From Sterile Processing Department (SPD) to Presentation in the OR

Laurie Clark, B.S., M.T. (ASCP)Senior Manager, Medical Sciences and Clinical Education – Halyard Health

Keep the Micro-Bugs Out!: From Sterile Processing Department (SPD) to Presentation in the OR

1. List requirements and expectations of SPD staff members

2. Identify vulnerable steps prior to sterilization that can result in non-sterile instruments and devices if not addressed properly

3. Describe how the contents of sterilized wrapped packs and rigid containers can become contaminated after sterilization.

Objectives

SPD (Sterile Processing Department)

• More than simply involved in the re-processing of surgical instrumentation and other equipment and supplies, the sterile processing technician is an essential component of perioperative healthcare.

SPD staff

Expectations:• Receive, clean, decontaminate, assemble,

disinfect and/or sterilize reusable medical and surgical devices for patient care.

• Cleaning and disinfection/sterilization of medical devices is critical for the patient, as is post-sterilization sterility maintenance!

Infection & Microbes

Crimean War: Death Rate Appalling Nightingale found 10 X soldiers died from

hospital infections than directly from their battle wounds!

She and volunteers cleaned & disinfected hospital and cared for wounds

Results: 6 months of disinfection dramatically reduced infections & deaths of wounded soldiers

Of The Wounded 42% died before disinfection started

2% died after disinfection

Infections

Remarkable Strides! 1940s WWII: Introduced antibiotics (penicillin)

1950s: integrated hospital design with hygienic practices

Late 1970s - 90s: drugs to combat viruses

1978: United Nations announced:

McGowan JE 1981; Maki DG 1982

1980s: believed antibiotics and infection control so successful that hospital environment made little impact on infection

by the year 2000, infectious diseases would not pose a major threat to human beings

even in the poorest countries !!

However…… Since 1970 over 30 new human infectious diseases emerged In 1998 alone, 15 million died of infectious diseases globally Bacteria and viruses have developed many ways to resist the

antibiotics and drugs used treat the infected patients!! In our hospitals: 1 out of 20 patients acquire an infection!

So…how do we prevent infections related to surgery and invasive procedures?

=Probability of serious infection and poor recovery

X__________________________

Number of that pathogen exposed to

Body’s ability to fight off an infection

What Determines Whether or Not You Get An Infection?

Decreased susceptibility of the pathogen to the

usual antibiotics

Pathogen aggressiveness (virulence)

Antibiotic Resistance: Who Will Win?

Within 2 yrs of first use of penicillin, cases of resistance reported

Today: 95% of Staphylococcus aureus are resistant to penicillin

WHO: 60% of S. aureus are methicillin-resistant (MRSA)

70% pathogens resistant to at least 1 of their primary treatment drugs

US Food and Drug Administration http://www.fda.gov/oc/opacom/hottopics/anti_resist.html

Kill Zone

Thick “lawn” of bacterial growth

Filter paper soaked in an effective antibiotic

Filter paper soaked in a different antibiotic to which the bacteria are now resistant

Test: Antibiotic Resistance

Thomas Frieden, M.D., M.P.H., Director Centers for Disease Control and Prevention

“… we are potentially headed for a post-antibiotic world in which we will have few or no clinical

interventions for some infections.”

CDC Congressional Testimony: April 28, 2010Antibiotic Resistance and the Threat to Public Health

Methicillin Resistant Staphylococcus aureus (MRSA)

MRSA Staphylococcus: antibiotic resistant

A few bacteria caused tiny infection after surgery

19 months and 17 surgeries later: leg removed

Then spread to other leg

“Just take it off ”

Robert McDougall (diabetic)

MRSA Resistance & Aggression

US: David Fitzgerald

Surgery to remove benign bump on head

Post surgical MRSA infection

Septic shock = damaged all limbs

Gangrene ensued: all limbs removed

Awarded $17.5 million by jury, but state caps on pain and suffering reduced to $7.5 million

MRSA: 50% higher death rate from infection than antibiotic susceptible Staphylococcus aureus (MSSA)

Antibiotic Resistant Bacteria +Secreted Toxins Increase Virulence

Vancomycin Resistant Enterococcus (VRE) Some bacteria have strong toxins: destroy tissues

