In a rather action-packed week from the US FDA, the drug regulator has provided yet another emergency authorisation to a system by research company ‘Battelle’, that will decontaminate used N-95 masks originally intended for one-time use. The company’s Critical Care Decontamination Systems (CCDS), that will be used to make N95 respirators re-usable, will reduce the strain on front-line medical equipment amidst the pandemic as health care systems world over face shortages.
Already in operation in Battelle’s Ohio facility, the system has a recorded decontamination capacity of up to 80,000 masks per day. The N-95 respirators are disposable snug-fitting face masks that keep the user averse from virus-laden droplets by covering their nose and mouth. With health care systems under constant strain, the mask is a front-line equipment by virtue of our current state of affairs. And it is in acute shortage world-over.
The system developed by Battelle will use “vapour based hydrogen peroxide” to decontaminate the masks. This will turn single use respirators into masks that can be used up to 20 times with a 2.5 hour decontamination process between each use. The system can decontaminate thousands of N95 respirators using concentrated, vapor phase hydrogen peroxide. The respirators are exposed at the validated concentration level to decontaminate biological contaminants, including the SARS-CoV-2.
Battelle CCDS can decontaminate the same respirator multiple times without degrading N95 respirator performance. Precautions are accordingly being taken where, masks from one medical facility that come in for decontamination are sent back to the same one.
The decontamination capacity was a development following criticism from Mike Dwain, governor of Ohio. The initial restrictions limited Battelle to decontaminating only 10,000 masks per day. Dwine, according to his tweet had appealed to President Trump to lift the limit. Following this, Lt. Governor Jon Husted tweeted “This Ohio driven solution has the potential to save lives now and in the future across the United States”.
The system used however, isn’t new and is frequently used to decontaminate equipments in labs. Its use to decontaminate N95 respirators is rather innovative. Battelle and the FDA began to work on the system in 2015 as a precaution against equipment shortages in case of circumstances such as the on-going pandemic.
