The U.S. Food and Drug Administration today alerted women and their doctors about serious adverse events related to the improper use of tests intended as an aid in detecting if a pregnant woman's water has broken (also known as a rupture of the membranes containing amniotic fluid). A rupture of the membranes (ROM) can pose immediate and severe risks to the patient and developing fetus without proper patient management and timely intervention.
As part of the agency's commitment to transparency in notifying the public about potential public health concerns, the FDA issued a Letter to Health Care Providers to remind providers that the labeling for these tests specifies that they should not be used on their own to independently diagnose a ROM in pregnant women. These tests have only been cleared for marketing by the FDA to be used by healthcare providers in conjunction with other clinical assessments to make critical patient management decisions regarding whether a ROM has occurred.
"Our most fundamental obligation to the American public is providing patients with access to safe and effective medical products. Sometimes this includes alerting healthcare providers and the public regarding the potential safety issues that can arise when providers are not using devices as they are intended. This is especially pertinent in this case, where we are dealing with a potential risk to the safety and well-being of pregnant women and their fetuses," said Courtney Lias, Ph.D., director, Division of Chemistry and Toxicology Devices in the FDA's Center for Devices and Radiological Health. "Our review of the risks associated with improper use of these ROM tests is ongoing, but we want to be transparent with providers and patients about the information that we have indicating an issue, and provide recommendations to minimize the risks. This is another example of our recently released Medical Device Safety Action Plan in practice. We are committed to streamlining and modernizing how we implement postmarket actions to address device safety issues to better protect the Americans who rely on us. 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. We urge healthcare providers to carefully follow the labeled instructions for use on these tests."
A ROM is when the amniotic membranes, in which the fetus develops, breaks. The ROM is a normal occurrence once a woman is in labor. However, if ROM occurs prior to the onset of labor, it can cause an increased risk of infection and injury to the fetus and the pregnant woman. Healthcare providers use ROM tests to aid in diagnosing ruptured membranes in pregnant women through analysis of vaginal secretions. ROM tests are point of care tests that provide on-site information to providers.
The FDA has received information that indicates healthcare providers may be relying solely on ROM test results when making critical patient management decisions, despite manufacturers' labeling instructions that ROM tests should not be used on their own to independently assess whether a ROM has occurred. The FDA reviewed these devices through its premarket clearance pathway and concurred with the manufacturers' labeling recommendations warning providers to not use these tests independently.
The FDA is concerned that misuse, relying solely on ROM tests without using other assessments (over reliance), and inaccurate interpretation of lab test results of ROM tests could result in an increased risk of fetal harm or death. In an ongoing assessment of medical device reports filed with the agency, the FDA has become aware of adverse events related to the use of ROM tests, including 15 fetal deaths and multiple reports of health complications in pregnant women. The test may provide a false negative result; without additional clinical assessment, providers may incorrectly assume ROM has not occurred. The agency is issuing communications today to share the most current information it has available.
The FDA is also urging pregnant women who may be concerned about amniotic membranes that may have ruptured too early, which can be characterized by either a rapid release of amniotic fluid or a small trickle, to contact their healthcare providers right away. Patients should speak with their healthcare providers about the signs and symptoms of ROM.
The FDA is also separately notifying the public of a voluntary recall for one brand of these products, the Amnisure ROM Test Strips, distributed between October 2017 and March 2018. Approximately 40,500 Amnisure tests have been recalled due to a device malfunction. These devices do not exhibit a control line, making it potentially difficult for healthcare providers to interpret the results of the test. At this time, the agency is not aware of adverse events related to the recalled products. The FDA will continue to communicate with the manufacturer regarding the recall of these products and will provide updated information if it becomes available. This recall is unrelated to the improper use of the tests and the FDA is not aware of device malfunctions associated with any other ROM tests made by other manufacturers.
The FDA will continue closely monitoring reports of adverse events associated with ROM tests. The agency will keep the public informed if significant new information becomes available. Patients, providers and healthcare facilities are encouraged to report adverse events to MedWatch, the FDA Safety Information and Adverse Event Reporting program.