La FDA de USA en la lucha para evitar la expansión de la pandemia autoriza/ recomienda los equipos como los de E. VILA PROJECTS para reducir los riesgos de contagio en superficies, aire y para descontaminación de artículos.
The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide a policy to help expand the availability and capability of sterilizers, disinfectant devices, and air purifiers during this public health emergency. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act). Given this public health emergency, and as discussed in the Notice in the Federal Register of March 25, 2020, titled “Process for Making Available Guidance Documents Related to Coronavirus Disease 2019,”
…..Air purifying devices are intended for medical purposes to kill pathogens/microorganisms in the air by exposure to UV radiation or remove them through filtration. The classification regulations and associated product codes for air purifying devices, to which the policy in this guidance applies, are listed in Table 3: Table 3 – Air Purifiers Classification Regulation Device Type Product Code Device Classification 21 CFR 880.5045 Medical recirculation air cleaner FRF II 21 CFR 880.6500 Medical UV air purifier FRA II IV. Policy In the context of the COVID-19 public health emergency, it is necessary to maintain an adequate 6 Subject to special controls. 7 Subject to special controls. 8 Subject to special controls. Contains Nonbinding Recommendations 8 supply of sterilizers, disinfectant devices, and air purifiers that can facilitate rapid turnaround of sterilized or disinfected medical equipment and that help reduce the risk of viral exposure for patients and health care providers to SARS-CoV-2. FDA believes that certain sterilizers, disinfectant devices, and air purifiers falling within the scope of this guidance (see Section III) may help reduce this risk of viral exposure based on our current understanding of these devices and SARS-CoV-2.