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Clinical Consultation: Fecal Incontinence Management Systems
A patient who is being treated for Clostridium difficile colitis is admitted to your transitional care unit. Along with orders for metronidazole (Flagyl), you find the order “Fecal Incontinence Management System—follow product protocol.” While assessing the patient, you note a thick, flat, pliable tube running from the rectum to a drainage bag. How do you provide care for this patient?
Historically, healthcare personnel have used multiple tactics to manage diarrhea incontinence— incontinence pads, adult briefs, foley catheters inserted into the rectum with the balloon inflated, rectal tubes, and external fecal incontinence collectors. However, many of these interventions had adverse outcomes, including incontinence-related dermatitis, damage to the rectal mucosa or sphincters, odor, leaking, and patient discomfort and embarrassment. Currently, two fecal incontinence management systems are commercially available (see Table 1 for comparison). Both devices are indicated for the management of acute fecal incontinence.
The ConvaTec Flexi-Seal® Fecal Management System (FMS) is a containment device intended for temporary use in patients who have liquid or semiliquid stool and are either immobilized or bedridden (ConvaTec, n.d.). The system consists of a silicone catheter, syringe, and collection bag. At one end of the silicone catheter is a retention balloon that is lubricated and inserted into the rectum. After insertion, the syringe is used to fill the retention balloon with 45 cc of water or saline. At the other end of the silicone catheter is a collection bag. This bag has a closed end and a capacity of 1,000 cc and needs to be changed, not emptied. The Flexi-Seal FMS can be left in place for 29 days. The device can be removed from and reinserted into the same patient to allow for procedures as necessary. When the patient’s stool becomes softly formed or solid, the device must be removed.
The Hollister Zassi™ Bowel Management System (BMS) also has a clear silicone catheter with a retention balloon on one end and a drainable collection device on the other end. The system is also intended to divert and collect fecal matter created by incontinence (Zassi Medical Evolutions, n.d.). However, the BMS also has an irrigation port that allows solutions to be instilled into the rectum. For this reason, a Stool Modification Plan™ using stool-modifying agents (such as Lactulose) and regular irrigation can be employed with the BMS to promote looser stools and allow the BMS to remain in place for fecal diversion and collection (up to 29 days). Therefore, the BMS can remain in place even when the patient’s diarrhea begins to resolve, so long as the Stool Modification Plan is adhered to. The retention cuff of the BMS should be deflated and reinflated every 7 days. The BMS has a drainable collection bag with a capacity of 3,000 ml. It is recommended that the tubing be rinsed with water twice daily, using the flush/sample port, and that the bag be changed every 7–10 days to combat odor. Using odor-eliminating products in the bag is not recommended. A closed-end bag system is also available. In addition, the BMS comes in two catheter sizes; it is necessary for a qualified practitioner to assess the patient and recommend the correct catheter size before it is placed. Most patients require the 6-cm catheter, but patients with a short anal canal require the 4-cm catheter.
Both systems are effective at containing fecal incontinence. Thus, both systems can be effective at decreasing nosocomial infections by protecting both patients and caregivers from exposure to potential infected feces. Both systems can decrease the potential for nosocomial incontinence-related dermatitis. Both systems can decrease costs related to incontinence care products (i.e., briefs, pads, cleansers, barrier ointments) and caregiver time. Both systems can enhance patient comfort and dignity. Stool sampling, if necessary, can be achieved using both devices. The BMS has a stool sampling port; however, the FMS requires that the bag be disconnected from the catheter for sampling.
Although there is minimal risk of rectal mucosal necrosis associated with a properly inserted and maintained FMS or BMS, reports of both rectal bleeding and mucosal erosion have been associated with both systems, usually occurring because the retention balloon or cuff has been overinflated. Other possible adverse events include infection, obstruction, perforation, leakage of fecal contents, or loss of anal sphincter tone. Patient assessment and selection is of utmost importance, and using the device requires a physician order. Depending on your institution’s policies and procedures, device insertion may be limited to gastrointestinal specialists; wound, ostomy, and continence nurses; advanced practice nurses; or physician assistants. Contraindications for insertion include patients with a recent history of anal or rectal surgery, a history of rectal bleeding, known allergies or sensitivities to components of the system (predominantly silicone), anal canal stricture or stenosis, fecal impaction, existing anal or rectal injury, and suspected or confirmed rectal mucosal impairment. Patients who are at risk for toxic megacolon, have a history of inflammatory bowel disorders, or have bleeding tendencies can use these systems if precautions are taken.
Patients who have either system in place should also be regularly assessed for signs and symptoms of bleeding, complaints of pain, or abdominal distention associated with the product’s use. If any adverse symptoms are identified, the system should be immediately removed. Also, additional fluid should not be added to the retention balloon or cuff of either device without first withdrawing and verifying the amount of fluid in the balloon or cuff. The retention balloon or cuff should never be inflated more than is recommended by the manufacturer.
Additional care of the patient includes noting the date of device insertion (the date should be written on the device with permanent marker when inserted) and monitoring for correct device placement. If the device is expelled, in many cases it can be cleaned, the retention balloon deflated, and the system reinserted (up to the 29-day time limit). Some leakage is to be expected around the device, particularly with the FMS. Therefore, the perianal skin should be protected with either a skin sealant (e.g., Smith-Nephew Skin Prep, 3M Cavilon NoSting) or a nonpetrolatum-based barrier ointment. Regular perianal cleaning should be provided. The BMS comes with straps with which to secure the device. The patient’s skin should be routinely assessed to verify the absence of pressure-related skin breakdown. The silicone catheter should also be routinely repositioned to decrease the potential for pressure-related skin damage.
Both systems are intended for temporary use only. For optimal outcomes, healthcare personnel should receive training on how to use these systems. Unless a management program with the BMS is desired, the device should be removed if the patient begins having formed stool. The device may not be used by mobile, nonbedridden patients. Patients with chronic fecal incontinence require additional assessment and alternative management methods.
About the Author
Mary Arnold Long, MSN RN CRRN CWOCN APRN-BC CLNC, is a clinical nurse specialist at the Drake Center in Cincinnati. Address correspondence to her at email@example.com.
ConvaTec. (n.d.). Flexi-Seal® Fecal Management System: “Clinical Study Results,” “Common Questions,” and “Directions for Use.” Retrieved July 10, 2006, from www.convatec.com
Zassi Medical Evolutions. (n.d.). Frequently Asked Questions. Retrieved July 10, 2006, from www.zassimedical.com/products/faq.asp.