Clinicians utilize balloon-based fecal management systems which exert significant radial pressure on rectal mucosa and can lead to major discomfort and pain. The inflated balloons compress the epithelial cells of the rectum during patient manoeuvring which can lead to necrosis and other complications. A major concern for WOC nurses regarding the use of inflatable balloon catheters is the potential harm to the patient’s internal sphincter and the inability to mobilize the patients. FDA’s MAUDE database reports complications like hematoma, sphincter injuries and erosion of the anal canal.
A clinical evaluation was carried out at a large academic research hospital in San Diego to evaluate 20 units of a new fecal management system (QoraTM SMK). The novel SMK utilizes a soft lattice based technology that does not utilize sphincter muscle contraction for device patency unlike balloon catheters, thereby eliminating the concern for sphincter injuries. Feedback from the study revealed 42% of patients were able to be mobilized using a cardiac chair with successful fecal diversion. Furthermore, two conscious patients verbalized that there was no discomfort while the device was in-situ. There were some instances of peripheral device leakage however none of the patients experienced any sphincter related trauma or severe adverse events. The use of SMK in these cases allowed safe and effective fecal management without inhibiting the post-operative activity in cardiac patients.