STERILIZATION of
    ENDOSCOPES
    Dr.T.V.Rao MD
Endoscopes and Infection

    Physicians use endoscopes to diagnose and treat

    numerous medical disorders. Even thoug...
Dealing with heat senstive
              Endoscopes
    To prevent the spread of health-care–associated

    infections, ...
Uses of Flexible Endoscopes
Flexible fiber optic or
video endoscope used
in the examination of
the hollow viscera
(i.e. co...
Why sterilizing Endoscopes
    Endoscopes are

    routinely exposed to
    mucus and other
    gastrointestinal
    secr...
Endoscopes are used in
         Invasive procedures
    Endoscopes are classified as semi critical

    instruments; if t...
Basic cleaning of Endoscopes

  Manual cleaning, which includes brushing

  with single-use wire brushes, and
  exposure ...
Dealing with Endoscopes
    Semi critical items contact mucous membranes

    or no intact skin. This category includes
 ...
Dealing with Endoscopes
    Intact mucous

    membranes, such as
    those of the lungs and
    the gastrointestinal tra...
Chemical Methods of
   sterilization
FDA cleared agents
    Glutaraldehyde, hydrogen peroxide, ortho-

    phthalaldehyde, and per acetic acid with
    hydrog...
Decontamination of
                    Endoscopes
    Decontamination of endoscopes should be

    undertaken at the begi...
Minimal requirements
     All disinfectants should be used at
    the correct temperature in
    accordance with the manuf...
The Ideal disinfectant ?
      Effective against a wide range of organisms

      including blood-borne viruses and Prion...
Ethylene Oxide
    Ethylene oxide gas has been the standard for

    sterilizing heat-sensitive items, including
    endo...
Ethylene Oxide
              A safety concern
    Ethylene oxide (EtO) gas sterilizers have been

    used by hospitals f...
OSHA regulates Use of Ethylene Oxide

    Strict regulations

    concerning EtO
    exposure have
    been imposed by
  ...
Use of Aldehydes
    It should be emphasised that aldehydes, such as

    ortho-phthalaldehyde and glutaraldehyde,
    fi...
Glutaraldehyde
    Glutaraldehyde should be in contact with all

    internal and external surfaces and channels of
    t...
Effectiveness of
            Glutarladehyde
    The FDA label claim for high-level

    disinfection with greater than 2%...
Hydrogen Peroxide
    Although hydrogen peroxide can damage rubber

    and plastics and corrode copper, zinc and brass,
...
Peracetic acid
  Peracetic acid is connected to several

  health hazards, including severe burns
  (from direct skin con...
Peracetic acid with hydrogen
             peroxide
 The    combination
   of these agents
   has been
   approved by the
...
Orthophalaldehyde
    Orthophalaldehyde apparently has several

    advantages over glutaraldehyde; it has
    quot;excel...
Emerging chemical agents
    Super oxidized water is the aqueous solution

    which is produced in the anode side by
   ...
Super Oxidized water in
              sterilization
    Super-oxidized water” –

    also known as anolyte –
    is water...
Super-oxidized water
    In recent years, neutral

    electrolyzed water
    ('NEW') has been
    developed as a high-le...
High level disinfection
    The FDA definition of high-level

    disinfection is a sterilant used for a shorter
    cont...
Physical exposure too is
               important
    Completely immerse the

    endoscope and its
    components in the...
Final removal of disinfectant
      after disinfection.
                    After high-level
               
            ...
STERIS® from Steris
                  Corporation
    STERIS®  is a quot;coldquot; liquid sterilization.

