new isolation gowns that provide aami level 1, 2 and 3...

Featuring KC100, KC200, KC300

Choose The Right Level of Protection for Your Situation

NEW Isolation Gowns That Provide AAMI Level 1, 2 and 3 Protection

*

Kimberly-ClarK* Isolation Gowns

Healthcare-Associated Infections (HAIs): A Critical Issue for You and Your PatientsAccording to World Health Organization statistics, at any given time, 1.4 million people worldwide suffer from infections acquired in hospitals2. And with the proliferation of MRSA (methicillin-resistant Staphylococcus aureus) and other multiple drug-resistant organisms (MDROs), that number is increasing. The Agency for Healthcare Research and Quality (AHRQ) reports that patients diagnosed with MRSA infections rose from 1,900 in 1993 to 368,800 in 2005.8

Because organisms such as MRSA can survive as long as several months on virtually any surface with patient or healthcare worker contact – such as stethoscopes, pagers, pens, blood pressure cuffs, otoscopes, bed rails, bed tables, doorknobs, patient charts – proper use of personal protective equipment (PPE) is crucial in preventing the contact transfer of infection to patients, visitors and fellow healthcare workers.

Special lighting and a luminescent substance representing bacteria show how easy it is to set the problem of contact transfer in motion. A healthcare worker merely has to touch a contaminated surface and then touch a patient.

HAIs at a Glance:

$6.7 billion annual impact on healthcare facilities1

1.4 million HAIs globally atany given time2

Over 368,000 MRSA infections in U.S. hospitals annually3

98,987 U.S. deaths in U.S. hospitals annually3 from HAIs in 20024

The additional cost to treat a single MRSA infection can be as high as $35,0005

Insurance reimbursement for HAIs is no longer a “sure thing”6

Proper use of PPE is a crucial step in helping control HAIs7

Electronmicrograph of MRSA bacteria

Kimberly-ClarK* KC100, KC200 and KC300 Isolation Gowns Conform to AAMI Levels 1, 2 and 3

The Right Protection for the Right Procedure at the Right PriceIn today’s healthcare environment, it’s more important than ever for clinicians to be equipped with the proper protective apparel to help reduce the spread of healthcare-associated infections (HAIs).

AAMI guidelines are a widely accepted system of classification for protective apparel based on liquid barrier performance. That’s why Kimberly-ClarK* Isolation Gowns now conform to AAMI Levels 1, 2 & 3.

Our new Isolation Gown portfolio provides barrier protection based on AAMI guidelines and helps reduce the risk of contamination and transmission of infectious organisms that lead to HAIs. These three levels of protection allow you to select the right gown for the procedure at the right price. Kimberly-ClarK* Isolation Gowns made from 3-layer SMS fabric give clinicians the confidence and comfort they need to deliver the best possible patient care.

If you think the right level of

protection isn’t important,

ask a clinician with a MRSA

patient in 104, a VRE patient in

218 and an HIV patient in 312.

KC100 Isolation GownLevel 1



AAMI Level / Performance Requirements at 4% AQL

Spray Impact Penetration < 4.5g

Spray Impact Penetration < 1.0gHydrostatic Pressure > 20cm


Anticipated Risk of Exposure to Fluid

Low Between Low and Moderate Moderate

Gown Characteristics(Weight)

Light-weight SMS fabric

Medium-weight SMS fabric

Heavy-weight SMS fabric

Recommended Areas of Use†

Med/Surg Unit Laundry Housekeeping

ICU, Dialysis, Med/Surg Unit NurseryLab PathologyLaboratoriesHyperbaric

ERTraumaBurn Units Critical Care Units

Recommended Tasks†

Transporting PatientsBasic Patient Care

Blood DrawSuturingInserting I.V. Lines

Drawing Arterial BloodInserting I.V. Lines

† Recommended areas and tasks are based on feedback from a research panel of 300 Registered Nurses, Infection Control Practitioners, and Materials Managers. Ultimately, the healthcare personnel using these gowns must make the final decision on which level of protection is appropriate, given the anticipated risk of fluid exposure.

