A May 16 report, from another team of experts, had said that the devices needed further technical validation before approval.
Part of India’s corona-care infrastructure sufficiency involves having enough ventilators in place—data available with the government, as per an unnamed government official cited in a Hindustan Times report, show that just 4.16% of the Covid-19 infected in India needed ventilator support as of June 25. With the government having ordered 60,000 Made-in-India ventilators—purchase funded by the PM CARES fund—India would seem prepared for infections running into 15 lakh, if the current proportion of cases requiring ventilator support within the total infected pool is maintained. Yet, as the Indian Express reported last week, only 3,000 of the ventilators ordered had been manufactured by June 24, and of these only 1,340 ventilators had been supplied to states and UTs. The slow pace of delivery though is just one of the concerns. There are multiple reports now of the new generation Made in India ventilators performing poorly when they were deployed in hospitals.
While Mumbai Mirror reported on Monday that two prominent hospitals in Mumbai treating Covid-19 patients have cited quality issues to return 81 Made-in-India ventilators they had received, news and analysis website HuffPost India reported last week that two government-panels have flagged issues with Made-in-India ventilators. Doctors at the two Mumbai hospitals flagged the failure of the new generation ventilators to reach a 100% level initial fraction of inspired oxygen (FIO2), which is critical for the patient’s safety after intubation—a 100% level is the default until the required arterial oxygenation is reported in the patient since 100% FIO2 protects against hypoxemia in case of unrecognised problems occurring as a result of intubation. The FIO2 is then regulated downwards to the minimum level required to maintain adequate oxygenation. The Mumbai doctors also reported discrepancies in ventilator reading and actual oxygen levels in the patients’ blood. In a critical care scenario, like that needed for Covid-19, there is little room for such lapses. The HuffPost report cites a June 1 report from a government set-up committee as saying that AgVa Healthcare’s (one of the companies contracted for supply) ventilators “should not be considered as replacement for high-end ventilators in tertiary care ICUs” and stress upon the need for a backup ventilator in the facility where these are to be used. A May 16 report, from another team of experts, had said that the devices needed further technical validation before approval.
Given the need for ventilators only in the most serious Covid-19 cases, with a large positive correlation with disease fatality, the government must not roll out new generation ventilators until these have passed the strictest quality control tests. It is surprising that, despite the government set-up expert panels flagging the ventilators, these reached hospitals, where such infrastructure could need urgent deployment to save lives. A false sense of security could prove far more dangerous.