    Acetic pero...
STERIS® from Steris
                   Corporation
    The working channel of rigid / flexible

    endoscopes can be att...
Ortho-phthalaldehyde: a New
         Chemical Sterilant

    Ortho-phthalaldehyde (OPA) received clearance by FDA

    in...
Ortho-phthalaldehyde: a New
         Chemical Sterilant
    When tested against a wide range of

    microorganisms, incl...
Emerging Methods
    Other agents

    currently being
    investigated for
    efficacy in sterilization
    and disinfe...
Emerging Technology – Gas
              Plasma
    Low-temperature

    hydrogen peroxide gas
    plasma has also made it...
Sterilization of autoclavable
                      Endoscopes          
    Prepare the Endoscope by washing the outside
...
Testing the sterilization
               activity
    Perform routine testing of the

    liquidsterilant/high-level disi...
Health care workers should
     follow standard guidelines
     All healthcare personnel in the endoscope

    suite shou...
Keep a Log for accountability
    of Transmission of Infections
    A record should be

    kept of the serial
    number...
Endoscopy staff – Occupational
           Safety
    Endoscopy staff should be educated regarding

    hazards associated...
Protection against the
             Chemical disinfectants.
     All personnel using

    chemicals should be
    educate...
Decontaminating vCJD
    At present conventional

    sterilisation methods
    cannot reliably destroy
    PrPsc, the in...
Routine Methods not effective
 in decontamination of vCJD
    Putative infecting

    agent in vCJD cannot
    be removed...
Emerging methods to sterilize
                   CJD
    ERI's new process, or MIDAS, will effectively

    reduce the in...
Compliance reduces
         transmission of Infections
    Compliance with accepted

    guidelines for the
    reprocess...
Created for Awarness to Medical and
  Paramedical staff in Developing
              world
         Doctorrao's ‘e’ learnin...
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Sterilization Of

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Sterilization of Endoscopes is an important procedure which can reduce infections transmitted thought the repeated use of endoscopes on several patients. The technology is changing to suit the needs of the newer instruments.

