OstreaVent2 Approved by the FDA of the Philippines

Congratulations to Dr. Enrique M. Ostrea, Jr., Professor of Pediatrics at the Wayne State University and Neonatologist at Hutzel Women’s Hospital and Children’s Hospital of Michigan. Dr. Ostrea led the team in the Philippines in developing the OstreaVent2 for adults last year. He was the honored recipient of the UPMASA 2019-2021 Presidential Award and the the Dr. Solita Camara Besa Academic Distinction Award for 2020.

The OstreaVent for adults (OstreaVent2 ), being the first of locally produced ventilators in the Philippines, has undergone a series of tests, modifications and retests by MedEquip, which is the agency authorized by the Department of Science and Technology of the Philippines to certify locally produced ventilators. Thereafter, the clinical test of the OstreaVent2 on patients needing ventilators will be undertaken in the ICU of the Philippine General Hospital. The protocol for the clinical test of the OstreaVent2 has been approved by the Institutional Review Board of PGH/UPNIH/UPCM. The certification of OstreaVent2  has been completed.  The FDA of the Philippines has approved the clinical testing on patients using the approved IRB protocol issued by UP Manila. The team of consultants, pulmonary fellows, respiratory therapists and the Monitoring Board will start the clinical tests on ventilated adults at PGH. If the clinical test is successful, then production of the ventilator will start.

The plan is to produce 10 ventilators initially. The cost of each OstreaVent2 ventilator will be $10,000 (PhP480,000) which is relatively low cost compared to the high cost of imported, commercial ventilators which retail between $28,000 to $48,000. Donations for the ventilator through online (Mighty Cause) and personal solicitations has so far raised $102,850. Of this, donations from UPMASA and its members have totaled $102,500 spearheaded by the BOG’s donation of $10,000 and major donations of greater than $1000 by some of its members,  viz., Dr. Minda Ancheta-Datoc ($50,000), Texas UPMASA chapter ($9500), Michigan UPMASA Chapter ($2000), Dr. Zacarias Asuncion ($6000), Drs. Maria Telenia and Edito Cabal ($5000), Drs. Robert and Betty Go ($1000). The total amount donated will fund 10 ventilators. We will continue to solicit for donations to provide adult ventilators to PGH and other major hospitals in the Philippines. Sadly, we are informed that there has been a significant lack of ventilators in government hospitals even prior to the COVID-19 pandemic. So the need is great!

The Dean of the UP College of Medicine, Charlotte M. Chiong MD PhD wrote: “Congratulations!! We are happy and are proud of this important milestone of having Ph FDA approval for conduct of clinical trials.  I still remember one year ago when I made that frantic call and broached the idea that perhaps you can have your neonatal ventilators developed for adults  given the scarcity of  ventilators in the country. Thank you for responding to the call of your beloved alma mater in helping our suffering nation in this pandemic. From the  UPCM Community of Scholars – we salute you!”

Certificate of Medical Device Listing

We will appeal for ventilator donors from UPMASA members and from civic and private organizations and individuals. As was done in the past, the donated ventilator will be given to the hospital of choice by the donor provided that the hospital has an adequate ICU and medical and support staff. The name/s of the donors in honor of their loved ones will be inscribed on a small plaque on the donated ventilator.