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Improper Fitting of Oxygen Mask cause of non-optimal functioning in at least one Ventilator

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Government of India has been supporting the efforts of States and UTs for effective management of COVID patients in hospital care, under the ‘Whole of Government” approach since last year. In order to augment the existing hospital infrastructure, the Union Government has been centrally procuring and providing States/UTs/Central Hospitals/ Institutes with essential medical devices including ventilators since April 2020.

There have been some media reports suggesting that ‘Make in India’ ventilators in the Aurangabad district of Maharashtra were not functioning optimally. These reports are baseless and incorrect, not supported by full information on the matter.

Ventilators were available in very limited numbers in Government Hospitals across the country at the beginning of the pandemic last year. Moreover, very limited manufacturing of ventilators was taking place in the country and most of the suppliers abroad were not in a position to make supplies of ventilators in large quantities to India. That is when the local manufacturers were encouraged to produce “Make in India” Ventilators to address the huge projected demand of the country and orders placed on them. Many of them were first time manufacturers of the ventilators. The ventilator models went through rigorous screening, technical demonstration and clinical validation process in the very limited time available for the same, through domain knowledge experts, and after their approval, these were put into supplies.

There are a few States which have received the ventilators but are yet to get these installed in their hospitals. Union Health Secretary has written to seven such States on 11th April 2021 which still have more than 50 ventilators lying uninstalled with them for the last 4-5 months. They have been requested to get the installation expedited so that the ventilators can be put to optimal use.

Ventilators manufactured by Jyoti CNC were supplied to Aurangabad Medical College. Jyoti CNC is one of the manufacturers of “Make in India” Ventilators. They have supplied ventilators centrally for COVID-19 management, as per the directions of Empowered Group-3. These ventilators were then made available to States as per the requests made by States. This supplier is not funded under PM CARES fund.

In Aurangabad Medical College, 150 ventilators were supplied by Jyoti CNC. The first tranche of 100 ventilators reached Aurangabad on 19th April 2021 and installation was carried out thereafter as per the allocations received from the State authorities. 45 out of 100 in the first lot were installed in the Medical College. Installation and successful Commissioning certificate in respect of all these ventilators was issued by the Hospital authorities after their successful commissioning and demonstration.

Out of these 45 installed ventilators, three were reinstalled in a private hospital (Cigma Hospital) by the State authorities. These were installed again by engineers of Jyoti CNC at the said private hospitals. Installation and Commissioning certificate was issued by the Hospital authorities also after their successful commissioning and demonstration.

20 ventilators out of the above 45 were reallocated to another private hospital (MGM Hospital) by the States authorities. No formal information was provided about this to Jyoti CNC. Therefore, Jyoti CNC engineers had no part in the reinstall of these ventilators. Therefore, the installation of these ventilators at the new location was got done by the State authorities at their own responsibility.

55 ventilators of the first tranche were diverted to other locations (04 locations namely Civil Hospitals at Beed, Usmanabad, Parbhani and Hingoli). Installation and Commissioning certificates for 50 ventilators were issued by the concerned hospital authorities after their successful commissioning and demonstration. Five ventilators are lying uninstalled at Beed Civil Hospital waiting for the directions from the hospital authorities.

The second tranche of 50 ventilators was sent to the Aurangabad Medical College and Hospital on 23rd April 2021. Only 02 ventilators were installed in a private hospital by the authorities (Cigma Hospital). Installation and Commissioning certificates for these 02 ventilators have also been issued by the concerned Hospital authorities after their successful commissioning and demonstration. Directions are awaited by Jyoti CNC & HLL for further installations of 48 ventilators lying packed in Government Medical College, Aurangabad.

On 23rd April (i.e. 04 days after successful installation of ventilators the Hospital authorities at GMC Aurangabad, a complaint was received telephonically informing that 08 ventilators were not functioning. The engineers went to the site and found that flow sensor (proximal) had not been installed in 03 ventilators by the Hospital. All 08 were recalibrated by the service engineers of the vendor. 01 ventilator had oxygen cell which was not functioning. A fresh oxygen cell was reinstalled and this ventilator also made functional and commissioned subsequently.

Jyoti CNC received a call on 10th May, 2021 informing that two ventilators have been used in ICU. Out of these, one on NIV (Non-Invasive (BiPAP) mode), is not being able to ensure saturation of the patient. The authorities said that this may be checked outside the ICU. The same was examined by the team of service engineers & was found to be in functional condition and the team returned after satisfying the Hospital authorities. This was put back in operation on a patient on night of 12th May 2021 on NIV mode. On 13th May afternoon Jyoti CNC was informed telephonically that they are not being able to get optimum PEEP. The technical team visited the hospital in the afternoon. However, by then the same ventilator had been put on the patient in invasive mode. The Ventilator was working on the patient on invasive (IV) mode and it was working perfectly fine on the patient.

However, Jyoti engineers had then taken the back up of the equipment from which complaint had arisen, taken its log and observed that the equipment had continuously given alarm about the excessive leakage arising out of improper mask fitting on the patient (which is usually corrected with the use of proper mask size and proper fitting on the patient).This conclusion was made out from the log of the ventilator.

The team of service engineers is still in the hospital and as soon as a ventilator is fitted on a patient with NIV mode, they shall be in a position to demonstrate this to the hospital authorities there.  At present the ventilator has been put on Invasive mode on the patient and is functioning fine.

GMC Hospital Aurangabad has thereafter desired that all the 22 ventilators already installed and commissioned there be demonstrated and re-commissioned before the hospital team. The same is being carried out again between today and tomorrow by the team of engineers of Jyoti CNC.

The Union Health Ministry had already written to the States and UTs on 9th May 2021 informing them once again of the Helpline numbers of the Ventilator manufactures, which are also available on the ventilators in the form of stickers. In addition, information has again been provided of state wise Whatsapp groups created with the concerned nodal officers of the States/UTs, representatives of the User Hospitals and technical teams of the manufacturers in order to address any technical issues in real time. Dedicated email IDs of these manufacturers have also been shared with the States/UTs to prevent such miscommunication and technical glitches.

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