Ali Mehrabi1, Patricia Dillon2, Kyle Kelly2, Kristina Hitchins2, Eileen Malatino3, Susan Gorman3, Madhusoodana Nambiar4, Hilda Scharen2. 1. Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Food and Drug Administration, Silver Spring, Maryland. 2. Center for Devices and Radiological Health, Office of the Center Director, Food and Drug Administration, Silver Spring, Maryland. 3. Centers for Disease Control and Prevention, Office of Public Health Preparedness and Response, Atlanta, Georgia. 4. Center for Devices and Radio-logical Health, Office of the Center Director, Food and Drug Administration, Silver Spring, Maryland.
Abstract
BACKGROUND: The Center for Devices and Radiological Health, Food and Drug Administration (FDA) launched a collaborative initiative with Centers for Disease Control and Prevention (CDC) to gain a better understanding of ventilators that are used during national emergencies. This initiative was intended to test reliability of ventilator devices stored long term in the CDC Strategic National Stockpile (SNS) and also used by the Department of Defense. These ventilators are intended to be used by trained operators to provide ventilatory support to adult and pediatric populations under diverse environmental conditions. The authors evaluated device performance and possible effects of long-term storage. METHODS: Three SNS ventilator models: Impact Uni-Vent 754 Eagle™, Covidien (Puritan Bennett) LP10, and CareFusion LTV 1200 were used in this study. A total of 36 ventilators, 12 per model, were evaluated for performance in simulated adult populations using a test lung. The parameters evaluated included battery charge status and capability, battery longevity, positive end expiratory pressure consistency, device performance on AC and DC (battery) power, and device durability testing. RESULTS: The out-of-the-box run time was equal to or higher than the manufacturer's specifications for fully charged batteries for all ventilators except 58 percent of the Impact 754 ventilators. No significant ventilator performance issues were observed in terms of tidal volume consistency, proximal pressure, oxygen consumption, and a 2000-hour run test in LP10 models. CONCLUSIONS: These findings provide information about the long-term storage of ventilators that have regular maintenance, and their ability to perform reliably during a public health emergency.
BACKGROUND: The Center for Devices and Radiological Health, Food and Drug Administration (FDA) launched a collaborative initiative with Centers for Disease Control and Prevention (CDC) to gain a better understanding of ventilators that are used during national emergencies. This initiative was intended to test reliability of ventilator devices stored long term in the CDC Strategic National Stockpile (SNS) and also used by the Department of Defense. These ventilators are intended to be used by trained operators to provide ventilatory support to adult and pediatric populations under diverse environmental conditions. The authors evaluated device performance and possible effects of long-term storage. METHODS: Three SNS ventilator models: Impact Uni-Vent 754 Eagle™, Covidien (Puritan Bennett) LP10, and CareFusion LTV 1200 were used in this study. A total of 36 ventilators, 12 per model, were evaluated for performance in simulated adult populations using a test lung. The parameters evaluated included battery charge status and capability, battery longevity, positive end expiratory pressure consistency, device performance on AC and DC (battery) power, and device durability testing. RESULTS: The out-of-the-box run time was equal to or higher than the manufacturer's specifications for fully charged batteries for all ventilators except 58 percent of the Impact 754 ventilators. No significant ventilator performance issues were observed in terms of tidal volume consistency, proximal pressure, oxygen consumption, and a 2000-hour run test in LP10 models. CONCLUSIONS: These findings provide information about the long-term storage of ventilators that have regular maintenance, and their ability to perform reliably during a public health emergency.
Authors: Logan Ryan; Carson Lam; Samson Mataraso; Angier Allen; Abigail Green-Saxena; Emily Pellegrini; Jana Hoffman; Christopher Barton; Andrea McCoy; Ritankar Das Journal: Ann Med Surg (Lond) Date: 2020-10-03