The Food and Drug Administration (FDA) is alerting healthcare professionals that serious adverse events have been reported with the use of rupture of membranes (ROM) tests when they are used alone to make critical patient management decisions.

ROM tests are used to aid in diagnosing ruptured membranes in pregnant women through analysis of vaginal secretions. These point-of-care tests provide on-site information to clinicians and are approved for use in conjunction with other clinical assessments. The Agency is concerned that over-reliance and inaccurate interpretation of ROM test results could lead to an increased risk for fetal harm or death. According to the FDA, 13 fetal deaths and multiple reports of health complications in pregnant women have already been reported with the use of these tests.

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In an effort to reduce the chance of adverse events, the Agency has issued a Letter to Healthcare Providers to remind clinicians of the limitations of ROM devices. These include the following:

  • A negative result does not assure the absence of membrane rupture. The test may provide a false negative result; without additional clinical assessment, providers may incorrectly assume ROM has not occurred.
  • False negatives may result if the amniotic sac has resealed or the position of the fetus has obstructed the rupture.
  • The presence of blood, meconium, antifungal creams or suppositories, baby powder, baby oil, or the use of lubricant with a vaginal exam may interfere with the device.
  • The test may not be accurate if sample collection and testing occurs after the timeframe recommended by the manufacturer.

“We will continue to monitor adverse events regarding these tests and will communicate further if there is additional information that will benefit women and their healthcare providers,” said Courtney Lias, PhD, director, Division of Chemistry and Toxicology Devices in the FDA’s Center for Devices and Radiological Health. “We urge healthcare providers to carefully follow the labeled instructions for use on these tests.” 

Recently, the FDA posted a recall notice for the Amnisure ROM Test (Qiagen Sciences LLC) due to device malfunction; the product was distributed between October 2017 and March 2018. The potential manufacturing defect may cause the control line not to display on the test which may lead to misinterpretation of the results.

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