This is Connor: While the post-mortem advice in the article below may be useful, it would be much better if governments could prevent this from happening in the first place.
How could the Magellan devices used in more than half of the blood lead tests done in the United States over a four-year period be defective and the FDA not know about it? 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 by ensuring the safety of our Nation’s food supply, cosmetics, and products that give off radiation.
Maybe I’m missing something, but if the safety system relies on rapid disclosure of problems to companies whose profits depend on the success of the product, I don’t see how the agency can accomplish those tasks. Perhaps the FDA’s system should also be tested. While that is not happening, the FDA instead “We are exploring the use of AI technology to streamline internal operations and regulatory processes. This could benefit both our institutional professionals and the public by streamlining workflows and expediting the delivery of high-quality, novel medical products to patients who need them.” That’s it.
One Good News The settlement in the Magellan case “does not affect the Department of Justice’s ongoing prosecution of three former Magellan employees who are no longer employed by the company,” it said.
The three employees, the company’s former CEO, COO and director of quality assurance and regulatory affairs, are charged with wire fraud, wire fraud conspiracy, conspiracy to defraud a U.S. government agency and introducing misbranded medical devices into interstate commerce with intent to defraud and mislead.
Each charge carries a possible fine of up to $250,000, and the wire fraud and wire fraud conspiracy charges carry a possible prison sentence of up to 20 years.
By Senior Correspondent Julie Appleby. KFF Health News.
A company that tests for lead poisoning has agreed to settle criminal charges that it concealed defects for years that led to inaccurately low results.
This is the latest in a long-running saga embroiled Massachusetts-based Magellan Diagnostics. Pay a $42 million fineAccording to the Department of Justice.
Many of the malfunction-prone devices were in use between 2013 and 2017, but some were subject to recalls. Until 2021The Justice Department said the glitch led to inaccurate results for “possibly tens of thousands” of children and other patients.
Doctors don’t believe any level of lead in blood is safe, especially for children. Several U.S. cities, including Washington, DC, and Flint, Michigan, have had widespread lead contamination of their drinking water over the past two decades, making accurate testing critical to public health.
In light of the 2021 recall, it’s possible that defective Magellan kits were being used to test children for lead exposure as late as the early 2020s. Here’s what parents need to know.
Which tests were affected?
The inaccurate results came from three Magellan devices: the LeadCare Ultra, LeadCare II and LeadCare Plus. According to the Department of Justice, LeadCare II primarily used finger-prick samples and accounted for more than half of the blood lead tests performed in the United States between 2013 and 2017. The devices were commonly used in doctor’s offices to check children’s lead levels.
The remaining two could also be used with blood drawn from a vein and may have been used more in laboratories than in doctors’ offices. The company “first learned that malfunctions in its LeadCare Ultra devices could cause inaccurate lead test results — specifically, falsely low lead test results — while seeking approval to sell the products in June 2013, the Department of Justice said. But the company did not disclose that information and continued to sell the tests, according to the settlement.
The agency said a 2013 inspection showed the same defect affected the LeadCare II device. The 2021 recall included most of the three types of test kits distributed after Oct. 27, 2020.
The company press release The company announced that “the underlying issues that affected the results of some of Magellan’s products between 2013 and 2018 have been fully and effectively remedied” and that the tests it currently sells are safe.
What do falsely low results mean?
Children are often tested at their pediatrician’s office at ages 1 and 2. Elevated lead levels can cause children to suffer developmental delays, lower IQs and other problems, and symptoms like stomach pains, loss of appetite and irritability may not appear until high levels are reached.
Falsely low test results may mean that parents or doctors were unaware of the problem.
That’s a concern because treatment for lead poisoning is primarily preventative at first. Results showing elevated lead levels should encourage parents and health officials to identify the source of lead and take steps to prevent continued exposure, said Janine Carr, health educator for the Virginia Department of Health. Childhood Lead Poisoning Prevention Program.
Children can die from drinking lead-contaminated water from old water pipes in places like Flint, Washington, ingesting lead-containing paint chips that are common in older homes, or, as recently reported A brand of cinnamon-flavored applesauce.
What should parents do now?
“Parents can contact their child’s pediatrician to find out if their child has been tested for blood lead with the LeadCare device and discuss whether a repeat blood lead test is necessary,” he said. Maida GalvezPediatrician and professor at the Icahn School of Medicine at Mount Sinai in New York.
When some Magellan devices were recalled in 2017, the Centers for Disease Control and Prevention Advise the patient to retest If you are pregnant, breastfeeding, or a child under 6 years of age and your blood lead level is less than 10 micrograms per deciliter as measured by a Magellan device from a venous blood draw.
The 2021 Magellan device recall recommended that children whose results were below the current CDC standard of 3.5 micrograms per deciliter be retested. Many of those tests were done by finger prick.
Carr, of the Virginia Department of Health, said the agency hasn’t received many calls about the recall.
“Fingerstick testing is not widely practiced in Virginia,” Carr said, adding that he has received “a lot of questions about the applesauce recall.”
Either way, “the best course of action for parents is to talk to a health care provider,” she said.
