Cheri Ackert-Burr, RN, MSN, CNOR, AGTS

Clinical Education Manager

BIOFILM AND MEDICAL DEVICES

Disclosures

1. Successful completion: Participants must complete the entire program and submit the required documentation

2. Conflict of interest: Planners disclose no conflict; the speaker discloses employment with Medivators, thereby declaring a conflict of interest.

3. Commercial company support: Fees are underwritten by education funding provided by Medivators

4. Non-commercial company support: None

5. Alternative Complementary therapy: None

Learner ObjectivesUpon completion of this presentation,

participants will be able to:Discuss the concept of biofilm communities in

medical devices and in the human bodyExplain the relationship between biofilm and

endoscope/instrument contaminationRelate findings from studies and literature to

clinical area practiceCompare two detergent agents in their

effectiveness against biofilmState three best practices of disinfection

which are particularly important in biofilm elimination

GlossaryExo-polysaccharide (EPS): polymers that

are composed of sugar residues and are secreted by a micro-organism into the surrounding environment. Capsular exo-polysaccharides can protect pathogenic bacteria and contribute to their pathogenicity.

Glycocalyx: a general term referring to extra-cellular polymeric material produced by some bacteria composed of carbohydrates, lipids, and proteins. AKA - SLIME

Glossary (cont’d)Planktonic: passively floating, drifting, or

somewhat motile organisms occurring in a body of water.

Sessile: fixed in one place; immobile. Attached by a broad base. Being attached to the substrate or base; not freely moving

Vegetative Bacteria: bacteria that are devoid of spores and usually can be readily inactivated by many types of germicides.

What is Biofilm?Biofilm: a collection of microorganisms

surrounded by the slime they secrete, attached to either an inert or a living surface. Up to 99% of all bacteria live in biofilm communities.

Three basic elements to a Biofilm:MicrobesGlycocalyx/Exo-Polysaccharide (EPS)Surface (inert or living)

Biofilm Lifecycle

Biofilm

Microbially derived sessile communityIrreversible attachmentMatrix embeddedAltered phenotype

Biofilm Formation

First observations Communities vs. free-floatingFormation in high-shear vs. low-sheer

environmentsPolysaccharides adhere to the surface of

medical device and allows other substances to adhere to the surface

Where does biofilm live?In industry—biofilms are used to aid in

decontaminating waterClogging filtersFound in water systems

Not just drains, but in the water supply as well—in fact, the higher the water pressure, the more tenaciously the biofilm attaches to the pipe!

But where else do they live???

River Rocks

On teeth

In the Body

Colonization Environments

Biofilm in the human body> 80% of microbial infections are

caused by biofilm – NIH estimate

Biofilm in Endoscopes

New endoscopes and biofilmUse of endoscopes and biofilm creationProper processing after each use

Studies and Literature Findings

Alfa and Howie (2010)Killing bioburden within young vs mature

biofilmGlutaraldehyde vs Accelerated Hydrogen

Peroxide (AHP) disinfection

Studies and Literature Findings

Pajkos (2004)Findings of scope contamination studiesEvaluation of effectiveness of endoscope

cleaning or reprocessing

On Medical Devices and Endoscopes

Photographic Documentation of Endoscopic Biofilm

Scope Tip after Manual Cleaning

Distal Tip after Cidex and Alcohol

Distal Tip after Peracetic Acid

Biofilm Debris in Channel

Biofilms

Biofilm

What has been observed:99% of bacteria grow as aggregated, sessile

communities (biofilm)Biofilm are highly protected and highly

resistant to antibacterial treatments (antibiotics and disinfectants)

Biofilm are genetically different than bacteria in the planktonic state

Biofilm form preferentially in high shear environments

Conditions suitable for biofilm development are practically limitless

Why we should be afraid, very afraid!Structure and physiology of biofilm confer

resistance to antibiotics, disinfectancts, and germicides

Experiment: biofilm can adhere to stainless steel, even highly polished SS, within 30 seconds

NIH estimates more than 80% of microbial infections in humans caused by biofilm

Biofilm in Endoscopes

Shortly after its first use, endoscopes develop a conditioning film composed of bodily fluids, proteins, polysaccharides and other components. This alteration of the surface characteristics allows bacteria to commence growth and colonization.

