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To schedule an in-service, contact your local ConvaTec representative or call 1-800-422-8811
Patient Assessment
- Fecal incontinence management with Flexi-Seal™ FMS is appropriate for patients with liquid and semi-liquid stool (flowing). When stool begins to become solid, the device should be discontinued.
- Prior to use of Flexi-Seal™ FMS, a digital rectal exam should be performed to rule-out the possibility of a fecal impaction. If a fecal impaction is present, consult with patient’s physician to determine if impaction removal is appropriate. The device can be inserted once the fecal impaction is removed.
- A digital rectal exam should also confirm presence of rectal shoulder and rectal sphincter tone. If the sphincter muscle anatomy or tone is compromised in any way, device retention will be compromised, and the device may be easily expelled.
Insertion
- Remove any indwelling or anal device prior to the insertion of Flexi-Seal™ FMS.
- Remove any air from the retention balloon prior to insertion. Insert a lubricated gloved finger into the finger pocket located above the black indicator line. Lubricate and insert the deflated balloon into the rectum.
- You may keep your finger in the pocket of the retention balloon during inflation to ensure that it stays in place inside the rectum.
- Fill the retention balloon with 45 ml of water or saline. Under no circumstances should the balloon be inflated with more than 45 ml.
Positioning Catheter
- Gently tug on the catheter after inflating the retention balloon, each time the patient is repositioned or if the black position indicator line moves upward to assure proper position within the rectal vault.
Dealing with Leakage
- Check to see if black indicator line has moved (except for bariatric patients). If so, gently tug on the tubing until the black line is repositioned. Verify that the retention balloon is in place by gently tugging on the catheter.
- Refer to your protocol in assessing rectal tone and in determining if the patient fits the selection criteria for this device.
- Initiate appropriate skin protection as per your facility’s skin care protocol.
- Should the leakage continue:
- Irrigate tubing to eliminate any stool blockage at the balloon site.
- Remove all fluid from the balloon. Ensure that the syringe is filled with 45 ml of water or saline. Refill balloon with correct amount of fluid.
- If leakage persists, deflate the retention balloon and remove the device. Wipe the unit with a disposable cloth and re-insert the balloon following insertion instructions.
Note: A small amount of leakage is normal.
Maintenance
- Position the length of the silicone catheter along patient's leg, avoiding kinks and obstruction.
- Periodic deflation/re-inflation of the balloon is not necessary.
- Irrigation is not mandatory. However, if stool happens to get trapped in the catheter, you may irrigate as needed. Ensure the syringe is not inadvertently attached to the balloon inflation port (marked 45 ml). Be sure to subtract the amount of irrigant used from the output of feces.
- If necessary, you may allow excess gas to escape by detaching the bag from the catheter and gently pressing on it.
- The collection bags are disposable, and should be replaced when there is approximately 800 ml of output.
Minimizing Odor
Odor may emit through the silicone tube as it is air permeable. If odor is present, follow the instructions below to minimize it:
- Irrigating the catheter using the BLUE IRRIG port can help to reduce odor by moving stool into the collection bag.
- Change the collection bag every other day at minimum, or when at 800 ml of output.
Device Removal
- If the patient’s stool is no longer liquid or semi-liquid, the unit should be removed.
- Remove the device if the patient no longer fits the selection criteria.
- Flexi-Seal™ FMS is not indicated for use for more than 29 consecutive days.
- To remove the device:
- Deflate the retention balloon. Disconnect the syringe and discard.
- Hold the catheter as close to the patient as possible and slowly slide it out of the anus.
- Dispose of the device in accordance with institutional protocol for disposal of medical waste.