There has been other information on this site and elsewhere detailing the change from enteral-only connectors to the ENFit connector. This design was intended to provide additional safeguards against misconnection errors. This is nowhere a problem more than in the neonatal unit. Virtually every baby has a feeding tube at some point during their stay and an IV in more than 90% of the cases. In the vast majority of cases, these two devices are in place simultaneously and often for a prolonged period of time. Connections are made to the feeding tube no less than 6 times a day and if medications are given, connections/disconnections happen more often. IV connections are made at least daily and again, if medications or more than one solution is infused, this could be much more often. Very sick babies often have more than one IV line, multiple drips and medications with multiple connections and disconnections during the acute period.
With each connection and disconnection, risk exists for a misconnection error to occur.
Some time ago now, enteral-only connections were introduced and have been implemented to varying degrees across the country. I believe it is safe to say that most neonatal units have at least some enteral-only supplies. This may vary from enteral-only syringes and tubes to enteral-only syringes, tubes, extension tubes and pumps. Furthermore, devices from one manufacturer often do not connect to devices from another manufacturer. In spite of every attempt to avoid backorder situations, they are sometimes out of the control of the manufacturer, and do occur. This may lead to use of non-enteral products in order to continue to provide the care patients need.
The ENFit Connector, California and Timing
In order to address the inconsistency in types of enteral-only connectors and to develop a type of connector that would not connect to any other device, GEDSA (Global Enteral Device Supplier Association) was formed by the manufacturing community. This is where the specific design called ENFit was developed and was planned for launch in 2015 to meet the safety standards for all patient populations.
Meanwhile, California had enacted a law for state facilities to adopt specific connectors. In the state of California, a device to prevent tubing misconnection was to be required by January 2016, under provision AB 1867. The California regulation specifically states:
“…..Prohibits general acute care, acute psychiatric, and special hospitals from using an epidural connection that would fit into a connection port other than the type for which it was intended, beginning January 1, 2014 or 36 months after specified prescribed standards are developed by the International Organization for Standardization (ISO), whichever comes first. Prohibits general acute care, acute psychiatric, and special hospitals from using an intravenous or enteral feeding connection that would fit into a connection port other than the type for which it was intended beginning January 1, 2013 or 24 months after specified prescribed standards are developed by the ISO, whichever occurs first…”
(View here for more detail)
This California law was recently extended to June 2016 in order to allow facilities and manufacturers more time for change management success.
GEDSA has also extended their ENFit date up to Jan 2016 nationally, as some manufacturers of enteral syringes are not yet ready to sell the ENFit products. However, this will soon be available for the NICU as neonatal enteral feeding manufacturers are largely ready to proceed. At present, this is not a mandate anywhere except California, but the products will likely be showing up in a storeroom near you over the next 2 to 3 years, at least!
The ISMP and ENFit
It seems like the transition to a new type of syringe should be a simple process. Nurses, after all are very skilled at using syringes! However, this connector is so unique that there are some differences that may present problems. The ISMP (Institute of Safe Medication Practices) has obtained some ENFit syringes and performed various tests to determine the “dead space” in the syringe. Because the new syringes have a female connector, it has a significantly larger dead space than current syringes (enteral or parenteral) with a male connector. This dead space, depending on manufacturer, has been determined to be 0.15 to 0.2 ml.
Using traditional syringes, the dead space is always filled with medication or fluid. When administered to the patient, it stays in the dead space, making it equal to the amount actually pulled up in the syringe.
The difference with the ENFit connector is that various devices have been or are being developed for use with the syringe when drawing up medications to prevent filling this area with medication. That is important because when it is connected to the tubing, that volume will not be delivered and is a significant portion of a neonatal medication dose. These additional devices that are being developed are a cap for drawing up liquid medication from a bottle, usually to be done in a pharmacy; and a straw to be used when drawing up medication from a medication cup, medications being dosed on the unit vs from the pharmacy. These may be available from the same company developing the ENFit supplies or may be available from other vendors.
The ISMP describes in detail problems with drawing up medication without use of a straw or cap (link below). If an ENFit syringe is used to deliver the medication to the unit and then it is given orally, this could result in a dosing error and vice versa. According to the ISMP, a 10% variance in actual dose delivered is “tolerable” but these scenarios could result in a difference of much more, particularly in the neonatal population where an entire dose may be 0.2 ml or less. Using some methods, a rather large air bubble in the syringe must be removed and in the process of removing it, since the opening is so large, a significant amount of the medication may be lost, spilled from the syringe and so forth, resulting in re-entry of the syringe tip into the solution, potential dosing errors and contamination. In the end, this will take some planning and preparation on the part of neonatal units and pharmacy personnel as part of the transition process.
However, in spite of all these issues that have been raised, they are not insurmountable. Manufacturers are developing or have developed the various devices mentioned, specifically, straws and caps. The important part is for the end users to realize this issue and purchase not only the syringe and tubing with the proper connection, but also the additional devices needed for accurate measurement and delivery of medications. This just serves to underline the need to have ALL the right tools. In the transition to the ENFit connector, not only are syringes and tubes necessary but also the cap, straw and perhaps other devices as this is rolled out and put in to clinical use. In planning for implementation of the new system, it is critically important that pharmacy be included in the discussion. And first and foremost to remember the overall goal of this change, which is to increase safety for the infants in our care.