According to a blog post from Visante, concerns from patient groups and advocates about the safety of a recently introduced tube feeding connector device called ENfit have caused major consternation among the tube feeding community. A diverse array of rare diseases and conditions may require patients to receive nutrients via tube feeding. There have always been concerns regarding the safety of tube feeding connectors as it is essential to avoid the possible transmission of infectious bacteria.
ENfit: Causing More Problems Than it Solves?
The creators of ENfit claim that the new connector will alleviate safety concerns, but independent research has indicated that ENfit may in fact be less safe than traditional connectors. Most connectors have a design in which delivering end of the tube surrounds the receiving end. ENfit reverses this configuration, but this change has the potential to cause problems related to how the syringes are filled, the measurement of doses, and the nature of the substance being delivered (liquid paste vs ground medication and others).
Physicians expect a dose variance within five percent or less, but ENfit was designed with a ten percent or less variance. Unfortunately, this standard was not agreed upon in an appropriate or inclusive process. The designers also developed a special low dose tip for ENfit to counteract some of the problems, but studies of this tip suggests that it actually appears to make dosing problems worse.
Risk of Infection
There have also been concerning reports about the buildup of bacteria in the moat area of the ENfit device. While there are special brushes designed for the cleaning of this area, reports suggest that the are almost entirely ineffective. A report, from Nelson Labs, resulted in bacterial concentrations deemed too numerous too count (TNTC) for 7 of 8 connectors that were scrubbed with the recommended brush.
Ultimately, studies that are in favor of ENfit have since been called into question as they were not peer-reviewed, nor were other labs able to replicate the positive results.
New Standards Needed for Testing Medical Devices
Regulations surrounding medical devices have historically been very loose when compared to medications. Without an effective process for objective, useful clinical testing of medical devices, many have gone on to be used despite major safety concerns. It appears that the ENfit syringes and connectors could be another example of a potentially unsafe device that has successfully infiltrated the market.