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1 Today s Topic Importance of Manufacturer Directions for Use to Achieve Efficacy of your Surgical Patient Prep Presenters Jodi Lippert, RN, BSN, CNOR Sally Bull, Clinical Research Specialist HouseKeeping Questions Live: Pause mid-way through the presentation End of presentation Chat: Available anytime on Global Crossing web meeting screen (lower-left corner) To Mute your Phone: *6 To Unmute your Phone *7 CE: Each 1 hour web meeting qualifies for 1 contact hour for nursing. 3M Health Care Provider is approved by the California Board of Registered Nurses CEP M All rights reserved. 3M Learning Connection Website 3 3M All rights reserved. 1

2 Today s Presenters Jodi Lippert, RN, BSN, CNOR Technical Service Specialist 3M Infection Prevention Division Sally Bull Clinical Research Specialist 3M Infection Prevention Division 4 3M All rights reserved. Disclosure Employees of 3M Infection Prevention Division Laboratory, Supporting Antiseptic Drug Products 5 3M All rights reserved. Objectives Describe how surgical skin prep directions for use are obtained Discuss the importance of following directions to achieve efficacy Describe the differences in directions for use of 3 surgical skin preps 6 3M All rights reserved. 2

3 Authoritative Guidance 7 3M All rights reserved. FDA Testing Criteria For Surgical Skin Preparations Definition of a patient preoperative skin preparation: A fast-acting, broad-spectrum, persistent antiseptic-containing preparation that significantly reduces the number of micro-organisms on intact skin 8 3M All rights reserved. FDA Federal Register/ Vol. 59 No.116 pg CFR Parts 333 and 339 Tentative Final Monograph for health-care Antiseptic Drug Products; Proposed rule TFM Testing Patient Pre-op Prep In vivo testing Healthy volunteers Abdomen/groin cup scrub method ASTM Designation: E , Standard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations ASTM Designation: E , Standard Test Methods for Evaluation of Inactivators of Antimicrobial Agents NEUTRALIZATION and baseline counts are required 9 3M All rights reserved. 3

4 Application In vivo Meets or exceeds FDA test criteria a,b 2 log reduction abdomen at 10 minutes 3 log reduction - groin at 10 minutes Both sites maintain counts below baseline out to 6 hours a. 21CFR Parts 333 and 369 Federal Register Vol. 59, No116 b. Safety and Efficacy Data M All rights reserved. Abdomen & Groin Efficacy Study 11 3M All rights reserved. Additional Considerations Skin Preparation Meets FDA Criteria Abdomen Meets FDA Criteria Groin 10 min 6 hour 10 min 6 hour Povidone Iodine Yes Yes Yes Yes Scrub & Paint Aqueous CHG scrub Yes Yes Yes Yes Iodine Povacrylx/alcohol Yes Yes Yes Yes CHG/alcohol Yes Yes Yes Yes 12 3M All rights reserved. 4

5 Surgical Site Infections US -occur in 2% - 5% of patients undergoing inpatient surgery ~ 500,000 occur each year Add ~7-10 additional postoperative days Costs vary according to procedure & type of infecting pathogen estimates $3,000-29,000 Account for up to $10 billion annually in healthcare expenditures Patients who have SSI have 2-11 times higher risk of death Anderson, D.J.et al S51 Strategies to Prevent Surgical Site Infection in Acute Care Hospitals. Infection Control and Hospital Control Epidemiology, Oct. 2008, Vol. 29, Suppl M All rights reserved. Process Variability Dose of Bacteria (Contamination) Resistance of the host (patient) X Virulence (Resistance) = Risk Patient Variability Guideline For Prevention Of Surgical Site Infection, M All rights reserved. According to the 1999 CDC Guideline: For Prevention of Surgical Site Infections, for most SSIs, the source of pathogens is the endogenous flora of the patient s skin, mucous membranes or hollow viscera Distribution of Top Ranking Pathogens (January October 2007) Pathogens SSI Staphylococcus aureus 30.01% Coagulase Negative Staph (CNS) 13.74% Enterococcus spp % Pseudomonas aeruginosa 5.55% Eschericia coli 9.55% Acinetobacter baumannii 0.60% Enterobacter spp. 4.17% Candida spp. 2.07% Abstract for SHEA 18th Annual Scientific Meeting Antimicrobial Resistant Pathogens Associated with Healthcare-Acquired Infectio(HAIs) Reported to the CDC's National Healthcare Safety Network (NHSN), M All rights reserved. 15 5

