The US Food and Drug Administration (FDA) has alerted women and their doctors to serious adverse events related to the improper use of membrane-rupture tests.
These tests are intended as an aid in detecting if a pregnant woman’s water has broken.
If a membrane (ROM) ruptures, it can pose immediate and severe risks to the patient and the developing foetus without proper patient management and timely intervention.
FDA Center for Devices and Radiological Health, Division of Chemistry and Toxicology Devices director Courtney Lias said: “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.”
The agency issued a Letter to Health Care Providers to remind them that the labelling for these tests specifies that they should not be used on their own to independently diagnose a ROM in pregnant women.
The move is part of the FDA’s commitment to transparency in notifying the public about potential public health concerns.
The FDA noted that these tests have only been cleared by the agency for use by healthcare providers in conjunction with other clinical assessments.
The ROM is a normal occurrence once a woman is in labour. However, if it occurs prior to the onset of labour, it can cause an increased risk of infection and injury to the foetus and the pregnant woman.
In an ongoing assessment of medical device reports, the FDA has become aware of adverse events related to the use of ROM tests, including 15 foetal deaths and multiple reports of health complications in pregnant women.