Associate Degree in Applied Science – Sterile Processing and ...

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  • After reprocessing, store endoscopes in a manner that will minimize the likelihood of contamination or collection/retention of moisture.

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  • 1. Reprocessing Endoscopes and Other Reusable Medical Equipment (RME): Lessons from the NMVA
    Carol Moore, MSN, RN, CICInfection Control Practitioner,NMVAHCS
  • 2. Updated Guidelines
  • 3. VA Health Care in the News
    Valve Problem Cited In Colonoscopy Issue (Lambert, 2009)
    VA Hospital: Patients Exposed To HIV, Hepatitis (JustNews, 2009)
    VA Continues Notification Process for Veterans Affected by Reprocessing Issues (Reuters, 2009)
    Congressional panel to analyze VA hospitals' mistakes (Poovey, 2009)
    Inspections find many VA facilities lack colonoscopy safety (CNN, 2009)
    VA Endoscope Problem is Department-Wide (House Committee on Veterans' Affairs, 2009 )
    VA Allocates $26M for Endoscopy Sterilization Equipment (EndoNurse, 2009)
  • 4. Safety Communication from FDA, CDC, and the VA
    Preventing Cross-Contamination in Endoscope Processing, November 2009
    (FDA, 2009a)
  • 5. The Joint Commission
    Infection Control Focus:
    Updated Position on Steam Sterilization (JC, 2009a)
    Reducing Infection Risks Associated with Medical Equipment, Devices, and Supplies(JC, 2009b)
  • 6. Reusable Medical Equipment (RME)
    RME is medical equipment designed by the manufacturer to be reused for multiple patients.
    Medical equipment designed to be used multiple times by one patient is not RME unless the manufacturer provides instructions for reprocessing between patients.
    Single-use disposable medical devices are not reprocessed for reuse.
  • 7. Reprocessing RME
    Reprocessing (cleaning, disinfection and/or sterilization) RME is essential to ensure that the equipment does not transmit infectious pathogens to patients.
    Failure to properly clean, disinfect or sterilize equipment creates a risk for:
    person-to-person transmission (e.g., Hepatitis B virus, HIV, Salmonella, M. tuberculosis, etc.)
    transmission of environmental pathogens (e.g., Pseudomonas, atypical mycobacteria, etc.)
    transmission of multi-drug-resistant organisms (MDRO)
    (Rutala, Weber, & HICPAC, 2008)
  • 8. Reprocessing Methods
    The selection of reprocessing method (cleaning, disinfection or sterilization) is determined by the:
    intended use of the equipment
    instructions of the RME’s manufacturer
    compatibility of the device with the methods available
    impact of the method on the device over time
    (Rutala, Weber, & HICPAC, 2008)
  • 9. Intended Use
    The Spaulding Scheme classifies RME according to the degree of risk for infection based on the intended use of the item.
    Critical
    Semi-Critical
    Non-Critical
    (Rutala, Weber, & HICPAC, 2008)
  • 10. Reprocessing Method by Intended Use
  • 11. Transmission Risk to Patients
    The most common reasons pathogens are transmitted to patients from RME include:
    Inadequate cleaning
    Improper selection of disinfecting agent
    Failure to follow recommended procedures for set-up and use or reprocessing the RME
    More healthcare-associated outbreaks have been linked to endoscopes than to any other RME
    (Rutala, Weber, & HICPAC, 2008)
  • 12. Use and Reprocessing RMEThe Process
    Set-up & Use
    Pre-cleaning / Cleaning
    Disinfection or Sterilization
    Storage
  • 13. SET-UP & USE
  • 14. Patient Safety AlertsVHA Dec 08 / Olympus Feb 09
  • 15. Washing Tube vs Auxiliary Water Tube
  • 16.
