1. Microbiological starting concepts and background

2. SPAULDING CLASSIFICATION SYSTEM Dr. Earle Spaulding – Microbiologist - of Temple University (Philadelphia) in 1939 proposed "a strategy for sterilization/disinfection” based on a classification of medical reusable devices. The Spaulding classification was originally proposed in 1957. Nowadays this classifications is recognized in National and International Guidelines. Background:

3. Level of disinfection or sterilization depends on intended use of the reusable device. Spaulding classification scheme: Categories based on degree of infection risk SPAULDING CLASSIFICATION SYSTEM

4. MICROORGANISMS SCALE OF RESISTANCE TOP BOTTOM

5. VEGETATIVE BACTERIA GRAM - ROD SHAPEDRETAIN RED COLOR WET ENVIRONMENT 90/95% ARE PATHOGENIC MORE RESISTANT TO ANTIBIOTICS GRAM + SPHERE SHAPED RETAIN BLUE COLOR DRY ENVIRONMENT LESS PATHOGENIC WATERBORNE BACTERIA

6. MOST COMMON PATHOGENS MRSA Methicillin-Resistant Staphylococcus Aureus (GRAM +) respiratory tract, open wounds, intravenous catheters and the urinary tract are potential sites for infection CLOSTRIDIUM DIFFICILE (GRAM +) Colitis, diarrhea ACINETOBACTER BAUMANII (GRAM -) bacteremia, urinary tract infections (UTIs), secondary meningitis, infective endocarditis, and wound and burn infections NOROVIRUS (GRAM -) nausea, vomiting, diarrhea, and some stomach cramping VRE Vancomycin Resistant Enterococci (GRAM +) infections can occur anywhere in the body, common sites include the intestines, the urinary tract, and wounds PSEUDOMONAS AERUGINOSA (GRAM -) P. aeruginosa typically infects the airway, urinary tract, burns, wounds and also causes other blood infections blood infections KLEBSIELLA PNEUMONIAE (GRAM -) pneumonia, thrombophlebitis, urinary tract infection, cholecystitis, diarrhea, upper respiratory tract infection, wound infection, meningitis and septicemia MYCOBACTERIUM TUBERCULOSIS (GRAM -) usually attack the lungs, but TB bacteria can attack any part of the body such as the kidney, spine, and brain

7. CRITICAL DEVICES Critical Devices: Items that contact sterile tissue or the vascular system: – Surgical instruments – Cardiac and urinary catheters – Ultrasound probes used in sterile body cavities

8. CRITICAL DEVICES METHOD  STERILIZATION: Destroys all microorganisms including bacterial spores Common sterilization methods: Steam LTS Hydrogen peroxide gas plasma LTS Ethylene oxide (ETO) LTS Gamma Ray/Beta Ray

9. STERILIZATION Sterilization is the complete elimination or destruction of all bacterial spores. The term sterilization is intended to convey an absolute meaning, not a relative one. Sterility Assurance Level (SAL) = SAL of 10 -6 (1:1.000.000) This means that there is less than one chance in a million that an item remains contaminated or non sterile. To mantein sterility devices must be packed in pouches, rolls, TNT tissues or containers. Definition:

10. SEMICRITICAL DEVICES Semicritical devices: Items that contact mucous membranes or non-intact skin: – Respiratory therapy and anesthesia equipment – GI Endoscopes – Laryngoscope blades – Trans-esophageal probes

11. SEMICRITICAL DEVICES METHOD  HIGH LEVEL DISINFECTION (Reference: Mycobacterium) : Destroys all microorganisms except high number of bacterial spores Chemical disinfectants (liquids): Peracetic acid Ortho-phathalaldehyde Glutaraldehyde

12. HIGH LEVEL DISINFECTION Disinfection describes a process that eliminates many microorganisms, with the exception of bacterial spores. HLD is achieved using liquid chemicals by immersion/bath procedures and automated washer disinfectors. Remember that even if a device has been disinfected with Peracetic Acid (Sporicidal action/Liquid sterilant), the device it’s not packed so, as soon as you take out the item from the liquid you’ll loose the claim! The efficacy of disinfection (and sterilization) is affected by a number of factors, each of which may nullify or limit the efficacy of the process: the previous cleaning of the object the organic load on the object the concentration of and exposure time to the biocide the physical configuration of the object the temperature and pH of the disinfection process Definition:

13. EN ISO 14973 covered all systems not subject to EUROPEAN NORMS such as: EN 550 ETO EN 554 VAPORE LACK OF PACKAGING SBS STERILE & STERILIZED STERILIZED

14. POINTS OF USE For Internal use only, not to be used with Customers SEMICRITICAL DEVICESCRITICAL & SEMICRITICAL DEVICES GI departments, for flexible endoscopesOperating rooms Physician’s officesUrology Dentist’s officesRespiratory Therapy, Anesthesia

