Evaluation of ten manual resuscitators across an operational temperature range of -18 degrees C to 50 degrees C.
Because of the temperature extremes encountered during emergency resuscitation and transport in the field, we sought to evaluate the performance and safety of 10 adult resuscitators (5 permanent units: Hope 4, Laerdal, Lifesaver, Mark 3, and PMR; and 5 disposable units: BagEasy, Code Blue, CPR Bag, DMR, and SPUR) across an operational temperature range of -18 degrees C to 50 degrees C.


METHODS
We tested the devices against the American Society for Testing and Materials (ASTM) Standard F-920 and the International Organization for Standardization (ISO) Standard 8382. We tested each resuscitator by using a lung model, the Bio-Tek VT-1 Ventilator Tester.


RESULTS
All of the resuscitators met the ventilation requirements for VT and F (600 mL X 20) and I:E less than 1:1 except the SPUR at -18 degrees C. Standards ASTM F-920 and ISO 8382 specify a fractional delivered oxygen concentration (FDO2) of 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/min (600 mL X 12). Nine resuscitators met Standards ASTM F-920 and ISO 8382 for FDO2 with attachments at 21 degrees C and 50 degrees C, but only 3 units (Code Blue, DMR, and PMR) passed at -18 degrees C. At 21 degrees C, the Hope 4 had an FDO2 of 0.77 +/- 0.03, which was significantly lower (p less than 0.001) than that of the other 9 resuscitators, all of which were greater than or equal to 0.93. Nine resuscitators met the FDO2 standard without attachments. All 10 resuscitators passed the tests for valve function after contamination with simulated vomitus (at an oxygen flow of 30 L/min) and for backward leakage. At the ventilation pattern recommended by the American Heart Association (AHA) (800 mL X 12) the PMR's mean FDO2 dropped to 0.86 +/- 0.03 because of air leaking into the bag where it attaches to the patient-valve assembly. All 10 resuscitators passed the test for mechanical shock at 21 degrees C and 50 degrees C, but 3 units failed at -18 degrees C.


CONCLUSIONS
We conclude that only the Code Blue and DMR meet the ASTM and ISO standards for operator-powered adult resuscitators across the operational temperature range of -18 degrees C to 50 degrees C.
Northeastern University, Boston, MA 02115.
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Barnes
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Stockwell
D004209:Disposable Equipment / Q000592:standards; D004869:Equipment Safety / Q000592:standards; D005069:Evaluation Studies as Topic; D008422:Materials Testing; D012015:Reference Standards; D012151:Resuscitation / Q000295:instrumentation*; D013696:Temperature; D014481:United States; D012122:Ventilators, Mechanical / Q000592:standards*