Kimberly-ClarK* KC100, KC200 and KC300 Isolation Gowns Conform to AAMI Levels 1, 2 and 3

Fluid Protection is Only Part of the Story...

Protection That Works for Workers and PatientsPPE is a two-way street. Originally developed to protect the healthcare worker, PPE when used properly can also represent the first line of defense against contact transfer of pathogens like MRSA and c. difficile. Our full line of AAMI-compliant isola-tion gowns provide an unmatched combination of protection from liquid strikethrough and also from penetration by live bacteria and spores. That’s protection both healthcare workers and patients need.

AAMI Guidelines: A Reliable Benchmark for ProtectionTo meet AAMI Guidelines, protective apparel must achieve minimum performance standards for strength, barrier perfor-mance and fluid resistance. Tested under controlled conditions, AAMI-rated gowns must demonstrate a 4% AQL level, which provides a high level of assurance that users are protected for the anticipated level of fluid contact. Each garment must be fully protective in the front, back and along the seams, and be clearly labeled to indicate the level of protection provided, from AAMI Level 1 (lowest) to AAMI Level 4 (highest). KC100, KC200 and KC300 Isolation Gowns meet all AAMI specifications for Level 1, 2 and 3 protection.

Bacterial and Spore Filtration TestingIn the fight against HAIs, reducing the risk of transfer of infectious organisms by contact is an important strategy. The ability of a gown to protect against the transfer of pathogens from the environment to the wearer’s work clothes or scrubs is a big advantage in reducing the spread of infectious agents. Gowns should be able to resist penetration by live organisms like MRSA or bacterial spores such as c. difficile.

Our line of KC100, KC200 and KC300 Isolation Gowns have been independently tested to measure their Bacterial Filtration Efficiency (BFE) and are shown to provide bacterial and spore holdout that equals or exceeds that of other gowns in the market today.

Kimberly-ClarK* Isolation Gowns: Protection You Can Truly Count On!

AAMI Level 1

AAMI Level 1

AAMI Level 1

AAMI Level 1

AAMI Level 1

AAMI Level 1

AAMI Level 1

AAMI Level 2

AAMI Level 2

AAMI Level 2

AAMI Level 2

AAMI Level 2

AAMI Level 2

AAMI Level 2

AAMI Level 3

AAMI Level 3

AAMI Level 3

AAMI Level 3

AAMI Level 3

AAMI Level 3

AAMI Level 3

AAMI Level 4

AAMI Level 4

AAMI Level 4

AAMI Level 4

AAMI Level 4

AAMI Level 4

AAMI Level 4

The entire gown is a Critical Zone including seams, but excluding cuffs, hems and bindings. AAMI also requires a closed back for isolation precautions.

Custom neck tapes on our Isolation Gowns make it easy to identify their AAMI Level of Protection.

KC100KC100 Isolation Gown

■ For use when expected risk of exposure to fluid is low

■ Meets AAMI Level 1 requirements

■ Light-weight SMS Fabric

■ Recommended for:†

• Transporting patients, basic patient care

• Med/Surg Unit, Laundry, Housekeeping

BFE: Holds out 79% of Staphylococcus aureus; 99.5% of dry spores.


■ For use when expected risk of exposure to fluid is moderate


■ Heavy-weight SMS fabric


• Drawing arterial blood, inserting I.V. lines

• ER, Trauma, Burn Units, Critical Care Units

Maximum Protection



■ For use when expected risk of exposure to fluid is between low and moderate


■ Medium-weight SMS fabric


• Suturing, blood draw, inserting I.V. lines, specimen handling, drawing arterial blood

• ICU, Med/Surg Unit, Hyperbaric and Dialysis Units, Labs and Pathology, Nursery

Facility-Wide Use


Basic Protection


Medline AAMI Level 1 NONLV100

# SamplesTested

4% AQL c value† SI test above 4.5 gm Meets

AAMI

Lot 1 336 19 156 fail

Lot 2 336 19 195 fail

Lot 3 336 19 298 fail

Kimberly-ClarK* KC100 Isolation Gown

# SamplesTested

4% AQL c value† SI test above 4.5 gm Meets

AAMI

Lot 1 35 3 0 pass

Lot 2 35 3 0 pass

Lot 3 140 9 0 pass

AAMI Level 1 Performance

(A small sample size was warranted due to SI values averaging 0.6 gm)



