19 May, 2017
Currently, the FDA believes the issue may date back to 2014. Lead poisoning is particularly unsafe to infants and young children. Other lead testings that involve blood collected by pricking the finger and heel are not thought to be affected.
It's a big issue because of the Flint, Michigan, water crisis, in which at least 100,000 people were exposed to unsafe levels of lead in their drinking water.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
Federal officials are warning that certain lead tests manufactured by Magellan Diagnostics, which have been commonly used to test those affected by the water crisis in Flint, Michigan, may provide inaccurate results that underestimate lead levels. To prevent children from exposure, they recommend to make your home more lead-safe by testing paint and dust in homes built before 1978 and preoperly disposing of recalled toys.
In a letter to customers, Magellan Diagnostics advised that facilities discontinue using venous blood samples with their testing systems.
If you think you or your child needs another lead test, talk with your doctor. "Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning".
Though Magellan had identified another inaccuracy issue with an additional product in 2015, that information was not conveyed to the FDA during the 510 (k) process despite repeated interactions, Dr. Shuren said, because the company saw it as a low-risk issue it considered resolved. Most people were tested using capillary blood drawn with a heel stick or finger stick and so far data suggests there is no problem with those tests.
And the FDA says it's aggressively investigating why these tests can give inaccurate results.
Neither are there problems with other blood tests used to detect lead, which account for about half the total, he said.
Asked why taxpayers or insurance companies should have to pay for retesting, Hill said the first priority is to get kids retested if they need retesting, and officials do not want reimbursement to hold that up.
If your child has been tested for lead poisoning, there's a chance the results may not have been accurate, and health officials say some people will need to be retested.
The CDC website states that 4 million U.S. households have children that are exposed to high levels of lead and approximately a half-million children under the age of five have lead levels above 5 micrograms per deciliter (µg/dL), a level at which the agency recommends public health actions be taken. It can be unsafe to the developing brains of babies and children, even at low levels, leading to learning disabilities, behavioral problems such as hyperactivity and attention problems, and low birth weight. Studies increasingly link conduct disorder, delinquency, and criminal behaviors to lead toxicity.
Adults with high lead levels are at risk of developing problems with memory and concentration, while pregnant women will high lead levels are more at risk of miscarriage, stillbirth or premature birth.