Reducing Biofilm FormationPrecleaningCleaning

Cleaning NomenclaturePrecleaning: Done in the OR, during and

immediately after use during a surgical procedure. Should occur at point of use. Can be a wipe down, cleaning spray, or foam to keep instruments moist and to begin the breakdown of bioburden.

Manufacturer’s Cleaning Instructions for Use

Utilities (eg, type of water, compressed air);Cleaning equipment;Accessories (eg, adaptors) for creating a

proper connection between the instruments and equipment, utilities, and cleaning equipment;

Accessories for cleaning lumens, ports, and internal parts;

Cleaning agents;Lubricants;Processing methods.

AORN RP 2014

Cleaning Medical InstrumentsManual cleaning

Detergents - typeBrushesDisassembly

Sonic cleaningDetergentTime and temperatureRepeat as instructed

Washer decontaminator

Eliminating Biofilm

Destruction of biofilm cell formationChemical/disinfection reaction with the

polysaccharide networkProtective shield inhibits cell destructionHazards of incomplete biofilm removal

What are Enzymatic Detergents?Enzymatic Detergents act by reducing

the cohesive force within the soil itselfBreaks up substances into fine particles

which are rinsed awayEnzymes act like a pair of scissors

“cutting off” soils piece by piece

Substrate Specific

Different types of Enzymes react to different substances

Proteins: #1 concern in a reprocessing roomHigh content of proteins in bodily fluids which

need to be removed(blood, tissue, mucous, etc)

Protease enzymes break down proteins into their components (amino acids) which are easily removed

Substrate SpecificLipids (fats): difficult to penetrate and

removeEx: Olestra is a very large and complex fat

moleculeLipase enzymes help break down lipids

(hydrolysis). Enzymatic reaction is slowAppropriate surfactants and detergents are

generally a bigger player in the effectiveness at removing lipids

Substrate Specific

• Carbohydrates (starches): very water soluble– a-Amylase enzymes speed up the

reaction which breaks starches down into sugars. The sugars are then quickly dissolved into the detergent water and removed

Biofilm detaching detergent

6 day growth of aPs Aeruginosa biofilm

Biofilm treated with a bio-detaching detergent

Remember the recipesCleaningConcentrationTemperatureTimePackagingHandlingStorageEach step has specific parameters that

must be met

Effective Disinfectant AgentsGlutaraldehyde

Saturated dialdehydeAcetic activated to alkaline to become

sporicidalUsed in manual or automated processing

protocolsPeracetic Acid (PAA)

Oxidizing agent for disinfection of flexible endoscopes

Highly biocidal in the presence of organic soil

Improper processing results in regrowth of biofilm

Ensuring Patient Safety

Shared responsibilityMedical instrument care and reprocessingBest practices of cleaningPolicies and proceduresTraining, resources, quality improvementInfection control

Orientation and Education TopicsStandard PrecautionsPersonal Protection Equipment (PPE)OSHA rules on occupational exposureReprocessing proceduresMechanisms of disease transmissionMaintenance of a safe work environmentSafe handling of HLD and sterilantsProcedures for waste management

Administrative Responsibility

Infection Control GuidelinesManufacturer’s RecommendationsIdentification of problems and lapses in

techniqueObservation of scope storage areasEnsure that reprocessing procedures are

followed.

Time Out: Test Your Knowledge

What are three best practices of medical devices which are particularly important in biofilm elimination?Spray instruments at the point of use

before transporting to SPD. Immediately flush the channel with

water when contaminated with bioburden.

Wipe the external surface of the medical device.

When all else fails

SGNA

AORN

IFU

Conclusions

Every patient deserves a clean endoscope Patient safety is a team responsibility Biofilm elimination is critical

Questions

Thank You

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