Conor here: While the after-the-fact advice in the following article might be helpful, it would certainly be better if our government could prevent this from happening in the first place.
How is it possible that the Magellan devices used for more than half of all blood lead tests in the United States over a four-year period were defective and the FDA didn’t know about it? THE first sentence of the FDA mission:
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, biological products, and medical devices; and ensuring the safety of our nation’s food supply, cosmetics, and radiation-emitting products.
Maybe I’m missing something, but it’s hard to see how the agency can accomplish these tasks if the security system relies on companies whose profits depend on the success of their products to quickly disclose problems. Perhaps the FDA system should also be tested. Even if this is not the case, the FDA rather “explore the use of AI technologies to facilitate our internal operations and regulatory processes, which could benefit both agency experts and the public by streamlining workflows and facilitating faster arrival new, high-quality medical products to patients who need them. ” So this is it.
A good news In the Magellan case, the “settlement does not affect the DOJ’s ongoing prosecution of three former Magellan employees who no longer work for the company.”
These three employees are the former CEO, COO and Director of Quality Assurance and Regulatory Affairs who are charged with wire fraud, conspiracy to commit wire fraud, conspiracy to defraud a U.S. agency and introduction of misbranded medical devices into interstate commerce with the intent to defraud and mislead.
Each of the charges carries a fine of up to $250,000, and those for wire fraud and conspiracy to commit wire fraud could result in prison sentences of up to 20 years.
By senior correspondent Julie Appleby. Originally published on KFF health news.
A company that conducts lead poisoning tests has agreed to resolve criminal charges that it covered up for years a malfunction that resulted in erroneously low results.
This is the latest in a long saga involving Massachusetts-based Magellan Diagnostics, which pay $42 million in penaltiesaccording to the Department of Justice.
While many fault-prone devices were used between 2013 and 2017, some were recalled. until 2021. The Justice Department said the malfunction produced inaccurate results for “potentially tens of thousands” of children and other patients.
Doctors do not consider any level of lead in the blood to be safe, especially for children. Several U.S. cities, including Washington, D.C. and Flint, Michigan, have struggled with widespread lead contamination of their water supplies over the past two decades, making accurate testing essential for public health.
It’s possible that 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.
Which tests were affected?
The inaccurate results came from three Magellan devices: LeadCare Ultra, LeadCare II and LeadCare Plus. One of them, LeadCare II, uses primarily fingerstick samples and accounts for more than half of all blood lead tests performed in the United States between 2013 and 2017, according to the Justice Department. It was often used in doctors’ offices to check lead levels in children.
The other two could also be used with blood drawn from a vein and may have been more common in laboratories than in doctors’ offices. The company “first learned that a malfunction in its LeadCare Ultra device could cause inaccurate lead test results – specifically falsely low lead test results” in June 2013, while it was looking for the regulatory approval to sell the product, the DOJ said. But the company did not disclose that information and subsequently marketed the tests, according to the agreement.
The agency said 2013 testing indicated the same defect affected the LeadCare II device. A 2021 recall affected most of the three types of test kits distributed since October 27, 2020.
The company said in a Press release announcing the resolution that “the underlying issues that affected the results of certain Magellan products from 2013 to 2018 have been fully and effectively resolved” and that the tests it currently sells are safe.
What does a falsely low result mean?
Children are often tested during pediatrician visits at age 1 and again at age 2. Elevated lead levels can put children at risk for developmental delays, lower IQ, and other problems. And symptoms, such as stomach upset, lack of appetite or irritability, may not appear until high levels are reached.
Falsely low test results could mean that parents and doctors were unaware of the problem.
This is worrying because the treatment of lead poisoning is, initially, mainly preventative. Results showing elevated levels should prompt parents and health officials to determine lead sources and take steps to prevent continued lead consumption, said Janine Kerr, a health educator with the Virginia Department of Health. . Childhood Lead Poisoning Prevention Program.
Children can be exposed to lead in a variety of ways, including drinking lead-contaminated water from old pipes, such as in Flint and Washington; ingesting lead-based paint flakes often found in older homes; or, as has been reported recently, by eating brands of cinnamon-flavored applesauce.
What should parents do now?
“Parents can contact their child’s pediatrician to determine if their child has had a blood lead test with a LeadCare device” and discuss the need for a blood lead test again, said Maïda Galvezpediatrician and professor at the Icahn School of Medicine at Mount Sinai in New York.
In a previous recall of certain Magellan devices in 2017, the Centers for Disease Control and Prevention recommended that patients be retested if they were pregnant, breastfeeding or had children under 6 years of age and had a blood lead level of less than 10 micrograms per deciliter, determined by a Magellan device from a venous blood test.
The 2021 recall of Magellan devices recommended retesting children whose results were below the current CDC reference level of 3.5 micrograms per deciliter. Many of these tests consisted of a finger prick.
Kerr, of the Virginia Department of Health, said his agency hasn’t received many calls about the recall.
Finger prick tests “are not widely used in Virginia,” Kerr said, adding that “we’ve gotten a lot of questions about the applesauce recall.”
Either way, she said, “the best course of action for parents is to talk with a health care provider.”