15. NON CRITICAL DEVICES Noncritical devices: Items that contact intact skin: – Bedpans – Blood Pressure cuffs – Crutches – Bed rails – Stethoscopes – Bedside tables

16. NON CRITICAL DEVICES METHOD  INTERMEDIATE-LEVEL DISINFECTION Destroys vegetative bacteria, most viruses, most fungi Quaternary ammonium salts Chlorine

17. Disinfection: is it time to reconsider Spaulding? G. McDonnell a,*, P. Burke b Journal of Hospital Infection 78 (2011) 163e170 This classification appears simple but it can be difficult to make a decision regarding the risk to a patient. Examples include flexible endoscopes and similar devices that are considered to be semi-critical devices. They may be considered semi-critical, but they are also critical in the case of an internal bleed, taking a biopsy during a procedure or in the surgical use. The person in charge of Sterilization processes inside the Hospital can decide if a semicritical device undergo terminal sterilization in case of immunosuppressed or transplanted patients.

18. VIRAL RESISTANCE Viral resistance to disinfection is not as well studied as bacterial resistance. Viruses have been classified into 3 groups based on their structure: 1.Enveloped viruses [e.g. HIV and hepatitis B virus (HBV); very sensitive to disinfectants] 2.Large non-enveloped viruses (e.g. adenoviruses; intermediate resistance to disinfectants) 3.Small non-enveloped viruses (e.g. poliovirus and papilloma viruses; highest resistance to disinfectants) It is expected that representative viruses from each of these three groups should be tested.

19. BACTERIAL RESISTANCE Acquired bacterial resistance to disinfection have been well documented. The development of glutaraldehyde resistance in mycobacteria associated with outbreaks has been reported in many countries since the 1990s. It does not appear, from these reports, that these strains caused serious infections in patients. Investigations have shown significant resistance to glutaraldehyde disinfection at recommended or extended contact times, but sensitivity to other types of disinfectants.

20. PROTOZOAL RESISTANCE It is suggested that protozoa (vegetative and dormant forms) should be included for high-level disinfection and sterilization claims. Protozoa are micro-organisms which are not generally considered in device disinfection/sterilization discussions. They are a particular challenge to inactivate as they have both vegetative and dormant (cyst or oocyst) forms during their life cycles. Protozoal are known to present greater resistance to environmental factors (such as drying and elevated temperatures compared with bacterial endospores) and chemical disinfection. Formulations containing hydrogen peroxide have been reported to have greater efficacy, although long contact times appear to be required.

21. INFECTIOUS PROTEINS Prions, as infectious proteins are notable in their resistance to disinfection and sterilization. Initial studies on the inactivation of prions indicated that aggressive physical (steam sterilization at 134 C for 18 min) and chemical (2% available chlorine, in the form of sodium hypochlorite, for 1 h) methods were required, and this was recommended by the World Health Organization in 1999. Removal of contaminated MD from clinical use is recommended.

22. LEARNING MORE ABOUT PRIONS

23. VARIANT CREUTZFELDT-JACOB DISEASE (vCJD) AND GASTROINTESTINAL ENDOSCOPY

24. Can GI endoscopes transmit CJD? Human Transmissible Spongiform Encephalopathies (TSEs): 1.Human TSEs are neurological disorders caused by infectious proteins called prions. (Pathological Prions PrP sc scrapie associated prion protein- Normal prion protein PrP c )Human TSEs are neurological disorders caused by infectious proteins called prions. 2.Creutzfeldt-Jakob disease (CJD) and variant CJD (vCJD) are examples of TSEs. 3.vCJD may be caused by consuming beef products contaminated with the bovine spongiform encephalopathy (BSE) agent. 4.Both CJD and vCJD are fatal neurodegenerative diseases. A theoretical concern is that surgical instruments, including GI endoscopes, could become contaminated with prions diseases. Because prions exhibit remarkable resistance to conventional disinfection and sterilization methods patient-to-patient transmission of prion diseases via a contaminated surgical instrument is a potential concern.

25. Can GI endoscopes transmit CJD? In general, only surgical instruments and endoscopes in contact with: 1.“High-risk” tissues of “high-risk” patients might pose a risk of contamination with prions. 2.“High-risk” tissues are typically neurological and include the brain and spinal cord. 3.“High-risk” patients are those known to be (or suspected of being) infected with a prion disease. https://www.youtube.com/watch?v=zRe_Rm_WIhY

26. Can GI endoscopes transmit CJD? To minimize the risk of transmission of vCJD during GI endoscopy, some guidelines in Europe recommend the following: 1.Do not perform GI endoscopy in patients with known vCJD. 2.When GI endoscopy is unavoidable, however, use an endoscope dedicated for vCJD patients. Alternatively, use an endoscope that is: 1.old or can be destroyed/incinerated after use; 2.or can be quarantined for use in the future exclusively on other vCJD patients.

