The U.S. Food and Drug Administration said Thursday it has warned Becton Dickinson (BD) about several violations of federal law. BD has until Feb. 1, 2018 to report the watchdog about the actions taken to resolve the issues.
The warning letter aimed at marketing significantly modified versions of certain BD Vacutainer blood collection tubes without required FDA clearance or approval and failing to submit medical device reports to the FDA within the required timeframe. The FDA has found this breach after inspecting BD’s New Jersey facility.
Furthermore, the FDA said that the inspection showed BD failing to deal with a complaint about variability in test results observed when certain BD Vacutainer blood collection tubes were used with Magellan Diagnostics’ LeadCare test systems.
The FDA conducted its inspection of the BD facility as part of its ongoing investigation into the cause of inaccurate blood lead test results associated with Magellan’s LeadCare test systems.
“Our inspection showed that BD violated the law by making a significant change to certain devices the company manufactures without notifying the FDA and failing to follow good manufacturing practice requirements,” said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health. He added that the FDA will focus on this issue, including whether the use of BD tubes led to inaccurate lead test results.
According to the FDA’s press release, the US food and drugs main authority pointed out in May 2017 that Magellan’s LeadCare test systems performed on blood drawn from the vein (venous) may show false results and it recommended that laboratories and health care professionals follow the its recommendations regarding retesting using blood drawn from a finger or heel stick.
Prior to this warning, FDA explains, Magellan informed its customers that the inaccurate results may potentially be related to the composition of the rubber stopper of certain BD blood collection tubes — specifically, tubes with lavender- or tan-colored tops — and advised customers to no longer use these types of tubes with Magellan’s blood lead tests. The FDA could not verify these findings at the time and launched its own investigation into the issue to determine the cause of the inaccurate results, which included an inspection of BD’s Franklin Lakes, New Jersey facility.
“At this time, the FDA does not have evidence showing that other blood tests are adversely affected when BD blood collection tubes are used, and these tubes remain on the market. We are actively communicating with BD about their investigation into this matter and will continue to keep the public informed,” FDA’s press release reads.
During the inspection, the FDA’s investigators found evidence of numerous violations, including BD’s failure to notify the FDA about a significant change that the company made to the rubber stoppers for certain BD Vacutainer blood collection tubes that could significantly affect the safety or effectiveness of these devices. The inspection also revealed evidence that the company failed to comply with the good manufacturing practice requirements of FDA’s Quality System regulation. For example, BD was cited for violations of device design validation requirements and for failure to adequately review, evaluate, and investigate complaints.
We’ve sent an email to BD for comments, and we’ll update the article with it, should we get one.
No safe blood lead level in children
According to Centers for Disease Control and Prevention, today at least 4 million households have children living in them that are being exposed to high levels of lead. There are approximately half a million U.S. children ages 1-5 with blood lead levels above 5 micrograms per deciliter (µg/dL), the reference level at which CDC recommends public health actions be initiated.
No safe blood lead level in children has been identified. Lead exposure can affect nearly every system in the body. Because lead exposure often occurs with no obvious symptoms, it frequently goes unrecognized. CDC’s Childhood Lead Poisoning Prevention Program is committed to the Healthy People 2020 goals of eliminating blood lead levels ≥ 10 µg/dL and differences in average risk based on race and social class as public health concerns. The program is part of the National Center for Environmental Health’s Division of Emergency and Environmental Health Services.
Image: FILE PHOTO – A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo