Thursday, April 23, 2020

Waiting for ventilators

The pandemic has fuelled demand for the devices as there is a scramble to procure them


Anywhere between 80-90 per cent ventilators in India are manufactured by foreign companies, and the rest by domestic companies.

M Sai Gopal   HYDERABAD  23.04.2020

In a short span of just three to four months of coronavirus pandemic, ventilators have become gold dust, the most sought after medical devices across the world. There is literally a mad rush by medical device companies, engineers, entrepreneurs, scientists and start-ups in India to design and manufacture ventilators that will meet industry benchmarks and at the same time are affordable and safe.

The Covid-19 outbreak has fuelled the demand for ventilators, as governments, policymakers and public health officials scramble to procure as many as possible. From being considered as high-end devices that are found in Intensive Care Units (ICU) of health care establishments, the ventilator technology now has become ‘open-source’ with DIY guides available to manufacture them even at homes.

As care givers understood the epidemiology of SARS-CoV2 better, it became clear that 15 per cent to 20 per cent of the positive cases need hospitalisation while 3 per cent to 5 per cent need critical care i.e. ventilator support in an ICU.

Among such patients needing critical care, SARS-CoV2 attacks lungs, making it impossible for them to breathe on their own. Such patients need to be put on ventilators so that the body gets some time to fight the virus while the ventilator does it job.

At present, there are non-invasive and invasive ventilation systems available for patients. In non-invasive ventilation, the air is passed through the mouth and nose with the help of a tightly fitting ventilation mask. In invasive ventilation, which is also known as intubation, a tube is pushed through the mouth or nose and into the trachea i.e. windpipe.

Often, depending on the condition of the patients, doctors go for tracheotomy, which means they make a direct access to trachea through a small hole in the throat. Patients, who are on ventilators, cannot speak and eat on their own and have to be fed artificially through a tube.

Moreover, invasive ventilation is tough on patients, a reason why they are put into artificial coma through anaesthesia while the body is allowed to fight coronavirus on its own.

How much is the  shortage?

As the intensity of coronavirus spreads, public health officials across the globe quickly realised that there was an acute shortage of ventilators to meet the huge demand. By estimates, there are 40,000 to 48,000 ventilators available in India and 1,100 to 1,300 ventilators in Telangana. The State government recently ordered 500 more ventilators, but challenges remain as to when they will be delivered. Anywhere between 80-90 per cent of these existing ventilators in India are manufactured by foreign companies while the rest were from domestic manufacturers. With demand outstripping the supply, governments have eased restrictions and also have issued basic guidelines and frameworks to design and manufacture ventilators domestically.

What is a ventilator?

A ventilator takes over the body’s breathing process when lungs fail, which gives patients enough time to fight the infection and recover. Any instrument that pushes or pumps air into the human lungs and releases the air from the lungs are ventilators.

There are many kinds of ventilators like Ambu bag that can be pressed and released with hands. A mechanical Ambu bag is a ventilator. There are some other versions of ventilators, including CIPAP (needed for sleep apnea patients) and portable ventilators that form an integral part of an ICU.

However, according to experts, devices like Ambu bag, CIPAP or BIPAP machines will not help or provide any clinical benefits for Covid-19 positive patients. To address these issues, the Ministry of Health and Family Welfare, United Kingdom, and other countries have issued specifications that define the minimum clinically accepted criteria for a rapidly manufacturable ventilator to address the covid-19 situation.

Can manufacturing   be scaled up?

According to medical device experts, in theory the manufacturing of ventilators can be scaled up. However, there are many practical difficulties as there are very few manufactures in the world who are involved in manufacturing medical devices for Intensive Care Units (ICU). Typically, depending on the configuration of ventilator, the cost of manufacturing them will hover between Rs 5 lakh and Rs 20 lakh. Apart from the high costs, there are difficulties in ensuring there is enough supply of parts in large quantities within a short duration of time. The devices that go into manufacturing ventilators comprise of highly precise sensors with very quick response time. Such medical devices, on which the lives of patients depend, can’t be introduced into the market without adequate testing. That’s the reason why the governments have come up with standard guidelines or specifications for rapidly manufacturing a Covid-19 ventilator.

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