F-Cal Device
A new innovative device-based solution for Fecal impaction
The F-Cal device is designed specifically to remove all forms of fecal impaction. The patented device places an effective, efficient, humanitarian solution for the removal of fecal impactions within the scope of car of midlevel providers including nurses, medical technicians and home healthcare providers.
F-Cal device is poised to change the Standard of Care for fecal impaction.
Advantages of F-Cal Over of Digital Dis-impaction in the Emergency Department
- With digital dis-impaction removing volume of stool is difficult and painful. Therefore, in general, what we do with our finger is to break up the structure of the impaction and then use a soap suds or milk and molasses enema to increase the pressure behind the impaction. We know from experience that this will work eventually but it does expose the patient to the risk of increased pressure behind an obstruction which can re sult in complications such as diverticular inflammation and even perforation. It also requires nursing time to administer the enema and to deal with the aftermath prolo nging the ED stay.
- The F-Cal device is designed to remove volume of stool such that the obstruction is removed and the remainder o f stool build up can be passed normally without increased pressure and likely without and enema of any sort. This shortens the over all time for the case an d reduces the likelihood of complications.
- The F-Cal device is a nursing or Tech level device. It is much safer and easier to perform than insertion of a foley catheter. Nurses and Techs to whom we have shown the device to are anxious to be able to help patients in this way but will not be willing to digitally dis impa ct with all the discomfort that is entailed in that procedure.
- The F-Cal device is cost effective since it reduces the need for enemas, nursing time and most importantly ED department time. It a lso frees up the ED physician to go on to other more acute cases while the impaction is removed by support personnel.
- The F-Cal device has been classified as Class One Exempt by the FDA. Essentially they consider it a tongue blade for the other end. As such because of its safety profile no studies or FDA oversight are required. Thus, no barriers exist on the regulatory side rega rding getting the device into use.
- The F-Cal device has been given a Class One Exempt status by the FDA because its safety profile is very good. This is because the o nly part of the device that touches the patient is the exterior of the funnel. There are two solid mechanisms that prevent the auger from escaping the end of the funnel. First it is recessed from the end of the funnel. Next there is a hard stop preventing over insertion of the auger and third t he auger itself is tapered to fit the funnel which means that even if the shaft of the auger broke the auger cannot move further down the funnel. Essentially the FDA considers it a tongue blade for the other end. Because of its safety profile, and its class one exempt status no studies or FDA oversight ar e required. Also, no K number is assigned. Thus, no barriers exist on the regulatory side regarding getting the device into use.
