In October 2006, the American Hospital Association invited key medical professionals together to discuss patient safety risks associated with enteral feeding systems. The challenge involved the problems with enteral misconnections and small-bore connectors.
In October 2013, the Global Enteral Device Supplier Association (GEDSA), a non-profit trade association, was formed to help address why tubing misconnections continued to pose risks to patient health and to introduce international standards in medical device tubing connectors.
Soon after, the U.S. Food & Drug Administration (FDA), the medical device industry, and the International Organizations for Standardization (ISO) took action to reduce risk by developing standards for medical device small-bore connectors. As a result, ISO 80369-3:2016 was published in July 2016.
The solution to the enteral misconnections issue was found with ENFit devices. Typical oral and parenteral syringes were made with male tips fitting into female connectors, whereas ENFit devices contain a female syringe tip that fits around male connectors.
To educate health systems and hospitals about the impending change, GEDSA introduced the Stay Connected initiative for using safer connectors in medical device tubing.
The real benefit is the connection that ENFit syringes offer over traditional oral syringes. ENFit syringes allow clinicians to deliver fluids, medications, or nutrition orally or through the tubes, promoting patient safety by reducing the risk of misconnection between unrelated systems with a unique mechanical design. The syringes are available in two tip versions: low dose and standard dose.
The standard ENFit tip is used on most syringe sizes. The low dose tip (available in smaller sizes as defined by the manufacturer) was developed to address clinicians’ concerns about dosing accuracy when delivering small medication volumes. For syringe performance information on the low dose tip and other currently available products, see GEDSA’s ENFit Low Dose Tip presentation (www.stayconnected.org).
The state of California is asking all health systems to transition from oral syringes to ENFit syringes, and some large health systems are requiring all hospitals within their network to completely switch over to ENFit syringes. Due to the COVID-19 pandemic and the overall strain on health systems nationwide, GESDA offers a revised ENFit connector conversion schedule:
July 1, 2021 — Legacy feeding tubes and cross-application adaptors will no longer be manufactured.
January 1, 2022 — Transition sets and adaptors sold separately from other devices will no longer be manufactured.
As a leading unit-dose repackaging company with customers across the country, Safecor Health provides both oral syringes and ENFit syringes to our customers. Our ENFit syringe partner, NeoMed, offers clinical education training modules to assist clinicians during the transition. As hospitals and health systems work to implement the change to ENFit, Safecor Health remains your trusted unit-dose repackaging partner.
Nothing is more important than patient safety. With a partner like Safecor Health, our team reduces the burden of unit-dose repackaging. While your team prepares for routine changes, our team manages safety and quality issues, streamlines operations, and delivers a supply ready for your team to inventory and distribute.
Safecor Health is ready to help you transition from oral syringes to ENFit oral syringes.
Sources
https://www.medicaldesignbriefs.com/component/content/article/mdb/features/technology-leaders/22072
https://www.iso.org/standard/50731.html
https://www.iso.org/standard/50734.html](https://www.iso.org/standard/50734.html
https://stayconnected.org/wp-content/uploads/2016/11/11-07-16_InfoGraphic_-Inpatients_-FINAL.pdf
https://stayconnected.org/wp-content/uploads/2016/07/California-Guidance-Final-Review-1.2.pdf
https://www.visanteinc.com/enteral-syringe-safety-unintended-consequences-of-enfit/
https://www.neomedinc.com/education/#enfit_resources