HouseKeeping 4/10/ M Learning Connection Website

(1)

Today’s Topic

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

5770.

3M Learning Connection Website

www.3M.com/IPEducation

(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

Disclosure

• Employees of 3M Infection Prevention Division Laboratory,

Supporting Antiseptic Drug Products

Objectives

• Describe how surgical skin prep directions for use are

obtained

• Discuss the importance of following directions to achieve

efficacy

y

• Describe the differences in directions for use of 3 surgical

skin preps

(3)

Authoritative Guidance

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

”

TFM Testing – Patient Pre-op Prep

•

In vivo

testing

– Healthy volunteers

– Abdomen/groin cup scrub method

• ASTM Designation: E 1173-01, Standard Test Method for

Evaluation of Preoperative Precatheterization or Preinjection

Evaluation of Preoperative, Precatheterization, or Preinjection

Skin Preparations

– ASTM Designation: E 1054-08, Standard Test Methods

for Evaluation of Inactivators of Antimicrobial Agents –

(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

http://multimedia.3m.com/mws/mediawebserver?66666UuZjcFSLXTtmXME48&cEVuQEcuZgVs6EVs6E666666--Abdomen & Groin Efficacy Study

Meets FDA Criteria

Abdomen

Meets FDA Criteria

Groin

10 min

6 hour

10 min

6 hour

Povidone Iodine

Yes

Additional Considerations

Skin Preparation

Scrub & Paint

Aqueous CHG scrub

Yes

Iodine

Povacrylx/alcohol

Yes

(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. 1.

=

Dose of Bacteria

(

Contamination

)

X

Virulence

(Resistance)

Risk

Process Variability

=

Resistance of the host (patient)

Risk

Patient Variability

Guideline For Prevention Of Surgical Site Infection, 1999

http://www.cdc.gov/ncidod/dhqp/gl_surgicalsite.html

Pathogens

SSI

Distribution of Top Ranking Pathogens

(January 2006 - October 2007)

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

Staphylococcus aureus 30.01%

Coagulase Negative Staph (CNS) 13.74%

Enterococcus spp. 11.21% 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), 2006-2007. http://www.cdc.gov/ncidod/dhqp/SHEA_Abstract1.html

(6)

•

Age

•

Compromised Immune System

•

Diabetes

•

Remote Site Infection (Not Treated Prior To Surgery)

•

Nutritional Status

Patient Variability

Resistance of the host (patient)

•

Nicotine Use

•

Prolonged Preoperative Stay

•

Obesity

•

Steroid Use

•

Duration Of Surgery

•

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

Process Variability

p

g

• Ventilation, Traffic, Environmental Surfaces • Sterilization

•

Patient Management

• Normothermia • Glucose control • Oxygenation

•

Surgical Technique:

• Hemostasis

• Failure to obliterate dead space • Tissue trauma

Evidence

surgical site infection

as the main outcome

measurement

(7)

Swenson et al.

(Infect Control Hosp Epidemiol 2009;

30:964-971)

Darouiche et al.

(N Engl J Med 2010; 362:18-26)

Title

“Effects of preoperative skin

preparation on postoperative wound

infection rates: a prospective study

“Chlorhexidine-Alcohol versus

Povidone-Iodine for Surgical-Site

Antisepsis”

Clinical Studies Evaluating Effect of Prep on SSI Rate

y

of 3 skin preparation protocols”

Design

Quasi-experimental

, (sequential

assignment of interventions)

single center

Randomized

six centers

Surgical Skin Preparations Used

Treatments:

Swenson et al.

(Infect Control Hosp Epidemiol 2009; 30:964-971)

Darouiche et al.

(N Engl J Med 2010; 362:18-26)

Povidone

Iodine

PVP-I scrub

(7.5% PVP-I) 3 consecutive applications

PVP-I scrub

Application protocol not described

Alcohol

paint

(70% isopropyl alcohol)

PVP-I paint

(10% PVP-I)

PVP-I paint

(10% PVP-I)

X

Iodine

(PVP-I)

pa t

( 0% ) 3 consecutive applications

pa t

( 0% ) Application protocol not described

Allow prep to dry Application protocol not described

CHG

2% CHG and 70% Isopropyl Alcohol

ChloraPrep®

30 sec or 2-min application – Application protocol not described in NEJM study

Iodine

Povacrylex

Iodine Povacrylex

[0.7% available iodine]

and Isopropyl Alcohol

(74% w/w)

DuraPrep™

X

Swenson et al.

(Infect Control Hosp Epidemiol 2009; 30:964-971)

Darouiche et al.

(N Engl J Med 2010; 362:18-26)

Surgery

Type

General surgery (clean,

clean-contaminated,

dirty)

Clean-contaminated (included

specialty surgeries, eg, gyn,

urol, gi, thoracic)

Primary

Any SSI within 30 days of surgery

y

outcome

y

g y

Secondary

outcome

Any SSI within 30 days of

surgery tracked by prep

received

Individual types of SSI

Number of

Subjects

(8)

Swenson et al.

