Return to Home Page

The Bowel Management System (BMS)

FAQ : The Product

Will the size of the BMS be traumatic during insertion and/or removal?

  • Inflated intralumenal balloon and tapered rectal tube leading edge provide smooth lead-in for insertion

  • Comparable in size to anoscopes and formed stool (~ 1 inch) elongated transsphincteric tube and inflated intralumenal balloon provides tapered leading edge for removal in an adult population

Is the BMS Retention Cuff the right size?

  • Retention Cuff was designed by Dr. J. Kim, a colorectal surgeon with a PhD in physiology

  • Inflated volume, size, and shape of retention cuff is below normal defecatory response trigger

Does the BMS Retention Cuff cause rectal mucosa erosion or necrosis?

  • Follow-up endoscopies on over 65 patients following BMS removal showed no mucosal injury (average indwell time of BMS Catheter: approx. 15 days)

  • Low pressure pre-distended and pre-shaped retention cuff expands symmetrically to occupy and comply with the normal non-distended rectum

Do I have to regularly deflate the BMS Retention Cuff to prevent rectal mucosa erosion or necrosis?

  • No, see question above

  • However, because of diffusion of water across the thin silicone retention cuff membrane, weekly verification is required

How long can the BMS be used?

  • The BMS Catheter has FDA Clearance for 29 day continuous use (at the end of 29 days, if the patient still requires fecal diversion a second BMS Catheter may be inserted immediately upon removal of the first BMS Catheter)

  • The BMS Collection Bag is recommended for 7-10 days of use

Which size catheter do I use?

  • Zassi BMS is available in 2 sizes, transsphincteric zone lengths 6 cm (standard) 4 cm (short)

  • Digital examination prior to insertion will assess anal canal length

Can the BMS Catheter pass formed stool?

  • Formed stool, either firm or soft, may block the BMS drain lumen

  • Loose is the ideal stool consistency for BMS use

  • A Stool Modification PlanTM, which includes the proactive use of stool modification agents (e.g. PEG, Lactulose, fiber) and regular irrigation are required to achieve and maintain loose stools during BMS use

How much pressure does the retention cuff exert on the rectal wall?

  • The retention cuff on the Zassi Bowel Management System™ catheter is a low pressure, compliant cuff specifically designed to reside in the sensitive anorectal anatomy. The cuff is manufactured in a pre-distended fashion such that upon inflation to normal use volumes of 35 to 40 ml, there is little pressure exerting on the wall of the cuff and the cuff readily complies with the changing anorectal environment.

    Specifically, Zassi performed animal testing, reviews of radiographic studies, and cadaver modeling to arrive at the current retention cuff design. Pre-commercialization human clinical testing confirmed the efficacy of our cuff design. Prior to commercial launch of the Zassi BMS™, data was collected on 72 patients that had the Zassi BMS Catheter in place for between 2 and 63 days. In the first 64 patients, endoscopic examination was performed every week to determine if the presence of the catheter caused any rectal erosions or necrosis. There was no evidence of rectal erosions or necrosis, or loss of sphincter function in any of these patients. In the remaining 8 patients, endoscopic examination was performed upon removal of the Catheter and again, there was no evidence of rectal erosion or necrosis, or loss of sphincter function in any of these patients. This data is available for review. The first 32 were published in Diseases of the Colon and Rectum; the next 32 were presented at International Colorectal Conferences. The results for the remaining 8 patients are on file.

    Reference:
    Kim J, Shim MC, Choi BY, Ahn SH, Jang SH, Shin HJ, Clinical Application of Continent Anal Plug in Bedridden Patients with Intractable Diarrhea, Dis Colon Rectum. 2001 Aug;44(8):1162-7.

FAQ : Usage

Will multiple irrigations daily disrupt the electrolyte balance of my patient?

  • The electrolyte balance of any patient should be well understood as part of the overall patient assessment and should be considered in the creation of a Stool Modification Plan

  • Medications, IV fluid, nutrition support and medical conditions also affect patient electrolyte balance

  • Research has established that in colostomy patients, daily irrigations are well tolerated

How can I prevent the odor emanating from the BMS?

  • Rinse the BMS Catheter (via the Flush/Sampling Port) per the Instructions For Use or more frequently as necessary to prevent feces from collecting in the catheter

  • Ensure that the end of the blue collection bag drain tube is free of feces and capped at all times

  • Change collection bag regularly

When I irrigate the patient, the infusion process goes very slowly or occasionally stops all together. What should I do to keep the irrigant flowing briskly?

When I irrigate the patient, there is occasional leakage. How do I prevent it?

When I irrigate the patient, only water returns, no feces. Is that a problem?

  • This may or may not be a problem depending on how long this persists

  • The goal of irrigation is to get irrigant into the colon, and to clear the rectum and as much of the distal colon as possible of feces

  • If the patient was stooling regularly prior to the insertion of the BMS, irrigation should produce stool return

  • If irrigation is not returning stool, please refer to the Zassi Bowel Management System Quick Reference Guide (Adobe Acrobat required. Download Acrobat here.) for guidelines on how to increase the effectiveness of irrigations

There is leakage between irrigations. How do I prevent it?

Will flatus escape through the BMS Catheter and inflate the BMS Collection Bag?

  • Flatus typically escapes around the BMS Retention Cuff and not into the Collection Bag

Can the BMS Catheter be used for decompression?

  • Decompression is not an indicated use of the BMS Catheter and the Company is not aware of any clinical experience where the product was used for this purpose.

To receive information not available directly from the web site, please refer to the “Contact Us” portion of the site.