And are resistant to Vancomycin, one of the most powerful antibiotics we have

Whole hospital units are often closed when VRE outbreaks occur

Antibiotic Resistance + Virulence (Aggressive Toxin)

Multi drug resistant Pseudomonas (MDRP)

Mariana Bridi 20 year old Brazilian finalist in Miss World pageant 2009

Acquired MDRP urinary tract infection

Infection went septic (blood stream & throughout body) within a few weeks as antibiotics failed

Necrosis of her hands and feet so they had to be removed in efforts to save her life

Died a week later

So…

• We must do everything in our power to prevent the micro-bugs from getting into the patient/surgical site in the first place!!

What Are These Micro-Bugs – These Infection-Causing Pathogenic Villains?

• Pathogens = germs = microorganisms that cause disease

• Human pathogens = microorganisms that cause infections/disease in humans

• Microorganisms: the basic categories– Fungi– Bacteria– Viruses

Yeast, Fungus, Mold: Larger Than Bacteria

Ex. Candida: yeast that buds into fungus

Aspergillus fungus (flavus, niger)– in nature – some houses especially after wetness– disturbed during remodeling and construction – devastating for bone marrow transplant &

cancer patients

Aspergillus on cotton fibers

Bacteria - Divided By Traits Shapes

• Spheres• Rods• Spirals

Gram Stain• Gram positive (+)• Gram negative (-)

(Many other bacterial stains used but this is most traditional)

Appendages

Ability to produce spores

Bacteria: Gram Staining Gram stain: First step in identifying bacteria Basically divides bacterial world into 2 colors Start: Drop suspension of bacteria onto slide Heat over flame – sticks bacteria onto surface

When acetone/alcohol added: Gram (+) stay purple Gram (-) lose purple & then

counter-stain red with safranin

Bacterial Shapes & Appendages

Shapes: Cocci

Rods; Bacilli

Sprillium

Appendages:

Anthrax: Standard Gram Stain & Scanning Electron Microscope

Standard Microscope Electron Microscope

How Fast Do Bacteria Multiply (Reproduce)? Depends on many variables, but an example below As they become crowded, they will slow down

Time Number of Bacteria

12:00 112:20 212:40 41:00 82:00 643:00 5124:00 4,0965:00 32,7686:00 262,144

In the Microbial WorldHow Big You Are, Is Irrelevant!

Bacteria: E. coli highly magnified being attacked by viruses

Note: Size relationship virus to bacteria Lack of fimbriae or pili (appendages)

on virus-infected E. coli

E. coli

Viruses: attacking E. coli

Bacteria: Escherichia coli (E. coli) green rods attacking the white blood cell trying to defend against invader(s)

White blood cell (orange)

Viruses That Infect Human Cells

Viruses that infect humans are divided into 2 types:– Non-enveloped viruses– Enveloped viruses

Further divided into RNA or DNA depending on their genetic nucleic acid (instructions to force human cells to replicate them)

Non-enveloped Viruses

Enveloped Viruses

Viruses Viruses cannot multiply on their own

• they must take over reproduction apparatus of living cell to multiply

• thus they are not considered alive• each infected human cell churns out 1,000’s to millions viral replicates

before the cell dies • you can kill bacteria & fungi, but you deactivate or destroy viruses

HIV

InfluenzaBacterialViruses (T-phage)

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What They Lose in ReproductionThey Make Up In Quantity Produced

Virus counts below are approximate- per 1 milliliter (ml) of blood (There are 5 mls in one teaspoon)

HIV: 10 to 10,000: (101-104) viruses HCV (hepatitis C): 1,000,000 (106) viruses! HBV (hepatitis B): 10,000,000 to 10,000,000,000,000 (107-1013) viruses!

Bennett NT 1994 American College of Surgeons 178 (2): 107 - 110

1013 = 10 quadrillion!!)

And How Successful Are They At Surviving on Surfaces?

VERY!!

