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The "fake ventilator" business in Gujarat isn't surprising. For two reasons. 1) What is being called a ventilator is murky, around the country. 2) There are false certifications floating around and the government is outright ignorant. Let me explain both points in this thread.
So there are two types of ventilators. One is called an "invasive" ventilator, the other "non invasive". The former has tubes going into the nose or mouth of the patient. Useful when there's respiratory failure. The latter is akin to oxygen mask support.
Invasive ventilators basically replace the function of the lungs, by "doing the breathing" for the patient. Non-invasive ones only provide a support, for those with minor breathing difficulties. In hospital parlance, only invasive ventilators are called ventilators.
And that's where the confusion arises. Both are ventilators, but used by the general public and a doctor, they mean different things. Building an invasive ventilator is complex, requires a ton of testing and even training. The tubes literally enter the body. It's difficult.
In March, @RuhiKandhari and I wrote about various institutions and startups working to build ventilators. None of them have delivered yet. Which isn't necessarily a bad thing. They're undergoing rigorous testing. But one company has, AgVa. https://bit.ly/2XyfCif
With AgVa, it's a whole different set of problems. They have made ventilators before Covid as well and have "FDA certification". Only, turns out, it's fake. No ventilator made in India has FDA certification, which is a long-drawn, expensive process.
Not just that. Even other certifications it claims to have, like IEC 60601, a must for medical equipment, are procured from shell companies. I wrote about this early this month in @TheKenWeb https://the-ken.com/story/ventilator-procurement-problems/
Is this to say that something like the Gujarat scam is going to recur? We don't know. The AgVa ventilators, which HLL Lifecare is buying more than 10,000 of, are *actual ventilators* but we don't know how safe they are because the underlying precautions haven't been taken.
What makes the AgVa episode worse is that the earliest tender which HLL released actually mandated FDA certification. Let me repeat. NO INDIAN VENTILATOR HAS IT. It takes one Google search to know that. What do we need to do to solve for wilful ignorance?
