FDA Advisory: Vacuum assisted delivery devices may cause serious or fatal complications, and to provide guidance to minimize the risk. While no instrumented delivery is risk free, we are concerned that some health care professionals who use vacuum assisted delivery devices, or those who care for these infants following delivery, may not be aware that the device may produce life-threatening complications.Over the past four years (a/o 1998), FDA has received reports of 12 deaths and nine serious injuries among newborns of whom vacuum assisted delivery devices were used, an average of five events per year.
Although all infants exposed to vacuum assisted delivery devices will have a caput succedaneum, healthcare providers need to be aware that two major life-threatening complications following use of vacuum assisted devices have been reported. (What is caput succesdaneum? An edematous swelling formed on the presenting portion of the scalp of an infant during birth.
Subgaleal hematoma - This condition is dangerous because of the large potential space for blood accumulation and the possibility of life-threatening hemorrhage. Symptoms: head swelling and shock; The swelling is usually diffuse, shifts dependently when the infant's head is repositioned and indents easily on palpation. However, in some cases the swelling is difficult to distinguish from the edema of the scalp.
Intracranial Hemorrhage may include subdural, subarachnoid, intraventricular, and/or intraparenchymal hemorrhage. Symptoms: cerebral irritation, convulsions, lethargy, apnea, bulging soft spot, poor feeding, increased irritability, and shock. Symptoms are sometimes delayed until several hours after birth.
Recommendations - Use these devices only when a specific obstetric indication is present. Be sure that that the personnel using the vacuum devices are versed in their use. Be sure to read the instructions and understand them thoroughly. Make sure that the care giving personnel is aware of side effects and symptoms of vacuum devices.
The Safe Medical Devices Act of 1990 requires hospitals and other user facilities to report deaths, serious illnesses, and injuries associated with the use of medical devices. This includes the complications described above from vacuum assisted delivery devices.
Childbirth: Caution When Using Vacuum Devices for Delivery - http://www.fda.gov/cdrh/fetal598.html