Kramer A. BMC Infect Dis 2006;6:130//(Viruses) Bonilla H F. ICHE.1996;17:770-71

Bacteria Survival on Dry Inanimate SurfacesAcinetobacter 3 days to 5 monthsClostridium difficile (spores) 5 monthsEscherichia coli 1.5 hours to 16 monthsEnterococcus spp. including VRE & VSE 5 days to 4 monthsPseudomonas aeruginosa 6 hours to 16 months; 5 weeks dry floorsStaphylococcus aureus (including MRSA)

7 days to 7 months

Streptococcus pyogenes 3 days to 6.5 months

Fungi/YeastAspergillus conidia (spores) Months or longerCandida albicans 1-120 days

VirusesHBV 2 hours to 60 daysHIV More than 7 daysPapillomavirus 16 More than 7 days

Survival Mechanisms

Situational protection• Crevices, scratches, cracks, grooves, etc.• Organic “gunk”: tissue debris, blood, mucous, feces, etc. • Mineral deposits, detergent residue, hard water deposits• Biofilm formation

Protective Mechanisms on the part of Bacteria• Toxins• Digestive enzymes• Form protective Capsules• Clump together• Spore formation

Before it transforms to a spore

After spore forms

Capsules

Clump

Toxin

FDA Inspection 2008

“Dirty instruments in sterile trays, specifically orthopedic (bone) trays.” In one documented case, “three out of three trays in one day had instruments with bone or cement on them.”

“Residue and debris on sterile instruments in sterile surgical containers.”

“A dirty and grimy sink in the Sterile Processing Department work area.”

“A number of outdated sterile devices and other outdated supplies”

“Failed to ensure the integrity and cleanliness of surgical suites, procedure rooms and sterile processing department.”

“Technician washed dirty surgical instruments with gloves on, then opened a door and answered the phone without removing the wet gloves”

Sterile Processing DepartmentAfter End Of Shift Cleaning: Organic Soil Present

Inspection Exposes Weak Areas• Unannounced Inspection 2009

Multiple hospitals: found that 57% of the time:– do not comply with SOPs for reprocessing– have not properly trained staff on how to clean

dirty endoscopesand 50% had no recorded task training

• Unannounced 2010 State Health inspectors for CMSAmong deficiencies listed: – dirty floors and sinks– soiled instruments & towels – residue on sterile instruments and trays – poor hand hygiene practices– outdated sterile devices and supplies

Endoscopes not sufficiently cleaned

SPD Requirements

• Receives Instruments/Devices• Clean/Decontaminate• Disinfect• Package and Sterilize• Store/Maintain Sterility

Cleaning/Decontamination

Why Removal of Organic Soil So Important?

Usually contains pathogens from infected patients

Almost always microorganisms (from any person)

Food source for bacteria to multiply rapidly

BloodUrineFoodVomitSalivaFecesMucousOil supplementsOoze from woundsRespiratory dropletsBody oils & skin flakes

Organic Soil or Load

Skin flakes: We shed 10,000 per minute!!

Skin flakes: With Staphylococcus

Mouse pad fibers with embedded skin flakes

Organic soil dries to hard shell protects organisms

Hard to clean and disinfect/sterilize

Promotes formation of biofilms

Inactivates many disinfectants

AST Recommended Standards of Practice:Decontamination of Surgical Instruments

“The cleaning of instruments should begin during the surgical procedure to prevent drying of blood, soil and debris on the surface and within lumens.”

• Wipe instruments clean using a sterile, water-moistened sponge

• Flush lumens of instruments with a sterile water-filled syringe

• Instruments that may not be used for the remainder of procedure, soak in sterile water basin

During Procedure

Post-Procedure: Instruments

• Wipe gross tissue residue and blood from instruments with water-moistened sponge

• Disassemble assembled instruments

• Water filled basin not recommended for fear of splashing

• Never soak in saline or sodium hypochlorite (bleach): chloride ions are corrosive

• Soak in sterile water & enzymatic detergent (refer to mfg.’s IFU)

Post-Procedure: Instruments

• Keep instruments moist in transport container by covering with wet towel preferably over instruments treated with spray, foam or gel product-specifically intended for this purpose.

• To prevent splashing, do not transport in soaking solution

• Take care to protect instruments and rigid containers!

