stump with endo stitch plus mesenteric dissection with conventional bipolar electrocoagulation; Technique 2: Clipping of stump with polymer endoclip plus mesenteric dissection with conventional bipolar electrocoagulation; Technique 3: Clipping of stump with polymer endoclip plus mesenteric dissection with monopolar electrocoagulation; Technique 4: Clipping of stump plus mesenteric dissection with polymer endoclip. Results: A total of 551 patients were included. No differences were found in the demographic characteristics of the patients between techniques during ANOVAs. The global outcomes were SSI (5.44%), unplanned reoperation (3.08%), readmission (15.97%) and mortality (0.18%). Significant differences were found (p < 0.05) in these outcomes explained by higher rates of SSI and unplanned reoperation with Technique 1. Conclusions: The overall outcomes of laparoscopic appendectomy, after the adoption of policies for the reuse and reprocessing of medical devices, are similar to those accepted globally when using operative techniques 2-3-4 in equivalent populations of patients with acute appendicitis. In this context, our results invite to use with caution technique-1.

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.

Decontaminating N95 Respirators for Reuse in a Hospital Setting.

With the global outbreak of the COVID-19 pandemic, hospitals in Canada and around the world have been forced to consider conservation strategies to ensure continued availability of personal protective equipment (PPE) for healthcare providers. To mitigate critical PPE shortages, Sinai Health System (Sinai Health), a large academic healthcare institution in Canada, has developed and operationalized a standard operating procedure for the collection, decontamination and reuse of N95 respirators and other single-use PPE using a vaporized hydrogen peroxide decontamination method. Sinai Health has incorporated stringent quality assurance steps to ensure that the N95 respirators are successfully decontaminated without deformation and are safe to use.

Deactivation of SARS-CoV-2 with pulsed-xenon ultraviolet light: Implications for environmental COVID-19 control.

OBJECTIVES: Prolonged survival of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on environmental surfaces and personal protective equipment may lead to these surfaces transmitting this pathogen to others. We sought to determine the effectiveness of a pulsed-xenon ultraviolet (PX-UV) disinfection system in reducing the load of SARS-CoV-2 on hard surfaces and N95 respirators. METHODS: Chamber slides and N95 respirator material were directly inoculated with SARS-CoV-2 and were exposed to different durations of PX-UV. RESULTS: For hard surfaces, disinfection for 1, 2, and 5 minutes resulted in 3.53 log10, >4.54 log10, and >4.12 log10 reductions in viral load, respectively. For N95 respirators, disinfection for 5 minutes resulted in >4.79 log10 reduction in viral load. PX-UV significantly reduced SARS-CoV-2 on hard surfaces and N95 respirators. CONCLUSION: With the potential to rapidly disinfectant environmental surfaces and N95 respirators, PX-UV devices are a promising technology to reduce environmental and personal protective equipment bioburden and to enhance both healthcare worker and patient safety by reducing the risk of exposure to SARS-CoV-2.

Extended use or reuse of single-use surgical masks and filtering face-piece respirators during the coronavirus disease 2019 (COVID-19) pandemic: A rapid systematic review.

BACKGROUND: Shortages of personal protective equipment during the coronavirus disease 2019 (COVID-19) pandemic have led to the extended use or reuse of single-use respirators and surgical masks by frontline healthcare workers. The evidence base underpinning such practices warrants examination. OBJECTIVES: To synthesize current guidance and systematic review evidence on extended use, reuse, or reprocessing of single-use surgical masks or filtering face-piece respirators. DATA SOURCES: We used the World Health Organization, the European Centre for Disease Prevention and Control, the US Centers for Disease Control and Prevention, and Public Health England websites to identify guidance. We used Medline, PubMed, Epistemonikos, Cochrane Database, and preprint servers for systematic reviews. METHODS: Two reviewers conducted screening and data extraction. The quality of included systematic reviews was appraised using AMSTAR-2. Findings were narratively synthesized. RESULTS: In total, 6 guidance documents were identified. Levels of detail and consistency across documents varied. They included 4 high-quality systematic reviews: 3 focused on reprocessing (decontamination) of N95 respirators and 1 focused on reprocessing of surgical masks. Vaporized hydrogen peroxide and ultraviolet germicidal irradiation were highlighted as the most promising reprocessing methods, but evidence on the relative efficacy and safety of different methods was limited. We found no well-established methods for reprocessing respirators at scale. CONCLUSIONS: Evidence on the impact of extended use and reuse of surgical masks and respirators is limited, and gaps and inconsistencies exist in current guidance. Where extended use or reuse is being practiced, healthcare organizations should ensure that policies and systems are in place to ensure these practices are carried out safely and in line with available guidance.

