ABSTRACT
Emergency Use Authorizations (EUAs) have been integral to the federal government's response to the COVID-19 pandemic. During a public health emergency, the Federal Food, Drug, and Cosmetic Act permits the U.S. Food and Drug Administration (FDA) the authority to issue EUAs to allow the distribution of unapproved medical products, or of already-authorized products for unapproved uses, when certain criteria are met, including that there are no adequate, approved, and available alternatives. When compared to standards for FDA approval of drugs, medical devices, and vaccines, the EUA pathway has a lower statutory bar to market. This lower bar provides FDA with flexibility in responding to public health emergencies, but also permits marketing of medical products where safety and effectiveness data are less robust than with full approval. Within the first thirteen months of the pandemic, FDA issued over 400 EUAs for a wide range of medical products. Products authorized under EUAs have had varying degrees of efficacy, safety, and reliability. While some EUA medical products have been essential elements of the health and public health responses to the pandemic, others were pulled from the market because they ultimately proved to be unsafe or ineffective. This Article discusses the EUA framework and the motivations that led to its creation, examines FDA's use of the EUA process during the COVID-19 pandemic, and offers suggestions for ways that Congress and FDA can recalibrate the EUA mechanism to help it better achieve its goals.
ABSTRACT
Background: A combined paediatric facemask-face tent provided nasal pre/apnoeic oxygenation and reduced aerosol spread in a COVID-19 positive patient during RSI/intubation/extubation.1,2 It avoided severe desaturation and reduced aerosol/droplet spread during difficult intubation/ extubation in a morbidly obese patient.3 We used it in a difficult airway patient with large neck haematoma. Case Report: A 56-year-old obese male with HTN and right parotid tumor s/p uneventful parotidectomy, developed neck haematoma and severe desaturation, presented for urgent neck exploration. He had swollen neck/lower jaw (right) and Class IV airway (Fig.1). While in incline position, a modified infant facemask-face tent was secured over his nose.1 He was pre-treated with lidocaine oral spray. He breathed comfortable with 4-5cmH2O nasal CPAP (4LO2/min). SpO2 improved from 96% to 100% (93% Expired O2). GA was titrated with midazolam/fentanyl/lidocaine/propofol. Pressurecontrolled nasal ventilation (PIP 15cm H2O/PEEP 5cm H2O/RR 20/min) was initiated. Videolaryngoscope (VL) revealed vocal cords and swollen larynx and tissues. He was then given succinylcholine/ propofol. Atraumatic VL intubation under the face tent was accomplished smoothly (Fig.2). SpO2 (100%) was maintained. He tolerated the procedure well. Prior to extubation, he received lidocaine (5cc 2%) spray via endotracheal-tube. The nasal mask-face tent was re-secured. He was extubated smoothly without coughing. The circuit was re-connected to the nasal mask. He maintained spontaneous nasal ventilation and 100% SpO2. Discussion: This simple nasal mask-face tent provided pressure-controlled ventilation/oxygenation in a patient with large neck haematoma during GA induction/intubation. It helped lower aerosol/ droplet spread during intubation/extubation. Amid COVID-19 pandemic, it should be used as a universal precaution to improve patient oxygenation and provide additional provider protection. (Figure Presented).
ABSTRACT
Purpose The severe acute respiratory syndrome coronavirus (SARS-CoV-2) pandemic has caused widespread changes to healthcare practice. Demand on capacity, concerns for transplant recipients, including the risks of nosocomial infection, and the availability and safety of donors, lead to continuation of transplantation for only urgent and super-urgent, in-patient candidates, in the UK from March to May 2020. The aim of this study is to evaluate the impact of these practice changes on heart and lung donor utilisation during the pandemic period. Methods Data on all adult and paediatric heart and lung donors offered, and transplants performed, between 1 March and 30 September 2019 and 1 March and 30 September 2020 were obtained from the UK Transplant Registry. The early pandemic period is defined as 1 March to 31 May 2020. Ideal lung donors are defined as age <56 years and no smoking history. Results Lung transplant activity during the early pandemic period fell by 77% (13 transplants compared to 56 in 2019). Heart transplant activity fell by 10% (38 compared to 42 heart transplants in 2019). The number of donors, who donated at least 1 solid organ, fell by 51%. The lung donor utilisation rate during the early pandemic period was 11%, compared to 24% for the same period of 2019. The heart donor utilisation rate during the pandemic period was 35% compared to 26% during the same period of 2019. The proportion of ideal lung donors, from donors where lung(s) were offered, was 23% in 2020 compared to 24% in 2019. Following the early pandemic period (1 June to 30 September 2020), there has been an increase in the number of lung donors, lung transplant activity and utilisation, rising from 11% in March to May to 14% in June to September. This compares with a utilisation rate of 21% for the same period of 2019. Conclusion During the SARS-CoV-2 pandemic, changes to practice led to the continuation of heart transplantation, with minimal impact on activity, whilst lung transplant activity fell. The number of organ donors fell, while the ‘quality’ of potential lung donors remained unchanged. As the evidence base guiding clinical practice is evolving, along with improved donor testing, lung transplant activity is again increasing, however the utilisation of donors remains lower than in 2019. On-going analysis of activity is required to fully assess the impact of the SARS-CoV-2 pandemic on the UK lung transplant population.