With each passing day, as the coronavirus that causes COVID-19 accelerates its spreads across India, fears that the country’s health infrastructure, in both government and private hospitals, cannot handle a surge in serious and critically ill patients are growing. The world over, one in 20 patients with COVID-19–usually older and suffering from other ailments–gets seriously ill and needs a bedside ventilator to supply higher levels of oxygen and to help open up the lungs. But there is an emerging trend in the US of younger patients requiring ventilator assistance to breathe. India, where the number of positive cases has crossed 400, is estimated to have just 40,000 ventilators, a vast majority of which are in metros. Karnataka, for instance, has about 1,200 ventilator beds across government and private hospitals; 700 of these are in Bengaluru alone. “Not all of these machines are functional. Many ventilators in government hospitals are not in use either because they are presumed to be obsolete or because they are missing small parts,” says Dr Sonal Asthana, a multi-organ transplant surgeon at Aster CMI Hospital in Hebbal, Bengaluru. “If we can get an inventory of such machines, and 3D print the parts that are not available in the open market, we could augment our capacity by 10-15 per cent.”
On March 20, the Union Health Ministry issued an advisory asking hospitals not to turn away any suspected COVID-19 or pneumonia cases and instructed them to set aside beds, to make provisions for isolation and to “procure sufficient numbers of ventilators and high-flow oxygen masks in preparation for future requirements”. “All hospitals are preparing for a surge, but the fact is, there is an acute shortage of protective clothing and ventilators across the country,” says Asthana. Doctors like him, who work at the intersection of medicine and technology, are crowd-sourcing and sharing ideas to make the most of the existing infrastructure. While there is precedent for using one ventilator to simultaneously support two or more patients, including in China and Italy during the COVID-19 crisis, circuit splitters have largely been blunt instruments so far. The volume and the pressure of air and the rate at which it needs to be supplied varies from patient to patient, and co-ventilating comes with the risk of underventilating and overventilating. But if one were to use flow restrictors to introduce pressure differentials, the risk could be significantly reduced, Dr Asthana says. “What this means is that we can hook up two or more patients to one ventilator, should the need arise. Since all ventilators only have forward flows, the risk of cross-contamination is very low,” he says. “There is of course a difference between what is necessary and what is ideal. Right now, this is all off label preparation for a possible surge in the coming weeks–no one takes any responsibility for it, but if it could save more lives, who wouldn’t use it? Even the COVID test kits available in the market right now are off label.”
On the eve of the people’s curfew on Sunday, Asthana downloaded open-source CAD drawings of a model, entitled ‘3D Printed Circuit Splitter and Flow Restriction Devices for Multiple Patient Lung Ventilation Using One Anaesthesia Workstation or Ventilator’, submitted to the journal Anaesthesia. He emailed them to Maltesh Somasekharappa, CEO of Supercraft3D, a printing company in Bengaluru, who designed special connectors and had the splitters ready by Sunday morning. By Monday evening, Asthana’s video, posted on Twitter, of his colleague testing the devices, had over 4,500 views. The devices, made of medical grade plastic, haven’t yet been tested on humans. They cost about Rs 500 and take just four hours to make. With a ventilator costing anywhere between Rs 7 lakh and Rs 15 lakh, and manufacturers in India dependant on electronic parts, which are in short supply since the crisis hit China, stopgap solutions using 3D technology could come in handy. “Our design team is in fact working on 3D printing an entire ventilator–the sort without electronic parts we had back in the day,” says Somasekharappa.
Upon the urging of captains of industry including Biocon Chairperson Kiran Mazumdar Shaw and Dr Devi Shetty of Narayana Hrudayalaya, medical equipment exporters like the Karnataka-based Skanray have pledged to come up with a design for a ventilator that could be manufactured locally in the tens of thousands. But this could take months.
Three-dimensional printing has gained traction in medicine in the past few years, especially in orthopaedics. In fact, Supercraft3D was started three years ago to make custom titanium implants. In 2015, a Bengaluru-based bio-technology startup, Pandorum Technologies, had developed artificial liver tissue through 3D printing to mimic human tissue for testing, and Asthana had been among the first doctors in the country to endorse the technology. “Engineers and doctors have to work together more than ever now,” says Dr Asthana. “My priority is to set up a website to connect hospitals that have disused equipment with, say, teams at the Indian Institute of Science, who are saying, give me a broken ventilator and I can fix it.”
Having underestimated the need for personal protective equipment for its medical workers, India is staring at a massive shortfall. HLL Lifecare Ltd, the government’s sole procurement agency for PPEs, is struggling to meet the requirement of 7.25 lakh coveralls, 60 lakh N95 masks and 1 crore multiply face masks–and even these, experts say, are gross underestimations by the Health Ministry. In a pinch, PPEs too can be 3D printed, says Dr Asthana.
Makers of large medical equipment such as CT scan machines, X-Rays and ventilators have already switched to getting certain parts 3D printed in China as convenional manufacturing is prohibitively expensive at small volumes. Only a handful of companies in India are equipped and certified to print medical equipment. Supercraft3D, based in Peenya in north Bengaluru, is a rare player that deals only with the medical sector. GE Healthcare is among its customers and so is Skanray. Somasekharappa says he spent over $100,000 to procure an ISO 13485 certification, the medical device industry’s most widely used international standard for quality management. “Traceability and accountability are paramount in the medical profession and we spent two years investing in putting those systems in place,” he says. He was approached by another doctor who wanted him to design a four-way ventilator splitter. “But a ventilator is not a garden hose you can split nine ways. We study original drawings carefully before designing an optimal co-ventilation solution. We use only FDA approved materials. We want to make the design open source but not before it is tested,” says Somasekharappa. One thing is clear: the gloves are off and Indian doctors are willing to do whatever it takes to save people from the clutches of the coronavirus.