FDA warns of presence of unregistered oxygen products in hospitals-A A +A
Thursday, August 21, 2014
THE Food and Drug Administration (FDA) warned Thursday the public of the presence of medical-grade oxygen-generating machines that are not registered with the government, and could pose safety concerns.
According to FDA Circular 2014-018, they have 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.
It said the presence of such machines and products could pose danger to the public since it did not pass through the FDA.
"Upon regulatory inspection, review, and validation of available data on unregistered medical oxygen, it is found that there is no quality assurance/quality control in place, thus safety, efficacy and quality may be compromised," said the health agency.
And in a bid to stop the said practice, the FDA has directed concerned hospitals to stop their ongoing activities until they are able to secure the required licenses.
"Hospitals with already established and working medical-grade oxygen-generating machines that are non-compliant with this FDA Circular shall be given three months from date of effectivity to apply for licensing of manufacturing facility and subsequent registration of medical-grade oxygen products," said the FDA.
"During the transition period, you are hereby ordered to cease and desist from using the said machine and use only FDA-registered medical-grade oxygen procured from FDA-licensed manufacturers or distributors," it added.
The FDA said failure of hospitals, health facilities, and other establishments to comply with the said requirement shall face appropriate regulatory sanctions.
Penalties may involve the imposition of fines, suspension, cancellation, or revocation of existing License-to-Operate, as well as possible legal actions as needed. (HDT/Sunnex)