The world is facing an unprecedented outbreak affecting all aspects of human lives which is caused by the COVID-19 pandemic. Due to the virus novelty, healthcare systems are challenged by a high rate ...of patients and the shortage of medical products. To address an increased need for essential medical products, national authorities, worldwide, made various legislative concessions. This has led to essential medical products being produced by automotive, textile and other companies from various industries and approved under the emergency use authorizations or legal concessions of national regulatory bodies. This paper presents a narrative commentary of the available documentation on emergency use authorizations and legal concessions for medical products during COVID-19 pandemic.
The basis for narrative commentary includes scientific articles published in Web of Science, Scopus, PubMed and Embase databases, official publications of international organizations: Food and Drug Agency (FDA), World Health Organisation (WHO), World Bank and United Nations (UN), and national regulatory agency reports in native languages (English, German, Bosnian, and Croatian) published from November 1, 2019 to May 1, 2020. This paper focuses on three types of essential medical products: mechanical ventilators, personal protective equipment (PPE) and diagnostic tests. Evidence-informed commentary of available data and potential identified risks of emergency use authorizations and legal concessions is presented.
It is recognized that now more than ever, raising global awareness and knowledge about the importance of respecting the essential requirements is needed to guarantee the appropriate quality, performance and safety of medical products, especially during outbreak situation, such as the COVID-19 pandemic. Emergency use authorizations for production, import and approval of medical products should be strictly specified and clearly targeted from case to case and should not be general or universal for all medical products, because all of them are associated with different risk level.
Presented considerations and experiences should be taken as a guide for all possible future outbreak situations to prevent improvised reactions of national regulatory bodies.
Italy has been the first-hit European country to face the outbreak of coronavirus disease 2019 (COVID-19). Aim of this survey was to assess in depth the impact of the outbreak on healthcare workers ...(HCW). A 40-item online survey was disseminated via social media inviting Italian HCW, with questions exploring demographics, health status and work environment of respondents. A total of 527 were invited to take part in March 2020, of whom 74% (n = 388) responded to the survey. Of these, 235 (61%) were women. HCW were mostly physicians (74%), from high-prevalence regions (52%). 25% experienced typical symptoms during the last 14 days prior to survey completion, with only 45% of them being tested for COVID-19. Among the tested population, 18 (18%) resulted positive for COVID-19, with 33% being asymptomatic. Only 22% of HCW considered personal protective equipment adequate for quality and quantity. Females and respondents working in high-risk sectors were more likely to rate psychological support as useful (OR, 1.78 CI 95% 1.14–2.78 P = 0.012, and 2.02 1.12–3.65 P = 0.020, respectively) and workload as increased (mean increase, 0.38 0.06–0.69 P = 0.018; and 0.54 0.16–0.92 P = 0.005, respectively). The insights from this survey may help authorities in countries where COVID-19 epidemic has not yet broken out. Management strategies should be promptly undertaken in order to enhance safety and optimise resource allocation.
Pandemics and re-emerging diseases put pressure on the health care system to prepare for patient care and sample logistics requiring enhanced personnel protective equipment (PPE) for health care ...workers. We generated quantifiable data on ergonomics of PPE applicable in a health care setting by defining error rates and physically limiting factors due to PPE-induced restrictions. Nineteen study volunteers tested randomly allocated head- or full body-ventilated PPE suits equipped with powered-air-purifying-respirators and performed four different tasks (two laboratory tutorials, a timed test of selective attention and a test investigating reaction time, mobility, speed and physical exercise) during 6 working hours at 22°C on one day and 4 working hours at 28°C on another day. Error rates and physical parameters (fluid loss, body temperature, heart rate) were determined and ergonomic-related parameters were assessed hourly using assessment sheets. Depending on the PPE system the most restrictive factors, which however had no negative impact on performance (speed and error rate), were: reduced dexterity due to multiple glove layers, impaired visibility by flexible face shields and back pain related to the respirator of the fully ventilated suit. Heat stress and liquid loss were perceived as restrictive at a working temperature of 28°C but not 22°C.
