BIOFILM AND MEDICAL
DEVICES
Cheri Ackert-Burr, RN, MSN, CNOR, AGTS
Clinical Education Manager
Disclosures
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Successful completion: Participants must complete the
entire program and submit the required documentation
Conflict of interest: Planners disclose no conflict; the
speaker discloses employment with Medivators, thereby
declaring a conflict of interest.
Commercial company support: Fees are underwritten by
education funding provided by Medivators
Non-commercial company support: None
Alternative Complementary therapy: None
Learner Objectives
Upon completion of this presentation, participants will
be able to:
 Discuss the concept of biofilm communities in
medical devices and in the human body
 Explain the relationship between biofilm and
endoscope/instrument contamination
 Relate findings from studies and literature to clinical
area practice
 Compare two detergent agents in their effectiveness
against biofilm
 State three best practices of disinfection which are
particularly important in biofilm elimination
Glossary
 Exo-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 extracellular 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:
 Microbes
 Glycocalyx/Exo-Polysaccharide (EPS)
 Surface (inert or living)
Biofilm Lifecycle
Biofilm
 Microbially derived sessile community
 Irreversible attachment
 Matrix embedded
 Altered phenotype
Biofilm Formation
 First observations
 Communities vs. free-floating
 Formation in high-shear vs. low-sheer
environments
 Polysaccharides 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 water
 Clogging filters
 Found 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 biofilm
 Use of endoscopes and biofilm creation
 Proper processing after each use
Studies and Literature Findings
 Alfa and Howie (2010)
 Killing bioburden within young vs mature biofilm
 Glutaraldehyde vs Accelerated Hydrogen Peroxide
(AHP) disinfection
Studies and Literature Findings
 Pajkos (2004)
 Findings of scope contamination studies
 Evaluation 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
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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 Formation
 Precleaning
 Cleaning
Cleaning Nomenclature
 Precleaning: 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
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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 Instruments
 Manual cleaning
 Detergents - type
 Brushes
 Disassembly
 Sonic cleaning
 Detergent
 Time and temperature
 Repeat as instructed
 Washer decontaminator
Eliminating Biofilm
 Destruction of biofilm cell formation
 Chemical/disinfection reaction with the
polysaccharide network
 Protective shield inhibits cell destruction
 Hazards of incomplete biofilm removal
What are Enzymatic Detergents?
 Enzymatic Detergents act by reducing the
cohesive force within the soil itself
 Breaks up substances into fine particles which are
rinsed away
 Enzymes 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 room
 High 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 Specific
 Lipids (fats): difficult to penetrate and remove
 Ex: Olestra is a very large and complex fat molecule
 Lipase enzymes help break down lipids (hydrolysis).
Enzymatic reaction is slow
 Appropriate 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 a
Ps Aeruginosa biofilm
Biofilm treated with a
bio-detaching detergent
Remember the recipes
 Cleaning
 Concentration
 Temperature
 Time
 Packaging
 Handling
 Storage
 Each step has specific parameters that must be
met
Effective Disinfectant Agents
 Glutaraldehyde
 Saturated dialdehyde
 Acetic activated to alkaline to become sporicidal
 Used in manual or automated processing
protocols
 Peracetic 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 responsibility
 Medical instrument care and reprocessing
 Best practices of cleaning
 Policies and procedures
 Training, resources, quality improvement
 Infection control
Orientation and Education Topics
 Standard Precautions
 Personal Protection Equipment (PPE)
 OSHA rules on occupational exposure
 Reprocessing procedures
 Mechanisms of disease transmission
 Maintenance of a safe work environment
 Safe handling of HLD and sterilants
 Procedures for waste management
Administrative Responsibility
 Infection Control Guidelines
 Manufacturer’s Recommendations
 Identification of problems and lapses in technique
 Observation of scope storage areas
 Ensure 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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