Process for disinfection of N95 respirators during COVID-19 utilizing sterile processing department: A single center acute care hospital.

During the COVID-19 crisis, disposable N-95 filtering face piece respirators became a critical supply in many health care institutions. Infection preventionists nationwide struggled with ensuring their facilities had personal protective equipment available while utilizing crisis capacity strategies. Many facilities began using US Centers for Disease Control and Prevention and US Food and Drug Administration guidance to disinfect and reprocess N95 respirators for extended use. N95 respirators are collected for all clinical units on a scheduled basis by the sterile processing department (SPD) in individually labeled bins. Bins are checked into SPD and logged into electronic system to track mask volumes by unit. Masks are inspected by SPD team members, packaged in sterile peel packs on the decontamination side and sent to the clean side of the department. Masks are then reprocessed in the appropriate equipment based on the US Food and Drug Administration Emergency Use Authorization guidelines. The facility was able to provide a consistent method of N95 reprocessing throughout the facility. Utilizing an interdisciplinary team to include the operating room, infection preventionist, SPD, and nursing leadership to troubleshoot and identify barriers on a routine basis was key to making the program a success for the many months of the COVID-19 pandemic.

Reúso de dispositivos médicos de uso único e implicações para a segurança do paciente / Reuse of single use medical devices and implications for patienty safety / Reutilización de dispositivos médicos de uso individual e implicaciones para la seguridad del paciente

Objetivo: Descrever aspectos do reúso dos dispositivos médicos de uso único e as implicações dessa prática para a segurança do paciente. Método: Ensaio acadêmico, utilizando dados de revisão integrativa e expertise da autora. Resultados: O reúso de produtos de uso único é realidade mundial e ocasiona debates regulatórios, técnicos, econômicos, éticos e de segurança do paciente, denotando diversos interesses dos distintos atores envolvidos: Estado, fabricantes, serviços de saúde, academia, profissionais e usuários. Embora haja risco teórico, dados não identificam relação causal entre evento adverso e reúso desses produtos. Existem argumentos a favor e contra que compreendem riscos e benefícios e justiça distributiva e social. O rótulo desses produtos representa nó crítico e elemento fomentador dos dilemas que permeiam essa prática. Conclusão: Há consenso de que o reúso de um produto médico deve ter o mesmo padrão de segurança, independentemente se rotulado como de uso único ou de multiuso. Alguns produtos ditos de uso único podem ser seguramente reusados, mas essa prática requer condições organoestruturais dos serviços de saúde, além de expertise, adoção de protocolos e supervisão dessas atividades.

Objective: to describe aspects of the reuse of single-use medical devices and implications for patient safety. Method: academic essay, using integrative review data and author's expertise. Results: the reuse of single-use products is a worldwide reality and causes regulatory, technical, economic, ethical and patient safety debates, denoting several interests of the different actors involved: State, manufacturers, health services, academia, professionals and users. Although there is a theoretical risk, data do not identify a causal relationship between adverse events and reuse of these products. There are arguments for and against and are involved: risks and benefits, distributive and social justice. The label of these products represents a critical node and fomenting element of the dilemmas that permeate this practice. Conclusion: There is consensus that the reuse of a medical product should have the same safety standard, regardless of whether labeled as single-use or multipurpose. Some so-called single-use products can be safely reused, but this practice requires organo-structural conditions of health services, as well as expertise, adoption of protocols and supervision of these activities.