# SamplesTested

4% AQL c value†

HH Tests below

20m bar

SI Tests above 1 gm

Meets AAMI

Lot 1 295 17 0 1 pass

Lot 2 295 17 0 0 pass

Lot 3 295 17 0 0 pass

Medline AAMI Level 2 NONLV200

# SamplesTested

4% AQL c value†

HH Tests below

20m bar

SI Tests above 1 gm

Meets AAMI

Lot 1 336 19 0 0 pass

Lot 2 336 19 0 0 pass

Medline AAMI Level 2 NONLV220/225

# SamplesTested

4% AQL c value†

HH Tests below

20m bar

SI Tests above 1 gm

Meets AAMI

Lot 1 336 19 0 0 pass

Lot 2 336 19 0 2 pass

Lot 3 336 19 0 1 pass

† The C value represents the maximum number of test results that do not meet the specified level and still satisfies the AQL requirement. PB70 provides an example of a sampling plan where n=32; c=3. While this plan provides an AQL value of 4% it has an RQL value of approximately 20%. The sampling plan used by Kimberly-Clark reduced this RQL value to less than 8%. The lower the RQL, the lower the probability that unacceptable test results are missed due to a small sample size.

AAMI Testing of Kimberly-ClarK* Isolation Gowns KC100, KC200 and KC300

KC100

KC200


# SamplesTested

4% AQL c value†

HH Tests below

50m bar

SI Tests above 1 gm

Meets AAMI

Lot 1 336 19 8 0 pass

Lot 2 336 19 6 0 pass

Lot 3 336 19 3 0 pass


Medline AAMI Level 3 Isolation Gowns NONLV325

# SamplesTested

4% AQL c value†

HH Tests below

50m bar

SI Tests above 1 gm

Meets AAMI

Lot 1 336 19 75 0 fail

Lot 2 336 19 73 0 fail

Lot 3 336 19 62 0 fail

Cardinal Isolation Gowns AAMI 3 AT6100/6200

# SamplesTested

4% AQL c value†

HH Tests below

50m bar

SI Tests above 1 gm

Meets AAMI

Lot 1 336 19 57 0 fail

Lot 2 336 19 24 0 fail

Lot 3 336 19 23 0 fail

Four areas are tested in each lot: body fabric, shoulder seam, sleeve seam, armhole seam.

AAMI Level Liquid Barrier Performance

■ Kimberly-Clark passes Levels 1, 2 & 3.

■ Medline Levels 1 & 3 fail. Medline Level 2 passes.

■ Cardinal Level 3 fails.

KC300

Many organizations have published general guidelines for the use of personal protective equipment, including gowns, within healthcare settings.

OSHA1

The Occupational Safety and Health Administration (OSHA) provides the healthcare industry with standards that encourage continual improvement in workplace safety and health. As it relates to apparel, OSHA’s Bloodborne Pathogen Standard is critical in defining and understanding what “protective” means:

“If a product is to be truly protective, no blood or other potentially infectious material may pass through or reach the employee’s work clothes, street clothes, undergarments, skin, eyes, mouth or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used.” OSHA further defines personal protective as “specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes (e.g. uniforms, pants, shirts, or blouses) not intended to function as protection against a hazard are not considered to be personal protective equipment.”

CDCCenters for Disease Control (CDC) Standard Precautions:2

■ Wear a gown that is appropriate to the task, to protect skin and prevent soiling or contamination of clothing during procedures and patient-care activities when contact with blood, body fluids, secretions, or excretions is anticipated.

■ Wear a gown for direct patient contact if the patient has uncontained secretions or excretions.

■ Remove gown and perform hand hygiene before leaving the patient’s environment.

■ Do not reuse gowns, even for repeated contacts with the same patient.

■ Routine donning of gowns upon entrance into a high risk unit (e.g., ICU, NICU, HSCT unit) is not indicated.

