Evaluation of ten disposable manual resuscitators

Area of Science:

• Emergency Medicine
• Medical Device Performance
• Respiratory Care

Background:

• Disposable resuscitators are crucial for emergency ventilation.
• Evaluating their performance against established standards is vital for patient safety.
• Previous assessments of disposable resuscitator compliance with ASTM F-920 are limited.

Purpose of the Study:

• To assess the performance and safety of ten disposable resuscitators (six adult, four pediatric) against ASTM Standard F-920.
• To identify which disposable resuscitators meet the stringent requirements for use as replacements for permanent devices.

Main Methods:

• Ten disposable resuscitators were tested: SPUR, Code Blue, 1st Response, Hospitak MPR, CPR Bag, Pulmanex (adult); CPR Bag, 1st Response, Hospitak MPR, LSP Bag Mask (pediatric).
• Testing followed the American Society for Testing and Materials (ASTM) Standard F-920, utilizing a Bio-Tek VT-1 Ventilator Tester lung model.
• Evaluations included ventilation parameters (VT, f, I:E), fractional delivered oxygen concentration (FDO2) with and without attachments, valve function after contamination, backward leakage, pressure-limit, and mechanical shock resistance.

Main Results:

• All resuscitators met basic ventilation requirements (VT, f, I:E) and FDO2 with attachments.
• Nine out of ten met FDO2 standards without attachments.
• Three pediatric models failed the pressure-limit test, and four models (adult and pediatric) failed the mechanical shock test.

Conclusions:

• Only Code Blue, 1st Response, Pulmanex (with tube-type reservoir), and SPUR met all ASTM Standard F-920 requirements.
• These four models are deemed acceptable replacements for permanent resuscitators.
• Several disposable resuscitators failed critical safety and performance benchmarks, highlighting the need for careful selection.