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Sterilization Of

  1. 1. STERILIZATION of ENDOSCOPES Dr.T.V.Rao MD
  2. 2. Endoscopes and Infection Physicians use endoscopes to diagnose and treat  numerous medical disorders. Even though endoscopes represent a valuable diagnostic and therapeutic tool in modern medicine and the incidence of infection associated with their use reportedly is very low (about 1 in 1.8 million procedures) 97, more healthcare–associated outbreaks have been linked to contaminated endoscopes than to any other medical device. Doctorrao’s ‘e ‘learning series 
  3. 3. Dealing with heat senstive Endoscopes To prevent the spread of health-care–associated  infections, all heat-sensitive endoscopes (e.g., gastrointestinal endoscopes, bronchoscopes, nasopharygoscopes) must be properly cleaned and, at a minimum, subjected to high-level disinfection after each use. High-level disinfection can be expected to destroy all microorganisms, although when high numbers of bacterial spores are present, a few spores might survive. Doctorrao’s ‘e ‘learning series 
  4. 4. Uses of Flexible Endoscopes Flexible fiber optic or video endoscope used in the examination of the hollow viscera (i.e. colonoscope, gastroscope, duodenoscope, sigmoidoscope, bronchoscope).
  5. 5. Why sterilizing Endoscopes Endoscopes are  routinely exposed to mucus and other gastrointestinal secretions, blood, saliva, faeces, bile, and sometimes pus. The process of decontamination comprises two basic components:
  6. 6. Endoscopes are used in Invasive procedures Endoscopes are classified as semi critical  instruments; if they enter sterile body cavities, they are critical equipment. Certainly some endoscopic accessories are considered critical -- sclerotherapy needles and cutting forceps are two named in the AJIC article.
  7. 7. Basic cleaning of Endoscopes Manual cleaning, which includes brushing  with single-use wire brushes, and exposure of all external and accessible internal components to a low-foaming enzymatic detergent known to be compatible with the endoscope;  Automatic disinfection, rinsing and drying of all exposed surfaces of the endoscope
  8. 8. Dealing with Endoscopes Semi critical items contact mucous membranes  or no intact skin. This category includes respiratory therapy and anaesthesia equipment, some endoscopes, laryngoscope blades , oesophageal manometer probes, cyst scopes, anorectic manometer catheters, and diaphragm fitting rings. These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible. Doctorrao’s ‘e ‘learning series 
  9. 9. Dealing with Endoscopes Intact mucous  membranes, such as those of the lungs and the gastrointestinal tract, generally are resistant to infection by common bacterial spores but susceptible to other organisms, such as bacteria, mycobacteria, and viruses Doctorrao’s ‘e ‘learning series
  10. 10. Chemical Methods of sterilization
  11. 11. FDA cleared agents Glutaraldehyde, hydrogen peroxide, ortho-  phthalaldehyde, and per acetic acid with hydrogen peroxide are cleared by the Food and Drug Administration (FDA) and are dependable high-level disinfectants provided the factors influencing germicidal procedures are met. Doctorrao’s ‘e ‘learning series
  12. 12. Decontamination of Endoscopes Decontamination of endoscopes should be  undertaken at the beginning and the end of each list, and between patients, by trained staff in dedicated rooms. Thorough manual cleaning with an enzymatic detergent, including the brushing of all accessible endoscope channels, must be undertaken before automatic endoscope disinfection. Doctorrao’s ‘e ‘learning series
  13. 13. Minimal requirements All disinfectants should be used at the correct temperature in accordance with the manufacturers’ instructions. Some manufacturers provide test strips and/or kits, the use of which they recommend in ensuring optimal activity of their product. Doctorrao’s ‘e ‘learning series
  14. 14. The Ideal disinfectant ? Effective against a wide range of organisms  including blood-borne viruses and Prions proteins. Compatible with endoscopes, accessories and  endoscope reprocesses. Non-irritant and safe for users.  Environmentally friendly  However yet no totally safe chemical available.  Doctorrao’s ‘e ‘learning series
  15. 15. Ethylene Oxide Ethylene oxide gas has been the standard for  sterilizing heat-sensitive items, including endoscopes. Sterilization cycles are typically one and one-half to two hours at 55°C. Items must then be aerated mechanically for eight to 12 hours. Ethylene oxide (EO) is being gradually replaced in some hospitals with other sterilization methods, such as steam, vapor- phase methods and par acetic acid because of cost and safety concerns. However, caution should exercised before eliminating EO,
  16. 16. Ethylene Oxide A safety concern Ethylene oxide (EtO) gas sterilizers have been  used by hospitals for over 40 years to sterilize surgical equipment and supplies that are heat sensitive or that cannot tolerate excessive moisture. However, in recent decades, EtO has been recognized as a potential mutagenic, reproductive, neurological, and fire and explosion hazard to workers, and one agency has reportedly voted to classify EtO as carcinogenic to humans.
  17. 17. OSHA regulates Use of Ethylene Oxide Strict regulations  concerning EtO exposure have been imposed by the Occupational Safety and Health Administration (OSHA),
