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.
Organizations should contact the manufacturer of the IV bag to obtain written approval prior to implementing any process inconsistent with its intended use, otherwise it would not be considered an acceptable practice.
Another option is to have pharmacy prepare flushes in a controlled environment (e.g., USP 797). Please note that syringes prepared in this way would be subject to the Medication Management standards as they would be considered medications and no longer a medical device.
It may also be helpful to research evidence-based sources, such as ISMP or your state pharmacy board for additional guidance.
Additional Resources
FDA: National Drug Code Directory
FDA: Product Classification - Heparin
FDA: Product Classification - Saline
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.
When organizations experience shortages of saline flushes, they want to prepare multiple flushes from a single use bag of saline. This process is generally not consistent with the product's intended use as defined by the manufacturer and not consistent with safe injection practices guidelines.
Organizations should contact the manufacturer of the IV bag to obtain written approval prior to implementing any process inconsistent with its intended use, otherwise it would not be considered an acceptable practice.
Another option is to have pharmacy prepare flushes in a controlled environment (e.g., USP 797). Please note that syringes prepared in this way would be subject to the Medication Management standards as they would be considered medications and no longer a medical device.
It may also be helpful to research evidence-based sources, such as ISMP or your state pharmacy board for additional guidance.
Additional Resources
FDA: National Drug Code Directory
FDA: Product Classification - Heparin
FDA: Product Classification - Saline
Manual:
Critical Access Hospital
Chapter:
Medication Management MM
New or updated requirements last added: January 19, 2022.
New or updated requirements may be based on revisions to current accreditation requirements, regulatory changes, and/or an updated interpretation in response to industry changes. Substantive changes to accreditation requirements are also published in the Perspective Newsletter that is available to all Joint Commission accredited organizations.
Last reviewed by Standards Interpretation: January 19, 2022
Represents the most recent date that the FAQ was reviewed (e.g. annual review).
First published date: August 06, 2021
This Standards FAQ was first published on this date.
This page was last updated on December 29, 2022
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