Healthcare workers exposed to coronavirus (COVID-19) may not have adequate access to personal protective equipment (PPE), safety procedures, and diagnostic protocols. Our objective was to evaluate ...the reality and perceptions about personal safety among healthcare workers in Latin America. This is a cross-sectional, online survey-based study administered to 936 healthcare professionals in Latin America from 31 March 2020 to 4 April 2020. A 12-item structured questionnaire was developed. A total of 936 healthcare workers completed the online survey. Of them, 899 (95.1%) were physicians, 28 (2.9%) were nurses, and 18 (1.9%) were allied health professionals. Access to protective equipment was as follows: gel hand sanitizer (
= 889; 95%), disposable gloves (
= 853; 91.1%), disposable gowns (
= 630; 67.3%), disposable surgical masks (785; 83.9%), N95 masks (
= 516; 56.1%), and facial protective shields (
= 305; 32.6%). The vast majority (
= 707; 75.5%) had access to personal safety policies and procedures, and 699 (74.7%) participants had access to diagnostic algorithms. On a 1-to-10 Likert scale, the participants expressed limited human resources support (4.92 ± 0.2; mean ± SD), physical integrity protection in the workplace (5.5 ± 0.1; mean ± SD), and support from public health authorities (5.01 ± 0.12; mean ± SD). Healthcare workers in Latin America had limited access to essential PPE and support from healthcare authorities during the COVID-19 pandemic.
Summary
Novel coronavirus 2019 is a single‐stranded, ribonucleic acid virus that has led to an international pandemic of coronavirus disease 2019. Clinical data from the Chinese outbreak have been ...reported, but experiences and recommendations from clinical practice during the Italian outbreak have not. We report the impact of the coronavirus disease 2019 outbreak on regional and national healthcare infrastructure. We also report on recommendations based on clinical experiences of managing patients throughout Italy. In particular, we describe key elements of clinical management, including: safe oxygen therapy; airway management; personal protective equipment; and non‐technical aspects of caring for patients diagnosed with coronavirus disease 2019. Only through planning, training and team working will clinicians and healthcare systems be best placed to deal with the many complex implications of this new pandemic.
Coronavirus disease 2019 (COVID-19) has had a substantial impact on the incidence of cardiac arrest and survival. The challenge is to find the correct balance between the risk to the rescuer when ...undertaking cardiopulmonary resuscitation (CPR) on a person with possible COVID-19 and the risk to that person if CPR is delayed. These guidelines focus specifically on patients with suspected or confirmed COVID-19. The guidelines include the delivery of basic and advanced life support in adults and children and recommendations for delivering training during the pandemic. Where uncertainty exists treatment should be informed by a dynamic risk assessment which may consider current COVID-19 prevalence, the person’s presentation (e.g. history of COVID-19 contact, COVID-19 symptoms), likelihood that treatment will be effective, availability of personal protective equipment (PPE) and personal risks for those providing treatment. These guidelines will be subject to evolving knowledge and experience of COVID-19. As countries are at different stages of the pandemic, there may some international variation in practice.
The MTA changed guidance to advise wearing face masks before the US Centers for Disease Control and Prevention (CDC) and WHO shifted their guidance, but being exposed to the public, even with ...adequate PPE, presents dangers. The International Labour Organization has reported that 2·7 billion people—81% of the world's workforce—had been affected by lockdown measures. 61% of workers are from the informal sector, 90% of whom are in low-income and middle-income countries, and social protection measures are often inadequate, with a lack of access to health-care support and economic protections. In Germany, infection rates rose as lockdown restrictions began to ease and in the UK Boris Johnson's vague, amorphous plan to end lockdown has caused confusion and angered many.
More than 40 percent of all reported coronavirus disease 2019 (COVID-19) deaths in the United States have occurred in nursing homes. As a result, health care workers' access to personal protective ...equipment (PPE) and infection control policies in nursing homes have received increased attention. However, it is not known whether the presence of health care worker unions in nursing homes is associated with COVID-19 mortality rates. Therefore, we used cross-sectional regression analysis to examine the association between the presence of health care worker unions and COVID-19 mortality rates in 355 nursing homes in New York State. Health care worker unions were associated with a 1.29-percentage-point reduction in mortality, which represents a 30 percent relative decrease in the COVID-19 mortality rate compared with facilities without these unions. Unions were also associated with greater access to PPE, one mechanism that may link unions to lower COVID-19 mortality rates.
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