  18. 18. Use of Aldehydes It should be emphasised that aldehydes, such as  ortho-phthalaldehyde and glutaraldehyde, fix protein, a property which may not only stabilise prion infectivity, but also render it more difficult to remove by other means. Aldehydes should never be used for disinfection until the equipment has been thoroughly cleaned, with all accessory channels manually brushed, washed with enzymatic detergent and rinsed with water. Doctorrao’s ‘e ‘learning series 
  19. 19. Glutaraldehyde Glutaraldehyde should be in contact with all  internal and external surfaces and channels of the device for at least 20 minutes. Since it is an irritant, the following measures should be considered to ensure safer working conditions (superior ventilation) for reprocessing staff: quot;ducted exhaust hoods, air systems that provide seven to 15 air exchanges per hour, ductless fume hoods with absorbents for the vapour, tight fitting lids on immersion baths, and automated endoscope processors.quot;
  20. 20. Effectiveness of Glutarladehyde The FDA label claim for high-level  disinfection with greater than 2% glutaraldehyde at 25°C ranges from 20 to 90 minutes depending on the product. However, multiple scientific studies and professional organizations support the efficacy of greater than 2% glutaraldehyde at 20 minutes at 20°C
  21. 21. Hydrogen Peroxide Although hydrogen peroxide can damage rubber  and plastics and corrode copper, zinc and brass, it is suitable for endoscope reprocessing as long as it is not contraindicated in the endoscope reprocessing instructions. The solution to be used should be 7.5 percent hydrogen peroxide and 0.85 percent phosphoric acid. Doctorrao’s ‘e ‘learning series
  22. 22. Peracetic acid Peracetic acid is connected to several  health hazards, including severe burns (from direct skin contact), irreversible damage or blindness (from direct contact with the eyes), and irritation of the nose, throat and lungs (from inhalation of the per acetic acid vapor).  However the compound found to be useful in decontamination of endoscopes.
  23. 23. Peracetic acid with hydrogen peroxide  The combination of these agents has been approved by the FDA for sterilizing semi critical medical devices Doctorrao’s ‘e ‘learning series
  24. 24. Orthophalaldehyde Orthophalaldehyde apparently has several  advantages over glutaraldehyde; it has quot;excellent stability over a wide pH range of 3-9quot; and does not irritate the eyes or nasal passages, and it does not require activation before use.
  25. 25. Emerging chemical agents Super oxidized water is the aqueous solution  which is produced in the anode side by electrolysis of sodium chloride or potassium chloride added to the water and shows strong sterilization action. The super oxidized water is a powerful disinfectant which follows glutaraldehyde, and it is effective for nutrition bacteria, MRSA, general viruses and other microbes. There is no resistant microbe against the super oxidized water. The super oxidized water is safe to the human body. Doctorrao’s ‘e ‘learning series 
  26. 26. Super Oxidized water in sterilization Super-oxidized water” –  also known as anolyte – is water that has had an electric current passed through it, thereby generating a number of oxidized species. This is an electrochemical (or oxidation-reduction) process. Specifically, it is an electrolysis process.
  27. 27. Super-oxidized water In recent years, neutral  electrolyzed water ('NEW') has been developed as a high-level non-corrosive disinfectant, able to penetrate cell membranes more effectively in comparison with acidic electrolyzed water ('AEW') or Sodium Hypochlorite or other traditional chemical disinfectants. Doctorrao’s ‘e ‘learning series
  28. 28. High level disinfection The FDA definition of high-level  disinfection is a sterilant used for a shorter contact time to achieve a 6-log10 kill of an appropriate Mycobacterium species. Cleaning followed by high-level disinfection should eliminate enough pathogens to prevent transmission of infection.
  29. 29. Physical exposure too is important Completely immerse the  endoscope and its components in the high- level disinfectant/sterilant and ensure that all channels are perfused. Nonimmersible gastrointestinal endoscopes should be phased out immediately.
  30. 30. Final removal of disinfectant after disinfection. After high-level  disinfection, rinse the endoscope and flush the channels with sterile, filtered, or tap water to remove the disinfectant. Discard the rinse water after each use/cycle. Flush the channels with 70% to 90% isopropyl alcohol.
  31. 31. STERIS® from Steris Corporation STERIS®  is a quot;coldquot; liquid sterilization.  Acetic peroxide is mixed with sterile water; the instruments to be  sterilized are washed with solvents. After twelve minutes of dipping the instrument in the sterilizing solution,     the solution is pumped out and the instrument is rinsed with sterile water four times Doctorrao’s ‘e ‘learning series 
  32. 32. STERIS® from Steris Corporation The working channel of rigid / flexible  endoscopes can be attached to a pressurized fitting for sterilization.  The mixture of water and acetic peroxide is controlled during the dipping procedure with recording concentration and temperature increasing to 50 0C (122 0F)  - 55.5 0C (131.9 0F) .  Doctorrao’s e learning series 
