Alhamdulilah, the OpenVentPk team had its first official trial with the regulatory bodies (PEC) at Dow University Hospital Ojha Campus with PEC rep. Sir Riasat along with Dr. Hamid and Tariq Sahab on 18th May, 2020.
I have attached the initial trial document. The summary is as follows:
1. We showed them VCV mode, PCV mode with different breaths and tidal volumes and pressures. These modes were comprehensively tested and were passed along with configuration of alarms.
2. The oxygen and air pipes that needed to connected through hospital outlets couldn’t get connected because our pipes did not have the standard outlets. So we could not verify the FiO2 mixing and control mechanism. We will be solving the connector issue in the next trial.
3. The team checked the assist control mode with a syringe at the end of test lung. Our system was NOT able to catch the trigger and perform assist control. We will need to work on this to resolve the issue.
4. We also requested them to give us a demo of the actual ventilator operation and Dr. Hamid was kind enough to walk us through different modes.
5. Riasat sahab asked for our documentation which was done comprehensively and duly provided. Link to the documentation is also attached for reference. https://drive.google.com/…/1Oq0x736uvv4xvAyjTnndLkvPGh0https://drive.google.com/open?id=1Oq0x736uvv4xvAyjTnndLkvPGh0h1s6Rh1s6…
6. They wanted an inhale safety valve incorporated as well. We said we will include it once we get the PEEP diverter and we will also be able to separate the inhale and exhale circuit.
We would say that we have achieved 75% of the required work alhamdulilah based on the reviews we received. Till now not even 1 ventilator design have been completely certified by regulatory bodies in Pakistan.
A big thanks to the perfect team we have. The team leads especially didn’t sleep for two nights in preparing for the trial. Special appreciation to Hamza Azeem, Sohaib Ashraf, Tayyab Alam, Hashir Azeem Chaudhary, Hassan Bhai, Rabi Imran,
Special thanks to Dr. Akber from AKU and Sir Azeem from Signaxes for accompanying us on the visit.
Another key contributor were our UI guys along with Danish Karim Iqbal, Ali and Aqil who made sure that our graphs look good.
And of course sir Bilal Siddiqui for facilitating the whole R7D process and making sure that we went into the trial earlier so that we can plan for the next phase.
These are many many other volunteers who have contributed in different ways to this project, We have our own website and social media pages which mention our complete team. You can check out here
Your prayers and support always requested.