FDA: Final Guidance on Heparin-Containing Devices, Combo Products

The manner in which the drug strength is shown on labeling was acknowledged as a cause in heparin overdose errors.
The manner in which the drug strength is shown on labeling was acknowledged as a cause in heparin overdose errors.

The Food and Drug Administration (FDA) has published a final guidance document, “Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing," providing labeling and safety testing recommendations for medical devices that contain heparin. 

The US Pharmacopeia (USP) drug substance monograph for Heparin Sodium, Heparin Lock Flush Solution, and Heparin Sodium Injection have been revised after serious and fatal events related to use of heparin sodium products. After an investigation, the manner in which the drug strength is shown on injectable product labeling was acknowledged by the FDA as a major cause in heparin overdose errors. Serious patient harm or death may occur as a result of incorrect dosing. The intent of the document is to help reduce heparin product overdose errors caused by misinterpretation of the drug strength displayed in the labeling. 

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The guidance is applicable for medical devices and device-led combination products that include heparin sodium or low molecular weight heparin. It clarifies the current labeling and safety testing recommendations for heparin lock flush solution products, heparin-bonded products, and for heparin-containing products. 

Specific labeling for the amount and strength of heparin for heparin-bonded products is generally not needed, the guidance states.

The full guidance can be found here.

For more information visit FDA.gov.