27. Examinations via endoscopy should be avoided in patients with suspected or confirmed variant Creutzfeldt-Jakob disease (vCJD). If endoscopy is considered essential in such patients, either a dedicated endoscope should be used or an endoscope nearing the end of its life which can be reserved for use in similar patients. The vCJD prion is resistant to all forms of conventional sterilization. In particular, all accessible endoscope channels should be brushed with a disposable brush-tipped wire assembly designed for the purpose which has an appropriate length and diameter for each channel. W orld G astroenterology O rganization and OMED Practice Guideline: Endoscope Disinfection December 14, 2005

28. BSG GUIDELINES FOR DECONTAMINATION OF EQUIPMENT FOR GASTROINTESTINAL ENDOSCOPY The Report of a Working Party of the British Society of Gastroenterology Endoscopy Committee (June 2014) The sporadic form of CJD affects approximately 1 person per million per annum worldwide. Variant CJD (vCJD) is an acquired form of CJD that was first reported in 1996. The incubation period for vCJD could be as long as 30 years: people might be infected while not showing any symptoms. vCJD can be transmitted via blood transfusion and could in theory be passed on by the re-use of surgical instruments. Endoscopy with biopsy have the potential to transmit the disease.

29. BSG GUIDELINES FOR DECONTAMINATION OF EQUIPMENT FOR GASTROINTESTINAL ENDOSCOPY The Report of a Working Party of the British Society of Gastroenterology Endoscopy Committee (June 2014) It should be emphasised that aldehyde disinfectants, such as ortho-phthalaldehyde (OPA) and glutaraldehyde, fix protein, a property which may not only anchor prion protein within endoscope channels, but also render it more difficult to remove by other means. The use of these agents should be avoided when decontaminating endoscopes that have been used in patients with definite or suspected vCJD, or in patients considered to be at risk. Conventional sterilization methods cannot reliably destroy the infecting agent in vCJD. Every effort should be made to employ single-use equipment. Adequate funding must be available to endoscopy units for the purchase of single- use biopsy forceps, cytology brushes, guidewires and other accessories.

30. BSG GUIDELINES FOR DECONTAMINATION OF EQUIPMENT FOR GASTROINTESTINAL ENDOSCOPY The Report of a Working Party of the British Society of Gastroenterology Endoscopy Committee (June 2014) The UK Advisory Committee for Dangerous Pathogens updated guidance states that quarantining of the endoscope is nowadays rarely necessary. If invasive endoscopy has been performed in any patient with or at increased risk of vCJD the endoscope used should be reprocessed singly before being quarantined. If a contamination risk is confirmed, the endoscope should be either destroyed or retained for dedicated re-use for the same patient.

31. It is recommended: 1.that single use disinfectants should be used for endoscopes that have been used in any “at risk” individual 2.that such endoscopes should be decontaminated separately from any other endoscope 3.that the endoscope washer disinfector should be put through an empty self-disinfection cycle after it has been used to decontaminate an endoscope that has been used in any “at risk” individual BSG GUIDELINES FOR DECONTAMINATION OF EQUIPMENT FOR GASTROINTESTINAL ENDOSCOPY The Report of a Working Party of the British Society of Gastroenterology Endoscopy Committee (June 2014)

32. National Healthcare Service UK

33. Choice Framework for local Policy and Procedures (CFPP) 01- 06 – Decontamination of flexible endoscopes: Policy and management Although it is extremely unlikely that contamination of a second endoscope would occur in an EWD designed to decontaminate two scopes in a single chamber, it is recommended that, following invasive procedures in any patients with or at increased risk of human prion disease, flexible endoscopes should be reprocessed singly using a single-use, non-aldehyde-based disinfectant. N ew protein test system has been developed: the ninhydrin protein detection test. The ninhydrin test should be used with caution owing to its lack of sensitivity. Clean instruments are swabbed to pick up any non-visual proteins that may be present. The swab is then placed in the vial of ninhydrin reagent and incubated at 57°C.

34. Choice Framework for local Policy and Procedures (CFPP) 01- 06 – Decontamination of flexible endoscopes: Policy and management New protein test system has been developed: the ninhydrin protein detection test. The ninhydrin test should be used with caution owing to its lack of sensitivity. Clean instruments are swabbed to pick up any non-visual proteins that may be present. The swab is then placed in the vial of ninhydrin reagent and incubated at 57°C.

