OxyJet: the long road to approval
From the drawing board to the approval stamp, it's been a long exhilarating process for OxyJet. But it isn't over yet.
A type of CPAP (continuous positive airway pressure) device, OxyJet can supply pure oxygen at the rate of up to 60 litres per minute without any electricity, and shows a similar clinical outcome as high-flow nasal cannula (HFNC) treatment.
On the upside, the whole set-up of OxyJet costs only Tk 20,000-25,000, whereas a high-flow nasal cannula costs Tk 4-5 lakh.
The idea began on the whiteboards of the biomedical engineering department of Buet last year and was led by Dr Taufiq Hasan, associate professor of the department.
Taufiq said, "My wife and many of my friends are doctors who shared horrific stories of deaths due to the shortage of high-flow oxygen supply. I spoke to doctors of several hospitals in Dhaka and learnt how Covid-19 patients were suffering due to a shortage of resources.
"We were previously involved with another research to develop bubble CPAP for adults. Realising that we need a higher flow of oxygen, we took up a plan to develop a CPAP using a Venturi-mechanism [which speeds up flow of a fluid] for the treatment of Covid-19 patients.
"Using this technique, the device can generate high-flow oxygenated air at a normal hospital bed with central oxygen supply and without any electricity."
Usually, general hospital beds are equipped with one oxygen flow metre which can supply only up to 15 litres per minute.
With OxyJet, two flow metres can be used simultaneously -- one that gives 15 litres per minute while the other delivers 50 litres per minute. OxyJet is also fitted with a peep valve to regulate the CPAP pressure as required by the patient, Dr Taufiq said.
Besides, viral filters in the inlet and outlet of OxyJet prevent infection and contamination, he added.
Once the design phase was done, it was time for clinical trials.
Over three phases, OxyJet was tried out on 26 patients and researchers found the device to be clinically "non-inferior" compared to HFNC treatment.
Prof Dr Mohammed Robed Amin, spokesperson of the Directorate General of Health Services (DGHS) and who was involved in the clinical trials, said he found OxyJet very effective and "non-inferior" to HFNC.
"While using OxyJet, we could avoid mechanical ventilation of critical Covid-19 patients for more than seven days whereas with HFNC, the number was 6.5. The recovery rate with OxyJet is 38 percent and with HFNC was 27 percent.
"Patients requiring mechanical ventilation after using OxyJet is 38 percent whereas with HFNC, it is 59 percent. We did not find any toxicity after using OxyJet and HFNC as well," stated Prof Dr Amin.
On July 28, approval of the device was signed by the directorate general of drug administration (DGDA), which allowed the production of 200 units of OxyJet for use in hospitals on a limited scale.
But this approval came with conditions -- the researchers will have to monitor 200 patients for benefits, side-effects, and potential risks. The researchers also have to monitor how this device can be improved further.
"At present, we have sufficient equipment to produce 50 units. But production of further 150 units, distribution of those to hospitals, and collecting all the data will take time," Dr Taufiq said.
The limited permission is valid under the condition that the device performs well during this interim period.
Permission for further production or emergency use authorisation of OxyJet will require another clinical performance trial through a contracted research organisation followed by ethical clearance from the Bangladesh Medical Research Council and the National Research Ethics Committee.
"Industrialists would have been more interested to fund this if there was less uncertainty regarding its future approval," observed Dr Taufiq.
Contacted, Md Salahuddin, deputy director of DGDA, said, "According to our rules, we have given some conditions to them and approved the limited use of OxyJet. If they fulfil these conditions, we shall proceed for its further production."
On the other hand, the researchers emphasise the importance of the device for patients in need.
"If this device can help the poor and the sick in this pandemic time, that is our success," said Dr Taufiq.
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