FDA Public Health Advisory: Need for Caution when Using Vacuum Assisted Delivery Devices.

Purpose

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. While no instrumented delivery is risk free, the FDA is 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. The FDA is 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 the signs and symptoms of device-related injuries.

Background

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. In contrast, during the preceding eleven years there were four deaths and five serious injuries reported, fewer than one event per year. Part, but probably not all, of this five-fold increase can be explained by an increase in usage--based upon data from 1989-1995, it is estimated that use of vacuum assisted delivery devices increased from 3.5 percent of all deliveries to 5.9 percent.

Although the number of complications seems small, the FDA believes that some of the complications could have been avoided and has still issued guidelines regarding the use of vacuum extraction.

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. The FDA will continue to investigate the possible causes of these complications.

Types of Complications

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:

* Subgaleal hematoma (Subaponeurotic hematoma). This occurs when emissary veins are damaged and blood accumulates in the potential space between the galea aponeurotica (epicranial aponeurosis) and the periosteum of the skull (pericraniaum). Since the subaponeurotic space has no containing membranes nor boundaries, the subgaleal hematoma may extend from the orbital ridges to the nape of the neck. This condition is dangerous because of the large potential space for blood accumulation and the possibility of life-threatening hemorrhage.

Signs: diffuse swelling of the head and signs of hypovolemic shock (e.g., pallor, hypotension, tachycardia, and increased respiration rate). The signs may be present at delivery or may not become clinically apparent until several hours or up to a few days following delivery. 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. On occasion, the hypotension and pallor are the dominant signs while the cranial findings are unremarkable.

* Intracranial Hemorrhage. This may include subdural, subarachnoid, intraventricular, and/or intraparenchymal hemorrhage.

Signs: indications of cerebral irritation, including convulsions, lethargy, obtundation, apnea, bulging fontanelle, poor feeding, increased irritability, bradycardia and/or shock. The signs and symptoms are sometimes delayed until several hours after birth.

Recommendations

Use these devices only when a specific obstetric indication is present (see device labeling and the resource and sample reference list attached).

* Be sure that persons who use vacuum devices for assisted delivery are versed in their use, and that they are aware of the indications, contraindications and precautions as supported in the accepted literature and current device labeling.

* Before using a vacuum assisted delivery device, read and understand the device's instructions. Pay particular attention to the manufacturer's instructions regarding cup placement, vacuum strength to be used, cumulative duration of applications, and number of recommended extraction attempts. The recommended use for all these products is to apply steady traction in the line of the birth canal. Rocking movements or applying torque to the device may be dangerous. Since the instructions may be different for each device type or style, it is important to use the instructions provided by the manufacturer of the particular product being used.

* 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). They should watch for the signs of these complications in any infant in whom a vacuum assisted delivery device was used.

* Report reactions associated with the use of vacuum assisted delivery devices to the FDA, as described following.

Reporting Adverse Events to the FDA

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 previously from vacuum assisted delivery devices. Questions about mandatory reporting can be answered by the Division of Surveillance Systems, Reporting Systems Branch. Phone [phone], FAX [phone], or write FDA, CDRH, MDR User Reporting, P.O. Box 3002, Rockville, MD 20847-3002.

When reporting adverse events, please include background information to help in the evaluation of the event(s). Describe the patient's general condition, concurrent complications, interventions in response to the adverse event, and any other potentially relevant circumstances. Even when a report is not mandatory, the FDA would appreciate your reporting it on a voluntary basis, since the report may provide important information on why these adverse events are occurring. Submit voluntary reports directly to the FDA'S voluntary reporting program, MedWatch, by telephone at 800-FDA-1088, by Fax at 800-FDA-0178, or by mail to: MedWatch, Food and Drug Administration, HFA-2; 5600 Fishers Lane; Rockville, MD 20857-9787.

Getting More Information

If you have questions about this Public Health Advisory; contact the Issues Management Staff, Office of Surveillance and Biometrics, HFZ-510, 1350 Piccard Drive, Rockville, Maryland, 20850 (attn: SJMurdock, Ph.D.), FAX [phone], or e-mail [e-mail]. To read the entire text of this report go to the CDRH homepage at www.fda.gov/cdrh/safety.html.

Future FDA Public Health Advisories, Safety Alerts, and other FDA postmarked safety notifications can be obtained by list server subscription via e-mail. To subscribe, send an e-mail request to [e-mail]. In the text of the message, type: subscribe dev-alert.

--Reprinted with permission posted at the FDA website, www.fda.gov/cdrh/safety.html