Evaluation of Five Adult Disposable Operator-Powered Resuscitators

Abstract

We evaluated the performance and safety of five adult disposable operator-powered resuscitators: BagEasy, Bag Mask Resuscitator, Pulmanex, 1st Response, and Stat Blue. METHOD: We tested the devices against the American Society for Testing and Materials (ASTM) Standard F-920-85. We tested each resuscitator by using it to ventilate a lung model, the Bio-Tek VT-1 Adult Ventilator Tester. RESULTS: All resuscitators met the requirements of V_T 600 mL, f 20/min, and I:E < 1:1. Standard F-920 specifies a fractional delivered O₂ concentration $\left({\text{F}}_{{\text{DO}}_{\text{2}}}\right)⩾0.85$ with attachments and ⩾ 0.40 without attachments, at oxygen flows of 15 L/ min and ${\dot{V}}_{\text{E}}$ of 7.2 L (600 mL × 12). The Pulmanex with bag reservoir attached had a mean ± SD ${\text{F}}_{{\text{DO}}_{\text{2}}}$ of 0.74 ± 0.02, and the other four devices had an ${\text{F}}_{{\text{DO}}_{\text{2}}}$ of 0.93 ± 0.02. Without attachments only the 1st Response and BagEasy had ${\text{F}}_{{\text{DO}}_{\text{2}}}⩾0.40$ . All devices when disabled with simulated vomitus were restored to proper function within 20 s and were functional at O₂ flow of 30 L/min. Only the Bag Mask Resuscitator did not pass the drop test. Only the Stat Blue did not pass the back-leak test. CONCLUSIONS: Although we do not have practical experience with these resuscitators, we conclude that only 1st Response and BagEasy meet the ASTM standard for operator-powered resuscitators and that, of the devices tested, only the 1st Response and BagEasy are acceptable replacements for permanent resuscitators. We recommend that the Pulmanex (bag reservoir attached) not be used when a high ${\text{F}}_{{\text{DO}}_{\text{2}}}$ may be needed. The clinical significance of the Stat Blue back leak needs further evaluation. We recommend that the Bag Mask Resuscitator not be used until the bag is permanently bound to the patient-valve assembly.