As many as 200 units of the device will initially be manufactured, the Directorate General of Drug Administration or DGDA Deputy Director Md Salahuddin confirmed on Wednesday.
“Production on a bigger scale will be approved after observing how these work,” Salahuddin said.
“This is a limited approval for production and use. We need to see whether the machine is working properly, whether there are any side-effects and whether it can be improved.”
The third stage of the device’s clinical trials began in May at Dhaka Medical College Hospital.
At that time, BUET in a statement said the device could be used as an alternative to high-flow nasal cannula subject to approval from proper authorities and advice from doctors if the third stage trials were successful.
The C-PAP ventilator, named Oxyjet, has been developed by Meemnur Rashid, Kawsar Ahmed, Farhan Muhib, Kayser Ahmed and Saidur Rahman at the BUET’s biomedical engineering department under the supervision of Assistant Professor Taufiq Hasan.
Dr Taufiq said, “We've received approval (for use) on a limited scale as we applied on behalf of the university. If it was done under any company, it would have been more. But we preferred applying from the university.”
“We still have to go through some stages. The authorities asked us to continue the trials.”
The easily movable and low-cost ventilator Oxyjet can be used as an alternative to high flow nasal cannula to supply oxygen from cylinders or tanks without power.
In the general beds of hospitals, a patient can be supplied a maximum of 15 litres of oxygen. When more oxygen is needed, patients require high-flow nasal cannula or have to be transferred to intensive care.
The developers of Oxyjet claim the machine can supply 60 litres of high-flow oxygen to a patient in general beds and would cost only between Tk 20,000 and Tk 25,000, whereas high-flow nasal cannulas cost patients from Tk 250,000 to Tk 500,000.
The developers applied for approval after the Bangladesh Medical Research Council gave them the go-ahead to hold late-stage clinical trials after phase one and two trials.
Later, they complained that Oxyjet was not receiving approval due to the complications of DGDA rules and non-cooperation from manufacturing companies.
The High Court asked to prod Prime Minister Sheikh Hasina for the device’s approval after Supreme Court lawyer Aneek R Haque brought the issue to the court’s attention.