WASHINGTON -- Tests that detect rupture of membranes (ROM) in pregnant women should not be used by themselves to diagnose this condition, the FDA said on Wednesday.
Citing 15 fetal deaths and multiple reports of health complications in pregnant women related to improper use of these tests, the agency reiterated that ROM tests should only be used in conjunction with other clinical assessments to manage patients.
"[T]he FDA has received information which indicates that health care providers may be over-relying on ROM test results when making critical patient management decisions, despite labeling instructions warning against this practice," the agency said in a .
In a , the FDA stated that these tests may provide a false negative result, and "providers may incorrectly assume ROM has not occurred" without additional clinical assessment.
"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," Courtney Lias, PhD, director of the Division of Chemistry and Toxicology Devices in the FDA's Center for Devices and Radiological Health, said in a statement.
ROM tests are point-of-care diagnostics that analyze vaginal secretions, and can help inform a provider when a rupture of membranes has occurred, the agency said. But they added that when these devices were reviewed through the pre-market clearance pathway, they "concurred with the manufacturers' labeling recommendations warning providers to not use these tests independently."
In addition, the FDA added the notice of a of Amnisure ROM Test Strips, and that 40,500 Amnisure tests have been recalled due to a "device malfunction." However, the recall is unrelated to improper use of the tests, and they are "not aware of adverse events related to the recalled products."