Biofilm and medical devices

1. Biofilm and medical devices Cheri Ackert-Burr, RN, MSN, CNOR, AGTS Clinical Education Manager

2. Disclosures • 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

3. 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

4. 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 extra-cellular polymeric material produced by some bacteria composed of carbohydrates, lipids, and proteins. AKA - SLIME

5. 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.

6. 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)

7. Biofilm Lifecycle

8. Biofilm • Microbially derived sessile community • Irreversible attachment • Matrix embedded • Altered phenotype

9. 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

10. 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???

11. River Rocks

12. On teeth

13. In the Body

14. Colonization Environments • Biofilm in the human body • > 80% of microbial infections are caused by biofilm – NIH estimate

15. Biofilm in Endoscopes • New endoscopes and biofilm • Use of endoscopes and biofilm creation • Proper processing after each use

16. Studies and Literature Findings • Alfa and Howie (2010) • Killing bioburden within young vs mature biofilm • Glutaraldehyde vs Accelerated Hydrogen Peroxide (AHP) disinfection

17. Studies and Literature Findings • Pajkos (2004) • Findings of scope contamination studies • Evaluation of effectiveness of endoscope cleaning or reprocessing

18. On Medical Devices and Endoscopes

19. Photographic Documentation of Endoscopic Biofilm

20. Scope Tip after Manual Cleaning

21. Distal Tip after Cidex and Alcohol

22. Distal Tip after Peracetic Acid

23. Biofilm Debris in Channel

24. Biofilms

25. Biofilm

26. 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

27. 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, within30 seconds • NIH estimates more than 80% of microbial infections in humans caused by biofilm

28. 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.

29. Reducing Biofilm Formation • Precleaning • Cleaning

30. 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.

31. 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

32. Cleaning Medical Instruments • Manual cleaning • Detergents - type • Brushes • Disassembly • Sonic cleaning • Detergent • Time and temperature • Repeat as instructed • Washer decontaminator

33. Eliminating Biofilm • Destruction of biofilm cell formation • Chemical/disinfection reaction with the polysaccharide network • Protective shield inhibits cell destruction • Hazards of incomplete biofilm removal

34. 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

35. 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

36. 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

37. 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

38. 6 day growth of a Ps Aeruginosa biofilm Biofilm treated with a bio-detaching detergent Biofilm detaching detergent

39. Remember the recipes • Cleaning • Concentration • Temperature • Time • Packaging • Handling • Storage • Each step has specific parameters that must be met

40. Effective Disinfectant Agents • Glutaraldehyde • Saturated dialdehyde • Acetic activated to alkaline to become sporicidal • Used in manual or automated processing protocols • PeraceticAcid (PAA) • Oxidizing agent for disinfection of flexible endoscopes • Highly biocidal in the presence of organic soil • Improper processing results in regrowth of biofilm

41. Ensuring Patient Safety • Shared responsibility • Medical instrument care and reprocessing • Best practices of cleaning • Policies and procedures • Training, resources, quality improvement • Infection control

42. 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

43. 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.

44. 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.

45. When all else fails SGNA AORN IFU

46. Conclusions • Every patient deserves a clean endoscope • Patient safety is a team responsibility • Biofilm elimination is critical

47. Questions

48. Thank You • Thank you for your attention. • Please be sure you have signed in legibly. • Please turn in your evaluations.