When intensive care was necessary but lost out to a breathless rush

A ventilator is nothing but a motley collection of sensors, actuators and controllers that help monitor and regulate supply of oxygen and air flow to the patient.

The plan was to import the components from China and other countries, assemble them in India and supply the government. This was how many domestic manufacturers had made ventilators for years. This isn't an aberration — India depends heavily on imports for its medical devices.

However, there was a critical shortage of oxygen, air flow and air volume sensors, which are critical components for a ventilator.

“There are about seven critical components in a ventilator, for which we are highly dependent,” explains Vishwaprasad Alva, Founder and Managing Director of Skanray Technologies. The Mysore-based medical devices company has tied up with state-owned BEL and DRDO to supply 30,000 units to the government.

Alva said that, though there are other companies, US-based Honeywell dominates the supply of these components.

Make in India

This was when the auto industry, PSUs and defence laboratories joined hands to help ventilator manufacturers overcome their component supply challenges.

“As soon as we were hit with shortages, they (Honeywell) started rationing supplies. DRDO, BEL and Skanray started looking out for alternative parts within the country. For components where we couldn't find suppliers, DRDO and BEL developed them in-house. Prototypes that took months and years have been made in two weeks,” Alva said.

Aditya Kohli, Director of Sales and Marketing at Gurugram-based ventilator maker Allied Medical, says it has reduced dependence on imported components to 50 percent, while Skanray said the indigenisation in its ventilator is as high as 80 percent.

Quality and reliability issues

While the journey to self-reliance is a good one, problems soon cropped up. Some of the ventilators were rejected by hospitals for not having critical specifications and functionalities, such as BiPAP (bilevel positive airway pressure).

Last month, St. George Hospital and JJ Hospital in Mumbai had rejected Agva’s low-cost ventilators, donated by an NGO, terming them unsuitable for Covid-19 patients. The hospitals said the test run showed a variation in concentration of oxygen inhaled and another machine failed five minutes after being plugged in.

Agva said the machines offered by the NGO were earlier versions, and not the ones made for public sector unit HLL Lifecare, under the aegis of the PM CARES Fund. The company said it had offered to replace the ventilators with upgraded versions but the hospitals did not take up the offer.

Deccan Chronicle reported in May that the Andhra Pradesh government's King George Hospital in Visakhapatnam had refused to test AMTZ’s ventilator as it did not meet specifications set by the Central Government. AMTZ, which has an order for 13,500 units, is yet to supply a single ventilator.

Experts say one of the key reasons for these issues is the fact that manufacturers such as BEL, Agva and AMTZ, among others, have no previous experience in making ICU ventilators, or providing large-scale service.

For instance, before the Covid-19 pandemic, Agva was making low-end ventilators with limited features and capabilities, mostly designed for home use. It had never built a full-fledged ICU ventilator. The same was the case with AMTZ, where a group of manufacturers came together to build ventilators. Again, BEL is best known for making defence equipment and electronic voting machines.

“To manufacture equipment like a ventilator, there have to be lots of checks and balances in place. Of course in March the whole world was going crazy — everybody was talking about crazy quantities and all that. But all the serious manufacturers limited themselves, saying that these quantities are not doable. New players jumped in not realising the importance of having certification and quality control, in place. They have taken orders,” said Kohli of Allied Medical.

“The government should rely on companies that have a service back-up and who have been in this field. Overnight you can't expect new companies to come up and have a pan-India service network,” Kohli said.

Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD), highlighted the extreme swings in decision making. “I am quite surprised at how the government was willing to place orders with someone not certified. In the first week of March, the government was talking about Europe’s CE and USFDA, from there they went to another extreme of making it zero,” he said.

Service and training concerns

While there is now a glut of ventilators, experts say there aren't enough trained people to operate them.

“Every ventilator has a different way of functioning. You have to understand the nuances of how to handle a ventilator. It could take 2-4 weeks, it can take more. It's complex equipment, and handling a ventilator is not an easy job,” says Dr Rajendra Patankar, Chief Executive Officer of Pune-based Jupiter Hospital.

Dr Patankar says that there is a serious shortage of intensivists, who specialise in running ICUs, leading to most Intensive Care Units being managed by doctors and nurses.

Skanray’s Alva says there is a challenge in terms of training hospital staff to operate ventilators due to Covid-19.

“There will always be a set of doctors and nurses going into quarantine after training, and a new set coming in.  This becomes an issue in terms of training.  Covid-19-related lockdowns also make it difficult to provide service staff to hospitals,” Alva said.

“It's a huge challenge — not enough biomedical engineers, not enough intensivists. Many government hospitals would be getting ventilators for the first time; they would be getting new technology exposure. There will be teething problems,” said Rajiv Nath of AiMeD.

Alva says that could be the reason hospitals are refusing to accept ventilators —because they simply do not have staff — and accepting them creates pressure to admit patients.

Some positive feedback

But despite these challenges, Dr Sudhir Bhandari, Senior Professor of Medicine and Principal and Controller of Sawai Man Singh (SMS) Medical College in Jaipur, the main public health institution leading Rajasthan's efforts to combat Covid-19, said he is satisfied with the ventilators supplied under the aegis of the PM CARES Fund.

“We have received 125 ventilators and all are working fine. The availability of so many ventilators has greatly enhanced our capacity to treat more people,” Bhandari said.

This is the final part of a three-part series. The first part was on how domestic manufacturers went from exuberance to despair in three months. The second part was on how arbitrary changes to specifications led to delays and cost overruns