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ICo-Vent: An innovation inspired by the pandemic

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The coronavirus pandemic has inspired many researchers and inventors all across the world to come up with innovations that can be handy to treat the increasing number of COVID patients. Indian inventors too have been racing against time to bring out the best possible solutions. Konda Vishweshwar Reddy, Engineer, Inventor, Entrepreneur and former Member of Parliament, recently announced the development of ICo-Vent Ventilator, which is designed for COVID patients. In an interview with Raelene Kambli, he explains more about the ventilator and its COVID specifications

How is ICO-Vent different from other ventilators?

There are various types of ventilators in hospitals – CPAP machines, BIPAP machines, portable ventilators, ambubags, ambubag squeezing machines, anesthesia ventilators, etc. However, none of these can be used in the Intensive Care Unit (ICU) for treating COVID patients in critical condition (ARDS- Acute Respiratory Distress Syndrome). Only ICU ventilators can be used on these critical COVID patients. The ICo-Vent is similar to an ICU ventilator which can be used on COVID patients in critical condition (ARDS).

It is significantly different from hundreds of “low-cost ventilator projects,” ambubags, ambubag squeezing machines, CPAP machines, BIPAP machines, portable ventilators and anesthesia ventilators. These push pump air in and out of the lungs… that does not suffice for oxygenating the patient’s blood for COVID patients in critical conditions and give no clinical benefits. Further, these types of ventilators can harm the patients by causing ventilator-induced lung injuries and can put the ICU doctors and nurses at great risk by pumping the viral load from the patient’s lungs into the ambient air in the ICU.  The efficacy of the N95 masks in a COVID ICU is still a matter of debate.

What are the COVID-19-specific requirements in a ventilator?

The first country to come with the COVID-19-specific requirements in a ventilator is the United Kingdom (UK). Subsequently, Canadian and Australian governments did the same.

COVID ventilators need precise control of pressures, flow/volume and timing. The ICU COVID ventilators should precisely be able to control the Peak Input Pressure, The Plateau Pressure, PEEP Positive End Expiatory Pressure, I/E Ratios, Tidal Volumes and several modes of ventilation.

The base UK Specs for COVID ventilators are

Tidal Volume          :  200 to 600 ml

Resp Rate                : 10 to 30

I:E ratio                    : 1:1 to 1:3

PIP                            : 0 to 40 cmH2O

Plateau Pressure    : 0 to 35 cms H2O

PEEP                         : 5 to 25 cmsH2O

Modes                     : 2 Modes – PRVC, SIMV-PC, BIPAP.

What is the potential impact that this ventilator can make in the fight against COVID-19?

COVID patients develop respiratory disorders. In that, a significant number of these patients go into a critical condition and have a severe form of ARDS – Acute Respiratory Distress Syndrome. Only an ICU ventilator or a COVID-specific ventilator can help the patient come out of ARDS and save his or her life.

It will not help in containing the spread of COVID-19. But it will save the lives of those infected and in critical condition.

How many of such ventilators will be manufactured and to which hospitals will these be supplied?

There is a worldwide shortage of ventilators; even developed nations are unable to procure them. Millions of ventilators are needed. The US and European manufacturers are unable to supply such large quantities quickly. The ventilators’ parts suppliers have also run out of parts.  Our companies Citadel Research and Solutions is in R&D and our group company Stephan can manufacture only 300 ICoVent ventilators per month.

Our strategy is to tie-up with companies with a track record of quality/GMP and capable manufacturing  20,000 units per month.

A US-based company and a Hyderabad-based company are in discussion with us.

What government support have you received so far?

We have not asked for any help, except for the Government of India to define the requirements for a COVID ventilator (like US Canada and other countries). The Govt of India DIPP and the empowered committee has looked into ventilators procurement. We have taken inputs from all and defined the COVID ventilators.

The Telangana Police has helped us in getting permission for our engineers and technicians to travel during the lockdown. The police also helped us locate owners of shops supplying industrial components, electronic components and sensors.

Have you received approval from DCGI and ICMR?

No, not yet. ICMR is not the appropriate authority to validate and certify ventilators. We will be applying to DCGI and DIPP only after the reliability testing is complete.

What about its cost-effectiveness?

There are three models – all meeting the British specs. The lower end ICoVent model costs Rs 50,000 and the more expensive models cost Rs 1.4 Lakhs. We also plan to build full-featured ICU ventilators costing Rs 3 to 5 lakhs.

What happens to these ventilators post the epidemic?

They need not be converted. They can be used on patients with other ailments. They can be used as ICU ventilators and can do the function of all the lower-end ventilators as ambubag squeezing machines and BIPAP machines. The ICo-Vent is not suitable as a portable ventilator.

You say that it is built to the UK and Canadian Government specifications, why?

The UK was the first government to specify what a COVID ventilator is, and came up with the following document: “a specification of the minimally clinically acceptable ventilator to be used in the UK hospitals during the current COVID-19 pandemic caused by SARSCoV-2 virus. It sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of the anaesthesia and intensive care medicine professionals and medical device regulators given the emergency situation. It is for devices, which are most likely to confer a therapeutic benefit on a patient requiring invasive ventilation because of respiratory failure caused by SARS-CoV-2, used in the initial care of patients requiring urgent ventilation. A ventilator with lower specifications than this is likely to provide no clinical benefit and might lead to increased harm, which would be unacceptable for clinicians.”  https://www.gov.uk/government/publications/specification-for-ventilators-to-be-used-in-uk-hospitals-during-the-coronavirus-covid-19-outbreak/rapidly-manufactured-ventilator-system-rmvs

In the absence of any specification for a COVID ventilator, when we started the ICoVent project, we set these specifications as a goal for our project. Subsequently, other governments also came up with nearly similar specs.

Do you have a plan for exports? If yes, to which nations?

Yes, we do plan to export. Ventilators for fighting COVID are required in developed and in the developing world.  Our manufacturing capabilities are limited to 300 units a month. Our priorities now are to complete the reliability testing and tie-up with manufacturers who have the scale and follow standards of manufacturing.

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