Evaluation of Ten Disposable Manual Resuscitators

Abstract

We evaluated the performance and safety of 10 disposable resuscitators-six adult units: SPUR, Code Blue, 1st Response, Hospitak MPR, CPR Bag, and Pulmanex; and four pediatric units: CPR Bag, 1st Response, Hospitak MPR, and LSP Bag Mask. METHOD: We tested the devices against the American Society for Testing and Materials (ASTM) Standard F-920. We tested each resuscitator by using a lung model, the Bio-Tek VT-1 Ventilator Tester. RESULTS: All resuscitators met the ventilation requirements for V₁ and f (adult: 600 mL × 12/min; child: 300 mL × 20/min and 70 mL × 30/min) and I:E < 1:1. Standard F-920 specifies a fractional delivered O₂ concentration (FDO₂) ≥ 0.85 with attachments and ≥ 0.40 without attachments, at oxygen flow of 15 L/min, and VE of 7.2 L (600 mL × 12/ min) for adult units and VE of 6 L (300 mL × 20/min) for pediatric units. All 10 resuscitators met standard F-920 for FDO₂ with attachments. Nine resuscitators met the FDO₂ standard without attachments. The 10 resuscitators passed the test for valve function after contamination with simulated vomitus, at an oxygen flow of 30 L/min, and for backward leakage. Three pediatric resuscitators (1st Response, Hospitak MPR, and LSP Bag Mask) did not pass the pressure-limit requirement of 40 ± 10 cm H2O. Four resuscitators, Hospitak MPR (adult and pediatric) and CPR Bag (adult and pediatric), were unable to pass the test for mechanical shock (a fall from a height of at least 1 meter). CONCLUSION: We conclude that only Code Blue, 1st response, Pulmanex (with tube-type reservoir), and SPUR meet ASTM Standard F-920 and are acceptable replacements for permanent resuscitators.