Clinical trial on use of DOST’s adult ventilator to be conducted at PGH

Published May 8, 2021, 8:12 PM

by Charissa Luci-Atienza 

The Metals Industry Research and Development Center of the Department of Science and Technology (DOST-MIRDC) has announced that the clinical trial on its newly developed prototype adult ventilator will be conducted at the Philippine General Hospital (PGH).

OstreaVent II (DOST Secretary Fortunato “Boy” T. de la Peña’s Facebook Page)

DOST-MIRDC Executive Director Robert O. Dizon disclosed this at the sidelines of DOST Secretary Fortunato “Boy” T. de la Peña’s weekly report on Friday, May 7.

“Nung April nabuo na ang medical team na magsasagawa ng trial na ito. Maayos na rin ang susundin nila na safety protocol. Hinihintay na lang ngayon na bumaba ang kaso ng COVID (coronavirus disease) kasi gagawin natin ang trial sa PGH (Last April, the medical team that will conduct this trial was formed. The safety protocol was also developed. We are just waiting for the cases of COVID to come down because we will conduct the trial at PGH),” he said.

De la Peña announced on Friday, May 7, that OstreaVent II, which was developed by the agency’s MIRDC in partnership with the Breath of Life Foundation Inc., can be used by both infants and adults.

http://https://mb.com.ph/2021/05/07/a-ventilator-for-both-infants-adults/

Dizon said OstreaVent II clinical trial will only involve 10 non-COVID-19 patients at the PGH.

He said the clinical trial could be completed by less than a month.

“Kung magiging maganda naman ang magiging resulta ng trial, magbubuo tayo ng lima ng Ostreavent 2 para naman makapgconduct tayo ng field trial na gagamitin sa ibang ospital at sa ibang pasyente (If the trial yields positive results, we will develop five Ostreavent 2 so that we can conduct a field trial that will be used in other hospitals and other patients),” the MIRDC top official said.

He expressed hope that they could mass produce OstreaVent II before the end of the year.

“Pag-successful ang field trial saka na tayo magsisimula ng mass production. Ila-license na natin sya at mass production na tayo. Sana sa katapusan ng taon meron na tayong mass produced na OstreaVent II (When the field trial is successful, then we will start mass production. We will have it licensed and we will engage in mass production. Hopefully, by the end of the year we will be able to mass produce OstreaVent II),” Dizon said.

OstreaVent II used the technology of its predecessor, the OstreaVent I, which is for infant use only.

De la Peña said it was in June last year when the OstreaVent II prototype was completed.

Since August 2020, OstreaVent II has undergone a series of performance and calibration tests by third company Medical Equipment Healthcare Group, Inc. (MedEquip). The ventilator eventually got the nod of MedEquip and received the Certificate of Medical Device Listing (CMDL) from the Food and Drug Administration (FDA) in March this year.

https://mb.com.ph/2021/03/19/fda-grants-certificate-of-medical-device-listing-to-dosts-adult-ventilator-prototype/

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.

The University of the Philippines Manila Research Ethics Board (UPMREB) approved OstreaVent II’s Safety Trial Protocol in July 2020.

“After the clinical trial, five units of the OstreaVent II will be produced: four will be used for field testing, one will be used for further design improvements. If all activities will proceed as planned, licensing and production may begin by November this year,” de la Peña said.

 
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