VENTILATOR is now one of the most needed medical equipment. Its existence has a vital role to reduce the death rate of COVID-19. However, in general hospitals, many do not have massive ventilators. That makes many people try to create modification ventilators that are more compact and more economical.
In the country, one of the local ventilators that have been developed is Vent-I. The process was initiated by the team Dr. Ir Syarif Hidayat, MT, a lecturer at the School of Electrical and Information Engineering (STEI) from the ITB Electrical Power Engineering Research Group. Vent-I is a portable breathing apparatus for patients who can still breathe on their own.
On April 21, 2020, Vent-I, which was also the result of a collaboration between ITB, Padjadjaran University (Unpad), and YPM Salman, had passed the product testing process from the Health Facilities Safety Center (BPFK) of the Indonesian Ministry of Health. Bypassing the product test, Vent-I should have been able to donate to help co-19 patients.
However, Syarif told Media Indonesia, the Vent-I distribution plan is currently still constrained. This is the following excerpt.
How did Vent-I begin?
In the case of a ventilator, you could say I did mission impossible. The reason is, there are not many raw materials. So it’s really hard to make something out of nothing. In fact, to this day I have not managed to buy a breathing tube from our home country, and I have to take risks. The risk of mission impossible is the ghost protocol. If it is successfully acknowledged by people if it is not successfully reviled.
With that impossible mission, how do you seek funding and other resources?
To create a ventilator, of course, I need funds and resources. Submitting a proposal to the government, it will only be realized next year. There is no way except to use Salman Mosque ITB funds for capital. I also use the mosque’s space as a manufacturing resource because I cannot get into campus. During the period of large-scale social restrictions (PSBB) in force in Bandung, there were no open workshops. It was the same to start there.
I then asked for the help of my doctor friends to review my design. The smart and brave doctors came to the Salman Mosque of ITB which was locked out. I have to take the risk because I do not want to die just by counting the number of people who have died and how close to my house. I do not want to be afraid of that.
What raw materials make it difficult?
The main part, for example, a blower, does not exist in Indonesia. In China, it can be bought, but it’s in line. It came somehow a few weeks after being ordered. I tried to order 100 seeds not served because of competitiveness. Therefore, I searched from around, what I could use with modification to suit my needs.
Because I not only want to make 1 or 10 units but also mass so that it is useful. Finally, I re-engineered it so I made my own patent for this blower. I modified the material from a pump whose characteristics most closely resemble a ventilator pump.
is the modification successful?
To this day the blower that I created has been tested day and night. Until the 14th day, it was still stable without dying. My target is, the blower can live for at least 20 days without even dying for a second. Because the blower is the heart.
The blower that I had bought on the market, whose characteristics were closest to what I needed, died after a day. Burnt out. I replaced it with a bigger engine and type, but only lasted 12 hours. Then, for the blower motor, there is no industry in Indonesia. Finally, I found a motor that can be stable for 14 days. From a toy motor.
So, how big is the technical challenge?
There are still many other components that I have to replace, for example a pressure regulator. That also doesn’t exist in Indonesia. I managed to get a suitable pressure sensor, one seed, I bought it scrambling from China. On the day of the ventilator testing at BPFK, the pressure regulator was broken. Even though only one seed.
A reasonable and safe solution finally uses a water column tube; the term uses a liquid that is better than water to replace the pressure gauge. Finally, I used glycerin which was 1.25 water density. Alhamdulillah, in terms of function, it is acceptable even if there is a record that there should be no liquid inside. That is understandable. I have to think of a replacement. I also have to find a maker who can work at home.
Yes, that’s then me and my friends patented a pressure gauge that can provide alarm and venting, a safety valve for overpressure on the ventilator. Those are examples of technical challenges.
What kind of patient’s condition can be helped with this ventilator?
This ventilator only performs one of the simplest functions of a ventilator in a hospital ICU, namely continuous positive airway pressure (CPAP). That’s what is needed to help patients extensively. All we have to do is help the early-stage patients, who start breathing difficulty. That can be with the simplest ventilator function, namely CPAP.