6 Patient Variability Resistance of the host (patient) Age Compromised Immune System Diabetes Remote Site Infection (Not Treated Prior To Surgery) Nutritional Status Nicotine Use Prolonged Preoperative Stay Obesity Steroid Use Duration Of Surgery 16 3M All rights reserved. Process Variability Hand Hygiene Appropriate Antimicrobial Prophylaxis Preoperative Bathing Nasal Decontamination Oral Decontamination Hair Removal Skin preparation Surgical Hand Antisepsis Appropriate Surgical Attire and Drapes Operating Room Characteristics Ventilation, Traffic, Environmental Surfaces Sterilization Patient Management Normothermia Glucose control Oxygenation Surgical Technique: Hemostasis Failure to obliterate dead space Tissue trauma 17 3M All rights reserved. Evidence surgical site infection as the main outcome measurement 18 3M All rights reserved. 6

7 Clinical Studies Evaluating Effect of Prep on SSI Rate Title Design Swenson et al. (Infect Control Hosp Epidemiol 2009; 30: ) Effects of preoperative skin preparation on postoperative wound infection rates: a prospective study of 3 skin preparation protocols Quasi-experimental, (sequential assignment of interventions) single center Darouiche et al. (N Engl J Med 2010; 362:18-26) Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis Randomized six centers 19 3M All rights reserved. Surgical Skin Preparations Used Treatments: Povidone Iodine (PVP-I) CHG Iodine Povacrylex Swenson et al. (Infect Control Hosp Epidemiol 2009; 30: ) PVP-I scrub (7.5% PVP-I) 3 consecutive applications Alcohol paint (70% isopropyl alcohol) PVP-I paint (10% PVP-I) 3 consecutive applications Allow prep to dry Darouiche et al. (N Engl J Med 2010; 362:18-26) PVP-I scrub Application protocol not described X PVP-I paint (10% PVP-I) Application protocol not described Application protocol not described 2% CHG and 70% Isopropyl Alcohol ChloraPrep 30 sec or 2-min application Application protocol not described in NEJM study Iodine Povacrylex [0.7% available iodine] and Isopropyl Alcohol (74% w/w) X DuraPrep 20 3M All rights reserved. Surgery Type Primary outcome Secondary outcome Number of Subjects Swenson et al. (Infect Control Hosp Epidemiol 2009; 30: ) General surgery (clean, clean-contaminated, dirty) Darouiche et al. (N Engl J Med 2010; 362:18-26) Clean-contaminated (included specialty surgeries, eg, gyn, urol, gi, thoracic) Any SSI within 30 days of surgery Any SSI within 30 days of surgery tracked by prep received 3, Individual types of SSI 21 3M All rights reserved. 7

8 Overall SSI Rates Swenson et al. (Infect Control Hosp Epidemiol 2009; 30: ) By Preferred Prep (Study Period): Period 1 PVP-I with alcohol 6.4% Period 2 Chlorhexidine-alcohol 7.1% Period 3 Iodine povacrylex 3.9% (P=0.002) Darouiche et al. (N Engl J Med 2010; 362:18-26) PVP-I 16.1% Chlorhexidine-alcohol 9.5% (P=0.004) By Prep Actually Received: PVP-I with alcohol 4.8% Chlorhexidine gluconate-alcohol 8.2% Iodine povacrylex 4.8% (P=0.001) Conclusions 22 3M All rights reserved. A strong trend of higher SSI rates with the use of CHG, compared with the two iodophor-based preps, was also observed in a multivariate analysis although not significant (P=0.073) Skin preparation is an important factor in prevention of SSIs. Iodophor-based compounds may be superior to chlorhexidine for SSI prevention in general surgery patients Preoperative cleansing of the patient s skin with chlorhexidine-alcohol is superior to cleansing with povidoneiodine for preventing SSI after cleancontaminated surgery Limitations 23 3M All rights reserved. Swenson et al. (Infect Control Hosp Epidemiol 2009; 30: ) Not randomized (justification: authors wanted to implement protocol as commonly seen in practice and maximize the consistency of prep p application) Single center Darouiche et al. (N Engl J Med 2010; 362:18-26) DuraPrep, one of the commonly used onestep skin preps in the USA, was not included Compared CHG/Alcohol with a reference prep containing only PVP-I, without alcohol, despite the well known synergistic effect of both antiseptics due to their different mechanisms of action Compared 2 agents with 1 agent Conclusions: Each of these studies has its limitations Body of evidence incomplete for widely recommending one prep over another Published Study Design Active ingredient neutralized per ASTM test methods Products Studied Bacterial Count Studies Comparing Surgical Preps Efficacy of surgical preparation solutions in foot and ankle surgery J Bone Joint Surg AM. 2005:87A: Roger V. Ostrander, et al. Prospective, randomized study evaluating 125 consecutive patients undergoing foot or ankle surgery Efficacy of surgical preparation solutions in shoulder surgery J Bone Joint Surg AM. 2009:91: Matthew D. Saltzman, et al Prospective, randomized study evaluating 150 consecutive patients undergoing shoulder surgery Efficacy of surgical preparation solutions in lumbar spine surgery J Bone Joint Surg AM. March 2012 Jason W. Savage, et al. Prospective, randomized study evaluating 100 consecutive patients undergoing elective lumbar spine surgery NO NO YES ChloraPrep DuraPrep Techni-Care ChloraPrep DuraPrep Povidone Iodine Scrub/Paint ChloraPrep DuraPrep 24 3M All rights reserved. 8

