Altogether 18 organizations and groups are developing ventilators in Bangladesh for the country to tackle the coronavirus pandemic.
In a bid to lend a hand in the fight against Covid-19, many organisations and individuals have come forward in manufacturing prototypes of ventilators in the country.
They came up with the initiative as importing ventilators, a lifesaving equipment for coronavirus patients, has become difficult with international manufacturers struggling to meet rising demand for them across the world in light of the coronavirus pandemic.
A ventilator is a machine that provides mechanical ventilation by moving breathable air into and out of the lungs, to deliver breathing facilities to a patient who is physically unable to breathe, or is breathing insufficiently.
According to the Access to information (A2i) of the government, a total of 18 organizations and groups are developing ventilators amid the pandemic to serve the country.
“Five of them are at the trial stage, waiting to get approval from the Directorate General of Drug Administration (DGDA),” said Faruq Ahmed Jewel, head of technology, Innovation Lab at A2i.
A ventilator manufacturing project is now in the process of manufature under Bangladesh Machine Tools Factory (BMTF), with a concept design from the Massachusetts Institute of Technology, US, and with cooperation from Tiger IT Ltd. The BMTF has already conducted a trial run.
Similarly, the local tech company Walton has developed functional ventilator prototypes with the support of the Information Communication Technology (ICT) Division and cooperation of Medtronic, a global leader in medical technology.
Minister Hi-tech Park Ltd, Giga Tech and Proshash are also in pre-trial stages of the development of ventilators.
Apart from that, Bangladesh Industrial Technical Assistance Center (BITAC), Grameen Intel, Dot University, and Spondon, the last mentioned a team of four youngsters, have also developed prototype ventilators.
Will local ventilators really add value in Covid-19 treatment?
The initiatives are plenty, but intensive care medicine experts have raised questions about the effectiveness of the locally manufactured ventilators for treating Covid-19 patients with a history of respiratory problems.
“A ventilator is a machine to help patients breathe or assist those who have lost all ability to breathe on their own. As a sensitive medical device, it is important that a ventilator functions properly when a patient is in critical condition; otherwise it may be a cause of death,” said Prof Dr Md Khalilur Rahman, a veteran anesthesiologist.
“Similarly, faulty ventilators can cause pneumonia as breathing tubes put in the airway can allow bacteria to enter the lungs,” he told Dhaka Tribune.
“Such medical devices should be used along the guidelines of the FDA. As we are now in an emergency situation, the government authorities concerned should evaluate the whole process before giving a nod of approval for them,” added Dr Khalilur Rahman, who is also member of the National Technical Advisory Committee (NTCA) for preventing coronavirus outbreak.
Bangladesh usually uses A/C, PSV or SIMV types of imported ventilators which are approved by the Food and Drug Administration (FDA), a federal agency of the US.
Such ventilators consist of some important features, notably checking respiratory rate per minute, highlighting the fraction of inspired oxygen, checking the option of the tidal volume as well as sounding off an alarm if the peak inspiratory pressure is high.
But locally manufactured ventilators are mostly based on an air compressor and Ambu bag which is a manual process commonly used to provide positive pressure ventilation to patients.
“A couple of teams met with me to share their ideas in order to produce ventilators and some of them exhibited their models at Dhaka Medical College Hospital (DMCH),” said Prof Dr Mozaffar Hossain, head of the department of Anesthesia and Critical Care Medicine.
“Although I don’t know the latest update, I think such ventilators will not fulfil our objective,” he told Dhaka Tribune.
“A ventilator does not mean that it only ensures breathing; it has many types of features in the total ventilation process,” said Dr Mozaffar, who is also head of ICU at DMCH.
Outcome of the trials
The ventilators developed by BMTF in cooperation with TigerIT Ltd are now in the test and trial phase, with more than 80% of the manufacturing work completed, according to a statement sent to the media by Inter-Services Public Relations (ISPR).
“That ventilator was applied on two patients at the critical care unit of Dhaka CMH and was found to be successful.”
“The patients will be able to use it soon,” reads the statement.
“It is now under process to get a nod from the government as far as I know,” said Sajjadul Hakim, Vice President of Software and Services, TigerIT Ltd.
“We are now working on a second version of the prototype ventilator, which will be more advanced to use,” he added.
The local tech company Walton has manufactured three functional ventilator prototypes. One of them is being manufactured under the guidance of the renowned global medical device company Medtronic and the remaining two models are patented by Walton.
The model designed in association with Medtronic is named WPB 560, whereas Walton’s own ventilators are named Walton Covid Build Ventilator 2020 or WCV-20.
“We have already emailed the protocol of the product to the DGDA for a clinical test as our factory trial was perfect,” said Engineer Golam Morshed, chief of Walton’s ventilator project.
Tajbiul Hasan Kabbo, EEE student of Ahsanullah University of Science and Technology (AUST), a member of Spondon ventilator team said: “We submitted the technology to the A2i for conducting a trial run.”
Getting an approval
The manufacturers have to follow some steps to get approval from the DGDA.
The steps are - innovate a medical device, test its sensitivity, conduct trial run, evaluate performance, clear verification of trial, and if the results are satisfactory then go to production.
According to the rules, the manufacturer will develop a protocol mentioning the details of the process, its function, and trial manual. Then Bangladesh Medical Research Center (BMRC) will examine the process to see if it is up to the standard.
“The process is mandatory for manufacturers to get approval,” said DGDA Director Major General Mahbubur Rahman.
“DGDA approves any medical device following the result of trial test and evaluation of BMRC,” he added.
Situation in Bangladesh
A study published in thelancet.com on March 11 said about 17% of the coronavirus patients actually required ventilation in China.
However, the Information, Communication, Awareness and Panic Management group of the Integrated Control Room for combating coronavirus in Bangladesh said it was assuming that some 5-6% patients might need ventilation if the crisis worsened. The rest of the patients would not require ventilation.
The World Health Organization (WHO) said data from China suggested that 15–20% of Covid-19 cases required hospitalization, with around 15% of cases showing severe symptoms and 5% requiring intensive care.
It emphasized that critical interventions, such as ICU beds and mechanical ventilators, must be made available to health care workers and others supporting the response in terms of services and infrastructure, whose training makes them indispensable.
The government of Bangladesh so far claimed to dedicate 349 intensive care unit (ICU) beds at hospitals in Dhaka and other districts in order to treat Covid-19 patients, with most of them having ventilators in place.