  • 17. Set-up & Use
    Record use of each endoscope, including model, serial number, and unique identifier
    Document the patient upon whom the endoscope was used, the date and time of use, the location of use, and the type of procedure
    Record the system (model and serial number of the Automatic Endoscope reprocessor (AER), if applicable, used to reprocess the endoscope and the identification of the person(s) responsible for reprocessing the scope.
    (FDA, 2009a)
  • 18. PRE-CLEANING / CLEANING
  • 19. Pre-cleaning
    At the point of use (immediately after use)
    Removes visible biomaterial so it does not dry and harden
    Flush all channels
    May include enzymatic detergents – follow manufacturers guidelines
    May use enzymatic sprays to prevent drying
    (Catalone & Koos, 2005)
  • 20. Cleaning
    Cleaning is the removal of biomaterial and microorganisms using water with detergents or enzymatic products
    Accomplished manually or mechanically
    Cleaning alone reduces bioburden by an average of 4 logs ( 99.99%)
    Is essential before high-level disinfection and sterilization because debris will interfere with these processes
    Cleaning and low-level disinfection of non-critical RME is sometimes completed at the same time with a combination detergent and disinfectant product
    (Rutala, Weber, & HICPAC, 2008)
  • 21. Enzymatic Detergent Errors
    Improper dilution of the detergent
    measure the detergent and the water
    Reuse of the Enzymatic Detergent Solution
    dispose after each use
    Device is not fully submerged
    make sure the sink or container is large enough
    Inadequate contact time
    use a timer
    Inadequate rinse
    determine the rinse volume and total number of rinses required
    (Catalone & Koos, 2005)
  • 22. Cleaning Endoscopes
    Leak test
    Enzymatic detergent recommended by the manufacturer (or equivalent)
    Channel brushes – the right size, single use or reusable brushes that are processed after each use, inspect before use
    Clean all channels, even if not used during the procedure
    Some scopes have unique channels
    Use cleaning adapters supplied by the manufacturer
    If using an AER, compare AER and endoscope manufacturer’s instructions – ensure they are compatible
    Prevent splash and aerosol contamination of processed scopes if cleaning and disinfection occur in the same room
  • 23. Preventing Exposure to Infectious Agents & Chemicals
    Transporting Soiled RME
    Transport to the reprocessing location in covered containers (impervious bags, covered/closed carts, tote-boxes, or red bags) identifiable as BIOHAZARDOUS
    Handling Contaminated RME
    Personal Protective Equipment (PPE) is required to reduce the risk of healthcare worker exposure to pathogens and to the chemicals used for cleaning/disinfection
    The choice of PPE is determined by the risk of exposure during the cleaning process or from the environment
    Disinfection is required before handling RME without PPE
  • 24. Disinfection & Sterilization
  • 25. Reprocessing MethodsChoose the correct process
    Sterilization
    Destroys or eliminates all forms of microbial life
    High level disinfection
    Eliminates all microorganisms, except large numbers of bacterial spores
    Clostridium difficile spores are reliably killed by high-level disinfection methods
    Intermediate level disinfection
    Kills vegetative bacteria, mycobacteria, most viruses, most fungi, but not bacterial spores
    Effective against bloodborne pathogens
    Low level disinfection
    Kills most vegetative bacteria, some fungi, and some viruses
    (Rutala, Weber, & HICPAC, 2008)
  • 26. Reprocessing Methods
    Sterilization methodsinclude:Heat (steam or hot air), Ethylene oxide (EtO), Peracetic acid (e.g. Steris System 1) and Hydrogen peroxide gas plasma (e.g. Sterrad)
    High level disinfection methods include: Orthophthalalde-hyde (Cidex OPA), >2% Glutaraldehyde , Hydrogen Peroxide (H2O2) and Wet Pasteurization
    Intermediate level disinfection methods include: Ethyl or Isopropyl alcohol (70-90%), Sodium hypochlorite (diluted bleach solution) Phenolic or Iodophor germicidal detergents
    Low level disinfection methods include: Same as Intermediate plus Quaternary ammonium germicidal detergents
    (Rutala, Weber, & HICPAC, 2008)
  • 27. Environmental Conditions: Central Processing & Endoscopy
    Physical barrier between the decontamination area and the clean area to prevent droplet contamination
    Work flows from contaminated to clean without backtracking
    Constructed of impervious surfaces that withstand scrubbing (floors, walls & ceilings)
    Flush ceilings with enclosed fixtures, no exposed pipes
    Appropriate PPE (e.g. gloves, fluid-impervious gowns, face-shields, etc) available
    Daily (when in use) cleaning schedule
    Eye Wash Station(s)
    Dedicated handwashing sink
    Traffic restricted to authorized personnel
    (AIA, 2006; AAMI, 2006)
  • 28. Ventilation, Temperature & Humidity
    (AIA, 2006; AAMI, 2006)
  • 29. Reprocessing Location
    “In hospitals, perform most cleaning, disinfection, and sterilization of patient-care devices in a central processing department in order to more easily control quality” Category II
    Issues:
    Do you chemically sterilize or high-level disinfect in the decontamination room or the prep (clean) room?