(Infect Control Hosp Epidemiol 2009; 30:964-971)

Darouiche et al.

(N Engl J Med 2010; 362:18-26)

Overall SSI

Rates

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)

By Prep Actually Received:

PVP-I with alcohol 4.8%

PVP-I 16.1%

Chlorhexidine-alcohol 9.5% (P=0.004)

Chlorhexidine gluconate-alcohol 8.2%

Iodine povacrylex 4.8% (P=0.001)

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)

Conclusions

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

povidone-iodine

for preventing SSI after

clean-contaminated surgery

Swenson et al.

(Infect Control Hosp Epidemiol 2009; 30:964-971)

Darouiche et al.

(N Engl J Med 2010; 362:18-26)

Limitations

•

Not randomized

(justification: authors wanted to implement protocol as commonly seen in practice and maximize the consistency of prep application)

•

DuraPrep,

one of the commonly used

one-step skin preps in the USA, was

not

included

•Compared CHG/Alcohol with a

reference

prep containing only PVP I without

y p p pp )

•

Single center

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

Bacterial Count Studies Comparing

Surgical Preps

Efficacy of surgical

preparation solutions in

foot and ankle surgery

preparation solutions in

shoulder surgery

preparation solutions

in lumbar spine

surgery

Published

J Bone Joint Surg AM. 2005:87A:980-985 Roger V. Ostrander, et al.

J Bone Joint Surg AM. 2009:91:1949-53 Matthew D. Saltzman, et al

J Bone Joint Surg AM. March 2012 Jason W. Savage, et al.

Study Design

Prospective, randomized study evaluating 125 consecutive patients undergoing foot or ankle surgery

Prospective, randomized study evaluating 150 consecutive patients undergoing shoulder surgery

Prospective, randomized study evaluating 100 consecutive patients undergoing elective lumbar spine surgery

Active ingredient

neutralized per ASTM

test methods

NO NO YES

Products Studied

ChloraPrep DuraPrep Techni-Care

ChloraPrep DuraPrep Povidone Iodine Scrub/Paint

ChloraPrep DuraPrep

(9)

and ankle surgery

in shoulder surgery

in lumbar spine

surgery

Study Endpoint

Positive cultures

after prep Positive cultures after prep after wound closurePositive cultures

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 skin-preparation 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

Skin Antisepsis

Post-Operative

Intra-Operative

Peri-Operative Process

Pre-Operative

•Antiseptic Skin Preparation •Persistent Activity of Skin Antiseptic •Removal

Pre-operative/Intra-operative

Surgical Site Patient Skin Preparation

Assessment

2012 AORN Recommended Practice # III

•

The antiseptic agent should be selected based on the

patient assessment

p

• Allergies

• Skin condition

• Surgical site

• Manufacture’s written information

• Contraindications

• Surgeon preference

• Antiseptic agent selection

(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 the Prevention of Surgical Site Infection2

Use an appropriate antiseptic agent for skin preparation (Table 6). Category IB

Apply preoperative antiseptic skin preparation in concentric circles moving toward the periphery. The prepared area must be large enough to extend the incision or create new incisions or drain sites, if necessar Categor II

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.

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. 1.

2. Centers for Disease Control and Prevention, “Guideline for Prevention of Surgical Site Infection,”

Infection Control and Hospital Epidemiology, Vol 20, No 4, April 1999 3. Perioperative Standards and Recommended Practices, Patient Skin Antisepsis AORN, 2009

None of these state that one antiseptic agent is preferred over another

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.”

(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

Intra-operative

Surgical Site Patient Skin Preparation

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

t

i ti

ki i t

it d

t ti

contamination, preserve skin integrity, and prevent tissue

damage

Intra-operative

Surgical Site Patient Skin Preparation

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

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

(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

http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter07-11.pdf

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

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).”

Label Change

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.”

Intra-operative

Manufacturers’ Directions

2012 AORN Recommended Practice # IX

•

Manufactures’ written recommendations and MSDSs

f h dli

t i

d h ti f ll ki

for handling, storing, and heating of all skin

preparation agents should be readily available,

reviewed, and followed.

(13)

Intra-operative

• Competency

• Education, training competency validation

• Agent selection

• Application procedures

Application procedures

• Patient assessments

• Policy & Procedures

• Written and reviewed annually

• Quality management program

• Respond to opportunities for improvement

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.

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

(14)

Patient Safety

Application Instructions

• Iodine Povacrylex/Alcohol

•

Paint a single uniform coat

• CHG/Alcohol

•

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

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

End user should read all directions and warnings

•

Safe use of the product

•

Achieve efficacy

“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

d ti i

i f ti t

t l

t f

i f ti t

”

reduction in

infection rates

, at least for some infection types.”

HHS Action Plan to Prevent Healthcare Associated Infections: Research