Endoscopes Can Be Difficult to Clean

Alvarado CJ. AJIC Am J Infect Control 2000;28:138-55

Encrustations of patient material (blood, feces, gastric mucin) inside scope even though flushed and brushed before disinfection

Contributes to disinfection failures by harboring microbial biofilm preventing germicide penetration

Endoscopes: Protective Tubes for Bacterial Growth and Multiplication

(A) Communities (biofilm) of healthy multiplying bacteria observed - after scope left for days before processing

(B) Soil & dried biofilm after scope processed and sterilized

Reports of contaminated devices into sterile field – bone – tissue– dried blood

Pajkos K J Hosp Infec 2004;58:224-9

B

A

Post Procedure: Endoscope

“Immediately after removing the endoscope from the patient, wipe the insertion tube with the wet cloth or sponge soaked in the freshly prepared enzymatic

detergent solution.”

“Cleaning of endoscopes and accessories should be performed with nonabrasive, manufacturer-recommended

enzymatic detergents for medical instruments promptly after use to prevent drying of secretions (this portion of

reprocessing takes place in the procedure room).”

Disinfection

How to Make A Disinfectant NOT Work!• Organic debris left on surfaces or instruments:

– protein containing materials – tissue– fats– dried bodily fluids

• Dried mineral deposits that hide microorganisms• Not opened during cleaning or disinfection

– scissors– box locks– jaw type devices

• Not disassembling complex devices• Not treating endoscopes immediately after

procedure• Not pre-cleaning instruments completely before

disinfection/sterilization

Problems with Disinfectants Concentration too low pH not adjusted to optimal Insufficient contact with organism

− contact time too short− physically not in contact with organisms

Wrong type of water used for dilution Tap water or deionized rinse when sterile required Recontamination of item after disinfection Wrong disinfectant for pathogen

(ex. C.difficile; Mycobacterium)

Contaminated disinfectant

Disinfectant

Hospital Outbreaks Traced Back To Contaminated Disinfectants

Disinfectant Pathogens ContaminatingDisinfectant

Alcohol (Isopropyl & Ethanol) • Clostridia (& other spore-formers)Chlorhexidine • Pseudomonas aeruginosaPhenolic based • Alcaligenes Formaldehyde • Serratia marcescensGlutaraldehyde • Flavobacterium Pine Essence • Stenotrophomonas maltophiliaQuaternary ammonium • Burkholderia cepacia

If disinfectant contaminated, pouring it out & refilling container does NOT remove microbial biofilm & will contaminate refill liquid

Do You Have The Right Disinfectant?

Levels of Kill Difficulty

PrionsTransmissible Spongiform Encephalopathy (TSE); Creutzfeldt-Jakob disease(CJD)Mad cow disease; Scrapies

Bacterial SporesSpores of: C. difficile; C. tetani; C. botulinum; C. perfringens; Anthrax

Mycobacteria M. Tuberculosis (TB); M. avium; M. leprae

Viruses without envelopesNorovirus; Rotavirus; Rhinovirus; Poliovirus; Papillomavirus (HPV); Coxsackie; Adenovirus

Fungi and fungal sporesAspergillus fumigatus, A. flavus; A. niger;Candida albicans

Gram negative bacteriaPseudomonas, Acinetobacter, Klebsiella, E. coli; Enterobacter, Legionella

Gram positive bacteriaStaphylococcus; Enterococcus; Streptococcus; Clostridia vegetative rods

Viruses with lipid envelopesInfluenza; HBV; HCV; HIV; RSV; Coronavirus; CMV; HSV; Measles, Mumps; Rubella; VZV (Varicella-Zoster) Shingles/ Chickenpox

Har

der

to K

illExtremely Hard to kill

Easy to kill 50

Example: Clostridium difficile spores are Hard To Kill

Normal cleaning and disinfection practices in most hospitals will not kill C. difficile spores

They are like golf balls with layers of tough hard protection

Below, the white or area of concentric circles are spores

Har

der

to K

ill

Easy to Kill

Surface Disinfectant ActivityBacterial spores

Mycobacterium (tuberculocidal)

Viruses without envelopes

Fungi & fungal spores

Gram negative bacteria

Gram positive bacteria

Enveloped (lipid) viruses

Soaps & Detergents

Quats

Quat/alcoholblendsPhenols

(Low to medium dependson conc.)

