COVID-19 Alerts: US FDA Revokes EUA Approvals For Intubation Boxes. Studies Show That These Intubation Boxes Are Harmful
: It was publicly announced that the US Food and Drug Administration (FDA) has revoked the umbrella emergency use authorization (EUA) it granted in May for intubation boxes once thought to keep healthcare providers safer when performing procedures on patients with COVID-19.
The US FDA specified in its announcement on Friday that the change applies to boxes that lack fans or air filters and do not generate negative pressure.
It was reported that in a letter to healthcare providers on Friday, the US FDA said these boxes "may pose an increased health risk to patients and healthcare providers."
Furthermore use may also result in "increased intubation times, lower first-pass intubation success rates, increased patient hypoxia time, and damage or tearing to PPE (personal protective equipment) from the enclosures," the letter states.
From now, without the umbrella EUA, box designs now must be evaluated individually to determine whether the equipment would meet the requirements for an EUA.
A research published in July suggested the boxes were not adding an extra layer of protection beyond PPE and may be doing more harm than good.
Dr Joanna P. Simpson, MbChB, an intensivist at Eastern Health in Melbourne, Victoria, Australia, and colleagues tested five models of barriers used for protection while intubating simulated "patients" with COVID-19 and compared the interventions with having no protection. They published their findings in Anaesthesia. https://drive.google.com/file/d/123CS7Cmv8Hp6vZYenceuJ2pti-UsOnTX/view
These intubation boxes, mostly made up of see through acrylics were highly publicized during the initial stages of the pandemic, mostly by medical start-up groups trying to show that they were innovative or to gain publicity of their organizations etc but none ever bothered to conduct any supporting studies on the safety and protection these boxes truly provided.
Worse on a psychological level, these boxes created a lot of anxiety and stress on the COVID-19 patients that were already undergoing a lot of mental stress.
Perhaps now, especially in countries like Thailand, these boxes could be re -used to entomb for good the stupid entities and personnel that were seeking cheap publicity to show that they were highly “innovative.”
Also one must not forget that Thailand was the first that invented the treatment protocol to treat COVID-19 using Lopinavir/ritonavir and Oseltamivir! (both drugs that have been proven in studies to not show any efficacy against the SARS-CoV-2 coronavirus and in fact certain studies have shown that Lopinavir/ritonavir could actually cause more problems for COVID-19 patients under therapy.)
Thailand was fortunate to have a low infection and mortality rate due to the fact that majority were luckily only exposed to the milder circulating strains of the SARS-CoV-2 coronavirus, it had nothing to do with the prowess of its medical industry or the authorities. In fact it is now assumed that many were infected but were asymptomatic or only experienced mild symptoms but we cannot
comment about the long term health complications of these individuals. It will be interesting to see how Thailand deals with the second wave considering that it is planning to open the country to tourism again soon as a result of economic desperation.
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