1. Skin Preparation: The Why, The Where, and The How Deb Danna RN BSN Clinical Consultant, CareFusion
Welcome to this continuing education seminar entitled: Skin Preparation: The Why, The Where, and The How

2. Overview Current Regulations and Guidelines Skin is the Source
Skin Antiseptic Review
Skin preparation Directions for Use
Conclusion
Return Demonstration and Competency

3. Current Regulations and Guidelines
FDA
CDC
AORN
NQF
Joint Commission
CMS
There are many organizations in the U.S. both government and professional that publish guidelines/recommendations on skin antisepsis.
CMS and The Joint Commission have made HAIs a top priority for healthcare facilities.
Many of the guideline recommendations are based on a review of the available evidence. These reviews typically include a weighting of the evidence based on several study design factors.

4. Joint Commission Best Practices Recommendations
Hospitals Should Focus on Infection Management
Policies and Procedures must address regulatory requirements and evidence based standards
Involves education of health care workers
At hire and annually thereafter
At the time of change in job responsibility within the surgical environment
Additional Hospital Responsibilities
Periodic Risk Assessments
Development of Metrics using Best Practices or Evidence-Based Guidelines
Compliance Monitoring and Evaluation

5. HAIs: A Costly Toll to U.S. Healthcare1 1 1 1
1. Patient Protection and Affordable Care Act (PPACA) of 2010, S 301, 3008 and 3011;CMS IPPS FY11 Proposed Rule, April 19, 2010

6. HAIs: A Costly Toll to U.S. Healthcare2
Key Talking Points:
Healthcare reform is going to significantly impact reimbursement and therefore net patient revenue for your Medicare patients. But you must look at the direct attributable cost of these HAIs to your hospital to understand the true financial impact.
Many of these incremental costs to treat patients are no longer be reimbursed by CMS and many private payers. The true financial impact of these preventable HAIs is staggering. And evidence-based Safe Practice guidelines, like the NQF-endorsed safe practices, can help you prevent these HAIs and avoid these costs.
More Data:
NQF (National Quality Forum), a not-for-profit organization , has developed safe practice standards for a better healthcare system. Those standards are tied directly to the most costly preventable HAIs.
CLA-BSI, SSI, and VAP represent about one-quarter of the annual infections, roughly 789,000 infections, cost nearly $30,000 per infection, and each result in an increased length of stay.
As we’ve discussed, each hospital will required to report its outcomes related to each of these infections.
We’ve highlighted the data from a national perspective, let’s now examine it’s impact on an typical US hospital.
2. Scott RD. The Direct Medical Costs of Healthcare-Associated Infections in U.S. Hospitals and the Benefits of Prevention. March 2009, Centers for Disease Control and Prevention. Accessed August 30, 2010 at:

7. Clinical and Economic Impact of HAIs
Attributable costs due to HAIs are substantial & carry significant morbidity and mortality
Approximately 12% (159 patients) developed an HAI
Avg. Length of Stay (LOS) was 5.9 to 9.6 days
Excess LOS totaled 844 to 1,373 hospital days
Attributable Costs $9,310 - $21,013 per patient
$1.48 to $3.34 million in medical costs
$5.27 million for premature death
Roberts RR, et al. Costs attributable to healthcare-acquired infection in hospitalized adults and a comparison of economic methods. Med Care Nov;48(11):

8. The National Spotlight-CMS Reimbursement
CMS Reimbursement Final Rule
ALL hospitals participating in the US Medicare program must report data on specific HAIs through the Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network (NHSN).
Hospitals that do not submit data per the final rule are eligible to continue to participate in the Medicare program, but will be subject to a reduction in their Medicare Annual Payment Update.
As with other quality measures, any HAIs that may be added in the future will be publicly reported on the CMS Hospital Compare website

