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References in periodicals archive ?
FDA public health advisory: need for caution when using vacuum assisted delivery devices.
This is to advise all health care workers that vacuum assisted delivery devices may cause serious or fatal complications, and to provide guidance to minimize the risk.
Over the past four years, the FDA has received reports of twelve deaths and nine serious injuries among newborns on whom vacuum assisted delivery devices were used, an average of five events per year.
At this point, the FDA does not have complete information on how use patterns, the clinical environment, or other specific circumstances might relate to adverse outcomes from vacuum assisted delivery devices.
Although all infants exposed to vacuum assisted delivery devices will have a caput succedaneum, care providers need to be aware that two major life-threatening complications following use of vacuum assisted devices have been reported:
* Before using a vacuum assisted delivery device, read and understand the device's instructions.
* Alert those who will be responsible for the infant's care that a vacuum assisted delivery device has been used, so that they can monitor the infant for signs of complications.
* Educate the neonatal care staff about the complications of vacuum assisted delivery devices that have been reported to the FDA and in the literature (see references).