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N95 Respirator Fit Test Study with Michigan Hospital System

Last week a major Michigan medical system research team came to Orbitform Medical to perform what is called a “Fit Test Study” on N95 respirators after the respirators have gone through the UVC Decontamination Chamber for several cycles. Why would we do this type of study? We wanted to answer some of the questions involved with using ultraviolet (UV) light to decontaminate the N95 face masks. Questions such as how will ultraviolet light impact the: • mask materials • mask fit • mask sealing ability • mask elastic straps or rubber straps Due to the shortage of personal protective equipment (PPE) such as N95 respirators, the hospital research team is investigating the decontamination and reuse of N95 face masks for their staff so they are just as interested as we are in the results. Also, part of our FDA medical device application process involves answering questions related to the integrity and performance of the N95 respirator after being exposed to numerous UV-C exposure cycles within the Orbitform Medical UVC Decontamination Chamber. Therefore, this study sort of accomplished 3 goals at once. Goals for the hospital, goals for Orbitform Medical, and goals for the FDA application. 10 Orbitform employees volunteered to be test subjects. This involved learning how to properly apply a N95 respirator to their own face, several different fit tests, smell tests, taste tests, etc. The good news is that all six (6) of the test subjects who passed the initial baseline respirator fit test also passed through all 10 UV-C decontamination cycles through the Orbitform Medical UVC Decontamination Chamber. The UVC Decontamination Chamber passed the test. The Michigan hospital system has now approved the UVC Decontamination Chamber for use in it’s facilities! And, we are able to augment our FDA application with this independent, third party research study!

Take care,


David




About the UVC Decontamination Chamber (UVC-DC):


The UVC Decontamination Chamber is a Portable On-Site Face Mask Disinfection Chamber for disposable face masks. The disinfection method is eight (8) germicidal UV-C bulbs positioned in front of and behind the N95 face masks. 10 face masks can be disinfected during each 15-minute cycle. The UVC-DC can be used at hospitals, fire stations, police stations, nursing homes, etc., and can be located near the actual point of use. One or more UVC-DC's can be located at each station, department, wing, hallway or emergency room, so there is no need to handle and disinfect mass numbers of masks at a central or off-site location. The UVC-DC is simple to operate, easy to roll around, and versatile enough to be transported in the back of a minivan or SUV.

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