Devices

Rupture of Membranes Tests Have Limits: FDA

FDA is reminding healthcare providers that tests to detect ruptures of the amniotic membranes should not be used without other clinical assessments to make critical patient management decisions. An agency letter says that healthcare providers using rupture of membranes (ROM) tests should be aware of the test limitations shown in the manufacturer instructions. Typical limitations are:

a negative result does not assure the absence of membrane rupture;
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, anti-fungal creams or suppositories, baby powder, baby oil, or the use of lubricant with a vaginal exam may interfere with the device; and
· the test may not be accurate if sample collection and testing occurs after the timeframe recommended by the manufacturer.

FDA says it is “concerned about misuse, over-reliance, and inaccurate interpretation of lab test results from ROM tests used to detect rupture of membranes in pregnant women. These can lead to serious adverse events, including fetal death, infection, and other health complications in pregnant women.”

The notice says the agency has received information indicating that healthcare providers may be over-relying on ROM test results when making critical patient management decisions, despite labeling instructions warning against the practice.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome