National Food and Drug Administration: Concerned about the use risk of infant incubators

The State Food and Drug Administration said on the 7th "Information on Medical Device Adverse Events" that clinical staff should pay attention to the use of infant incubators.

According to the report, an early-born child and a female were hospitalized in a hospital using a baby incubator for constant temperature training due to premature delivery on July 16, 2010. On the morning of July 21, 2010, the nurse on duty watched the body temperature of the child to be 37.9 degrees Celsius when measuring the body temperature. At the same time, it was found that the temperature in the incubator was high. The actual temperature of the incubator was measured to be 39 degrees Celsius, which was significantly higher than the set value of 35 degrees Celsius, resulting in increased body temperature in children. The nurse on duty immediately replaced the incubator and physically cooled the child.

According to reports, the baby incubator is a "convection heat regulation" method, the use of computer technology to implement the incubator temperature servo control equipment, mainly by the baby cabin, temperature control device, incubator chassis, blue light irradiation light box and other components. Its function is to provide a maternal uterine cavity-like environment for preterm infants, sick infants and newborn infants.

It is reported that from 2002 to October 2011, the National Center for Adverse Drug Reaction Monitoring received a total of 332 reports of suspicious medical device adverse events related to infant incubators. The main manifestations were temperature out of control, ventilation system failure, skin rashes, and scratches. Among them, 167 cases were out of control of temperature, 50 cases of ventilation system failure, and 4 cases of scratch.

In response, the State Food and Drug Administration reminds clinical staff to strictly operate in accordance with the diagnostic and therapeutic norms and to strengthen maintenance. Manufacturers should strictly control the quality of products and strengthen the training of operators and users.

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