Conor here: While the latest advice from the next episode would be helpful, it would certainly be better if our government could prevent this from happening in the first place.
How could the Magellan instruments used in more than half of all blood lead tests in the US over a four-year period be defective and the FDA not know? The first sentence of the FDA Mission:
The Food and Drug Administration is responsible for protecting public health by ensuring the safety, efficacy, and security of human and animal drugs, biological products, and medical devices; and ensuring the safety of our nation’s food supply, cosmetics, and radioactive products.
Maybe I’m missing something, but it’s hard to see how the agency can do those jobs if the security system relies on for-profit companies that depend on the success of their products to quickly disclose problems. Maybe the FDA plan should be in court again. Although that is not possible, the FDA is instead “exploring the use of AI technology to simplify our internal operations and regulatory processes, which can benefit both agency professionals and the public by streamlining workflows and facilitating high-quality, novel medical products to reach faster.” patients who need them. “That’s right.
Another positive story from the Magellan lawsuit, “the settlement does not affect the DOJ’s ongoing prosecution of three former Magellan employees who no longer work at the company.”
Those three employees are the former CEO, COO and director of quality assurance and regulatory affairs who have been charged with fraud, conspiracy to defraud, conspiracy to defraud a US agency and introduction of mislabeled medical devices into interstate commerce with intent to defraud and mislead.
Each charge carries a fine of up to $250,000, and those for fraud and conspiracy to defraud, can result in up to 20 years in prison.
By senior author Julie Appleby. Originally published on KFF Health News.
A lead poisoning testing company has agreed to settle criminal charges that it covered up years of inaction that led to unfairly low results.
The latest in a long-running saga involving Massachusetts-based Magellan Diagnostics, which will pay $42 million in penalties, according to the Justice Department.
While most of the faulty devices were used from 2013 to 2017, some were being recalled as late as 2021. The Department of Justice said the malfunction produced “potentially tens of thousands” of negative outcomes for children and other patients.
Doctors do not consider any level of lead in the blood to be safe, especially in children. Several American cities, including Washington, DC, and Flint, Michigan, have struggled with widespread lead contamination of their water supplies over the past two decades, making accurate tests critical to public health.
It is possible that the faulty Magellan kits were used to test children for lead exposure in the early 2020s, based on the 2021 recall. Here’s what parents should know.
What Exams Are Affected?
Inaccurate results appeared on three Magellan devices: LeadCare Ultra, LeadCare II, and LeadCare Plus. One, LeadCare II, uses finger stick samples primarily and accounted for more than half of all blood tests performed in the US from 2013 to 2017, according to the Department of Justice. It was often used in doctors’ offices to check children’s lead levels.
The other two can also be used with blood taken from a vein and may have been more common in labs than doctors’ offices. The company “first learned that a malfunction in its LeadCare Ultra device could cause inaccurate lead test results — specifically, lead test results that were illegally low” in June 2013 when it sought regulatory approval to market the product, the DOJ said. But it did not disclose that information and continued to market the tests, according to the settlement.
The agency said a 2013 test revealed a similar defect affected the LeadCare II machine. The 2021 recall includes most of all three types of test kits distributed as of October 27, 2020.
The company said in a press release announcing the decision that “the underlying issues that affected the results of some of Magellan’s products from 2013 to 2018 have been fully and successfully addressed,” and that the tests it is currently selling are safe.
What Does a Falsely Low Result Mean?
Children are usually screened during pediatrician visits at age 1 and again at age 2. High lead levels can put children at risk for developmental delays, low IQ, and other problems. And symptoms, such as abdominal pain, loss of appetite, or irritability, may not be apparent until high levels are reached.
Falsely low test results can mean that parents and doctors were unaware of the problem.
That’s troubling because treating lead poisoning, initially, is mostly about prevention. Results showing elevated levels should prompt parents and health officials to determine sources of lead and take steps to prevent further exposure to lead, said Janine Kerr, a health educator in the Virginia Department of Health’s Childhood Lead Poisoning Prevention Program.
Children can be exposed to the source in a variety of ways, including drinking lead-contaminated water from old pipes, such as in Flint and Washington; importing lead-based paint flakes often found in older homes; or, as recently reported, eating other types of cinnamon-flavored applesauce.
What Should Parents Do Now?
“Parents can contact their child’s pediatrician to find out if their child has had a LeadCare blood test” and discuss whether repeat blood tests are needed, said Maida Galvez, a pediatrician and professor at the Icahn School of Medicine at Mount Sinai. New York.
During the early recall of some Magellan devices, in 2017, the Centers for Disease Control and Prevention recommended that patients be retested if they are pregnant, breastfeeding, or children under the age of 6 and have a blood lead level of less than 10 micrograms per deciliter as determined by the Magellan device from a venous blood draw.
The 2021 recall of Magellan devices recommended retesting children whose results were below the CDC’s current reference level of 3.5 micrograms per deciliter. Most of those tests were finger sticks.
Kerr, of the Virginia Department of Health, said his organization has not had many calls about the recall.
The finger stick test is “not widely used in Virginia,” Kerr said, adding that “we’ve gotten a lot of questions about applesauce recalls.”
In any case, he said, “the best thing for parents to do is talk to a health care provider.”
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