FDA on Wednesday warned health care providers and laboratories against using a blood test by Magellan Diagnostics that measures lead levels in children and women, saying the tests might underestimate lead levels and provide inaccurate results.
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The warning includes Magellan tests that use blood drawn from the vein and those given as far back as 2014.
While lead is considered extremely toxic and unsafe at any level, the New York Times reports that providers typically will take action to identify and reduce the exposure when levels reach five micrograms per deciliter or more. FDA said by underestimating lead levels, some children and adults might have had prolonged exposure to lead.
FDA said the warning does not include Magellan tests that rely on blood obtained by pricking the finger or from a heel stick known as a capillary test, which the agency said are the two most common ways to test for lead poisoning in children. FDA estimated that, since 2014, about eight million tests have been conducted using Magellan's tests, but the majority of tests were done using blood from the finger or heel.
FDA said it is in the preliminary phases of its investigation and has yet to identify a source for the inaccuracies or why they only affect venous blood tests. But the agency said it believes the issue dates back to 2014, when Magellan first received reports of inaccuracies. FDA said the issue resurfaced in April 2017 when Magellan requested label changes to the devices and had to prove that the products are accurate and reliable, the Washington Post's "To Your Health" reports.
Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said the agency believed that the company had underestimated the risk to the public after the 2014 reports, and that the company's mitigation plan was not supported by sufficient data.
Federal officials are recommending retesting for children, pregnant women, and nursing mothers who have received negative results from a Magellan venous blood test since 2014.
Federal officials are recommending retesting for children younger than age 6 who received a Magellan venous test that showed lead levels of less than 10 micrograms per deciliter. FDA and CDC also said women who are pregnant or nursing should get retested if they have had a Magellan venous test. Officials said other adults worried about lead exposure should consult their doctors about whether to be retested.
Tim Hill, an official at CMS, said Medicaid would cover the cost of retesting for children enrolled in the program and that people covered by private insurance should reach out to their health plans about retesting.
Patrick Breysse, director of CDC's National Center for Environmental Health, said the agency has closely monitored communities at higher-risk of lead poisoning, such as Flint, Michigan. He estimated that "less than 1 percent" of children in Flint could be affected by the inaccurate readings.
Meridian Biosciences, which acquired Magellan in 2016, in a statement said venous blood testing accounts for about 10 percent of Magellan's revenue.
The company said it is working closely with FDA and CDC "to address the concerns identified with venous samples as quickly as possible." The company added that, in light of the warning, it is voluntarily working to move customers from venous testing systems to finger-prick systems.
Magellan in a separate letter to customers wrote that facilities using venous blood collection tubes should "use an alternative method for blood lead testing until further notice" (McGinley, "To Your Health," Washington Post, 5/17; Greenfieldboyce, "Shots," NPR, 5/17; Caryn Rabin, New York Times, 5/17).
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