35. FRENCH DOCUMENT N°138/2001 (BELOW THE LINK): Circulaire DGS/5 C/DHOS/E 2 n° 2001-138 du 14 mars 2001 relative aux précautions à observer lors de soins en vue de réduire les risques de transmission d'agents transmissibles non conventionnels http://www.sante.gouv.fr/fichiers/bo/2001/01-11/a0110756.htm In the document the suggestion is one hour contact with hypoclorite. http://www.sante.gouv.fr/fichiers/bo/2001/01-11/a0110756.htm In the document the suggestion is one hour contact with hypoclorite. Groupe III Procédés d'efficacité importante Procédures physiques ou chimiques simples (20) Par ordre décroissant d'efficacité : 1. Immersion dans l'hypochlorite de sodium (21) pendant 1 heure. 2. Immersion dans la soude (22) pendant 1 heure. 3. Autoclavage à 134° C pendant 18 minutes en autoclave à charge poreuse. The premise is that we know that anything is effective against prion today, but we have to deal with tenders requirements. We’ll have a prion cycle available in our AERs running with Hypochlorite (in use concentration 3%) for one hour contact.

36. REUSABLE MEDICAL DEVICES REPROCESSING CYCLE

37. CLEANING PHASE OF REUSABLE MEDICAL DEVICES Cleaning is the MOST important step in instrument reprocessing for the prevention of infection transmission – regardless of the method used for high level disinfection or sterilization. Proper pre-cleaning can remove > 99% of bioburden from medical instruments. BIOBURDEN = number of bacteria living on a surface that has not been treated. For Internal use only, not to be used with Customers CLEANING PHASE Items must be cleaned using water with detergents alkaline/enzymatic cleaners before reprocessing (sterilization and HLD)

38. THE IDEAL DETERGENT Rapid activity to allow preparation in minimal time Controlled foaming to avoid potential overflow Free rinsing to prevent residue and blockage of the sterilant or the disinfectant action Bacteriostatic to inhibit/retard growth of bacteria Good compatibility with a wide range of instruments User-friendly: easy to use and store Cost effective Manual Cleaning the ideal detergent features:

39. DETERGENTS Detergents can be divided in two main groups: 1.with enzymatic and/or alkaline boosters  Detergents with enzymatic boosters contain one or more different types of enzymes, e. g. protease, amylase, or lipase.  Protease breaks down proteins into amino acids more soluble  Alkaline substances lift off soil and help to dissolve it in the cleaning solution. 2.with antimicrobial active substances  Use of this type of product may reduce the infection risk to reprocessing personnel. Most detergents from both groups contain low foaming surfactants to lift off soil Low-foaming property allows the clear visualization of the endoscope

40. DETERGENT ENZYME LEGENDA There are 3 basic types of enzymes used in detergents: PROTEASE, AMYLASE, LIPASE PROTEASE breaks down protein into individual amino acids is the most important type of enzyme to look for when choosing an enzymatic detergent for medical use because there is a high content of protein in most body fluids (including blood, tissue and mucous) which cannot be easily removed with regular detergents/surfactants and water. AMILASE is not essential components in enzymatic detergents because is has limited action on carbohydrates. In addition, carbohydrates/starches are very soluble in water and tend to be easy to remove with most detergents/surfactants and water. LIPASE is useful for removing lipids/fats. Another common enzyme is CELLULASE: which breaks down cellulose to beta-glucose.

41. DETERGENT ENZYME LEGENDA How rapidly an enzymatic product works on a soil depend on a number of factors as: Soils, pH and temperature amount and type of soil concentration of enzymatic product used pH and temperature pH SCALE The pH scale measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.

42. CHEMICAL DISINFECTANTS Disinfectants based on glutaraldehyde are offered as concentrated (single shot) or as ready−to−use (RTU) products The RTU glutaraldehyde solutions range in concentration from 2.0% to 3.4% Concentrated solutions 20% Glutaraldehyde has the advantages that it is effective, relatively inexpensive, and does not damage endoscopes, accessories, or AERs. However, there are a number of disadvantages to glutaraldehyde, both for clinical staff and for patients. It has irritant and sensitizing properties.

43. CHEMICAL DISINFECTANTS Disinfectants based on orthophthalaldehyde (OPA) are offered as RTU solutions containing 0.55% of the active substance. Concentrated solutions contain 5,75% of the active ingredient. Studies have shown better microbiological efficacy compared with glutaraldehyde does not produce noxious fumes, also the RTU solutions requires NO activation. OPA causes coagulation and fixation of proteins. It’s important to ensure an adequate rinsing. Stain removal with citrus-based products and toothpaste with whitening properties.

44. CHEMICAL DISINFECTANTS Disinfectants based on PAA are commercially available as liquids or powder and as two−component systems both in the RTU and concentrated formula. The efficacy of PAA higher than that of glutaraldehyde and OPA chemicals. Regarding staff safety, PAA is claimed to cause less irritation than glutaraldehyde and OPA and to be safer for the environment. PAA disadvantages are its vinegary odour and corrosive action. PAA may also cause cosmetic changes of endoscope surfaces (brass & copper parts), but without any functional impairment.