CDC Isolation Precautions:3

■ Don gown upon entry into the room or cubicle. Remove gown and observe hand hygiene before leaving the patient-care environment.

■ After gown removal, ensure that clothing and skin do not contact potentially contaminated environmental surfaces that could result in possible transfer of microorganism to other patients or environmental surfaces.

Personal Protective Equipment Performance Standards & Guidelines

Healthcare Guidelines and Personal Protective Apparel

APIC4

The Association for Professionals in Infection Control and Epidemiology (APIC) Standard Precautions:Wear a gown to protect skin and to prevent soiling of clothing during procedures and patient-care activities that are likely to generate splashes or sprays of blood, body fluids, secretions, or excretions. Select a gown that is appropriate for the activity and amount of fluid likely to be encountered. Remove a soiled gown as promptly as possible, and wash hands to avoid transfer of microorganisms to other patients or environments.

APIC Contact Precautions:In addition to wearing a gown as outlined under Standard Precautions, wear a gown when entering the room if you anticipate that your clothing will have substantial contact with the patient, environmental surfaces, or items in the patient’s room, or if the patient is incontinent or has diarrhea, an ileostomy, a colostomy, or wound drainage not contained by a dressing. Remove the gown before leaving the patient’s environment. After gown removal, ensure that clothing does not contact potentially contaminated environmental surfaces to avoid transfer of microorganisms to other patients or environments.

AAMI5

Level 1 Level 2 Level 3

AAMI Level / Performance Requirements at 4% AQL

Spray Impact Penetration < 4.5g



Anticipated Risk of Exposure to Fluid

Low Between Low and Moderate Moderate

Gown Characteristics(Weight)

Light-weight SMS fabric

Medium-weight SMS fabric

Heavy-weight SMS fabric

Recommended Areas of Use†

Med/Surg UnitLaundry Housekeeping

ICUMed/Surg UnitDialysis NurseryLab PathologyLaboratoriesHyperbaric

ERTraumaBurn Units Critical Care Units

Recommended Tasks†

Transporting PatientsBasic Patient Care

Blood DrawSuturingInserting I.V. Lines

Drawing Arterial BloodInserting I.V. Lines


Only the Association for the Advancement of MedicalInstrumentation (AAMI) offers a widely accepted system of classification for protective apparel based on liquid barrier performance.

Bacterial Filtration Efficiency (BFE) measures the filtration effectiveness of materials when challenged with a biological aerosol of Staphylococcus aureus or other organisms. Items such as face masks, surgical and isolation gowns, and other barrier materials can be tested. Known quantities of the challenge agent are applied, under positive air pressure, to the surface. Organisms migrating through the fabric are measured as a percentage of the original sample.

Kimberly-ClarK* AAMI-rated Isolation Gowns and BFEAn independent laboratory conducted BFE testing on a variety of isolation gowns, including KC100, KC200 and KC300. In addition to Staphylococcus aureus, the fabrics were challenged with the dry spore form of Bacillus atrophaeus, which is smaller than a typical Clostridium difficile spore.

This table shows the results of that testing and can be used to evaluate the effectiveness of isolation gowns in preventing penetration and possible pass-along of pathogens. Different gowns offer different levels of fluid and bacterial passage protection. Gowns should be chosen based on the tasks performed and the type of risk likely to be encountered.

BFE1 79% 69% 59%

Dry Spore2 99.5% 98.2% 56.1%

KC100 Cardinal 2100PG Medline NONLV100 aami Level 1

KC200 Medline NONLV225 aami Level 2 aami Level 2

BFE1 92% 95% 94%

Dry Spore2 99.8% 99.8% 99.9%

KC300 Cardinal AT6100 Medline NONLV325 aami Level 3

Bacterial Filtration Efficiency (BFE) Testing

BFE1 85% 63%

Dry Spore2 99.4% 92.2%

1 Tested method complies with ASTM F2101 (data on file)

2 All values are presented as a median percentage of filtration efficiency.

(Chest Width/Gown Length/Sleeve Length)

