Proper Labelling and Training Materials Requested from Manufacturers
POWELL, Ohio–(BUSINESS WIRE)–#ENFit–On October 12, 2021, the FDA released a safety communication after a singular field concern on dosing accuracy of the ENFit® LDT syringe. The Global Enteral Device Supplier Association (GEDSA) supports and thanks the FDA for this recent communication that concludes the ENFit LDT syringe performs as expected, provided the user follow the instructions for use, and that it is safe to use as directed.
While the FDA’s analysis has identified a potential risk for overdose using ENFit LDT syringes if users fail to follow the instructions for use, no patient injuries have been reported. In contrast, serious patient injuries and deaths have been reported due to misconnections with legacy devices, and the FDA reemphasizes that the risk of adverse events outweighs the risk of mis-dosing with ENFit LDT syringes.
As a result of the FDA’s investigations, it “sent letters to manufacturers requesting they update their labeling and training materials” to include expanded instructions on proper product use (FDA, 2021). The ENFit LDT syringe has reported more than 120 million sold, reestablishing its successful/safe use and asserting its global impact with the correct use of the product.
In support of their previous statement in 2017, “The FDA continues to recommend the use of enteral devices and syringes that reduce the risk of misconnections, such as ENFit LDT syringes.” (FDA, 2021). GEDSA again thanks the FDA for its vigorous support of ENFit and diligent market surveillance.
“To reduce the risk of misconnections and serious patient injuries and death, the FDA recommends use of enteral devices with connectors that meet the International Organization for Standardization (ISO) 80369-1 or ISO 80369-3 standard or that are otherwise designed to reduce the risk of misconnections. There are currently marketed enteral connectors that follow the ISO 80369-3 standards, many of which are identified by the tradename ENFit,” (FDA, 2021).
GEDSA is reporting a surge of conversions to ENFit as hospitals respond to the sharp increase in ICU patients on enteral nutrition. ENFit conversions are ahead of schedule, reaching the tipping point of 50% of hospitals using ENFit in North America. GEDSA and its members continue to focus on supporting hospitals as they implement this important safety initiative around the world.
Additional Resources
FDA Safety Communication: Potential for Medication Overdose with ENFit Low Dose Tip Syringe – October 12, 2021
FDA Letter to Manufacturers: Labeling Change Request – October 7, 2021
FDA Statement: The FDA Encourages Use of Enteral Device Connectors That Reduce Risk of Misconnection and Patient Injury – September 7, 2018
Procedure for Inpatient Settings: Preparing and Administering Medications Using ENFit – February, 2017
Dose Accuracy – Performance Testing of Enteral, Oral, ENFit®, and ENFit LDT Syringes – October, 2016
Statement by the ISMP/ECRI Institute – March 9, 2017
The Joint Commission: Phase out dates coming up for ISO standard on legacy feeding devices, adaptors – October 1, 2020
Centers for Medicare & Medicaid Services: Luer Misconnection Adverse Events – March 8, 2013
About GEDSA
The Global Enteral Device Supplier Association (GEDSA) is a nonprofit trade association formed to establish a voice for addressing issues that face enteral device manufacturers, suppliers, and distributors, and to help introduce international patient safety standards for healthcare tubing connectors. For More Information, Visit StayConnected.org.
Contacts
Media Contact
Natalie Bigler, GEDSA
natalie@gedsa.org
