Technical Feasibility Testing of Medical Materiel: Evaluation of a Commercial Blood Gas Analyzer

摘要

Arterial blood gas analysis is an important tool for making accurate diagnoses and therapeutic decisions regarding trauma patients. Several commercial blood gas analyzers were field tested by the U.S. Army and found to be insufficiently durable and reliable. A new product, the GEM-6 Portable Blood Gas Analyzer, may be more suitable for field hospital use because of the design concept it utilizes. The device incorporates a disposable cartridge containing all sensors and reagents, which minimizes tubing and moving parts. High and low storage temperature, transit vibration and shock were the test conditions studied, using the manufacturer's quality control solutions as samples. Results indicated that high storage temperature tripped a circuit breaker in the analyzer, preventing power from being supplied to the heater block. This problem, could be rectified by using a standard fuse in place of the circuit breaker. Low storage temperature of the consumable supplies revealed that they will require protection to prevent freezing. A minor malfunction occurred with the analyzer following shock testing; but was easily remedied by the operator. Cartridge durability was a problem; however, the manufacturer is redesigning the cartridges to alleviate the weak point, so future versions should be acceptable. The instrument should be considered for deployment by the Army, pending review of the minor areas in which it does not meet the LR.