9 Efficacy of surgical preparation solutions in foot and ankle surgery Efficacy of surgical preparation solutions in shoulder surgery Efficacy of surgical preparation solutions in lumbar spine surgery Study Endpoint Positive cultures after prep Positive cultures after prep Positive cultures after wound closure Results Hallux site Toe site ChloraPrep 30% 23% DuraPrep 65% 45% Techni-Care 95% 98% (p <0.0001) ChloraPrep 7% DuraPrep 19% Povidone Iodine 31% (p 0.01) ChloraPrep 34% DuraPrep 32% (p = 0.22) Conclusions ChloraPrep was the most effective for eliminating bacteria from the forefoot prior to surgery ChloraPrep is more effective than DuraPrep or Povidone Iodine Equally effective skinpreparation solutions Additional Study Comments Postop Infections: Technicare 2 ChloraPrep 1 DuraPrep 0 No postoperative wound infections in any of the patients Infection data not reported in abstract When Alcohol containing preps are studied using a validated test method with neutralization both Iodine/alcohol and CHG/alcohol preps are equally effective 25 3M All rights reserved. Skin Antisepsis Peri-Operative Process Pre-Operative Intra-Operative Post-Operative Preoperative bathing Hair removal Antiseptic Skin Preparation Persistent Activity of Skin Antiseptic Removal 26 3M All rights reserved. Pre-operative/Intra-operative Assessment 2012 AORN Recommended Practice # III The antiseptic agent should be selected based on the patient assessment Allergies Skin condition Surgical site Manufacture s written information Contraindications Surgeon preference Antiseptic agent selection 27 3M All rights reserved. 9

10 Intra-operative Agent Selection SHEA/IDSA 1 Wash and clean skin around incision site; use an appropriate antiseptic agent A-II CDC Guideline for Use an appropriate antiseptic agent for skin preparation (Table 6). Category IB the Prevention of Apply preoperative antiseptic skin preparation in concentric circles moving toward the periphery. The Surgical Site Infection 2 prepared area must be large enough to extend the incision or create new incisions or drain sites, if necessary. Category II AORN 3 Recommendation II Preoperative skin antiseptic agents that have been FDA-approved or -cleared and approved by the health care organization s infection control personnel should be used for all preoperative skin preparation. None of these state that one antiseptic agent is preferred over another 28 3M All rights reserved. 1.Anderson, D.J.et al Strategies to Prevent Surgical Site Infection in Acute Care Hospitals S51, Infection Control and Hospital Control Epidemiology, Oct. 2008, Vol. 29, Suppl Centers for Disease Control and Prevention, Guideline for Prevention of Surgical Site Infection, Infection Control and Hospital Epidemiology, Vol 20, No 4, April Perioperative Standards and Recommended Practices, Patient Skin Antisepsis AORN, 2009 National Quality Forum (NQF) 2010 Safe Practice #22 on Surgical Site Infection Preoperatively use solutions that contain isopropyl alcohol as skin antiseptic preparation until other alternatives have been proven as safe and effective, and allow appropriate drying time per product guidelines. 29 3M All rights reserved. 30 3M All rights reserved. 10