Kimberly-ClarK* Protective 3-Layer SMS Fabric:Outer layers—Cloth-like, yet tough and abrasion-resistant

Middle layer—Intricate web of microfibers that filters out many water-based liquids

The entire gown is a Critical Zone including seams, but excluding cuffs, hems and bindings. AAMI also requires a closed back for isolation precautions

AAMI Level 1

AAMI Level 1

AAMI Level 1

AAMI Level 1

AAMI Level 1

AAMI Level 1

AAMI Level 1

AAMI Level 2

AAMI Level 2

AAMI Level 2

AAMI Level 2

AAMI Level 2

AAMI Level 2

AAMI Level 2

AAMI Level 3

AAMI Level 3

AAMI Level 3

AAMI Level 3

AAMI Level 3

AAMI Level 3

AAMI Level 3

AAMI Level 4

AAMI Level 4

AAMI Level 4

AAMI Level 4

AAMI Level 4

AAMI Level 4

AAMI Level 4

Custom neck tapes on our Isolation Gowns make it easy to identify their AAMI Level of Protection.

Here are the new codes for the Kimberly-ClarK* Isolation Gown Portfolio:Code Description Dimensions (") Quantity

KC300 Isolation Gown 54300 KC300 Isolation Gown, Yellow, Large 26/46/22.25 100 eaches/case54301 KC300 Isolation Gown, Yellow X-Large 30/50/24.5 100 eaches/case 54310 KC300 Isolation Gown, Blue, Large 26/46/22.25 100 eaches/case 54311 KC300 Isolation Gown, Blue, X-Large 30/50/24.5 100 eaches/case

KC200 Isolation Gown69979 KC200 Isolation Gown, Yellow, Large 26/46/21 100 eaches/case69988 KC200 Isolation Gown, Yellow, X-Large 30/50/24.5 100 eaches/case69981 KC200 Isolation Gown, Blue, Large 26/46/21 100 eaches/case69987 KC200 Isolation Gown, Blue, X-Large 30/50/24.5 100 eaches/case

KC100 Isolation Gown54100 KC100 Isolation Gown, Yellow, Large 26/46/22.25 100 eaches/case 54101 KC100 Isolation Gown, Yellow, X-Large 30/50/24.5 100 eaches/case 54110 KC100 Isolation Gown, Blue, Large 26/46/22.25 100 eaches/case 54111 KC100 Isolation Gown, Blue, X-Large 30/50/24.5 100 eaches/case

The following codes have been discontinued:Code Description Quantity

69978-77 Control* Cover Gown, Yellow, X-Large 40 eaches/case69980-37 Control* Cover Gown, Blue, X-Large 40 eaches/case69983-70 Control* Cover Gown, White, Universal Size 100 eaches/case

Important: All other Isolation and Film Gown codes will remain the same.

Kimberly-Clark’s Full Range of PPE SolutionsGowns are only one important tool for helping prevent the spread of HAIs. Kimberly-Clark offers a full range of PPE, including latex-free PurPle nitrile* and Sterling* Nitrile Exam Gloves; face masks, N95 respirators, and eyewear; and a unique PPE Dispensing System that helps prevent contamination and promotes compliance in the selection and donning process.

Our new zoned packaging makes it easy to select the right gown for the right level of protection.

Personal Protective Equipment Performance Standards & Guidelines

Kimberly-ClarK* Isolation Gowns

NEW Website! Choose the right level of protection for your situation at: www.kcprotectionselection.com

Use the Kimberly-ClarK* Protection Selection Model to help choose the right level of protection from Kimberly-Clark’s full range of PPE solutions. With the help of our virtual healthcare professional, the tool will assist you in selecting the most effective PPE for most healthcare procedures or tasks. Just answer a few brief questions and the model will display the appropriate PPE. It’s simple!

More Information and Resources from Kimberly-Clark

Visit Kimberly-ClarK* Isolation Gowns online at: www.kchealthcare.com/aamigowns

Get up-to-date information with the latest industry news, articles, and clinical education.

