Advancing Lives and the Delivery of Healthcare.™

Best in ClassC. difficileContainment*

The Evolution ofFecal Management

*Class defined as market leading stool/fecal management systems. Non-Clinical data, may not correlate to clinical outcomes.

FECAL MANAGEMENT OF THE PAST

INEFFECTIVE1

Flexi-Seal™ Signal™

FECAL MANAGEMENT TODAY

STANDARD OF CARE FOR PROTECTING THE SKIN1

FECAL MANAGEMENT SYSTEM

HOSPITAL ACQUIRED CONDITIONREDUCTION PROGRAM

75%*

85%*

CLABSI

CLABSI

(Central Line-Associated

BloodstreamInfection)

Clostridiumdifficile

MRSA

C. diff

(Methicillin-resistant

Staphylococcusaureus)

SSI+

SSI+

(SurgicalSite Infection)

CAUTI

CAUTI

(Catheter AssociatedUrinary Tract Infection)

FISCAL YEAR 20162

FISCAL YEAR 20172

For Applicable Acute Care Hospitals

*HAC ScoreDomain 2 Weighting

+ SSI measures include colon

and abdominal hysterectomy only

Closed System Design demonstrated to be effective in a bench study simulating clinical use5

Reduce the Risk of:

Airborne dispersal3

Environmental contamination3,4

FECAL MANAGEMENT INTO THE FUTURE

Average Contaminationa of the Absorbant PadsUnder the Collection Bags:

DigniShield® SMS Versus Flexi-Seal™ Signal™ FMS

Ave

rage

CFU

s on

Abs

orbe

nt P

ads

a. Statistically significant difference (P<.001) average contamination quantified as CFU/device on Study days 3, 10, 20 and 30

Non-Clinical Data, may not correlate to clinical outcomes

8 DigniShield® SMS devices and 8 Flexi-Seal™ FMS devices used. 168 observations yielded in total

DigniShield®

Stool Management System

Flexi-Seal™ Signal™ FMSFecal Management System

600,000

400,000

200,000

0

525K

200K

135K

60K0 0 0

3 10 20 30

CONTAINING C. difficile

REDUCE THE RISK OF MISCONNECTIONS

The ENFit™ Connector

Today’s stool management

device

Rectalmedication

delivery

f ENFit™ compatible irrigation port allows for the use of ENFit™ syringes

fDelivery of medication through the rectal route

f Instill fluid to check patency or to irrigate the rectum

fAll while reducing the risk of device misconnections

ODOR CONTROL

LOW PRESSURE CUFF DESIGN

Average retention cuff pressure for subjects in three different positions and at three different elevation angles.

In-Vivo Resting Cuff Pressure vs. Fill Volume

90

80

70

60

50

40

30

20

10

0BARD®

DIGNISHIELD®

SMS

Competitor 1

Pre

ssu

re (

mm

Hg

)

• Low pressure, anatomical cuff design• In simulated bench tests the Bard®

DigniShield® SMS offers an average of 69% less resting pressure than other commercially available fecal management devices

76% less permeable to odor causing compounds*

*Bench data on file, may not correlate to clinical use

25

20

15

10

5

0

Bard® DigniShield® SMS Tubing

Competitor 1Device A

Competitor 1Device B

Hydrogen Sulfide Detected Over 8 hrs.M

axim

um

Co

ncen

trati

on

(p

pm

)

*Bench data on file, may not correlate to clinical useBard®

DigniShield® SMS Tubing

Competitor 1

Bard, Advancing Lives and the Delivery of Healthcare, DigniShield and Permalene are trademarks and/or registered trademarks of C. R. Bard, Inc.ENFit is a registered trademark of GEDSA used with their permission. Flexi-Seal and Flexi-Seal Signal are trademarks of ConvaTec, Inc. ©2016 C. R. Bard, Inc. All Rights Reserved. 1604-19 R05/16 BMD/BOWL/1016/0018

C. R. Bard, Inc.Covington, GA 30014800.526.4455bardmedical.com

For more information about the DigniShield® Stool Management System and other Bard® products, please contact your sales representative or call 800.526.4455.

Product Code

Case Quantity

Product Code

Case Quantity

DigniShield® Stool Management System

SMS002

2

DigniShield® Stool Management System with the ENFit™ Connector

ENSMS002

2

DigniShield® SMS Collection Bags

SMS2B1L

10

DigniShield® SMS Collection Bags

SMS2B1L

10

Indications: The Bard® DigniShield® Stool Management System (SMS) with odor barrier properties is intended for fecal management by diverting and collecting liquid or semi-liquid stool in bedridden patients and to provide access for the administration of medications.

Contraindications: The device should not be used for more than 29 consecutive days, on patients with certain medical conditions including rectal or anal abnormalities, or on patients who have had lower large bowel or rectal surgery within the last year. Do not use on patients with indwelling rectal or anal device, delivery mechanisms, or enemas in place.

Warnings and Adverse Events: There is a potential risk of misconnections with connectors from other healthcare applications. As with the use of any rectal device, adverse events can occur including: leakage of stool, loss of anal sphincter muscle tone, pressure necrosis, infection, bowel obstruction, and perforation of the bowel. Changes to the patient including: rectal bleeding indicating possible pressure necrosis, abdominal distention, cuff migration, and rectal pain should be investigated.

Please consult package insert for more detailed safety information and instructions for use.

1. WOCN^(R) Society’s Continence Committee. A Quick Reference Guide for Managing Fecal Incontinence.

2. Federal Register. Vol. 80 No. 158. Pages 49570-49581.

3. Katherine Roberts et al. Aerial Dissemination of Clostridium difficile Spores. BMC Infectious Diseases. 2008

4. Greg S. Bobulsky et al. Clostridium difficile Skin Contamination in Patients with C.difficile-Associated Disease. Clinical Infectious Diseases. Vol 46 Issue 3.

5. Mikel Gray, Amin Omar, Brenton Buziak. Stool Management Systems for Preventing Environmental Spread of Clostridium Difficile A Comparative Trial. J Wound Ostomy Continence Nurs. 2014;41(5):460-465.