LNJP says ventilators from PM CARES don’t have BIPAP; MOHFW insists they do
A pattern of inconsistencies raised with several ‘local’ ventilator manufacturers
NEW DELHI: After the Lok Nayak Jai Prakash Hospital here raised a red flag that ventilators supplied to it by the Government of India and procured with funds from the PM CARES Fund under its “Make in India” initiative did not have the key function of BIPAP mode, the Ministry of Health and Family Welfare put out a statement on Wednesday insisting that all ventilators being manufactured, procured and supplied to various states and UTS, including Delhi, had the BIPAP mode and were in compliance with all specifications prescribed by domain experts and the Directorate General of Health Services of the Health Ministry.
The Bilevel Positive Airway Pressure (BIPAP) mode is a mechanism that allows doctors to supply oxygen to patients without having to insert a tube into their airways.
The statement came after reports surfaced that 175 ventilators supplied to the LNJP Hospital had been flagged to the Delhi Directorate-general of Health Services for not having this crucial mode on them.
The Health Ministry said all these ventilators were meant for ICUS. However, authorities in the LNJP Hospital have said they have submitted this feedback and sought for 250 BIPAP machines as they are not available in these ventilators.
According to a statement from the Prime Minister’s Office, of the 50,000 ventilators that the Central government is supposed to procure with Rs 2,000 crore of the PM CARES Fund, a bulk on 30,000 would be manufactured by Bharat Electronics Limited with Mysore-based Skanray Technologies, 10,000 is to be manufactured by Agva Healthcare, 5,650 by AMTZ Basic, 4,000 by AMTZ High End and 350 by Allied Medical.
Of the 175 ventilators flagged by LNJP, 155 were manufactured by Skanray Technologies and 20 by Agva Healthcare.
A PATTERN OF INCONSISTENCIES
However, there have been other concerns raised with regards to COVID-19 ventilators being manufactured by Agva.
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In fact, at least two government-appointed committees have raised issues with these ventilators, concluding in clinical assessments that they should not be used as replacements to “high-end” Icu-grade ventilators and that while they may be purchased, they should be deployed in hospitals that have backup options available with them.
While this assessment by a team of doctors was submitted in a June 1 report, on May 16, another committee of experts had evaluated Agva ventilators and concluded that they could not be approved as the devices needed further “technical validation”. Agva has said in statements to the media that their efforts to produce “costeffective” Icu-grade ventilators were disrupting a “nexus” between established doctors and medical equipment manufacturers and that their device complied with all necessary specifications.
Moreover, the company has also pointed towards faulty installation as a reason, LNJP doctors were not able to locate the BIPAP mode on their devices.
In addition, it has now also been revealed that two Mumbai hospitals have returned 81 Agva ventilators over what they called non-performance issues. Doctors at the St George Hospital and JJ Hospital said that these devices should not be used for COVID-19 patients under any circumstance and that one device had shown failure within five minutes of plugging it in.
Significantly, this is not the only private player engaged by the Central government to procure ventilators that have been flagged by authorities for purported inconsistencies in their devices. In March, the Centre had placed an order for 5,000 ventilators from Jyoti CNC Automation through its wholly-owned subsidiary HLL Lifecare.
Interestingly, reports had revealed that ventilators manufactured by Jyoti CNC and supplied to government hospitals in Gujarat did not have a mandatory license from the Drug Controller General of India and its “performance trial” included testing only on one patient. Curiously, it later emerged that the devices manufactured by Jyoti CNC were not ventilators but, in fact, a device known as mechanised Ambu bags, which needed to be physically pumped by a professional to assist in a patient's breathing. This despite government authorities in Gujarat and the Centre having repeatedly, in several press releases and public statements to the press, referred to the Jyoti CNC devices as ventilators while placing orders for them.
The Health Ministry on Wednesday said: “The technical specifications for these COVID ventilators have been laid down by a Technical Committee of domain knowledge experts headed by the Director-general Health Services (DGHS), MOHFW against which the ventilators have been procured and supplied. The ventilators procured and supplied comply with these specifications.” It added: “Ventilator models BEL and Agva supplied to the States/uts are complying with the requirements as per the specifications laid down by the Technical Committee. These cost-effective, made in India ventilators have BIPAP mode and other such modes as have been prescribed in the technical specifications. The ventilators are being supplied along with User Manuals and Feedback Forms which must be referred to for clarity.”