*

Access the latest information about Healthcare-Associated Infections at

www.HAIwatch.com

The HAI issue is one of critical importance to

every healthcare facility and every healthcare

consumer. This site is dedicated to providing

information about healthcare-associated infec-

tions – what they are, why and how they occur

and what can be done to help prevent them.

HAI Watch is your trusted resource for news,

information, education, and additional industry

resources to help keep your organization aware

of the importance of healthcare-associated

infection prevention.

For more information, please call 1-800-KCHELPS in the United States or visit our website at www.kchealthcare.com.

*�Registered�Trademark�or�Trademark�of�Kimberly-Clark�Worldwide,�Inc.�The�COLOR�ORANGE�and�COLOR�PURPLE�are�Registered�Trademarks�of�KCWW.�COLOR�GREY�Trademark�of�KCWW.�©2009�KCWW.�H01549

H0866-09-01

Healthcare-Associated Infection Solutions

Surgical Solutions

Digestive Health

Pain Management

At Kimberly-Clark, our mission is to deliver innovative healthcare solutions supported by in-service training, clinical research and accredited education that you can depend on to meet the demands of your fast-paced world. Whether your needs involve preventing healthcare-associated infections or finding surgical, digestive health, or pain management solutions, with Kimberly-Clark you’ll always have one less worry.

The Kimberly-ClarK advantage*

Knowledge networK* Accredited EducationOnline at HAIwatch.com

On-site rep-facilitated programsHAI Education Bus

Ongoing Customer Support

In-service training Product technical support

Unsurpassed customer service

Expert Sales ForceHealthcare Industry Representative Credentialed

On-site trained in hospitals

Tools & Best PracticesInfection Prevention Education Toolkits

Utilization ReviewsProduct Use and Selection Tools

Best Practices/ Industry GuidelinesPandemic Planning Demand Calculator

Exam Glove Space and Waste CalculatorLatex-Free Exam Glove Community Outreach Program

Clinical ResearchStaff medical professionals to advise and direct clinical research

Peer-to-peer consultation

Commitment to Excellence Guarantee

www.HAIwatch.com

Infection prevention website:

1.�http://www.cdc.gov/ncidod/eid/vol10no4/02-0754.htm2.�http://www.who.int/features/factfiles/patient_safety/en/index.html3.�http://www.hcup-us.ahrq.gov/reports/statbriefs/sb35.pdf4.�Public�Health�Reports�/�March-April�2007�/�Volume�122,�p.1605.�http://www.cdc.gov/eid/content/13/12/1840.htm6.�http://well.blogs.nytimes.com/2007/12/19/making-hospitals-pay-for-their-mistakes/index.html7.�http://www.cdc.gov/ncidod/dhqp/pdf/ppe/PPEslides6-29-04.pdf8.��Elixhauser,�A.�(AHRQ)�and�Steiner,�C.�(AHRQ).�Infections�with�Methicillin-Resistant�Staphylococcus�

Aureus�(MRSA)�in�U.S.�Hospitals,�1993-2005.�HCUP�Statistical�Brief�#35,�July�2007.�Agency�for�Healthcare�Research�and�Quality,�Rockville,�MD.�http://www.hcup-us.ahrq.gov/reports/statbriefs/sb35.pdf

9.�http://www.cdc.gov/ncidod/dhqp/pdf/ppe/PPEslides6-29-04.pdf10.�ANSI/AAMI�PB70:2003,�P.6

1.��http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=DIRECTIVES&p_id=2570#XIII

2.�http://www.cdc.gov/ncidod/dhqp/gl_isolation_standard.html3.�http://www.cdc.gov/ncidod/dhqp/gl_isolation_contact.html4.��Siegel�JD,�Rhinehart�E,�Jackson�M,�Chiarello�L,�and�the�

Healthcare�Infection�Control�Practices�Advisory�Committee,�2007�Guideline�for�Isolation�Precautions:�Preventing�Transmission�of�Infectious�Agents�in�Healthcare�Settings,�June�2007�P.49-53

5.��http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/pb700310preview.pdf

Healthcare Guidelines Page References

new isolation gowns that provide aami level 1, 2 and 3...

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