scholarly journals The Inadequacy of Regulatory Frameworks in Time of Crisis and in Low-Resource Settings: Personal Protective Equipment and COVID-19

2020 ◽  
Vol 10 (6) ◽  
pp. 1375-1383 ◽  
Author(s):  
Leandro Pecchia ◽  
Davide Piaggio ◽  
Alessia Maccaro ◽  
Claudio Formisano ◽  
Ernesto Iadanza

Abstract COVID-19 pandemic is plaguing the world and representing the most significant stress test for many national healthcare systems and services, since their foundation. The supply-chain disruption and the unprecedented request for intensive care unit (ICU) beds have created in Europe conditions typical of low-resources settings. This generated a remarkable race to find solutions for the prevention, treatment and management of this disease which is involving a large amount of people. Every day, new Do-It-Yourself (DIY) solutions regarding personal protective equipment and medical devices populate social media feeds. Many companies (e.g., automotive or textile) are converting their traditional production to manufacture the most needed equipment (e.g., respirators, face shields, ventilators etc.). In this chaotic scenario, policy makers, international and national standards bodies, along with the World Health Organization (WHO) and scientific societies are making a joint effort to increase global awareness and knowledge about the importance of respecting the relevant requirements to guarantee appropriate quality and safety for patients and healthcare workers. Nonetheless, ordinary procedures for testing and certification are currently questioned and empowered with fast-track pathways in order to speed-up the deployment of new solutions for COVID-19. This paper shares critical reflections on the current regulatory framework for the certification of personal protective equipment. We hope that these reflections may help readers in navigating the framework of regulations, norms and international standards relevant for key personal protective equipment, sharing a subset of tests that should be deemed essential even in a period of crisis.

2020 ◽  
Vol 10 (31) ◽  
pp. 87-95
Author(s):  
Nicole Maria Miyamoto Bettini ◽  
Fabiana Tomé Ramos ◽  
Priscila Masquetto Vieira de Almeida

A Organização Mundial da Saúde - OMS confirmou a circulação internacional do novo Coronavírus em janeiro de 2020, nomeando-o como COVID-19 e, declarando uma pandemia. É de extrema importância que durante a pandemia, os profissionais de saúde tenham acesso e conhecimento sobre o uso correto dos Equipamentos de Proteção Individual (EPIs) e suas indicações, tomando assim, as devidas precauções na prevenção de infecções. O presente estudo buscou identificar a padronização mundial quanto ao uso dos EPIs utilizados no atendimento a pacientes suspeitos e/ou confirmados de COVID-19 no Brasil, EUA, China, Espanha, Itália e demais países europeus. Os guidelines apresentam a padronização quanto ao uso dos EPIs utilizados no atendimento a suspeitos e/ou confirmados de COVID-19, indo ao encontro das recomendações fornecidas pela OMS. Até o momento, o uso de EPIs é sem dúvida a estratégia mais importante e eficaz para proteger os profissionais de saúde durante a assistência ao paciente com COVID-19.Descritores: Infecções por Coronavírus, Equipamento de Proteção Individual, Pessoal de Saúde, Enfermagem. Recommendations for personal protective equipment to combat COVID-19Abstract: The World Health Organization - WHO confirmed the international circulation of the new Coronavirus in January 2020, naming it as COVID-19 and declaring a pandemic. It is extremely important that during the pandemic, health professionals have access and knowledge about the correct use of Personal Protective Equipment (PPE) and its indications, thus taking appropriate precautions to prevent infections. The present study sought to identify the worldwide standardization regarding the use of PPE utilized to take care of suspected and confirmed patients with COVID-19 in Brazil, USA, China, Spain, Italy and other European countries. The guidelines present a standardization regarding the use of PPE utilized to take care of suspected and confirmed with COVID-19, in line with the recommendations provided by WHO. To date, the use of PPE is undoubtedly the most important and effective strategy to protect healthcare professionals during care for patients with COVID-19.Descriptors: Coronavirus Infections, Personal Protective Equipment, Health Personnel, Nursing. Recomendaciones para el equipo de protección personal para combatir COVID-19Resumen: La Organización Mundial de la Salud - La OMS confirmó la circulación internacional del nuevo Coronavirus en enero de 2020, nombrándolo COVID-19 y declarando una pandemia. Es extremadamente importante que durante la pandemia, los profesionales de la salud tengan acceso y conocimiento sobre el uso correcto del Equipo de Protección Personal (EPP) y sus indicaciones, tomando así las precauciones adecuadas para prevenir infecciones. El presente estudio buscó identificar la estandarización mundial con respecto al uso de EPP utilizado para atender a pacientes sospechosos y/o confirmados con COVID-19 en Brasil, Estados Unidos, China, España, Italia y otros países europeos. Las pautas presentan la estandarización con respecto al uso de EPP utilizado para cuidar COVID-19 sospechoso y/o confirmado, de acuerdo con las recomendaciones proporcionadas por la OMS. Hasta la fecha, el uso de EPP es, sin duda, la estrategia más importante y efectiva para proteger a los profesionales de la salud durante la atención de pacientes con COVID-19.Descriptores: Infecciones por Coronavirus, Equipo de Protección Personal, Personal de Salud, Enfermería.