    How do you transport items that are packaged & sterilized?
    Are chemical sterilization or high-level disinfection point of use methods only?
    (Rutala, Weber, & HICPAC, 2008)
  • 30. The Joint Commission
    Update: Steam Sterilization
    Flash Sterilization
    Unwrapped instruments for 3 minutes at 2700F at 27-28 pounds of pressure
    Survey process-related issues:
    Flash sterilization utilization
    Cleaning process before flash
    Chemical indicators
    Transport back to sterile field
    (JC, 2009a)
  • 31. Laparoscopes / Arthroscopes / Cytoscopes
    Sterilize or at least high level disinfect, follow high level disinfection with sterile water rinse
    Endoscopes used in normally sterile body sites are critical and must be sterilized.
    Steam
    Low temp chemical gas/plasma/vapor
    Liquid chemical sterilants only if incompatible
    (Rutala, Weber, & HICPAC, 2008)
    (FDA, 2009a)
  • 32. Endoscope Accessories
    Reusable accessories inserted into endoscopes that break the mucosal barrier are critical items – sterilize between uses (e.g. biopsy forceps)
    Check manufacturers instructions - sterile processing is recommended for many accessories used with endoscopes (e.g. in-sheath baskets, savory guide wires and water bottles)
    (Rutala, Weber, & HICPAC, 2008)
  • 33. Protective Sheaths
    OK to use probe covers to reduce the level of contamination
    Condoms Can FailDo not use a lower category of disinfection or cease to follow the appropriate disinfectant recommendations
    • Ultrasound probes used during surgical procedures also can contact sterile body sites - Use sterile sheath
    • 34. Sterilize between each patient use or if not possible at a minimum high-level disinfect
    • 35. Replace non-immersible probes with fully immersible probes as soon as possible
    (Rutala, Weber, & HICPAC, 2008)
  • 36.
  • 37. FDA notice and recommendations for Steris System 1
    Dec 2009:
    FDA has not determined whether the SS1 is safe or effective for its labeled claims, including claims that it sterilizes medical devices
    Assess patient care needs and disinfection and sterilization requirements and transition to an alternative as soon as possible (within 3-6 months)
    Some reports of malfunctions of the SS1 that had the potential to cause or contribute to serious injuries to patients, such as infections.
    No confirmed infections (no patient notification required)
    Reports of injuries, mostly burns from exposure to the sterilant solution
    Feb 2010:
    Steris Corporation has chosen not to seek FDA clearance of this device, discontinue use as soon as practicable.
    Transition period extended to 18 months
    (FDA, 2009b; FDA, 2010b)
  • 38. FDA-cleared Endoscope Washer Disinfectors / Automated Endoscope Reprocessors
  • 39. FDA-Cleared Low Temperature Sterilizers Using Hydrogen Peroxide or Ozone
  • 40. Ortho-phthaldehyde
  • 41. Glutaraldehyde
    Glutaraldehyde is noncorrosive to metal and does not damage lensed instruments, rubber. or plastics.