9. Antiseptic Categories
Patient Preoperative Skin Preparation
Pre-injection vs. Pre-operative
Surgical Hand Scrub
Healthcare Personnel Hand
wash
In the post-Lister era, efforts to cleanse skin were concentrated on the skin of the hands of the surgeon. It was not until the 20th Century that serious consideration was given to preparation of the patient’s skin, and no distinction was made between cleansers, antiseptics and skin protectants.
The differences have been clarified in order to provide guidance when choosing products.
In 1994, the FDA’s The Tentative Final Monograph for Over-The-Counter Topical Antimicrobials defined testing requirements for use of antiseptic agents on skin in the professional healthcare setting. (The Tentative Final Monograph) .
Patient Preoperative Skin Preparation. Used to prepare the skin prior to invasive procedures. Have to have a 3 log reduction on wet sites (groin) or a 2 log reduction on dry sites (abdomen) within 10 minutes of application, the bacterial cell count for each test site cannot subsequently exceed the base line 6 hrs after application.
Prior to injection only has to have a 1 log reduction within 30 seconds –.
Surgical Hand Scrub-Primarily used by surgical personnel to scrub hands before invasive surgery. Has to have a 1 log reduction on each within 1 minute and bacterial cell count on each had does not subsequently exceed baseline within 6 hours on day 1; has to have a 2 log reduction within 1 minute by the end of day 2 compared to baseline; has to have 3 log reduction on each hand within 1 minute by the end of day 5 compared to baseline.
Healthcare Personnel Hand wash: 2 log reduction within 5 minutes after first use; 3 log reduction on each hand within 5 minutes after the 10th use

10. How are you prepping the skin?
One Major risk factor for infections:
Heavy skin colonization of bacteria at incision site
80% of resident and transient skin flora resides in the first 5 layers of the stratum corneum.
Does your application methodology assure that the solution reaches into the cracks and fissures of the stratum corneum layer?

11. Disinfecting the Skin
The recommended antimicrobial agent should have the following properties:
Broad spectrum
Rapid bactericidal activity
Persistence or residual properties on the skin
Effective in the presence of blood
Non-irritating or have low allergic and/or toxic responses
No or minimal systemic absorption