Objetivo: Describir aspectos de la reutilización de dispositivos médicos de un solo uso e implicaciones para la seguridad del paciente. Método: ensayo académico, utilizando datos de revisión integradores y la experiencia del autor. Resultados: La reutilización de productos de un solo uso es una realidad mundial y provoca debates regulatorios, técnicos, económicos, éticos y de seguridad del paciente, que denotan diversos intereses de los diferentes actores involucrados: Estado, fabricantes, servicios de salud, academia, profesionales y usuarios. Aunque existe un riesgo teórico, los datos no identifican una relación causal entre el evento adverso y la reutilización de estos productos. Hay argumentos a favor y en contra y están involucrados: riesgos y beneficios, justicia distributiva y social. La etiqueta de estos productos representa un nodo crítico y un elemento que fomenta los dilemas que impregnan esta práctica. Conclusión: Existe un consenso de que la reutilización de un producto médico debe tener el mismo estándar de seguridad, independientemente de si está etiquetado como de uso único o multipropósito. Algunos de los llamados productos de un solo uso pueden reutilizarse de manera segura, pero esta práctica requiere condiciones organoestructurales para los servicios de salud, además de experiencia, adopción de protocolos y supervisión de estas actividades.

[Reuse process of positive pressure powered air-filter protective hoods].

OBJECTIVE: To establish reuse process of positive pressure powered air-filter protective hoods during coronavirus disease 2019 (COVID-19) epidemic. METHODS: The procedure of pretreatment, storage, recovery, cleaning, disinfection and sterilization process of positive pressure powered air-filter protective hoods, which were used in the treatment of COVID-19 infection patients was established in Central Sterile Supply Department of the hospital. The cleaning and disinfection effects of the protective hoods after treatment were examined by magnifying glass method, residual protein detection method, real-time PCR, and agar pour plate method. RESULTS: Twenty five used protective hoods underwent totally 135 times of washing, disinfecting and sterilizing procedures. After washing, all the protein residue tests and COVID-19 nucleic acid tests showed negative results. After sterilizing, all the protective hoods met sterility requirement. All the tested protective hoods were undamaged after reprocessing. CONCLUSIONS: The established reuse procedures for used positive pressure powered air-filter protective hoods are safe.

Gravity steam reprocessing in healthcare facilities for the reuse of N95 respirators.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has significantly impacted the health of millions of people around the world. The shortage of personal protective equipment, including N95 respirators, in hospital facilities has put frontline healthcare professionals at high risk for contracting this virus. AIM: To develop a reproducible and safe N95 respirator reprocessing method that satisfies all presented regulatory standards and that can be directly implemented by hospitals using existing available equipment. METHODS: A non-toxic gravity steam reprocessing method has been developed for the reuse of N95 respirators consisting of 30 min of steam treatment at 121°C followed by 30 min of heat drying. Samples of model number 1860, 1860s, 1870+, and 9105 N95 respirators were either collected from hospitals (for microbiology testing) or purchased new (for functionality testing), with all functionality tests (i.e. filter efficiency, fit evaluation, and strap integrity) performed at the Centers for Disease Control and Prevention using standard procedures established by the National Institute for Occupational Safety and Health. FINDINGS: All tested models passed the minimum filter efficiency of 95% after three cycles of gravity steam reprocessing. The 1870+ N95 respirator model is the most promising model for reprocessing based on its efficient bacterial inactivation coupled with the maintenance of all other key functional respirator properties after multiple reprocessing steps. CONCLUSIONS: The gravity steam method can effectively reprocess N95 respirators over at least three reprocessing cycles without negatively impacting the functionality requirements set out by regulators. Enabling the reuse of N95 respirators is a crucial tool for managing both the current pandemic and future healthcare crises.