Evaluation of ten disposable manual resuscitators.

UNLABELLED

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 VT and f (adult: 600 mL x 12/min; child: 300 mL x 20/min and 70 mL x 30/min) and I:E less than 1:1. Standard F-920 specifies a fractional delivered O2 concentration (FDO2) greater than or equal to 0.85 with attachments and greater than or equal to 0.40 without attachments, at oxygen flow of 15 L/min, and VE of 7.2 L (600 mL x 12/min) for adult units and VE of 6 L (300 mL x 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.