FDA Informs Healthcare Professionals of Prefilled Saline Flush Syringe Conservation Strategies
On March 21, 2022, the U.S. Food and Drug Administration (FDA) announced (https://www.fda.gov/medical-devices/letters-health-care-providers/prefilled-saline-flush-syringe-conservation-strategies-letter-health-care-personnel) that the United States is experiencing interruptions in the supply of prefilled 0.9% sodium chloride (saline) IV lock/flush syringes because of an increase in demand during the COVID-19 pandemic and vendor supply chain challenges, including the permanent discontinuance of certain prefilled saline lock/flush syringes.
Prefilled 0.9% sodium chloride IV lock/flush syringes are single-use syringes filled with sterile saline solution in various volumes. A prefilled 0.9% sodium chloride IV lock/flush syringe is used to help prevent vascular access systems blockage and to clear any medication that may be left at the catheter site.
For healthcare facilities affected by the shortage, FDA recommended that providers first use prefilled 0.9% sodium chloride lock/flush syringes as supplies allow. When those are not available, the agency recommended that healthcare professionals follow conservation strategies to maintain quality and safety of patient care:
- Use preservative-free, sterile 0.9% sodium chloride single-dose vials.
- Use heparin lock flush syringes, typically used to flush an IV catheter, to help prevent blockage within the catheter after receiving an IV infusion, if medically appropriate and in accordance with your facility’s policy, unless contraindicated in the manufacturer’s labeling.
- Do not use expired prefilled saline lock/flush syringes because they may have decreased volume, degraded ingredients, or sterility that may compromise the device’s performance and increase patient risk.
- Do not use prefilled saline lock/flush syringes that are not FDA cleared (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?start_search=1&Center=&Panel=&ProductCode=ngt&KNumber=&Applicant=&DeviceName=&Type=&ThirdPartyReviewed=&ClinicalTrials=&Decision=&DecisionDateFrom=&DecisionDateTo=03/01/2022&IVDProducts=&Redact510K=&CombinationProducts=&ZNumber=&PAGENUM=500).
- Contact FDA at email@example.com (mailto:firstname.lastname@example.org), as well as your group purchasing organization, local product representative, distributor, or account manager, if the conservation strategies are not adequate to maintain sufficient supply.
- Consider recommendations from FDA or professional organizations, for other strategies that might be appropriate for your healthcare facility or system.
FDA also added prefilled 0.9% sodium chloride IV saline flush syringes to its medical device shortage list (https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-device-shortages-during-covid-19-public-health-emergency#shortage) and device discontinuance list (https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-device-shortages-during-covid-19-public-health-emergency#discontinuance) on March 21. On January 14, 2022, the agency updated its table of device types (https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-device-types-help-determine-section-506j-notification-obligations) and corresponding product codes critical to public health during the COVID-19 pandemic under section 506J(a)(1) of the Federal Food, Drug, and Cosmetic Act to include prefilled saline flush syringes. Additional FDA-cleared prefilled saline flush syringes (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?start_search=1&Center=&Panel=&ProductCode=ngt&KNumber=&Applicant=&DeviceName=&Type=&ThirdPartyReviewed=&ClinicalTrials=&Decision=&DecisionDateFrom=&DecisionDateTo=03/01/2022&IVDProducts=&Redact510K=&CombinationProducts=&ZNumber=&PAGENUM=500) are listed in FDA’s 510(k) premarket notification database under the product code NGT (saline, vascular flush).
The agency said it is working with manufacturers to monitor and mitigate the shortage and ensure that prefilled 0.9% sodium chloride IV lock/flush syringes are available for patients where IV infusions are medically necessary. It will inform the public as significant new information becomes available.
Healthcare professionals should report any adverse reactions or quality problems (https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda) they suspect are associated with the use of prefilled saline flush syringes to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.
Healthcare professionals who have trouble obtaining devices, as well as other stakeholders who may help mitigate potential shortages, should contact FDA at email@example.com (mailto:firstname.lastname@example.org).