FDA Issues Alert for Women, Healthcare Providers on Membrane Rupture

Proper management, timely intervention keys to handling process

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,” said Courtney Lias, PhD, director of the Division of Chemistry and Toxicology Devices in the FDA’s Center for Devices and Radiological Health.

“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.”

SOURCE: FDA

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