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Posted 19 September 2018 | By Ana Mulero 

CDRH Finalizes Guidance to Reduce Heparin Product Overdose Errors

2838 The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) issued final guidance Wednesday to aid manufacturers in reducing the risk of patient injury associated with heparin-containing medical devices and combination products.
The final guidance, which is largely consistent with the draft version from 2015, aligns CDRH policies with the US Pharmacopeia (USP) drug substance and product monographs for heparin sodium, heparin lock flush solution and heparin sodium injection.
Heparin is an anticoagulant—derived from pig intestine—used during heart surgeries and kidney dialysis. Yet heparin products can cause serious adverse events when dosed incorrectly.
Several revisions to the USP monographs became final in 2009, following the 2008 heparin crisis that led to the death of about 100 Americans. The crisis “prompted 16 drug and device firms to recall at least 11 drug products and 72 heparin-containing medical devices,” according to a 2010 Government Accountability Office report.
FDA has issued several warning letters to heparin facilities in China in recent years. These include a 2014 warning to a company “associated with historical” over-sulfated chondroitin sulfate contamination.
Final Guidance
The 7-page final guidance “addresses these safety concerns by clarifying new expectations for labeling with regard to the revised heparin USP monographs, as well as outlining safety testing recommendations,” CDRH said. The specific goal is to “help reduce heparin product overdose errors caused by misinterpretation of the expression of drug strength in product labeling.”
The guidance also describes how to ensure compliance in conjunction with the policies FDA set forth in 2013 final guidance on monitoring crude heparin for drug and device use to ensure quality control.
Few comments were submitted to CDRH on the draft version, but the modifications suggest these were taken into consideration. For example, the final version clarifies “specific labeling for the amount and strength of heparin for heparin-bonded products is not generally needed.” This clarification was recommended by medical device manufacturer Cook Group.
Guidance for Industry: Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing


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