NEW DELHI: Oxygen concentrators with a flow capacity of less than five litres per minute are "not suitable" for COVID-19 patients on home care and should not be used, India's drug regulator has said in an advisory, adding that sellers should not push such devices using "misleading label" amid the coronavirus second wave.
The advisory has been issued to inform people about minimum standards of oxygen concentrators for COVID-19 case management, especially for use in home settings, the Central Drugs Standard Control Organisation (CDSCO) said.
At present various models of oxygen concentrators, having different capacities of continuous flow (1 to 10 litres/minute) and widely varying concentration of oxygen, are being marketed, the advisory stated.
The health ministry has from time to time advised that oxygen concentrators with flow capacity of five litre per minute or more and delivering oxygen with concentration of 90 per cent or more are suitable for management of COVID-19 patients at COVID Care Centres, Dedicated COVID Health Centres and in home settings.
The World Health Organisation has also prescribed these norms for oxygen concentrators.
Besides, continuous flow of concentrated oxygen (>90%) from room air through one oxygen outlet, minimum continuous flow of up to 5 litre/min or more, oxygen concentrators which contain oxygen monitor to verify concentration and digital or analogue metre that displays cumulative hours of device operation may be used in home settings.
"Many people are not aware about these minimum parameters of oxygen concentrators and therefore may be using the concentrators that are not suitable for COVID-19 case management.
This advisory is issued to inform people about minimum standards of oxygen concentrators for COVID-19 case management, for use especially in home settings," the advisory stated.
It further advised that oxygen concentrators must be purchased with consumables required to operate, user care instructions and protocols including guidance for replacement of accessories and consumable and safe decontamination of reusable parts, indicating if they are generic or brand related, the advisory said.
"It is strongly advised that all sellers must prominently display the following information for each model of oxygen concentrator for sale -- continuous flow capacity in litres per minute, the percentage of oxygen that a concentrator generates and the maximum retail price.
"The aim of this advisory is to provide minimum parameters that must be verified by people before using an oxygen concentrator for COVID-19 case management in home settings," the CDSCO said.
India is under the grip of a devastating second wave of COVID-19, which has triggered a shortage of medical oxygen and other critical drugs.