Risks Of Misconnecting Enteral Devices

A medical facility is a busy one with the professionals being a harried lot and often bogged down with responsibilities. Unfortunately, there are many instances of connecting a feeding tube to another type of clinical aid and jeopardizing the safety of the patient. It has thus become necessary to take note of certain standardized regulations that prohibit attaching two tubes for diverse purposes by means of a connector. This has definitely gone a long way in ensuring safety of the patients while providing the professionals to obtain peace of mind.

‘The Global Enteral Device Supplier Association (GEDSA)’ had been formed with the sole purpose of introducing GEDSA Connectors and products that will help to keep the patients completely safe and the care givers totally anxiety free. There is nothing more important for the manufacturers than adhering to ISO 80369-3:2016 while creating and introducing new enteral devices for varied requirements. The regulations do not pertain to one single connector or product though. On the contrary, the standard specifies the design and guidelines about the dimensions to be utilized for small bore connectors that are usually used for connecting different types of enteral devices as well as their accessories together.

The standard does not ask the manufacturer to follow any particular design either. However the ENFit products have proved to be most effective for avoiding misconnections at present. The FDA has already approved a new kind of low dose tip syringe for two manufacturers who have made their products compliant with the regulations. There have been numerous other submissions though by manufacturers hoping to obtain a FDA 510(k) clearance for their own products.

These syringes pose almost no risk of misconnections. Sadly, there is not one connector that could be pronounced as 100% safe. The ones deemed to be safe were ascertained on the basis of their low risk capacity. ENFit has devised a specific orientation for the diverse components to ensure compatibility. The system requires the syringes and gravity along with pump sets and devices for bolus feeding to have a standardized female connector to fit perfectly into the male end of the feeding tubes including but not limited to G-Tube, PEG, and NG Tubes. GEDSA has gone a step ahead and ensured that all the components that adhere to the standardization will fit with the other end perfectly regardless of the supplier.

That does not mean that only the ENFit design needs to be adapted though. GEDSA is all for a standardized solution and encourages using a single design as many patients have to be shifted between health care facilities without disturbing the enteral tubing. It is therefore necessary to ensure compatibility and portability of the devices without necessitating long term use of adaptors prone to disconnection.