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December 3, 1982

Malfunctioning Neonatal Incubators

JAMA. 1982;248(21):2835. doi:10.1001/jama.1982.03330210027017

To the Editor.—  In a recent letter to the editor (1982;247:2372), Marlene Haffner, MD, of the Food and Drug Administration, reported the results of an FDA investigation of an infant death attributed to a malfunctioning incubator. She stated that an Air Shields C86 Isolette incubator over-heated because the primary thermostat functioned intermittently and the backup thermostat (a mercury-in-glass thermometer) was also broken. She went on to state the following:Analysis shows further that backup safety thermostats can malfunction from mercury column separation caused by rough handling of the incubator or its power pack.Once again, the inadequacies of the FDA are painfully apparent. In September 1976, Emergency Care Research Institute (ECRI) completed a contract study for the FDA and specifically informed them of the possible dangers of mercury-in-glass thermostat failures.1 We stated the following:Mercury-in-glass fixed temperature point thermostats shall not be used as safety thermostats because they are