Hydrogen Peroxide

or

BleachHypo-

chlorite

Peracetic acid

or

Peracetic acid/

hydrogen peroxide

blend

Extremely hard to Kill

Alcohol

AldehydesGlutaraldeFormalde

Ortho-phthalde(fewer Resistantbacteria)

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Clostridium difficile

Important: The following will NOT kill bacterial spores

Quaternary ammonium compounds

Phenols

Alcohols

They are not sporicidal

30,000 deaths/year

Case: Harrison 63yr Oil Industry Salesman, TX

• Shoulder surgery and one night hospital stay, Couple weeks later: – scar bright red – hot to the touch– oozed puss

• 2 weeks later: 7 hrs back to hospital, infection had:– eaten away part of shoulder bone and rotator cuff– screws were loosened– sutures came loose

• 6 follow-up surgeries over next 2.5 yrs: still can’t lift arm in the morning

• He’s only one of 7 patients who acquired infections over 2 weeks in same orthopedic surgical unit (shoulders, knees)

• CDC found 2 culprits: Debris deep inside arthroscopic, & inflow/outflow cannula

“But Not In Our Facility!”• 2009-2010: FDA audits of 1,500 outpatient surgical centers

found 28% cited for infection control

• Azizi used camera down 350 post-processed suction tips in one hospital: all contained debris.

Packaging & Sterilization

Remember:

• We must do everything in our power to prevent the micro-bugs from ever getting into the patient/surgical site in the first place!!

• Therefore… we MUST deliver clean, sterile instruments and devices to the point of care.

Inspection and Assembly

• Scrupulous inspection of cleaned devices and packaging is critical

All devices must be completely clean:“If it is not clean, it can’t be sterilized”

• All packaging must be inspected for any possible damage which might lead to contents becoming unsterile after sterilization.

Inspection: Sterilization Wrap

Linting, fraying, organic soil

Edmiston AORN J 1999 lint in OR paper & cotton

Check for Holes & abraded areas:

Check for Linting:

Inspection: Rigid Containers

– Rigid Containers must be thoroughly inspected prior to use:

• Gaskets• Filter(s)• Filter retention plates (gasket and for proper fit)• Or valves (if appropriate)• Latches

Inspection: Rigid ContainersReusable:Barrier integrity may be compromised:

Latch securement to container can deteriorate, stress loosen

Gasket seals can be damaged by repeated high heat, steam, mechanical stress, oxidation, dents, gouges, cracks

Rivets, bolts, nuts loosened by reprocessing, transport, jostling

Transport/handling:dents, cracks, chips, stress fracture, warping

Filters poorly secured, retention plates loose, gasket seals oxidize, deteriorate; are punctured, gouged, abraded

Packaging• Wrap:

– Use proper grade for weight of item to be packaged– Two sheets, wrapped sequentially or simultaneously– Folds: Square fold, envelope fold or smart-fold

• Pouches:– Used for lightweight items– Remove excess air before sealing (heat or self)– Not to be used inside wrapped trays or rigid containers– Label on film side

• Rigid Containers:– Filters must cover entire perforated area– Lid must fit tightly to bottom to make seal– Latches should click when closed– Tamper-evident locks should be used

Properly Package Item(s)

– Packaging must be compatible with sterilization processes

– Finished package should not exceed 25 pounds– Proper monitoring:

• Gauges and charts• Chemical Indicators

– Chemical Integrators

• Biological Indicators

Loaners Receiving loaners: Should be received with sufficient

time to clean and sterilize in advance of procedure:– contents considered contaminated upon receipt– you are responsible for the contents sterility– transported in uncontrolled vehicle– require FDA cleared instructions: handling & reprocessing– inspect for damage– remember BI (Biological Indicator) for implants; quarantine until

results received

Verify Manufacturer’s Validation for theSterilization Process & Cycle

Packaging Materials Recommended Sterilization Compatibilities

Muslin (aka: cotton, linen, textile) wovens Steam, EO, dry heat (if not in excess of 425˚F)

Peel packs (plastic &/or laminated paper) Steam, EO

Paper wrap (crepe paper) Steam, EO

Tyvek* (polyethylene) EO, low temperature gas plasma - NOT STEAM

Polypropylene (aka: Polyolefin - plastic) nonwovens Steam, EO, low temperature gas plasma

• If not compatible, the packaging:– not let the sterilant into the device– melt – catch fire– lose its barrier integrity

