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

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1 Kimberly-Clark * Isolation Gowns Featuring KC100, KC200, KC300 * NEW Isolation Gowns That Provide Level 1, 2 and 3 Protection Choose The Right Level of Protection for Your Situation

2 Kimberly-Clark * KC100, KC200 and KC300 Isolation Gowns Conform to Levels 1, 2 and 3 Healthcare-Associated Infections (HAIs): A Critical Issue for You and Your Patients According to World Health Organization statistics, at any given time, 1.4 million people worldwide suffer from infections acquired in hospitals 2. 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 Electronmicrograph of MRSA bacteria 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. HAIs at a Glance: $6.7 billion annual impact on healthcare facilities million HAIs globally at any given time 2 Over 368,000 MRSA infections in U.S. hospitals annually 3 98,987 U.S. deaths in U.S. hospitals annually 3 from HAIs in The additional cost to treat a single MRSA infection can be as high as $35,000 5 Insurance reimbursement for HAIs is no longer a sure thing 6 Proper use of PPE is a crucial step in helping control HAIs 7 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.

3 The Right Protection for the Right Procedure at the Right Price In 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). Organisms such as MRSA can survive as long as several months on virtually any surface with patient or healthcare worker contact. Proper use of personal protective equipment (PPE) is crucial in preventing the contact transfer of infection to patients, visitors and fellow healthcare workers. guidelines are a widely accepted system of classification for protective apparel based on liquid barrier performance. That s why Ki m b er ly-clark * Isolation Gowns now conform to Levels 1, 2 & 3. Our new Isolation Gown portfolio provides barrier protection based on 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-Cl ark * Isolation Gowns made from 3-layer SMS fabric give clinicians the confidence and comfort they need to deliver the best possible patient care. KC100 Isolation Gown Level 1 KC200 Isolation Gown Level 2 KC300 Isolation Gown Level 3 Level / Performance Requirements at Anticipated Risk of Exposure to Fluid Spray Impact Penetration < 4.5g Low Spray Impact Penetration < 1.0g Hydrostatic Pressure > 20cm Between Low and Moderate Spray Impact Penetration < 1.0g Hydrostatic Pressure > 50cm Moderate 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. 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 Nursery Lab Pathology Laboratories Hyperbaric ER Trauma Burn Units Critical Care Units Recommended Tasks Transporting Patients Basic Patient Care Blood Draw Suturing Inserting I.V. Lines Drawing Arterial Blood Inserting 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.

4 Fluid Protection is Only Part of the Story... Protection That Works for Workers and Patients PPE 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 -compliant isolation 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. The entire gown is a Critical Zone including seams, but excluding cuffs, hems and bindings. also requires a closed back for isolation precautions. Custom neck tapes on our Isolation Gowns make it easy to identify their Level of Protection. Guidelines: A Reliable Benchmark for Protection To meet Guidelines, protective apparel must achieve minimum performance standards for strength, barrier performance and fluid resistance. under controlled conditions, -rated gowns must demonstrate a 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 Level 1 (lowest) to Level 4 (highest). KC100, KC200 and KC300 Isolation Gowns meet all specifications for Level 1, 2 and 3 protection. Bacterial and Spore Filtration Testing In 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!

5 Basic Protection KC100 Isolation Gown For use when expected risk of exposure to fluid is low 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. Facility-Wide Use KC200 Isolation Gown For use when expected risk of exposure to fluid is between low and moderate Level 2 requirements Medium-weight SMS fabric Recommended for: Suturing, blood draw, inserting I.V. lines, specimen handling, drawing arterial blood ICU, Med/Surg Unit, Hyperbaric and Dialysis Units, Labs and Pathology, Nursery BFE: Holds out 85% of Staphylococcus aureus; 99.4% of dry spores. Maximum Protection KC300 Isolation Gown For use when expected risk of exposure to fluid is moderate requirements Heavy-weight SMS fabric Recommended for: Drawing arterial blood, inserting I.V. lines ER, Trauma, Burn Units, Critical Care Units BFE: Holds out 92% of Staphylococcus aureus; 99.8% of dry spores. 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.

6 Testing of Kimberly-Clark * Isolation Gowns KC100, KC200 and KC300 Level 1 Performance Kimberly-Clark * KC100 Isolation Gown SI test above 4.5 gm Lot pass Lot pass Lot pass (A small sample size was warranted due to SI values averaging 0.6 gm) Medline Level 1 NONLV100 SI test above 4.5 gm KC100 Lot fail Lot fail Lot fail Level 2 Performance Kimberly-Clark * KC200 Isolation Gown HH Tests below 20m bar SI Tests above 1 gm Lot pass Lot pass Lot pass Medline Level 2 NONLV200 HH Tests below 20m bar SI Tests above 1 gm Lot pass Lot pass KC200 Medline Level 2 NONLV220/225 HH Tests below 20m bar SI Tests above 1 gm Lot pass Lot pass Lot 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.

7 Performance Kimberly-Clark * KC300 Isolation Gown HH Tests below 50m bar SI Tests above 1 gm Lot pass Lot pass Lot pass Medline Isolation Gowns NONLV325 HH Tests below 50m bar SI Tests above 1 gm Lot fail Lot fail Lot fail KC300 Cardinal Isolation Gowns 3 AT6100/6200 HH Tests below 50m bar SI Tests above 1 gm Lot fail Lot fail Lot fail Level Liquid Barrier Performance Kimberly-Clark passes Levels 1, 2 & 3. Medline Levels 1 & 3 fail. Medline Level 2 passes. Cardinal Level 3 fails. Four areas are tested in each lot: body fabric, shoulder seam, sleeve seam, armhole seam.

