Evaluating the Negligent Vacuum
A professor of obstetrics introduced vacuum extraction in 1849. Today, it is a common method of vaginal delivery that is used by midwives, family physicians, obstetricians, and perinatologists. In 1998, the US. Food and Drug Administration (FDA) issued a public health advisory in which it reported 12 deaths and nine serious injuries in babies delivered using vacuum extraction over a four-year period.
The agency's advisory stated that "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. . . We are also concerned that if health care professionals responsible for the care of neonates are not alerted when a vacuum-assisted delivery device has been used on a particular infant, they may not adequately monitor for signs and symptoms of device-related injury."
The FDA made these recommendations concerning vacuum extractions:
- Read the specific instructions for the device used.
- Make sure the vacuum extractor is used only when the indications are included on the device's labeling.
- Understand that all products require traction (pulling) in line with the birth canal and that rocking movements may be dangerous.
- Be sure your medical staff knows how to use the device and is aware of the indications, contraindications, and precautions, as found on the device's labeling and in the accepted medical literature.
- Notify neonatal care staff that the device was used, and alert them to monitor the infant for any complications.
- Report adverse events to the FDA.
Essential medical guides
Williams Obstetrics, considered the premier source for the specialty, describes the indications, prerequisites, and techniques for the proper use of a vacuum extractor, emphasizing that proper vacuum cup placement on the fetal head is the most important factor. The book lists the numerous complications that can arise from the procedure, ranging from bruises and scalp lacerations to hemorrhages, fractures, nerve damage, and fetal death. Cunningham et Williams Obstetrics, 503 (McGraw-Hill 2001).
The book recommends following the same classifications, indications, and contraindications that apply to of forceps. It also warns that the vacuum should not be plied to a fetus whose head is above the mother's pelvis. Finally, it notes that the operator must be experienced should abandon the procedure if it does not progressively or if the cup pops off more than three times.
Another publication that addresses the potential complications of vacuum assisted deliveries is the Amer College of Obstetricians and Gynecologists' (ACOG Practice Bulletin No. 17, Operative Vaginal Delivery (J 2000).
Preparing a vacuum extraction case
In reviewing a case alleging injury to the neonate caused by a vacuum extractor, you should do the following:
- Obtain all of the records, including physician's progress notes, nurses' notes, and the fetal monitor strips. It is imperative that you determine whether the fetus was vertical or horizontal in the uterus (the lie), how far the fetus had descended into the pelvis (the station), and the fetal position when the vacuum extractor was applied. Did the physician note pelvic and fetal size?
- Determine the indications for the vacuum extraction, the time it was applied, and the number of tractions compared with the number of contractions the mother experienced. Ascertain whether there were any pop-offs am total length of time the vacuum extractor was on. The vacuum extractor may have multiple pressure settings, you need to determine what the vacuum extractor sure setting was during delivery.
- Determine the manufacturer of the vacuum and inquire all its product information and recommendation Certain vacuums can be used only by the physician; others require the nurse to set and release the pressure \ the doctor applies the cup and performs traction.
- Obtain the hospital's policies and procedures requiring vacuum extraction. Determine whether they also monitor the physician's conduct. Hospitals may also have visual or lecture material regarding vacuum extraction; find out whether the staff reviewed them.
- Review the neonate's clinical condition. Were abrasions, bruising, or hemorrhaging on the surface of the cranial bone? Remember that the vacuum cup's placement is of utmost importance: If it is misplaced on the fetal, the cup will apply the wrong type of traction force to the fetus, complicating the delivery and increasing the risk of injury to both the mother and the neonate.