    Might have toxic effects on the gametes and embryos –consider other HLD for transvaginal transducers
    Acute or chronic exposure can result in skin irritation or dermatitis, mucous membrane irritation (eye, nose, mouth), or pulmonary symptoms
    Enforcement of the OSHA ceiling limit was suspended in 1993 by the U.S. Court of Appeals 577
    ACGIH recommends limiting employee exposure to 0.05 ppm (>0.05 can irritate the eyes, throat, and nose)
    Ducted exhaust hoods, ductless fume hoods with absorbents, provide 7-15 AEH, tight-fitting lids on immersion baths
    PPE: nitrile or butyl rubber gloves but not natural latex gloves and goggles to minimize skin or mucous membrane contact
    Schedule Monitoring
    (AAMI, 2005)
  • 42. Hydrogen Peroxide
    Haag-Streit reusable tonometer tips (prisms):
    3% hydrogen peroxide and soak for 10 minutes
    3% hydrogen peroxide solution must be disposed of and replaced after 4 hours, once poured out of the bottle
    Rinsing under running cold tap water suitable for drinking for ten minutes
    (VHA, 2007)
  • 43. Rinse & Drying
    Remove all residual solution
    Rinse according to manufacturers (device and HLD) instructions (duration, number of water exchanges, running water, water exchanges, water quality, etc)
    Flush all channels multiple times with water, followed by air
    Flush channels with alcohol, followed by forced air to facilitate drying (see manufacturers instructions)
    External surfaces of instruments should be thoroughly wiped dry with a sterile, lint-free cloth.
    Transport in a manner to protect from contamination (handle with clean gloves)
  • 44. Delayed Endoscope Reprocessing
    More than 1 endoscope used during same procedure, scopes used in beginning of an OR case
    Weekend and Emergent Use (GI scopes, bronchoscopes, TEE)
    Some manufacturers' recommend a 10 hour soak in the event of delayed reprocessing, yet unnecessary or extended immersions may damage the scope
    (Catalone & Koos, 2005)
  • 45. STORAGE
  • 46. Storage RMEStore in a manner that reduces the potential for contamination
    Sterile products
    Limited access area that is well-ventilated, protected from dust, moisture, insects and temp/humidity extremes
    8 to 10 inches above the floor, at least 18 inches below the ceiling or the level of the sprinkler heads, and at least 2 inches from outside walls.
    Positioned to prevent crushing or puncture
    Time or event related shelf-life
    Just-in-time processed products (Sterilization or HLD)
    Protect from contamination or damage
    Storage container must be cleanable
    (AAMI, 2006)
  • 47. Endoscope Storage Cabinets
    Doors that close
    Vented- allows air circulation
    Adequate height to allow endoscope to hang vertically without touching the bottom
    Internal surfaces with cleanable materials
    Hangers constructed to support endoscopes
    Sufficient space to store without touching
    Do not store in the carrying case
    (Burlingame, 2009; Rutala, Weber, & HICPAC, 2008 )
  • 48. Reprocessing before use
    No recommendation is made regarding the reprocessing of an endoscope again immediately before use if that endoscope has been processed after use according to the recommendations in this guideline. Unresolved issue. (Rutala, 2009)
    American Association for the Study of Liver Diseases (AASLD), American College of Gastroenterology (ACG), American Gastroenterological Association (AGA) and American Society for Gastrointestinal Endoscopy (ASGE) jointly recommend the processed flexible endoscopes should be reprocessed within 10-14 days (VA memo, Dec 2, 2009)
    VHA Policy: Reprocess after 12 days
    Scopes not used frequently should be stored separately, consider sterilizing and storing sterile.