12. Choosing a Preoperative Skin Prep Antiseptic
Antiseptic agent
Mechanism of action
Gram + bacteria
Gram – bacteria
Viruses
Rapidity of action
Persistent/
residual activity
Use on eye
or ear
Use on mucous membranes
Contraindications
Cautions
Alcohol
Denatures proteins.
Excellent
Good
None
No. Can cause corneal damage or nerve damage. No
Flammable. Does not penetrate organic material. Optimum concentration is 60% to 90%
Chlorhexidine gluconate
Disrupts cell membrane.
Moderate
No. Can cause corneal damage. Can cause deafness if in contact with inner ear. Use with caution.
Use with caution.
Known hypersensitivity to drug or any ingredient. Lumbar puncture and use on meninges.
Prolonged skin contact may cause irritation in sensitive individuals. Rare severe hypersensitivity reactions have been reported. Use with caution on mucous membranes.
Povidone-Iodine
Oxidation/
substitution with free iodine.
Minimal
Yes. Moderate ocular irritant.
Yes.
Sensitivity to povidone-iodine (shellfish allergies are not a contraindication).
Prolonged skin contact may cause irritation. May cause iodism in susceptible individuals; avoid use in neonates. Inactivated by blood.
Chlorhexidine gluconate with alcohol
Disrupts cell membrane and denatures proteins.
No. Can cause corneal damage. Can cause deafness if in contact with inner ear.
Flammable.
Iodine-based with alcohol
substitution by free iodine denatures proteins.
No.
Parachoroxylenol
(PCMX)
Fair
Yes
Known hypersensitivity to PCMX or any ingredient.
Minimally effective in the presence of organic matter. The FDA has classified PCMX as a Category III (data are insufficient to classify it as safe and effective). The FDA continues to evaluate PCMX.
The 2011 AORN recommendation on preoperative skin antisepsis: [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.]
Here is a chart showing the available skin antiseptics in the marketplace.
ALCOHOL is an antiseptic agent whose mechanism of action denatures protein, excellent for killing Gram positive and negative bacteria, and good for killing viruses. Rapidity of action is excellent but has no persistent or residual activity. Alcohol is not to be used on the eye or ear, can cause corneal damage or nerve damage. Alcohol is not to be used on mucous membranes. Caution, alcohol is FLAMMABLE! Because alcohol attacks certain protein functional sites, many of which are present in blood, the effects can or may be reduced by blood.
Chlorhexidine gluconate’s mechanism of action is disruption of the cell membrane. It is excellent for killing gram positive bacteria, good for killing gram negative bacteria and certain viruses, and has a moderate rapidity of action. Chlorhexidine gluconate has an excellent persistent, residual activity. Chlorhexidine gluconate remains effective in the presence of blood. It is not to be used on the eye or ear and can cause corneal damage. Chlorhexidine gluconate can cause deafness if in contact with the inner ear. Chlorhexidine gluconate can be used on mucous membranes with caution. The contraindication for chlorhexidine gluconate is known hypersensitivity to drug or any ingredient. It is also contraindicated for lumbar puncture and use on the meninges. Caution, prolonged skin contact may cause irritation in sensitive individuals. Rare severe hypersensitivity reactions have been reported. Again, use with caution when applying to mucous membranes.
Povidone-iodine’s mechanism of action is oxidation and substitution with free iodine. Povidone-iodine is excellent for killing gram positive bacteria, and good for killing gram negative bacteria and viruses. It has a moderate rapidity of action and minimal persistent and residual activity. Povidone-iodine is not effective in the presence of blood. Povidone-iodine is okay to use on eyes and ears, it is a moderate ocular irritant. Povidone-iodine can be used on the mucous membranes. It is contraindicated for those who have a sensitivity to povidone-iodine. Shellfish allergies are NOT a contraindication. Caution, prolonged skin contact may cause irritation. Povidone-iodine may cause iodism, a systematic type of poisoning, in susceptible individuals, avoid use in neonates. Also povidone-iodine is inactivated by blood.
The combined antiseptic agent Chlorhexidine gluconate with alcohol, mechanism of action is disruption of the cell membrane and denaturing proteins. This combined antiseptic is excellent for killing gram positive and gram negative bacteria, good for killing viruses, and has an excellent rapidity of action. Chlorhexidine gluconate with alcohol has excellent persistent and residual activity, and remains effective in the presence of blood. Chlorhexidine gluconate with alcohol is not to be used on the eyes or ears. This combined antiseptic can cause corneal damage and can cause deafness if in contact with the inner ear. Chlorhexidine gluconate with alcohol is not to be used on the mucous membranes. Contraindication for use of this combined antiseptic in known hypersensitivity to drug or any ingredient. Also contraindicated for lumbar puncture and use on the meninges. Caution, because alcohol is in this combined antiseptic it is flammable.
The antiseptic agent iodine-based with alcohol mechanism of action is oxidation and substitution by free iodine denatures proteins. Iodine-based with alcohol is excellent for killing gram positive and gram negative bacteria, good for viruses, and excellent for rapidity of action. Iodine-based with alcohol has a moderate persistent and residual activity. Blood? This combined antiseptic is not to be used on the eyes or ears. Iodine-based with alcohol can cause corneal damage or nerve damage. Iodine-based with alcohol is not to be used on the mucous membranes. Contraindications for this combined antiseptic agent is a sensitivity to povidone-iodine. Shellfish allergies are NOT a contraindication. Caution, because alcohol is in this combined antiseptic it is flammable.
Parachoroxylenol’s (PCMX) mechanism of action is disruption of the cell membrane. Parachoroxylenol is good for killing gram positive bacteria and fair for killing gram negative bacteria and viruses. This antiseptic agent has moderate rapidity of action and moderate persistent and residual activity. Parachoroxylenol can be used on the eye, ear, or mucous membrane. Contraindications is known hypersensitivity to parachoroxylenol or any other ingredient. Caution parachoroxylenol is minimally effective in the presence of organic matter. The FDA has classified parachoroxylenol as a category III meaning data are insufficient to classify it as safe and effective. The FDA continues to evaluate Parachoroxylenol.
Note: Even though AORN states that PCMX is ok  for use in mucous membranes; it  is not approved for use on mucous membranes.

