FDA warns vs inferior oxygen machines

PHOTO from fda.gov.ph

MANILA, Philippines—Health authorities on Thursday warned against unregistered medical-grade oxygen-generating machines in some hospitals, which could cause health hazards to patients.

In a circular, the Food and Drug Administration (FDA) said it had received reports of the existence of oxygen-generating machines established by some hospitals for their own production of medical-grade oxygen.

“FDA has received reports of the existence of oxygen-generating machines being set-up by both public and private hospitals for their own production of medical-grade oxygen, either stored initially in cylindrical tanks, or directly fed into tubes to patients,” said the FDA.

Upon inspection, the FDA said it found that these had “no quality assurance/quality control in place, thus safety, efficacy and quality may be compromised.”

The FDA said hospitals with established and working medical-grade oxygen-generating machines that are noncompliant with the FDA circular are given three months to apply for a license.–Tina G. Santos