  • 49. QUALITY ASSURANCE
  • 50. Standard Operating Procedures
    SOPs
    Endoscopes are NOT all processed the same – review manufacturer guidelines for differences (e.g. you cant have one SOP for all GI scopes)
    “Cheat sheets” – make sure they match
  • 51. Performance Measures
    Supervision / Authority / Responsibility / Accountability
    Training
    Competency
    Monitoring - Audits
    Reporting
  • 52. Verification of processing
    No recommendation is made about routinely performing microbiological testing of either endoscopes or rinse water for quality assurance purposes. Unresolved issue
    VHA highly recommended: Testing to ensure bio-burden has been removed after reprocessing endoscopes that have been used for biopsy, (both the biopsy and suction channels). (VHA Directive, 2009)
    (Rutala, Weber, & HICPAC, 2008 )
  • 53. Surveillance
    “A method for detecting clusters of infections or pseudo-infections associated with endoscopic procedures (e.g., a surveillance system). If a cluster is discovered, this should be reported to the manufacturer of the endoscope, the endoscope accessories, the AER, and the germicide”
    (FDA, 2009a)
  • 54.
    • ID nature of breach, procedure, biologic substances involved
    • 55. Review recommended reprocessing methods
    • 56. Institute corrective action
    Infection control breach
    • Determine time frame, # patients exposed
    • 57. ID exposed patients with evidence of HBV, HCV or HIV
    • 58. Literature Review, consult experts
    Additional data gathering
    • ICP / ID, Risk, Affected providers
    • 59. DOH, Licensing / Regulatory agencies (if applicable)
    Notify & involve key stakeholders
    • Category A – gross error or high-risk
    • 60. Category B – breach with lower likelihood of blood exposure
    Qualitative assessment
    • Category A – patient notification/testing is warranted
    • 61. Category B – Consider: Potential risk of transmission, public concern, duty to warn vs. harm of notification
    Patient Notification & testing
    • Develop material
    • 62. Consider post-exposure prophylaxis; determine who will conduct testing, counseling; determine if follow-up needed
    • 63. Facilitate public inquiry & communication
    • 64. Address media & legal issues
    Communication & Logistical issues
    Adapted from Patel, Srinivasan, Perz, 2008
  • 65. Reprocessing Quality Assurance
    Infection Control Cmt
    Med Exec Cmt
    IP
    (HAI)
  • 66. The Final Frontier: Non-Critical RME
    Inventory
    General SOP
    Contact times for intermediate to low-level disinfection
    Include some environmental surfaces (e.g. keyboards)
    Specific SOP for difficult to clean/disinfect items or items with very precise instructions
  • 67. References
    American Institute of Architects [AIA]. (2006). Guidelines for design and construction of hospital and health care facilities. Washington, DC: The American Institute of Architects Press.
    Association for the Advancement of Medical Instrumentation [AAMI]. (2005). Chemical sterilization and high-level disinfection in health care facilities. ANSI/AAMI ST58. Arlington, VA: AAMI
    Association for the Advancement of Medical Instrumentation [AAMI]. (2006a). Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79. Arlington, VA: AAMI
    Burlingame, B. (2009). Reprocessing flexible endoscopes before use. AORN Journal, 89(2). 403-405.