11 Intra-operative Application 2012 AORN Recommended Practice # V The skin around the surgical site should be free of soil, debris, exudates, and transient microorganisms to minimize contamination of the surgical wound before application of the antiseptic skin preparation. Efficacy dependent on clean skin Umbilicus cleaned before prep Specific information on several areas 31 3M All rights reserved. Intra-operative Application 2012 AORN Recommended Practice # VII The antiseptic agent should be applied to the skin over the surgical site and surrounding area in a manner to minimize contamination, ti preserve skin integrity, it and prevent tissue damage 32 3M All rights reserved. Intra-operative Special Precautions Flammable Prep Agents 2012 AORN Recommended Practice # VIII If a flammable prep agent is used, additional precautions should be taken to minimize the risk of a surgical fire and patient burn injury. Storage, use & disposal Single use Contact with fabrics remove solution soaked materials Pooling wicked away Allowed to dry & vapors to dissipated Trapping solution or vapors under drapes increases risk of fire/burn injury Disposal Alcohol product use discussed during time out 33 3M All rights reserved. 11

12 Intra-operative Special Precautions Flammable Prep Agents CMS Guidance on Alcohol-based Skin Preparations in Anesthetizing Locations Risk Reduction Measures 2007 Use unit dose applicators Manufacture directions Prevent soaking into patient s hair or linens Completely dry before draping Verification and documentation Establish & document use of policies & procedures When risk reduction measures not taken could be cited as non-compliance with CMS M All rights reserved. Label Change Drug Facts: Warnings New Required FDA Labeling Change, effective February 2010 To reduce risk of fire, PREP CAREFULLY: avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry. do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Drug Facts: Directions When Applying Solution: avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry. After Applying Solution: to reduce the risk of fire, wait until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Solution will turn from a shiny to dull appearance on skin alerting the user that the solution is completely dry and no longer flammable. 35 3M All rights reserved. Intra-operative Manufacturers Directions 2012 AORN Recommended Practice # IX Manufactures written recommendations and MSDSs for handling, storing, and heating of all skin preparation agents should be readily available, reviewed, and followed. 36 3M All rights reserved. 12

13 Intra-operative Competency Education, training competency validation Agent selection Application procedures Patient assessments Policy & Procedures Written and reviewed annually Quality management program Respond to opportunities for improvement 37 3M All rights reserved. Intra-operative/Post-operative Persistent Activity 2012 AORN Recommended Practice # X At the end of the surgical procedure, the skin preparation agent should be thoroughly removed from the skin unless otherwise indicated by the manufacturer s written instructions. 38 3M All rights reserved. Additional Considerations Skin Preparation Characteristics of a surgical procedure Irrigation, blood, body fluids Drape adhesion Certain aqueous based preps and antiseptic agents interfere with the adhesion of drapes and tapes. Patient Safety Product warnings and contraindications. May increase personal and institutional liability if warnings and contraindications are disregarded Application Instructions The efficacy of an antimicrobial product is based on proper application Check application instructions carefully prep applicators from various manufacturers have very different instructions for use Check warnings /contraindications 39 3M All rights reserved. 13

14 Iodine Povacrylex/Alcohol Paint a single uniform coat CHG/Alcohol Patient Safety Application Instructions Dry site (abdomen or arm) use repeated back-and-forth strokes for 30 seconds Wet site (inguinal folds) use repeated back-and-forth strokes for 2 minutes Iodophor/Alcohol Preps Read Instructions Prep time will vary by product 40 3M All rights reserved. Patient Safety Warnings Product warnings required by FDA Protect the patient from misuse May increase facility s liability if warnings are disregarded Will vary significantly based on the active ingredients End-user should read all directions and warnings Safe use of the product Achieve efficacy 41 3M All rights reserved. Adherence to current prevention recommendations in healthcare settings has been generally suboptimal, even when knowledge of recommended practices is sufficient. Several lines of evidence suggest that merely increasing adherence to currently recommended practices can result in a dramatic reduction in infection rates, at least for some infection types. HHS Action Plan to Prevent Healthcare Associated Infections: Research M All rights reserved. 14