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FDA Warns Over Improper Use of Tests for Detecting Rupture of the Membranes

Posted 09 August 2018 | By Ana Mulero 

FDA Warns Over Improper Use of Tests for Detecting Rupture of the Membranes

In a letter issued Thursday, the US Food and Drug Administration (FDA) warned over risks associated with improper use of tests intended for detecting rupture of the membranes (ROM).
 
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 letter states. 
 
The tests are designed to aid providers in diagnosing ROM in pregnant women at the point of care. But in contrast with the use recommendations provided in manufacturers’ labeling, the agency has also received information that suggests healthcare providers have made “critical patient management decisions” entirely based on results obtained from ROM tests.
 
Separately, the agency also issued a notice Thursday on a recall of Qiagen Sciences’ AmniSure ROM Test. The recall, identified as Class I, involves 1,585 kits containing 39,625 tests that were distributed throughout the US between October 2017 and March 2018.
 
The firm initiated the recall of the affected assays in May, following customer complaints over some tests reportedly failing to display the control line needed for accurate and timely interpretation of results. The adverse events were attributed to a potential manufacturing defect.
 
The 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,” FDA clarified.

Categories: Regulatory News

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