    Catalone, B. & Koos, G. (2005). Reprocessing flexible endoscopes. Avoiding reprocessing errors critical for infection prevention and control. Managing Infection Control, June. Retrieved January 30 fromhttp://www.olympusamerica.com/msg_section/files/mic0605p74.pdf
    CNN.com (2009). Inspections find many VA facilities lack colonoscopy safety. Retrieved July 11, 2009 from http://www.cnn.com/2009/HEALTH/06/16/veterans.colonoscopies/
    EndoNurse. (2009). VA allocates $26M for endoscopy sterilization equipment. Retrieved July 11, 2009 from http://www.endonurse.com/hotnews/va-allocates--26-million-to-fix-endoscopy-pro.html
    House Committee on Veterans' Affairs .(2009). VA endoscope problem is department-wide. Retrieved July 11, 2009 from http://www.military.com/news/article/va-endoscope-problem-is-departmentwide.html
    Joint Commission on Accreditation of Healthcare Organizations, [JC]. (2009a). Update: The Joint Commission’s position on steam sterilization. Joint Commission Perspectives,29,(7)
    Joint Commission on Accreditation of Healthcare Organizations, [JC]. (2009b). Clarification: Reducing infection risks associated with medical equipment, devices, and supplies. Joint Commission Perspectives,29,(10)
    JustNews. (2009). VA hospital: Patients exposed to HIV, Hepatitis. Retrieved July 11, 2009 fromhttp://www.justnews.com/health/18996113/detail.html
    Lambert, D. (2009). Valve Problem Cited In Colonoscopy Issue. WSMV.com. Retrieved July 11, 2009 from http://www.wsmv.com/news/18439461/detail.html
    Olympus America Inc. (2009). Important safety notice. Retrieved January 30, 2010 from http://www.olympusamerica.com/files/MAJ-855_CustomerLetter_2112009.pdf
  • 68. Patel, PR., Srinivasan, A., & Perz,JF. (2008). Developing a broader approach to management of infection control breaches in health care setting. American Journal of Infection Control,36(10). 685-690.
    Poovey, B. (2009). Congressional panel to analyze VA hospitals' mistakes. Associated Press. Retrieved July 11, 2009 from http://www.boston.com/news/nation/articles/2009/05/30/congressional_panel_to_analyze_va_hospitals_mistakes/
    Reuters. (2009). VA continues notification process for veterans affected by reprocessing issues. Retrieved July 11, 2009 from http://www.reuters.com/article/pressRelease/idUS196904+03-Apr-2009+PRN20090403
    Rutala, W.A., Weber, D.J., & Healthcare Infection Control Practices Advisory Committee [HICPAC]. (2008). Guideline for disinfection and sterilization in healthcare facilities, 2008. Retrieved January 30, 2010 from http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf
    US Food and Drug Administration [FDA]. (2009a) Preventing Cross-Contamination in Endoscope Processing. Safety Communication from FDA, CDC, and the VA. Retrieved January 30, 2010 from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm190273.htm
    US Food and Drug Administration [FDA] (2009b). FDA Notice: Concerns About the Steris System 1 Processor, Components, and Accessories, and FDA Recommendations. Retrieved January 30, 2010 from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm191585.htm
    US Food and Drug Administration. (2010a). Alternatives to STERIS System 1. FDA cleared sterilization and disinfection products. Retrieved January 30, 2010 from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm194429.htm
    US Food and Drug Administration [FDA]. (2010b) Steris System 1 Processor: Extension of Recommended Time Period for Healthcare Facilities To Transition to Legally-Marketed Alternatives. Retrieved January 30, 2010 from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm199567.htm
    Veterans Health Administration [VHA]. (2007). Patient safety alert AL08-03; Addendum to patient safety alerts AL07-06 and AL07-02: Reprocessing instructions for Haag-Streit reusable tips (prisms) used to measure intraocular pressure. Retrieved February 1, 2010 from http://vaww.ncps.med.va.gov/Guidelines/alerts/Docs/TonometerTipsReprocessingAL08-03.pdf
    Veterans Health Administration [VHA]. (2008). Patient safety alert: Improper set-up and reprocessing of flexible endoscope tubing and accessories. Retrieved January 30, 2010 from http://www.patientsafety.gov/alerts/OlympusScopesAlertAL09-07-WWW.pdf
    Veterans Health Administration [VHA]. (2009) VHA Directive 2009-031: Improving safety in the use of reusable medical equipment through standardization of organizational structure and reprocessing requirements. Retrieved January 30, 2010 fromhttp://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2039