13. Common Skin Preparations and Application Techniques

14. 7.5% PVP Scrub and 10% PVP Paint Solution
Scrub and Paint
7.5% PVP Scrub and 10% PVP Paint Solution

15. Preoperative Skin Prep: Application Techniques
7.5% Povidone Iodine Scrub and 10% Povidone Iodine Paint Solution
Scrub of the operative site should begin at the incision site, working out to the outer parameter in a concentric circular motion for 5 minutes.
Paint solution should be applied starting at the site of incision and working in a circular motion out to the perimeter of the area prepped. It should be allowed to dry for 2 to 3 minutes or until completely dry. Dry time of the paint application is a must for full efficacy of the product, due to the release of free available iodine necessary to kill bacteria on the skin.
When using a commercially available skin preparation applicator, the manufacturer’s written instructions should always be followed to ensure uniform distribution of the antiseptic.
For application of 7.5% Povidone Iodine Scrub and 10% Povidone Iodine Paint Solution
Scrub of the operative site should begin at the incision site, working out to the outer parameter in a concentric circular motion for 5 minutes.(This time can be broken up between multiple sponges. Blot and apply paint
Paint solution should be applied starting at the site of incision and working in a circular motion out to the perimeter of the area prepped. It should be allowed to dry for 2 to 3 minutes or until completely dry. Iodine’s bactericidal effect relies on the release of free iodine, which penetrates cell walls and alters or discontinues protein synthesis. This mechanism of action, unlike that of CHG, requires several min. to achieve maximal effect.
The total prep time is 8+ minutes.
It is important to note that:
The effectiveness of Povidone iodine is reduced in the presence of blood due to its affinity for certain functional groups present in blood.
Special consideration on the skin prep implementation is necessary when the incision site is more highly contaminated than the surrounding skin. If the highly contaminated area is part of the prepped area, the area of lower bacteria count is prepped first, followed by the area of higher concentration, as opposed to working from the incision outward to the periphery.

16. DuraPrep/Prevail-FX/Prevail
DuraPrep: 0.7%Povidone Iodine /74% Isopropyl alcohol, povacrylex (6 ml & 26 ml) PREVAIL-FX: 0.83%Povidone Iodine /72.5% Isopropyl alcohol, polymer (40 ml) PREVAIL: 0.5% Povidone Iodine/ 62% ethanol alcohol (59 ml & 40 ml)

17. Preoperative Skin Prep: Application Techniques
To activate the applicator: twist the applicator head and push down. Lightly squeeze the bottle to initiate the flow of the prep solution.
Application: Apply for thin even coat starting at the incision site and working outward in a circular motion. The flow of the solution is controlled by squeezing the applicator body. The solution should not be blotted, but simply allowed to dry.
Dry time for larger volume alcohol based skin antiseptics is a minimum 3 minutes in non-hairy areas and up to 1 hour in hairy areas
To activate the applicator: twist the applicator head and push down. Lightly squeeze the bottle to initiate the flow of the prep solution.
Application: Apply thin even coat starting at the incision site and working outward in a circular motion. The flow of the solution is controlled by squeezing the applicator body. The solution should not be blotted, but simply allowed to dry.
Dry time for larger volume alcohol based skin antiseptic products is a minimum 3 minutes in non-hairy areas and up to 1 hour in hairy areas.
Allow to dry, DO NOT blot
Dry time:
Minimum 3 minutes non-hairy areas
Hairy areas up to 1 hour

18. Chlorhexidine Gluconate
2%-4% formulations
Hibiclens/BetaSept/ Exidine

19. Preoperative Skin Prep: Application Techniques
2% - 4% Chlorhexidine Gluconate
Chlorhexidine Gluconate skin prep agents should be applied liberally to the surgical site and swabbed for at least 2 minutes, starting from the incision site out to the periphery. The prepped area should be blotted dry with a sterile towel; this procedure is then repeated for an additional 2 minutes and dried with a sterile towel.
Total prep time is 4 minutes.
2 to 4% Chlorhexidine gluconate skin prep agents should be applied liberally to the surgical site and swabbed for at least 2 minutes, starting from the incision site working out to the periphery. The prepped area should be blotted dry with a sterile towel; this procedure is then repeated for an additional 2 minutes and dried with a sterile towel.
Total prep time is 4 minutes.