8 Personal Protective Equipment Performance Standards & Guidelines Healthcare Guidelines and Personal Protective Apparel Many organizations have published general guidelines for the use of personal protective equipment, including gowns, within healthcare settings. OSHA 1 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. CDC Centers 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. APIC 4 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. 5 Only the Association for the Advancement of Medical Instrumentation () offers a widely accepted system of classification for protective apparel based on liquid barrier performance. Level / Performance Requirements at Anticipated Risk of Exposure to Fluid Gown Characteristics (Weight) Recommended Areas of Use Recommended Tasks Level 1 Level 2 Level 3 Spray Impact Penetration < 4.5g Low Light-weight SMS fabric Med/Surg Unit Laundry Housekeeping Transporting Patients Basic Patient Care Spray Impact Penetration < 1.0g Hydrostatic Pressure > 20cm Between Low and Moderate Medium-weight SMS fabric ICU Med/Surg Unit Dialysis Nursery Lab Pathology Laboratories Hyperbaric Blood Draw Suturing Inserting I.V. Lines Spray Impact Penetration < 1.0g Hydrostatic Pressure > 50cm Moderate Heavy-weight SMS fabric ER Trauma Burn Units Critical Care Units Drawing Arterial Blood Inserting 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.

9 Bacterial Filtration Efficiency (BFE) Testing 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* -rated Isolation Gowns and BFE An 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. KC100 Cardinal 2100PG Medline NONLV100 Level 1 BFE 1 79% 69% 59% Dry Spore % 98.2% 56.1% KC200 Level 2 Level 2 Medline NONLV225 BFE 1 85% 63% Dry Spore % 92.2% KC300 Cardinal AT6100 Medline NONLV325 BFE 1 92% 95% 94% Dry Spore % 99.8% 99.9% 1 method complies with ASTM F2101 (data on file) 2 All values are presented as a median percentage of filtration efficiency.

10 Personal Protective Equipment Performance Standards & Guidelines Kimberly-Clark* Isolation Gowns 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 Here are the new codes for the Kimberly-Clark * Isolation Gown Portfolio: Code Description Dimensions (") Quantity (Chest Width/Gown Length/Sleeve Length) KC300 Isolation Gown KC300 Isolation Gown, Yellow, Large 26/46/ eaches/case KC300 Isolation Gown, Yellow X-Large 30/50/ eaches/case KC300 Isolation Gown, Blue, Large 26/46/ eaches/case KC300 Isolation Gown, Blue, X-Large 30/50/ eaches/case KC200 Isolation Gown KC200 Isolation Gown, Yellow, Large 26/46/ eaches/case KC200 Isolation Gown, Yellow, X-Large 30/50/ eaches/case KC200 Isolation Gown, Blue, Large 26/46/ eaches/case KC200 Isolation Gown, Blue, X-Large 30/50/ eaches/case KC100 Isolation Gown KC100 Isolation Gown, Yellow, Large 26/46/ eaches/case KC100 Isolation Gown, Yellow, X-Large 30/50/ eaches/case KC100 Isolation Gown, Blue, Large 26/46/ eaches/case KC100 Isolation Gown, Blue, X-Large 30/50/ eaches/case The entire gown is a Critical Zone including seams, but excluding cuffs, hems and bindings. also requires a closed back for isolation precautions Custom neck tapes on our Isolation Gowns make it easy to identify their Level of Protection. The following codes have been discontinued: Code Description Quantity Control * Cover Gown, Yellow, X-Large 40 eaches/case Control * Cover Gown, Blue, X-Large 40 eaches/case Control * Cover Gown, White, Universal Size 100 eaches/case Important: All other Isolation and Film Gown codes will remain the same. Our new zoned packaging makes it easy to select the right gown for the right level of protection. Kimberly-Clark s Full Range of PPE Solutions Gowns 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.

11 * More Information and Resources from Kimberly-Clark Visit Kimberly-Clark* Isolation Gowns online at: Get up-to-date information with the latest industry news, articles, and clinical education. Access the latest information about Healthcare-Associated Infections at 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 infections 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. NEW Website! Choose the right level of protection for your situation at: 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!

12 The Kimberly-Clark Advantage * Knowledge Network * Accredited Education Online at HAIwatch.com On-site rep-facilitated programs HAI Education Bus Ongoing Customer Support In-service training Product technical support Unsurpassed customer service Expert Sales Force Healthcare Industry Representative Credentialed On-site trained in hospitals Infection prevention website: Tools & Best Practices Infection Prevention Education Toolkits Utilization Reviews Product Use and Selection Tools Best Practices/ Industry Guidelines Pandemic Planning Demand Calculator Exam Glove Space and Waste Calculator Latex-Free Exam Glove Community Outreach Program Clinical Research Staff medical professionals to advise and direct clinical research Peer-to-peer consultation 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. Healthcare-Associated Infection Solutions Surgical Solutions Digestive Health Pain Management Commitment to Excellence Guarantee Public Health Reports / March-April 2007 / Volume 122, p Elixhauser, A. (AHRQ) and Steiner, C. (AHRQ). Infections with Methicillin-Resistant Staphylococcus Aureus (MRSA) in U.S. Hospitals, HCUP Statistical Brief #35, July Agency for Healthcare Research and Quality, Rockville, MD ANSI/ PB70:2003, P.6 Healthcare Guidelines Page References 1. document?p_table=directives&p_id=2570#xiii 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 Preview%20Files/pb700310preview.pdf For more information, please call KCHELPS in the United States or visit our website at * 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 KCWW. H01549 H