The Department of Science and Technology (DOST) has announced that the clinical trials for a prototype and locally developed mechanical ventilator for adults may start soon.
During his weekly report on Friday, April 9, DOST Secretary Fortunato “Boy” T. de la Peña said OstreaVent II, which was developed by the DOST-Metals Industry Research and Development Center (MIRDC) in collaboration with Breath of Life Foundation. has already secured the major requirements to proceed with clinical trials.
He said the modified OstreaVent got the certification from third company Medical Equipment Healthcare Group, Inc. (MedEquip), which conducted the safety testing and performance verification.
Since August 2020, OstreaVent II has undergone a series of performance and calibration tests by MedEquip.
De la Peña said aside from MedEquip certification, OstreaVent II also got "ethics approval" from the University of the Philippines Manila Research Ethics Board (UPMREB) as well as the Certificate of Medical Device Listing (CMDL) from the Food and Drug Administration (FDA).
"The project proposal for the conduct of safety trial of the modified OstreaVent among adult patients on mechanical ventilation is currently under evaluation,” he said.
Last month. de la Peña announced that the FDA has granted the CMDL to OstreaVent II "after months of design, prototyping, and a series of tests.”
The CMDL refers to the authorization issued for a medical device that is intended for research, clinical trial, exhibit, donation, among others and that is not intended for sale.
OstreaVent II was patterned after OstreaVent I, which was designed by Dr. Enrique R. Ostrea to treat respiratory diseases among infants.