The United States Food and Drug Administration (FDA) has issued a medical device safety alert and a letter to health care providers concerning risks associated with use of rupture of membrane tests.
The FDA has alerted women and their doctors about serious adverse events related to the improper use of tests intended as an aid in detecting if a rupture of the membranes (ROM) containing amniotic fluid. A ROM can pose immediate and severe risks to the patient and developing fetus without proper patient management and timely intervention.
The FDA has received information which indicates that health care providers may be relying solely on ROM test results when making critical patient management decisions, despite manufacturers' labeling instructions that ROM tests should not be used on their own to independently assess whether a ROM has occurred.
The FDA 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 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 test may provide a false negative result; without additional clinical assessment, providers may incorrectly assume ROM has not occurred.
The FDA is reminding health care providers that tests to detect rupture of the amniotic membranes should not be used without other clinical assessments to make critical patient management decisions. Health care providers using ROM tests should be aware of test limitations listed within manufacturer instructions. The following limitations are typically stated in ROM device labeling:
To help protect patients and reduce the chance of adverse events, ROM tests should be part of an overall clinical assessment, which may include physical examination of the patient and testing to detect leaking amniotic fluid. The FDA is also urging pregnant women who may be concerned about amniotic membranes that may have ruptured too early, which can be characterized by either a rapid release of amniotic fluid or a small trickle, to contact their healthcare providers right away. Patients should speak with their healthcare providers about the signs and symptoms of ROM.
In addition, the FDA is separately notifying the public of a voluntary recall for one brand of these products, the Amnisure ROM Test Strips, distributed between October 2017 and March 2018. These devices do not exhibit a control line, making it potentially difficult for healthcare providers to interpret the results of the test. The FDA will continue to communicate with the manufacturer, Qiagen Sciences, regarding the recall of these products and will provide updated information if it becomes available. According to the local supplier, the affected products are not distributed in Hong Kong. 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.
For details, please refer to the following FDA websites:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm616220.htm
https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm616128.htm
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616137.htm
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 9 August 2018