Author(s):  
Chin Yan SUEN ◽  
Hong Hang LEUNG ◽  
Ka Wo LAM ◽  
Karen P HUNG ◽  
Mei Yan CHAN ◽  
...  

The possibility to extend the lifespan or even reuse one-off personal protective equipment, especially for N95 respirator and surgical mask become critical during pandemic. World Health Organization has confirmed that wearing surgical mask is effective in controlling the spread of respiratory diseases in the community, but the supply may not be able to satisfy all the demands created all over the world in a short period of time. This investigation found that dry heat and UVC irradiance could effectively disinfect the mask material without creating significant damage to surgical mask.


2018 ◽  
Vol 112 ◽  
pp. 281-283
Author(s):  
Mary Saunders

The International Organization for Standardization (ISO) is an independent, non-governmental, not-for-profit organization that develops and publishes fully consensus-based International Standards. ISO members are national standards bodies (NSBs), which may be government, private, or public-private entities. 163 NSBs are members of ISO. The ISO standards portfolio numbers more than 20,000 standards. ISO also has a large network of liaison organizations—which can participate in the ISO process but do not vote. These include many treaty organizations, including the World Health Organization, Codex, the International Labour Organization (ILO), the Organisation for Economic Co-operation and Development (OECD), and so on; as well as numerous other international organizations.


2021 ◽  
Vol 18 (4) ◽  
pp. 5-16
Author(s):  
D. V. Grinko ◽  
D. V. Moiseev ◽  
E. V. Voropaev ◽  
I. O. Stoma

For more than a year and a half, the entire world has been experiencing the COVID-19 pandemic. Only the development of safe and effective vaccines may make the most significant changes in the fight against this infection. The World Health Organization (WHO) and its partners are contributing to accelerated development of vaccines because it is the vaccination along with social distancing and the use of personal protective equipment that is an effective way to prevent the coronavirus disease. This review covers general characteristics of vaccines registered or approved by at least one national regulator, the risks and side effects of the vaccines, as well as approaches to assess the effectiveness of COVID-19 vaccination.


Author(s):  
Rami AL Edwan

Background: The healthcare workers are exposed to dangerous pathogen agents during the outbreak of the new coronavirus COVID-19. To minimize the risk of becoming infected by this virus, healthcare workers need to wear the most appropriate personal protective equipment (PPE). Objective: The objective of this study was to analyze the guidelines that the World Health Organization (WHO) and the Centers for the Disease Control and Prevention (CDC) recommend for the rational use of EPP to protect healthcare workers against the novel coronavirus COVID-19.Methodology: To learn how to effectively protect healthcare workers against the COVID-19, a detailed analysis and comparison of the WHO and CDC guidelines related to the proper use of personal protection equipment (PPE) in different healthcare settings was carried out. Results: The results of this study based on an analysis of PPE recommended by the World Health Organization (WHO) and the Centers for the Disease Control and Prevention (CDC) indicated that the safety and protection of healthcare workers can be maximized if the guidelines suggested by these institutions are followed. In general, the WHO and CDC recommendations based on medical practices are similar, and depending on the healthcare activities and settings where the healthcare workers perform their work, suggest wearing medical/surgical facemasks, respirators, googles and face shields (eye protection), gloves, gowns and aprons. Conclusions: The protection and safety of the healthcare workers can be maximized during the outbreak of COVID-19 by following the WHO and CDC recommendations described in this study. The general guidelines offered by these institutions are similar and based on medical practices.


