Patients who need medications, nutrients and other fluids delivered simultaneously via tubes and catheters are at risk of enduring potentially fatal tubing misconnections. One reason why connection errors occur is because of the universal design of Luer connectors, the small-bore connectors used in most healthcare settings to connect the tubes of various medical devices. Since the connectors can be used interchangeably from one device to another, the chance of making a mistake — connecting a feeding tube to an intravenous line, for example — is great.
As a result, design changes have been underway and new products are becoming increasingly available so that tubing connectors are unique to their intended device only. Recognized by the Food and Drug Administration, the connectors are modeled after new ISO 80369 standards, which are now being released in a series, one clinical application at a time, for breathing systems and driving gases, enteral, limb cuff inflation, neuraxial devices and intravascular-hypodermic systems.
The Global Enteral Device Supplier Association (GEDSA) is a nonprofit trade association comprised of manufacturers, distributors, and suppliers working to develop and introduce the new enteral and other standards to healthcare facilities (new connectors in the enteral category will fall under the ENFit brand name), as well as educate and assist with a safe and efficient transition.
“Collaboration between GEDSA members and supporting organizations including the FDA, Joint Commission, AAMI, ASHP, ASPEN, Feeding Tube Awareness Foundation, ISMP, NPSF, The Oley Foundation, and multiple group purchasing organizations are the main reason we are reaching a safer place in this patient safety initiative,” said GEDSA Executive Director Tom Hancock.
He says GEDSA members frequently engage in break-out sessions that give everyone a chance to come to the table and share ideas on how to reach common goals and that bi-weekly meetings are also held to determine where manufacturers are in the conversion process and product availability. These meetings also shed light on the concerns that healthcare providers/customers have expressed to suppliers.
“A particular a-ha moment that we often refer to is the problems that arose with Dose Accuracy and how GEDSA and its members overcame it,” said Hancock. “Back in 2015, children’s hospitals brought concerns on dosing accuracy with small volume doses while using a standard ENFit syringe to GEDSA’s attention. Feedback from healthcare providers, primarily children’s hospitals, revealed to GEDSA and its members how big of a concern it really was at a summit hosted by Children’s Hospital of Philidelphia (CHOP). Dosing accuracy was originally going to be solved with implementing a new protocol when using the standard ENFit syringe but was vetoed as a poor solution.
“A technical team of industry experts worked collaboratively to select and vet a solution to address small volume dose accuracy known today as the ENFit Low Dose Tip (LDT) Syringe,” Hancock continued. “After polling clinical experts and inspecting commonly used enteral/oral syringes in practice today, the team further determined that the target ranges for dosing accuracy among small doses of medication say (i.e., 0.2mL within +/-10% dose when delivered from a 1mL syringe).This is not a standard, however GEDSA has evaluated enteral/oral tip syringes most commonly used today and confirmed the syringes used today fall within this same error range.”
Global performance tests and usability studies confirm the ENFit LDT syringe delivers accurate doses substantially equivalent with current male orientated enteral/oral syringes, outperforms existing female orientated syringes significantly and fits appropriately into current practice and maintains compatibility with other ENFit devices.
NeoMed, Inc. offers a wide portfolio of neonatal/pediatric enteral feeding products to support consolidation of multiple vendors. Since receiving FDA 510(k) clearance in June, NeoMed said 60 hospitals are seeking to convert to the company’s ENFit Low Dose Tip design along with other enteral ENFit (NeoConnect) solutions and the NeoConnect Pharmacy.
“Our pharmacy solution harmonizes with our Enteral Delivery System to streamline vendor selection and bridge the critical clinical/supply gap between NICU/PICU and pharmacy,” said Aaron Ingram, President. “NeoMed’s solution also complies with GEDSA’s November 2015 Position Statement Supporting ISO 80369-3 ENFit Enteral Connectors and Low Dose Medication Solutions: ‘GEDSA and its supporting organizations strongly suggest you work with your supplier representative and distributor network to understand their specific plans for conversion. In particular, you must confirm that your syringe supplier has adequate supply of syringes before you convert to ENFit feeding tubes.’”
The “NeoMed Loyalty Program” also helps to identify hospital staff training needs, establish and review process protocols, and ensure supply chain integrity before conversion.
Supply Chain questions
Hancock said the ENFit transition has been a challenge not only for nursing, dietary control, and pharmacy but for Supply Chain too.
“Supply Chain has been impacted by having to identify all components used within an enteral system, identifying suppliers with ENFit solutions, creating a plan for inventory management, coordinating item code changes, and other various usage challenges,” he said. “Another challenge facilities have come across has been verifying adequate supply of all necessary components that they will need to transition. Since the last in-person GEDSA meeting, GEDSA members have aligned to communicating they are ready with adequate supply in Q4 2016.
“Healthcare providers have been waiting patiently for signals that it is time to transition,” added Hancock. “Some delays in the past have left some skeptical that the transition is ever moving forward. We can now assure every healthcare provider that the majority of suppliers have adequate supply of all ENFit enteral feeding components in order to make a successful transition. Healthcare providers are now encouraged to plan their transition to ENFit to reduce the risk of misconnections and ensure compatibility. Clinicians and purchasing teams should focus on understanding what products are transitioning to ENFit including new item numbers. Another focus should be on educating staff members on the transition and communicate a transition date openly.” Visit http://stayconnected.org/ and click on the Enteral (ENFit) tab for more information.
Up next: The new Neuraxial Connectors “NRFit” will be phased in next year with product availability expected in Q2 of 2017. For more information on the NRFit transition visit the StayConnected.org website at http://stayconnected.org/.
Valerie J. Dimond | Managing Editor
Valerie J. Dimond was previously Managing Editor of Healthcare Purchasing News.