  33. 33. Ortho-phthalaldehyde: a New Chemical Sterilant Ortho-phthalaldehyde (OPA) received clearance by FDA  in October 1999. OPA solution is a clear, pale-blue liquid (pH, 7.5), which typically contains 0.55% OPA. OPA has demonstrated excellent microbiocidal activity in in vitro studies For example, it has shown superior mycobactericidal activity (5-log10 reduction in 5 minutes) compared with Glutaraldehyde. The mean time required to effect a 6-log10 reduction for M. bovis using 0.21% OPA was 6 minutes, compared with 32 minutes using 1.5% glutaraldehyde Doctorrao’s ‘e ‘learning series 
  34. 34. Ortho-phthalaldehyde: a New Chemical Sterilant When tested against a wide range of  microorganisms, including glutaraldehyde- resistant mycobacteria and Bacillus subtilis spores , OPA showed good activity against the mycobacteria tested, including the glutaraldehyde-resistant strains, but 0.5% OPA was not sporicidal within 270 minutes of exposure. Increasing the pH from its unadjusted level (about 6.5) to pH 8 improved sporicidal activity. Doctorrao’s ‘e ‘learning series 
  35. 35. Emerging Methods Other agents  currently being investigated for efficacy in sterilization and disinfection include chlorine dioxide, ozone, vapor- phase hydrogen peroxide and plasma technology. Doctorrao’s ‘e ‘learning series
  36. 36. Emerging Technology – Gas Plasma Low-temperature  hydrogen peroxide gas plasma has also made its mark on device manufacturers for sterilizing temperature- sensitive polymeric materials. This method offers rapid turnaround time, in-house control of the sterilization process, and lower inventory requirements.
  37. 37. Sterilization of autoclavable Endoscopes           Prepare the Endoscope by washing the outside  with mild soap and warm water. Approved instrument wraps should  be folded around the Scope and it should be placed in an approved sterilizer tray on a soft surface. The instrument should be autoclaved.  At present few endoscopes can be sterilized by  heat ( Autoclaving ) Doctorrao’s e learning series
  38. 38. Testing the sterilization activity Perform routine testing of the  liquidsterilant/high-level disinfectant to ensure minimal effective concentration of the active ingredient. Check the solution at the beginning of each day of use (or more frequently) and document the results. If the chemical indicator shows that the concentration is less than the minimal effective concentration, the solution should be discarded. CategoryIA
  39. 39. Health care workers should follow standard guidelines All healthcare personnel in the endoscope  suite should be trained in and adhere to standard infection control recommendations (eg, standard precautions), including those to protect both patients and healthcare workers.Category IA9
  40. 40. Keep a Log for accountability of Transmission of Infections A record should be  kept of the serial number of each endoscope used in each patient. This is important for any future contact tracing when possible endoscope transmission of disease is being investigated.
  41. 41. Endoscopy staff – Occupational Safety Endoscopy staff should be educated regarding  hazards associated with performing/assisting with endoscopies and with reprocessing. They should be trained regarding the Occupational Safety and Health Administration (OSHA)s hazardous communications standard, and should have access to a spill containment plan pertinent to the sterilant or disinfectant being used when reprocessing occurs. Doctorrao’s ‘e ‘learning series 
  42. 42. Protection against the Chemical disinfectants. All personnel using  chemicals should be educated about the biological and chemical hazards present while performing procedures that use disinfectants. Doctorrao’s ‘e ‘learning series 
  43. 43. Decontaminating vCJD At present conventional  sterilisation methods cannot reliably destroy PrPsc, the infecting agent in vCJD, but the likelihood of equipment becoming contaminated with infective tissue is small. Rigorous cleaning techniques will reduce the risk even further. Doctorrao’s ‘e ‘learning series 
  44. 44. Routine Methods not effective in decontamination of vCJD Putative infecting  agent in vCJD cannot be removed or destroyed by conventional sterilisation or decontamination methods.
  45. 45. Emerging methods to sterilize CJD ERI's new process, or MIDAS, will effectively  reduce the incidence of CJD infection and number of operations cancelled due to contaminated instruments, according to ERI researchers. The team at ERI also reports that their studies demonstrate that the MIDAS process is at least 1,000 times more effective than traditional cleaning methods and does not damage surgical instruments. Doctorrao’s ‘e ‘learning series 
  46. 46. Compliance reduces transmission of Infections Compliance with accepted  guidelines for the reprocessing of gastrointestinal endoscopes between patients is critical to the safety and success of their use. When these guidelines are followed, pathogen transmission can be effectively prevented.  Doctorrao’s ‘e ‘learning series
  47. 47. Created for Awarness to Medical and Paramedical staff in Developing world Doctorrao's ‘e’ learning series Dr.T.V.Rao MD Email doctortvrao@gmail.com
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