20. 2% Chlorhexidine gluconate 70% Isopropyl Alcohol
ChloraPrep
2% Chlorhexidine gluconate
70% Isopropyl Alcohol

21. Preoperative Skin Prep: Application Techniques
2% CHG / 70% Isopropyl Alcohol
For dry surgical sites (e.g., the abdomen or arm): Repeated back-and-forth strokes of the sponge should be used for approximately 30 seconds on the incision site and outward to the periphery.
For moist surgical sites (e.g., inguinal fold or axilla): Repeated back-and-forth strokes of the sponge should be used for approximately 2 minutes on the incision site and outward to the periphery.
As noted above, using a back and forth scrub applies the antiseptics with sufficient friction to encourage exfoliation and/or deeper penetration of the superficial layers, as well as the cracks and fissures of the skin.
Total prep time is 30 seconds / 2 minutes followed by a 3 minute dry time in non-hairy areas and up to 1 hour for hairy areas
For dry surgical sites (e.g., the abdomen or arm): Repeated back-and-forth strokes of the sponge should be used for approximately 30 seconds on the incision site and outward to the periphery.
For moist surgical sites (e.g., inguinal fold or axilla): Repeated back-and-forth strokes of the sponge should be used for approximately 2 minutes on the incision site and outward to the periphery.
Total prep time is 30 seconds / 2 minutes followed by a 3 minute dry time in non-hairy areas and up to 1 hour for hairy areas
AORN Recommends the use of Sterile Gloves during prepping unless the applicator is of sufficient length to prevent antiseptic and patient’s skin from contact with non-sterile glove.

22. Preoperative Skin Prep: Application Techniques
2% CHG/70% Isopropyl Alcohol
Latex free
External use only
No contact to patient’s eyes, ears, or mouth, lumbar puncture, intravaginal, etc.
Do not use on children under 2 months
Avoid freezing and excessive heat
Allow to dry
No pooling of solution
26 ml Not recommended for head and neck surgery
Remove wet materials before starting procedure
Other important clinical considerations for using 2% Chlorhexidine gluconate with 70% Isopropyl Alcohol is that it is latex free and for external use only.
The 26ml This combined antiseptic agent is not recommended for head and neck surgery and the solution should not be permitted to come in contact the patient’s eyes, ears, or mouth.
2% Chlorhexidine gluconate with 70% Isopropyl Alcohol should not be used on children less than 2 months of age.
Also be sure 2% Chlorhexidine gluconate with 70% Isopropyl Alcohol is stored at temperatures between 15° and 30° celsius (or between 59° and 86° fahrenheit); avoid freezing and excessive heat above 40° celsius (or 104° fahrenheit). Storing this product outside of the recommended temperature range may cause an inconsistent appearance in its tint.
2% Chlorhexidine gluconate with 70% Isopropyl Alcohol should be allowed to dry. Do not allow solution to pool, and be sure to remove wet materials, especially before a heat source during a procedure is used.

23. Preoperative Skin Prep: Application Techniques
2% CHG / 70% Isopropyl Alcohol
Allow to dry completely
Do not let solution pool
Do not use 26ml applicator for head and neck
Do not use on small areas
Remove any wet materials prior to using ignition source
As with all products containing alcohol:
Do not drape or use an ignition source until the solution is completely dry (a minimum of 3 minutes on hairless skin and up to 1 hour in hairy areas);
Do not allow the solution to pool;
Do not use for head and neck surgery on an area smaller than 8.4 in. x 8.4 in. - use smaller applicator instead; and
Remove any wet materials on drapes and gowns before starting procedure
Special note:
According to the AORN guidelines, marking of the skin done with an alcohol based surgical site marker before preparation does not increase amount of microorganisms on the skin. Water-based markers may wash/rub off during skin preparation and have been found to transmit MRSA in labatory testing.

