11/14/2008
Introducing New Flexi-Seal™ FMS Advanced Odor Control

Introducing New Flexi-Seal™ FMS Advanced Odor Control

Flexi-Seal™ FMS Advanced Odor Control creates
a more pleasant environment for patients & clinicians


Designed to safely:

  • Manage Odora
  • Reduce the risk of skin breakdown
  • Reduce the risk of spread of infection
  • Improve patient care

Fecal odor can be an issue for patients and caregivers

  • Fecal odor is due to volatile organic compounds (VOCs).1
  • Fecal VOCs include indole and sulfur compounds (e.g., Dimethyl trisulfide).1
  • Odor level can vary considerably from patient to patient based on:
  • Medical conditions (e.g., infections such as
    C. difficile).2
  • Diet.1
  • Increased concentration of fecal VOCs.1

  • These conditions contribute to increased fecal odor, which can permeate through silicone and parylene-coated, silicone catheters.3


New Flexi-Seal™ FMS Advanced Odor Control manages odor in two ways:

  • New nylon inner odor barrier that HOLDS the odor molecules within the silicone catheter.3

  • New collection bag has a charcoal filter to deodorize gas as it is released.


The fecal catheter with proven odor management

Revolutionary catheter technology

  • Flexi-Seal™ FMS Advanced Odor Control successfully eliminates catheter odor permeation to levels below those that are humanly detectable.3
  • In-vitro results demonstrated undetectable levels of indole and sulfur compounds (e.g., Dimethyl trisulfide).3

State of-the-art pouch

  • Specialized charcoal filter keeps air flowing, providing:
  • Exceptional deodorization
  • Reduction of ballooning

  • The ConvaTec pouch prevents odor transmission.4
  • Collection bags made of PVC are inferior at blocking gas transmission.4


Demonstrated clinical safety

  • The soft low pressure balloon is designed to reduce the risk of tissue necrosis and conform to sphincter anatomy.
  • In a clinical study, rectal mucosa was healthy after Flexi-Seal™ FMS use for patients who had baseline and follow-up endoscopy.5
  • 92% patients had their skin condition maintained or improved.5
  • 83% of caregivers reported that Flexi-Seal™ FMS improved fecal incontinence control, was efficacious, and time efficient.5

Outstanding ease of use

  • Unique cuff-finger pocket for easy insertion.
  • The soft, flexible silicone catheter can collapse to an 8mm diameter to ease insertion and removal.


Flexi-Seal™ Fecal Management System:

  • Number one brand in unit sales in the US.6
  • Used at over 1,800 ICU hospitals.7
  • Flexi-Seal™ FMS is entirely latex- and PVC-free.

Use the family of ConvaTec Solutions™ products to maintain skin integrity

  • Flexi-Seal™ FMS is a simple, effective fecal diversion and containment system designed to reduce the risk of skin breakdown and infection.
  • In a clinical study, 92% of patients had their skin condition improved or maintained.5
  • Reducing the risk of friction injuries is recommended by the Agency for Healthcare Research & Quality (AHRQ).8
  • A process improvement project that used Sensi-Care® and Aloe Vesta® products in a protocol of care showed a 43% reduction of pressure ulcer incidence.9b
  • A comprehensive protocol of care that included Aloe Vesta® products showed an 87% reduction of pressure ulcer incidence.10c
  • Over 110,000 nurses educated to help maintain skin integrity.11





References [+]

  1. Moore JG, Jessop LD, Osborne DN.Gas-Chromatographic and Mass-Spectrometric Analysis of the Odor of Human Feces.Gastroenterology. 1987; 93:1321-1329.
  2. Recurrent Clostridium difficile (antibiotic diarrhea). GI Health.com. http://www.gihealth.com/html/education/cdifficileRecurrent.html. Accessed July 23, 2008.
  3. Odor Reduction in Fecal Management Devices. White Paper. Data on file, ConvaTec.
  4. Odor Barrier of Fecal Management System Collection Bags. White Paper. Data on file, ConvaTec.
  5. Padmanabhan A, Stern M, Wishin J, Mangino M, Richey K, DeSane M, Flexi-Seal Clinical Trial Investigators Group. Clinical evaluation of a flexible fecal incontinence management system. Am J Crit Care. 2007; 16(4):384-93.
  6. HPIS. Q2 2009. Moving Annual Total (MAT) Fecal Control Category. Data on file, ConvaTec.
  7. Cognos. Redistributed YTD Sales through May 2008. Data on file, ConvaTec.
  8. Clinical Practice Guideline Number 3: Pressure Ulcers in Adults: Prediction and Prevention. Rockville, Md: US Dept of Health and Human Services, Agency for Health Care Policy and Research; 1992. AHCPR publication 92-0047.
  9. Stoelting J, McKenna L, Taggart E, et al. Prevention of nosocomial pressure ulcers: A process improvement project. J Wound Ostomy Continence Nurse. 2007; 34(4): 382-388.
  10. Lyder CH,Shannon R, Empleo-Frazier O, McGeHee D, White C. A comprehensive program to prevent pressure ulcers in long-term care: exploring costs and outcomes. Ostomy Wound Mgmt. 2002;48(4):52-59.
  11. Inventiv. Monthly In-Service Report through June 2008. Data on file, ConvaTec.

Notes [+]

  1. Eliminates perceptible naphthalenic (indole) and sulfide odors radiating from catheter tube.
  2. Study conducted at an acute care hospital where incidence was reduced from 7% to 4% following implementation of a process improvement project.
  3. Study conducted at two long-term care facilities where incidence has reduced from 13.2% to 1.7% and from 15.0% to 3.5% respectively, following implementation of a comprehensive protocol of care utilizing Solutions® Algorithms for Pressure Ulcer Prevention.



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