(You are encouraged to copy and distribute this advisory.)
May 21, 1998
| To: | Obstetricians, Birthing Centers, Nurse Mid-Wives, Pediatricians, Ultrasonographers, ObGyn Nurses, Family Practitioners, Radiologists, Hospital Risk Managers, Hospital ObGyn Departments |
PURPOSE
This is to advise you 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, 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 (see attached list for sample of references). 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 the signs and symptoms of device-related injuries.
BACKGROUND
Over the past four years, FDA has received reports of 12 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 11 years there were four deaths and five serious injuries reported to us, 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.
The total number of serious complications reported to FDA from vacuum assisted delivery devices remains small in relation to the total number of births per year in which these devices are used – 228,354 in 1995, as reported to the National Center for Health Statistics. Nonetheless, we are concerned that at least some of these complications might be avoidable. This is why we are providing the recommendations below.
At this point, 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. We 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 to us:
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.
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).
REPORTING ADVERSE EVENTS TO 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 above from vacuum assisted delivery devices. Questions about mandatory reporting can be answered by the Division of Surveillance Systems, Reporting Systems Branch. Phone 301-594-2735, FAX 301-827-0038, 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). Let us know about 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, we 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, by fax at 240-276-3356, or by e-mail at phann@cdrh.fda.gov. Additionally, a voice mail message may be left at 240-276-3357 and your call will be returned as soon as possible. You may print additional copies of this notice by photocopy or from the CDRH homepage at www.fda.gov/cdrh/safety.html.
Future FDA Public Health Advisories, Safety Alerts, and other FDA postmarket safety notifications can be obtained by list server subscription via e-mail. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDACDRH_10
| Sincerely yours, D. Bruce Burlington, M.D. Director Center for Devices and Radiological Health |
Resources and Sample of References
* For additional technical and clinical practice information the American College of Obstetricians and Gynecologists (ACOG) has given FDA permission to use them as a resource. Call 202-863-2518 or fax requests to the ACOG Resource Center at 202-484-1595.
** Note: This reference discusses in detail the recognition and treatment of subgaleal hemorrhage in neonates.
Updated May 19, 1998
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