24. Fire Safety Flammable prep agent = ALCOHOL
Do not allow prep agent to pool on or under body parts
Allow prep agent to dry
Allow vapors to dissipate before applying drape
The AORN Recommended Practices for Preoperative Patient Skin Antisepsis provides guidance for fire safety: 
If a flammable prep agent is used, such as alcohol, minimize the risk of a surgical fire and patient burn injury.
Be familiar with the flammability characteristics of all prep agents stored or used in the patient care area.
Prep agent should not contact fabric or be allowed to pool on or under body parts (for example, the umbilicus or groin)
The prep agent should be allowed to dry and vapors to dissipate before applying an incise drape or surgical drape, or before using electro surgery, laser, or other heat source, since the prep agent remains flammable until it is completely dry.
Picture source -

25. Fire Safety
Alert all personnel about the use of a flammable preparation agent through active communication and during the “time out” period
Do not heat flammable
skin preparation agents
The use of a flammable preparation agent should be discussed during the “time out” period to alert all personnel to the inherent risks and also verify that all appropriate precautions have been taken.
Active communication about the use of flammable prep agents alerts all personnel to the inherent risks and also verifies that the appropriate precautions have been taken.
Flammable skin preparation agents should not be heated, as heating flammable preparation agents poses a serious risk of fire. When the temperature of these agents increases, they become more unstable and may ignite more easily.

26. Issues Related to Shaving
Shaving attributed to microscopic cuts in the skin
Cuts are foci for bacterial multiplication1
If shaving performed >24 hours prior to operation, infection rate exceeds 20%2
When considering why use of a razor should be discontinued and replaced with clippers, the safety and integrity of the skin must be a prime concern. The act of shaving results in microscopic cuts to the skin. These cuts allow introduction of transient and resident organisms to get by the body’s first line of defense. These organisms continue their usual patterns of multiplication and are able to begin an invasive process. The issues involved in shaving of the operative site have been of interest to surgeons for a number of years. Research done by Seropian has been accepted as a major demonstration of the negative impact of operative site shaving. That work showed that shaving performed more than 24 hours before surgery yielded an infection rate of more than 20%.
References
Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol 1999; 20: ; quiz
Seropian R, Reynolds BM. Wound infections after preoperative depilatory versus razor preparation. Am J Surg 1971;121:251-4.
1. Martorell C, Engelman R, Corl A, Brown RB. Surgical site infections in cardiac surgery: an 11-year perspective. AM J Infect Control. 2004;32(2):63-68.
2. Institute of Healthcare Improvement. Surgical Site Infections. Available at: Accessed December, 2007.
Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol 1999; 20: ; quiz
Seropian R, Reynolds BM. Wound infections after preoperative depilatory versus razor preparation. Am J Surg 1971;121:251-4. 26 26

27. Micro Abrasions Before Clipping After Clipping Before Shaving
After Shaving

28. Recommended Practices for Clipping
Leading healthcare industry organizations recommend that, when preoperative hair removal is necessary, it should be done with clippers instead of razors.
• Centers for Disease Control and Prevention (CDC)
• Association of Perioperative Registered Nurses (AORN)
• The Institute for Healthcare Improvement (IHI)
• The Surgical Care Improvement Project (SCIP)
• The 2008 ISDA Compendium
• Greater Healthcare now-Canadian SSI guidelines

29. Recommendations: AORN
If hair interferes with the surgical procedure, ideally remove it:
the day of surgery
outside the operating or procedure room
From only those areas where it interferes with the surgical procedure
using a single-use electric or battery-operated clipper, or a clipper with reusable head that can be disinfected between patients
Always follow Manufacturers’ Directions for Use (DFUs)
Influential organizations such as the Association for Perioperative Registered Nurses (AORN) has taken steps to include evidence-based recommendations in their standards and practices. AORN recommends that if the presence of hair will interfere with the surgical procedure and it is in the best interests of the patient, hair removal should occur the day of surgery, removal should be performed in a location outside the operating or procedure room, hair should only be removed from the patient from areas where its presence will interfere with the surgical procedure, and hair should be clipped using a single-use electric or battery operated clipper, or a clipper with a reusable head that can be disinfected between patients. 29 29

30. In Conclusion KEY to effective preoperative patient skin antisepsis
Antiseptic agents supported by clinical evidence
Proper application technique
So in conclusion -
Effective preoperative patient skin antisepsis - including the use of an appropriate antiseptic agents supported by clinical evidence and proper application technique as specified in the manufacturer’s written instructions – is a key strategy in reducing the microbial count on the patient’s skin.
Picture source -

31. Questions?