Center for Improvement in Healthcare Quality Newsletter
March 2022

CIHQ-ARS Blog

One and Done - Pre-Filled Syringes

By: Gina Miller
As drug companies look to become more patient-centric, and hospitals comply with requirements around supplying medications in the “most ready to administer form available from the manufacturer” (§CMS 482.25(b)(1)), prefilled syringes have become more popular for a multitude of reasons. Not only do they provide improved dosage accuracy, but there is also a reduced risk of contamination, reduced chance of injury for both patients and clinicians, and provide a patient-friendly experience with quick administration. Not to mention the ease of use. Prefilled syringes essentially eliminate multiple steps of gathering supplies and withdrawing from vials, and often contain the exact doses required. They are a time-saver, especially in an emergent situation, and produce less waste. Since pre-filled syringes have become more readily available and used, lets explore a few misunderstandings around the use of syringes, especially the use of pre-filled flush syringes.

Prefilled 0.9% Saline Syringes may not be used to Reconstitute and Dilute IV Medications

As tempting as it may be, prefilled saline syringes may not be used to dilute or mix medications for either IV piggyback or IV push. The FDA has approved the syringes as devices approved for the flushing of vascular access lines. They have NOT been approved as a medication, therefore their use to reconstitute, or dilute medication would be considered “off label” use. Put the prefilled syringe down and withdraw from a saline or sterile water vial for this use.

Prefilled Syringes may not be used Twice

Many organizations supply 10mL prefilled saline flush syringes. Can you use these for the flush prior to and after an IV push medication? The answer is a definite NO! Once the syringe has been used to connect to a patient’s IV administration tubing or solution container or penetrate a rubber stopper, it is considered contaminated, and may not be reused, even on the same patient. You may not inject 5mL flush to prepare the line, and the remaining 5mL after the medication to clear the line. While you may think you are cost-saving, don’t do it. The risk of a blood-borne infection is not a risk you want to take. Likewise, it should go without saying, but you may never use the same a prefilled syringe on more than one patient.
During a code situation, prefilled syringes may not be partially used, recapped, and the remainder used later on the same patient. One Needle, One Syringe, Only One Time.

Prefilled Syringes may not be used as a Vial

Carpuject or other prefilled type cartridge syringes are not to be used as vials from which you open and withdraw from the rubber diaphragm. They are not intended to be used as single- or multi-dose vials and can lead to contamination or dosing errors. Transferring medication from one syringe to another increases the risk of errors and contamination.

When is a Medication ‘not’ a Medication?

Medication requires special handling and secure storage…or not…sometimes. Believe it or not, the FDA reclassified all forms of prefilled Heparin flush syringes as medical devices. Previously, they were classified as a drug or device dependent upon the FDA application and approval. With the new classification, they do not meet the definition of a medication and are considered a counterpart to saline flushes which were already classified as a device. The reasoning is that the product acts to keep the line open because of a physical effect and not a therapeutic effect on the patient. Storage of IV flushes must follow the organization’s policies for safe storage of supplies, however there is greater leniency with the current classification as a device rather than a medication. Do not confuse prefilled Heparin flush syringes with therapeutic doses of Heparin, which are also available in a prefilled syringe and are obviously considered medication.
Protecting your patients from infection is a basic standard of care. In recent years, misuse and reuse of syringes has been a significant finding among healthcare providers and resulted in dozens of outbreaks. Assure that staff are provided orientation on even the most basic concepts of infection control and syringe reuse, and that your organization’s safe injection policies reflect current CDC and ISMP guidelines.

References

Centers for Disease Control and Prevention, (n.d.). The one & only campaign. cdc.gov
Gaunt, Michael, (2018). An unsafe practice: Reuse of prefilled saline flush. Pharmacy Times 84(10). pharmacytimes.com Institute of Safe Medication Practices, (2015). ISMP safe practice guidelines for adult IV push medications.
U.S. Food and Drug Administration, (n.d.). Product Classification. accessdata.fda.gov
View Other CIHQ-ARS Blog's at CIHQ-BLOG.org