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June 2015 Enteral Connectors Update

There have been recent important developments in deployment of the new, safer, enteral connectors. As of January 2016, California law prohibits hospitals and skilled nursing facilities from using enteral feeding connectors that would fit into other types of connectors (e.g., intravenous), unless an emergency or urgent situation exists and the prohibition would impair the ability to provide health care.

An international design, usability testing and engineering effort resulted in the new ISO-standard “ENFit” connectors, intended to prevent cross connections with intravenous connectors. ENFit connectors mechanically block dangerous feeding solution to intravenous misconnections by their design.

Availability delay

Few manufacturers produce suitable syringes for the North America market. Production challenges will delay the date by which we anticipate enough syringes will be in the supply chain to reliably supply North American hospitals.

Manufacturers originally developed a three-phase approach to the introduction. First come the administration sets, which come with a removable adapter attached. With the adapter on, the administration sets work with current feeding tubes. Removing the adapter allows the set to connect to the ENFit connectors on the new feeding tubes. These sets should be reaching the market now.

Second to be introduced was to be the syringes with the new ISO-standard connector, which, with the adapter, could be used on current feeding tubes. Without the adapter, these new syringes would fit the new feeding tubes.

Last was to be the feeding tubes with the new ENFit connector. Legacy administration sets and syringes would not fit the new feeding tubes. Providers, by then having supplies of the new administration sets and syringes, could accommodate patients with the new feeding tubes as well as those patients who still have a legacy tube.

Due to the syringe availability issues, in North America the second and third phases will be introduced at about the same time, in January 2016. Deployment schedule for the rest of the world is not affected and is at stayconnected.org. For example, introduction in Europe, Middle East, Africa, Australia and New Zealand is scheduled to start 3rd quarter of 2015.

Bill AB 444 is under review by the California state legislature. It would delay the deadline for implementation of the new enteral connectors to July 2016 to allow time for orderly and safe adoption of the new devices in California.

Syringe dead space

The ENFit connector design reverses genders from the traditional intravenous arrangement. The female connector, which in intravenous applications is the distal connector, will be proximal.

When a syringe bearing the female ENFit connector is attached to a feeding tube fitted with the male ENFit connector, the male connector enters the lumen of the female syringe connector. This changes the dead space within the tip by about 0.15 ml (a range of 0.089 to 0.179 ml). This contrasts with intravenous connectors, in which the dead space change occurs in the distal tubing, not the syringe.

If the syringe is always used in conjunction with the mating male ENFit connector this effect is constant, cancelling out the dead space changes. Tests show that medication accuracy is similar to traditional syringes. For example, laboratory testing with a draw up straw shows the volume error is just 0.003 ml.

If the mating connector is used for either dispensing or administration of the drug but not both, volume error can be as much as 0.2 ml. Erroneous use examples:

  1. The syringe is used to draw up medication directly from a cup or container without attaching a straw or other male ENFit device then used for enteral administration through the male ENFit connector on a feeding tube.
  2. The syringe is used to draw up medication with a straw or other male ENFit device then used for oral administration without using a matching male ENFit connector.

Recommendations for low-volume medications:

  • Do not draw up medications using the bare syringe for administration via feeding tube. In pharmacies, use an ENFit bottle adapter for bulk medications. This also helps prevent accidental filling of IV syringes with enteral medications. If drawing up from a unit dose cup or other open container, use an ENFit straw.
  • Transport filled syringes with a cap in place.
  • Avoid using ENFit syringes for oral administration, use oral syringes instead. While there are procedures to ensure accurate dosing, this adds complexity. If ENFit syringes need to be used for oral medication administration, follow the instructions in the ISMP Safety Alert: www.ismp.org/newsletters/acutecare/showarticle.aspx?id=105
  • Low-volume medications used in the NICU that might be given orally include vitamins K1 and D, caffeine citrate, digoxin, morphine, methadone and ranitidine.

Dead space illustration

diagram of male and female ENFit connectors attached to each other

In the above illustration, the ENFit syringe is left (grey, female) and the feeding tube right (blue, male). The portion of the right connector that is inside the left connector partially occupies its lumen, reducing its volume.

Where to get help

The first-line information source for the new connectors should be the provider’s supplier, who should have the most current information on market availability and instructions regarding the specific products the provider buys. Many group purchasing organizations, including HealthTrust, MedAssets, Novation and Premier, are directly involved in this effort and should be an information source. Manufacturers are also cooperating in providing standardized provider resources, found at stayconnected.org. CHPSO is extensively involved in both the international standardization process and the rollout planning and is available to answer questions at info@chpso.org.