Author(s):  
Yosef Dastagirzada ◽  
Olga Klauberg ◽  
Kathleen Sheerin ◽  
Seth Lieberman ◽  
Richard Lebowitz ◽  
...  

AbstractSoon after the World Health Organization declared the severe acute respiratory syndrome coronavirus 2 a global health emergency on January 30, 2020, New York City was plagued by the virus and its health system and economy pushed to their limits. The majority of the limited neurosurgical data in relation to COVID-19 is anecdotal and the higher theoretical risk of transmission of the virus among skull base aerosol generating (SBAG) cases has not been investigated or discussed in a neurosurgical population. We discuss a series of 13 patients who underwent 15 SBAG surgical procedures during the peak of COVID-19 in our hospital system and the protocols use perioperatively for their procedures. Our data support that with proper preoperative testing, a well-delineated surgical algorithm, and appropriate personal protective equipment, emergent/urgent cases can be done safely in hospitals that are currently experiencing high volumes of COVID-19 cases as we did in March to May of 2020.


Author(s):  
Soo Ah Son ◽  
Se Hwan Hwang

The coronavirus disease 2019 (COVID-19) epidemic originated in Wuhan, China and spread rapidly worldwide, leading the World Health Organization to declare an official global COVID- 19 pandemic in March 2020. The upper aero-digestive tract is known to be the highest viral load reside. The infection spreads via droplets or direct contact with contaminated surfaces via aeorsol. The otolaryngologists deal with diseases of the upper-aerodigestive tract and routinely are engaged in respiratory droplet and aerosol-generating procedures (AGP). In particular, because airborne transmission occurs during examination and AGP, otolaryngologists are considered to be at a high risk of contracting COVID-19 during this pandemic. Therefore otolaryngologists need to do precautions to protect staff and patients and minimize transmission of the disease. We also need to wear adequate personal protective equipment according to the examination and procedure. This article discusses the disease transmission and clinical characteristics of COVID-19 as well as precaution guidelines in outpatient clinics of otorhinolaryngology.


1988 ◽  
Vol 117 (1) ◽  
pp. 147-152 ◽  
Author(s):  
R. E. Wehmann ◽  
D. L. Blithe ◽  
A. H. Akar ◽  
B. C. Nisula

ABSTRACT Highly purified preparations of human choriogonadotrophin (hCG), hCGα and hCGβ, including those preparations which are being distributed by the World Health Organization as International Standards, cross-reacted in a new radioimmunoassay with increased relative specificity for the β-core fragment of hCG. A major portion of the β-core immunoreactivity in the hCG and hCGα preparations eluted from Sephadex G-100 in a position (approximate apparent molecular size 15 000–18 000) corresponding to that of purified β-core fragment prepared from pregnancy urine. However, in the case of hCGβ-subunit preparations, virtually all of the β-core cross-reacting material eluted from Sephadex G-100 in the same fractions as the native hCGβ-subunit. Quantitatively, the cross-reacting β-core material accounts for less than 1% (w/w) of the total hCG or subunit immunoreactivity, as measured by conventional radioimmunoassays. The presence of the β-core fragments as discrete molecular components of the hCG and hCGα preparations should be borne in mind when these preparations are used to calibrate new radioimmunoassays for hCG-related molecules. J. Endocr. (1988) 117, 147–152


2021 ◽  
Vol 4 ◽  
pp. 102-106
Author(s):  
Ankita Kar ◽  
Udayan Bhaumik ◽  
Vineeth Kumar ◽  
V. Shwetha ◽  
Shruthi Nagaraja

The coronavirus pandemic of 2019 has increased the risk of occupational cross infections among dentists. Dental procedures are inherently risky in this scenario due to the need for close proximity with patients and generation of aerosols and splatters. Regulatory dental health bodies, including World Health Organization, Center for Disease Control, and American Dental Association, have devised guidelines for various forms Personal protective equipment for routine outpatient procedures during this pandemic and in the post-COVID-19 world. Stringent regulations are also advisable to conserve these resources at a time when the threat of COVID-19 is likely to persist indefinitely.


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