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FDA Inspectors Find Possible Violations At Lead Testing Manufacturing Facility

Federal regulators issued additional information about problems with certain lead poisoning testing devices, which have been found to provide inaccurate results according to a safety warning first issued in May, indicating that the manufacturer may have been in violation of a number of federal medical device standards. 

Albert Gutierrez, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, issued a statement on July 13, announcing that FDA investigators found a number of problems at a Magellan Diagnostics facility in North Billerica, Massachusetts, where the company manufactures LeadCare testing systems.

Those systems were linked to an FDA warning on May 17, which indicated that drawing blood from veins for the tests may not give accurate results. The warning applies to LeadCare Testing Systems by Magellan Diagnostics, Inc., including the LeadCare, LeadCare II, Lead Care Plus and LeadCare Ultra testing systems. They are used in clinics, laboratories, doctor’s offices and hospitals nationwide.

The FDA has released the inspection report (PDF) for the facility, indicating that investigators found that the company’s validation studies did not test the kits under actual use conditions. They also found that the company did not properly evaluate the risk of falsely low test results, and did not properly record a number of customer communications as actually being complaints.

“We are carefully reviewing the evidence collected during the inspection to determine if there have been violations of federal law and whether further action is warranted,” Gutierrez said in the statement. “The FDA takes these observations and the risks these tests may have posed to patients very seriously and continues to encourage people to follow the FDA’s and Centers for Disease Control and Prevention’s recommendations from May 17.”

The FDA is recommending that health care professionals discontinue using the systems for venous blood samples, but says they can still be used to test blood drawn from capillary sources. The U.S. Centers for Disease Control and Prevention (CDC) are also recommending that parents of children younger than six, as well as pregnant or nursing mothers, who may be concerned about previous test results, should consult a health care professional about whether to have themselves or their child retested.

Elevated blood lead levels are an indicator that children may be at risk for side effects of lead poisoning, which can lead to serious nervous system injury, brain damage, seizures, growth or mental disability, as well as other severe health problems throughout the rest of their childhood and life.

One of the more common causes of of lead poisoning is lead-based paint, which was banned in the United States in 1978 due to the risk of severe and permanent brain damage and developmental problems, particularly in children. However, a number of older homes still contain the toxic paint on the walls, and if it flakes or peals off, young children could ingest the paint chips or breathe dust that comes from the paint, resulting in lead poisoning. Many of those homes are owned by HUD or receive HUD assistance.

In recent years, there has also been an increased focus on lead in drinking water, stemming from the recent and ongoing Flint water crisis, during which a change to the water system in the Michigan city resulted in high levels of lead in residents’ drinking water, causing thousands of children to suffer lead exposure and, potentially, lead poisoning.

The CDC estimates that 535,000 children ages 1-5, or about 2.6% of such children in the U.S., have levels of lead in their blood that place them at risk for adverse health effects. To come up with that number, the CDC analyzed data from the National Health and Nutrition Examination Survey from the years 1999 to 2002, and 2007 through 2010.

The majority of those children are poor and live in older urban areas, mainly in the inner city. Most are minorities, meaning such exposures add to numerous problems already plaguing inner city black and Latino youths, such as poverty, high crime and poor schools.

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