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Saline and Heparin Flush Classification

Are pre-filled saline flushes and pre-filled heparin flushes considered medications?

Any examples are for illustrative purposes only

No. The FDA reclassified all forms of pre-filled heparin and pre-filled saline flushes as medical devices. Previously, they were classified as either a device or a drug depending on how the manufacturer submitted its application to the FDA. Their reasoning was that these products act to keep lines open as a result of a physical effect and not as a result of a chemical or therapeutic effect. In addition, the flush has no therapeutic action on the body of the patient when used as directed. Based on this reasoning and the fact that the FDA reclassified these as devices, they no longer meet The Joint Commission's definition of a medication and do not have to meet the Medication Management standards. Storage of IV flushes must be in compliance with the organization's policies for safe storage. Caution must be taken to ensure that heparin flushes are not confused with therapeutic doses of heparin.
If you have any questions regarding a specific product please check the FDA website to determine if the product is considered a device or a medication.

Last updated on August 18, 2021
Manual: Ambulatory
Chapter: Medication Management MM

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