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