Post-Sterilization

We MUST keep the Micro-Bugs OUT

Sterilized Package

After sterilization, sterile contents can becomere-contaminated

even though chemical indicators have turned

Cool Down Period: Packs & Containers A Vulnerable Time

• Cool down starts inside sterilizer, reducing potential for condensation (packs & containers): usually door left slightly ajar

• After removal from sterilizer:– cool for a minimum 30 minutes– some loads require 2 hours or more – should stay on sterilizer cart until adequately cooled: both packs &

containers

• Place cart away from traffic and air conditioning vents• While cooling, Do Not:

– touch hot packs as they can absorb moisture and with it bacteria from hands (wicking)

– place warm packs on cool storage racks: condensate could form– place dust-covers on until cooling completed (moist vapor cannot escape so

condensate forms on inside and covers are not sterile)

• A Wet Pack is not acceptable (considered non-sterile)

Storage ConditionsCan compromise pack/container sterility• Handling for access and rotation: abrasion,

tears, puncture• Environment: moisture, temp control,

microbial contamination• Human traffic patterns: stir up bacteria

Focused areas to preserve pack sterility• Environmental and pest controls• Appropriate storage systems & placement• Proper handling

Storage Conditions• Limit traffic to authorized personnel only

– Healthy staff, vaccinations, proper attire, personal hygiene, no food– Lift, don’t drag sterile packs– Hair totally enclosed/contained– Strict hand washing or alcohol based hand rub policy enforced/monitored

• Filter air from ventilation system – Positive air pressure in relation to adjacent areas – Temperature: Not to exceed 75◦ F

• Moisture a major cause of contamination – wetted fabric may allow bacteria through (wicking) – high humidity can cause wicking if not fluid resistant– tapes lose adherence strength– labels or indicator tapes may lose adherence– microbial growth can occur– humidity not to exceed 70% in storage area (AAMI ST79)

Examine for Possible ContaminationIndicator shows pack was exposed to conditions leading to sterility, not that it is (still) sterile

Check Wrapped Packs & Pouches:

No holes, abrasions, snags, tears

Closure still intact

Not wet, or stained indicating past wetness

Check Rigid Containers:

Container lock secured & no evidence of tampering

No dents or breached gaskets

Filter(s) still properly secured by retention plate & no evidence of breach

No dirt, lint, dust, debris on container or wrap

Transport

Clean and dry cart before storage or return to use– automated system: prepare & place cart as directed– or wash by hand

Use for transporting sterilized items only

Transport challenges:– dirty carts– rough handling, bumping, abrasion– stacking, shoving– pressure variations with elevators – temperature variations

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In the Operating/Procedure Room

• Contents of pouches, packs dropped into position, take care not to puncture or contaminate sterile table cover

• OR should open close to time of procedure

• Dalstrom Study: Contaminated when left open in OR− 4% at 30 minutes− 15% at one hour− 22% at 2 hours− 26% at 3 hours− 30% at 4 hours

• AORN recently removed recommendation not to cover

Dalstrom DJ, 2008

Keep the Micro-Bugs Out Daily Reminders

Things we often fail to think about:

• Keep things dry

• Hang scrubbers and brushes

• Do NOT refill soap or lotion containers

• Clean and disinfect dead spaces

• Scrub surfaces, don’t just glide over

• Clean & disinfect thoroughly at end of shift

• Don’t leave mineral residues on surfaces

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Essential Take-Home Reminders

Education a must!: − patient consequences &− task requirements – certification & kept current

Clean, remove soil− prevent drying on surface− use proper techniques to disassemble

Right disinfectant/sterilization products/practices Ensure sterility is achieved and protected

− use correct packaging− inspect for defects/damage− use correct sterilization parameters− appropriate cool-down − store and handle appropriately− employ protected clean transport

Not Just a job, but a critical

healthcare profession!

New Healthcare: CMS blessing will be essential for payment, attracting

patients, reducing legal liability

With…• the best cleaning, disinfection, sterilization practices

• the right up-to-date products and technologies

• an embraced attitude of Continuous Improvement

• an inner realization that we alter people’s lives daily

Remember

We All Win!!

Staff areProud of it

Patients couldn’t be happier!

Accounting loves it