(FACEBOOK/MANILA BULLETIN)
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).