That is why I created a tool whose function is very simple, but it is important in the beginning so that the patient does not get worse. In essence, preventing patients from entering the ICU. Thus, I created a tool that was relatively easy and fast to make. It is also easy to operate because it does not need requirements such as a hospital ICU ventilator.
What is the production capacity?
Ventilators can be produced 1,000 units a week even though there are components that still need to be imported. If the time is long, no problem, I can design it linearly. But, this time is not enough. In my mind, at the end of May, everything must be finished. Around 2,000 ventilators. Because of funds from the public alone to be as many as 1,000 ventilators I have to deliver in two weeks. These are not tools to be traded, but to be donated to hospitals.
What is the licensing process for using the Vent-I After bypassing test phase?
We got help from the Ministry of Health. But, it must be admitted, our country has been arranged in a complicated way. Good intentions to help even sometimes hampered internal regulations in the ministry as well. We can produce 1,000 units a week. But, according to the rules, every single seed/unit of equipment must be tested again by a third party, which takes 1 hour for only one item.
If my items are sent 10 seeds to a third party (metrolog) appointed by the Ministry of Health to inspect the goods, and he has 8 hours of work a day, meaning that in a day he can only test 8 units. In a week, only 48 devices can be tested, even they have to be tested, not only for their function but also for their durability. Just like when I type-test with BPFK.
So, the ventilator can’t be donated to the hospital yet?
The items are ready, there are already dozens, as we continue to produce. But, to be able to deliver to the hospital, must wait for a third party test. We ask the government, the Ministry of Health, please help. At least in this COVID-19 period. That’s a difficulty when we make medical devices in Indonesia. The complicated turned out like that.
I agree to have quality control. However, not this way, where goods must be sent, tested 1 hour one seed, then takes a long time to send the goods, and the results are returned.
What’s good, in your opinion?
Just bring in the examiner, see that this equipment was tested by the manufacturer correctly. If it is correct, please stamp it, marked with quality control. Not to mention the fact that clinical trials must be supplemented with documents that are not entirely relevant to the function of the tool. The tool has been functionally tested on a machine in a laboratory by BPFK. Then to prove the tool is suitable for use by patients, the function was tested on patients. There is no business that should be dealt with with the company’s administrative matters. Incidentally we are a college, not a company.
To understand why I would be too late to deliver this item. It has been more than a week since this tool was passed by BPFK, I have not been able to officially deliver it to patients. This is the authority at the ministerial level to provide policies, for this emergency situation.
How much longer can it be used at the hospital?
I do not know. We continue to work, but, when this can be delivered to the community, we must wait for the results of clinical trials. We have also taken the risk again by starting to order raw materials first so as not to be late serving the government. However, the government has not yet determined how much to produce.
We, with the available funds, have secured 2,000 units of raw materials. If we only move after there is clarity from the government, the government will surely be too late to move. Not to mention the delay in delivery because the goods must be tested one by one by a third party. Who knows when we can help our patients.
So, that is what the government needs to clarify?
I ask the government to determine how many ventilators are needed and provide a way out for the length of the process of examining clinical trials in third parties so that the device can be used immediately to help patients. If there are industries ready to make, they also need clarity. Industry is not a social institution like us at Salman Mosque ITB. Industry must calculate profit and loss. They will not dare to buy things if there is no clarity.
Does your product allow for duplicated industry or other institutions?
For multiple productions, you don’t need to bother. I leave the equipment to the industry, not only for design but also for the molding. Industry only has to install and assemble. I have provided the pump, pressure sensor, casing, and own production. They want to buy it themselves, please, but we have bought at least 2,000 imported components for 2,000 units.
I want to help COVID-19 patients quickly. I don’t want to be stuck waiting. I ask that authority from the Salman Mosque of ITB which collects funds. I ask permission from the community who entrust funds to us. We have to take responsibility. (M-2)