Understanding the Transition to ENFit®
The transition to ENFit® enteral connectors has been in the works for well over a decade. Here’s your guide to making sense of it all.
Over a decade ago, The Joint Commission, Food and Drug Administration (FDA), and Global Enteral Device Supplier Association (GEDSA) recommended that all hospitals transition from legacy enteral connectors to an ENFit® system to reduce the rate of misconnections and improve patient outcomes in the NICU.
However, because the medical device industry is among the most highly regulated industries in the world, a shift of this magnitude takes time to unfold. While a growing number of hospitals have successfully made the switch to ENFit®, many facilities are still developing a plan to do so effectively. Below, we explore the details of this long-awaited change, and explain how Kentec Medical can help make the transition to ENFit® go as smoothly as possible.
A Call for Safer Enteral Connectors
The road to ENFit® began in 2008 when The Joint Commission published a position statement detailing its concerns about the safety of certain enteral connectors. Six years later, The Joint Commission published a report in Sentinel Event Alert that dug deeper into the potential for adverse events related to enteral misconnections.
Misconnections occur when one medical device is mistakenly attached to another device that performs a different function. The Joint Commission’s research found 116 case studies involving misconnections in which enteral feeding solutions were directed into IV lines, resulting in at least 21 deaths. Unfortunately, 21 deaths is a conservative estimate. Tubing misconnections often go underreported and adverse events are reported even less frequently. Most of the time, a misconnection is only reported as a “medication error,” especially if the misconnection doesn’t harm the mother or the baby.
The Joint Commission’s 2014 report urged hospitals to assess the risk of injury presented by their enteral connectors and stay tuned for changes to the International Organization for Standardization (ISO) regulations for enteral connectors that would dramatically improve patient outcomes. The Joint Commission received resounding support from the FDA and GEDSA, with each organization publishing a letter in 2018 that encouraged an industry-wide shift toward the adoption of safer enteral connectors.
How Enteral Connectors Have Changed
The healthcare industry’s concerns over the safety of certain enteral connectors served as a catalyst for new regulations. Now, all healthcare organizations are strongly encouraged to ensure their enteral connectors are compliant with the ISO 80369 series in general, and standard 80369-3 in particular. The final draft of this standard has been published, approved, and moved forward into global adoption.
ISO 80369-3 establishes a master standard for all small-bore connector designs to reduce adverse events caused by misconnections. These enteral connectors feature a new design that’s incompatible with luer connectors and passes multiple misconnection tests. Moving forward, medical equipment manufacturers will have to implement these design changes, procurement managers will need to take ISO 80369-3 into consideration when purchasing new inventory, and NICU nurses will need to adjust their best practices.
However, transitioning from older enteral connectors to ENFit® requires a strategic, systematic approach. The speed with which a procurement manager transitions their hospital to ENFit® depends on, among other things, how long their medical equipment manufacturer is planning to continue offering legacy options. For example, GEDSA members have extended their production phase-out dates in light of the novel coronavirus pandemic. Starting July 1, 2021, GEDSA will no longer manufacture legacy feeding tubes and cross-application adaptors.
How Kentec Can Help
Phasing out legacy systems in favor of ENFit® can seem overwhelming, but working with an experienced NICU device manufacturer can help make the transition go as smoothly as possible. If you’re a procurement manager transitioning your hospital to ENFit®, you need a partner who will be in your corner throughout the entire process.
At Kentec Medical, we believe that unmatched customer service is the key to delivering value, providing better patient experiences, and improving health outcomes in NICUs around the world. We’ll see you through your transition to ENFit® and ensure your facilities are outfitted with the best, safest enteral connectors available. If you’re still working through the ENFit® transition and need legacy enteral products for your hospital, we can assist you with that as well.