At least 81 ventilators, manufactured by AgVa Healthcare-Maruti consortium, have been returned by Mumbai hospitals — JJ Hospital and St George Hospital — citing their failure to boost oxygen to required levels in critical COVID-19 patients.
Thirty-nine ventilators were donated to St George Hospital by private charity organisation Rotary Club and 42 ventilators to J J hospital by American India Foundation (AIF). The donation to JJ was facilitated by Aslam Shaikh, city’s guardian minister.
Both hospitals have returned the ventilators on account of desired usability in critical Covid care.
In a letter dated June 19, doctors have highlighted that the AgVa ventilators were not able supply 100 percent oxygen and that oxygen level did not increase to desired level. The letter highlighted that the variation in FiO2 (level of inspired oxygen available to patients) was more than 10 percent.
On invasive ventilation, the FiO2 levels achieved was 67 percent and in non-invasive ventilation it was only 42 percent.
One of the ventilators failed within 5 minutes of starting on test lungs.
Besides manual setting for managing FiO2 was not possible and the doctors say these ventilators were delivered without quality control/assurance test that puts the patients’ life in danger.
A senior doctor in St George Hospital told CNBC TV18 that not even once during multiple tests the ventilators touched 100 percent oxygen levels.
“The primary objective of any ventilator is to provide oxygen and at varying levels, because the oxygen requirement for every patient is different. Some patients require 100% oxygen. We can’t keep changing ventilators, we need ones that can achieve 100% oxygen saturation.”
Another doctor at J J Hospital said these ventilators are not meant for managing critical COVID-19 patients. However, AgVa Healthcare disputes this claim.
The company’s founder Prof Diwakar Vaish told CNBC TV18 that AgVa ventilators are not a replacement for full-scale, high-end ICU ventilator but are good for COVID-19 patients.
“All our ventilators are fully functional. AgVa ventilators are completely tested by a government panel and qualified on tender specifications. A few specifications were changed in HLL tender before purchase and those were also complied with before supply.”
The government has placed orders for 50,000 ventilators, of which orders for 10,000 ventilators are with AgVa-Maruti consortium. A sum of Rs 2000 crore from the PM Care Fund has been allocated for the purchase of 50,000 ventilators.
Agva says it has till now supplied 3,000 ventilators to HLL Lifecare under the government orders and additional 200-300 ventilators have been sold to private companies and NGOs.
Prof Vaish said the company was willing to send higher versions of the ventilator to these hospitals, however, the proposal was rejected.
Prof Vaish told CNBC TV18 that the company’s COVID Plus model with automatic FiO2 setting and costing Rs1.8 lakh is being supplied to the government under PM CARE fund. The model that was supplied to St George and JJ hospital was a basic version with manual settings and costing Rs 1.5 lakh.
A conventional full-scale ICU grade ventilator cost upwards of Rs10 lakhs.
The senior doctor from St George hospital quoted above said no comparisons were being made with high-end ventilators and there was no mismatch with specification asked.
“Ventilator is to assist breathing for critical patients and is used to pump oxygen. If it fails in providing desired levels of oxygen to patients, whether COVID-19 or otherwise, the ventilator is not good enough.” Reports have highlighted that two separate government panels have flagged concerns about reliability, capability of AgVa Ventilators. A June 1 clinical evaluation report had said while the government could buy these ventilators, these should not be considered as a replacement for high-end ventilators in tertiary care ICUs. A provision for backup ventilator must be made where these ventilators are used.
Another May 16 report had called for “further technical validation” for the AgVa-Maruti ventilators.
Prof Vaish says clinical trials have been conducted in early May in Lady Hardinge Medical College, Delhi, where 4 patients were put on Agva ventilators for 48 hours. The results were acceptable.
The central government in a statement last week had said 3,000 ventilators under the orders have been manufactured and 1,340 have been delivered to various states. Maharashtra has a total of 3,028 ventilators, nearly one-third of these are in Mumbai, and with the fast rise in number of COVID-19 cases the number is not adequate. – CNBC TV 18