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  • Sections:

    1. Reprocessing Guidelines
    2A. Infection Control Guidelines
    2B. Neonatal Infection Control Guidelines
    3. CDC Guidelines
    4. Other Guidelines
    5. Guidance on sterile fields, aseptic technique
    6. Technology Assessments, Position Statements
    7. FDA Guidance Documents
    8. How to sample flexible endoscopes
    9. Monitoring the quality of the rinse water
    10. Checklists, Competency Evaluations

    A.  GI endoscopes

    SGNA's Standards for reprocessing of GI endoscopes | The Multi-Society guideline for reprocessing GI endoscopes | Yale-New Haven Hospital: Cleaning and reprocessing of flexible GI endoscopes | AORN's Recommended Practices for Use of Endoscopes | APIC's Guideline for Infection Prevention in Flexible Endoscopy, 2000 | Pentax instructions for reprocessing GI endoscopesOlympus disinfecting guide/chart for bronchoscopes |  Olympus disinfecting guide/chart for GI endoscopes | ESGE-ESGENA guideline for quality assurance in reprocessing: Microbiological surveillance testing in endoscopy | ESGE-ESGENA guideline for process validation and routine testing for reprocessing endoscopes in washer−disinfectors


    CSGNA's Infection Control in the endoscopy settingQueensland Health Policy Guidelines of the French Society of GI Endoscopy  | BSG: Cleaning and disinfection of GI endoscopes | BSG Guidelines For Decontamination of Equipment for Gastrointestinal Endoscopy (BSG Working Party Report 2003) | ESGE's Guidelines on reprocesssing GI endoscopes |  OMED | Decontamination of returned endoscopes (Pentax) | Cleaning and Disinfection in Europe according to the Endoscopic Societies’ Guidelines  | 

    B. Liquid Chemical Disinfectants/Sterilants

    SGNA's Guideline for the Use of High-Level Disinfectants and Sterilants for Reprocessing of Flexible GI Endoscopes  |  ESGE-ESGENA guidelines  | FDA list of disinfectants for reprocessing flexible endoscopes  |  Regulatory Framework for Disinfectants and Sterilants | Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants | Queensland Health's Chemical Sterilants and High-level Disinfectants | FDA Labeling of Liquid Chemical Sterilants: Are Modifications Needed?  | Anticipated reliability of liquid chemical sterilants

    C. Bronchoscopes

    American College of Chest Physicians and American Association for
    Bronchology Consensus Statement. Prevention of Flexible Bronchoscopy-Associated
    Infection. Atul C. Mehta, et al. Chest 2005; 128:1742–1755

    D.  Surgical instruments

    1. World Health Organization's (WHO) Practical Guidelines for Infection Control in Health Care Facilities (2004): Contents; Complete Book
    2. A comprehensive list of "Infection Control - Guidelines and Recommendations.
    3. Cleaning, Disinfection, and Sterilization of Medical Equipment (Egypt).
    4. Sterilization and Disinfection (Saudi Arabia).
    5. Guidelines for Cleaning, Disinfection, Sterilization (UK)
    6. HICPAC's Draft guideline for Disinfection and Sterilization in Healthcare Facilities.

    E.  Instruments potentially contaminated with prions, Creutzfeldt-Jakob Disease (CJD)

    1. CJD: WHO infection control guidelines for transmissible spongiform encephalopathies.
    2. CJD: An infection control policy and procedure for Creutzfeldt-Jakob Disease (CJD).
    3. CJD: CJD and instrument reprocessing.  
    4. CJD: Risks and Prevention of Nosocomial Acquisition
    5. ESGE Guidelines: Variant Creutzfeldt-Jakob disease (vCJD) and gastrointesitnal endoscopy

    F. Washer-Disinfectors

    1. Check List for Purchase of Washer Disinfectors for Flexible Endoscopes

    AAGBI's Infection Control in Anesthesia, 2002AORN Guidance Statements | Canada's Guidelines for Infection Control, 2000 | Canada's Prevention and Control of Occupational Infections in Health Care (2002) | Cleaning, Disinfection, and Sterilization of Medical Equipment (Egypt).Comprehensive list of "Infection Control - Guidelines and Recommendations." | Guidelines for Infection Control (New York State; 2004) | Infection Control in Healthcare Settings (UK; 2004).| Guidelines for Cleaning,Disinfection, Sterilization (UK) | Infection Control Guidelines (Queensland Health; 2001) | NSW's guidelines for infection control, 2002 | Queensland Government. Infection Control guidelines. November 2001 | Infection Control in the Health Care Setting (Western Australia) | Infection Control Guidelines for Oral Health Care Settings | Infection Control in the Health Care Setting (Australia) Infection Control in the Physician's Office (Canada, 2004) |  | Sterilization, Disinfection (Saudi Arabia). | Infection prevention and control policies and guidelines for health care services. Ministry of Health Trinidad and Tobago | Infection Prevention Guidelines for Healthcare Facilities with Limited Resources (JHPIEGO), March 2003.
    1. Infection control in the NICU April 2001
    2. Infection control in the nursery 
    3. Neonatal care units

    CDC's Management of Multidrug-Resistant Organisms In Healthcare Settings, 2006.CDC's Guidelines for preventing the transmission of M. tuberculosis in health-care settings, 2005  |  CDC's Guidelines for environmental infection control in health-care facilities, 2003.  |  CDC's Guidelines for infection control in dental health-care settings-2003.  |  Guidelines and Recommendations | Sterilization and Disinfection  |  Recommendations for preventing transmission of infections among chronic hemodialysis patients.  |  Guideline for Prevention of Surgical Site Infection - 1999  |  Guidelines for Preventing Health-Care Associated Pneumonia, 2003  |  Guideline for Handwashing, Hospital Environmental Control, 1985  |  Guideline for Hand Hygiene in Health-Care Settings, 2002   |  Regulatory framework for disinfectants, sterilants  |  Viral hepatitis C infection  |  Public health guidance for SARS | Disinfection and Sterilization of Patient-Care Equipment, 1985 | HICPAC's Draft guideline for Disinfection, Sterilization in Healthcare Facilities, 2002. 

    1. SHEA Position Papers, Statements.
    2. Strategies for Norovirus Infection Control Aboard Cruise Ships.
    3. Infection Control Guidelines for use in Tattooing/Skin Piercing Practice
    4. Policies and procedures for patients with confirmed or suspected CJD
    5. Recommended practices for environmental cleaning in the surgical practice setting AORN Journal, Dec, 2002.
    6. Clinical Issues: AORN recommends reprocessing endoscopes before the first patient of the day.
    7. Guidelines for handling large volumes (greater than 1 gallon)
      spills of Cidex, Cidex Plus solutions
      .  
    8. Guidelines for cleaning, disinfection, sterilization (UK)
    9. Guidelines for the control of nontuberculosis mycobacteria, 2002.
    10. HICPAC's Draft guideline for disinfection and sterilization in healthcare facilities.
    1. Creating and maintaining a sterile field

     

    1. Gastrointestinal Endoscopes (ASGE), 2003.
    2. Enteroscopy (ASGE), 2005.
    3. Capsule Endoscopy (ASGE), 2004.
    4. Statement on reprocessing of water bottles used during endoscopy (SGNA), 2002.
    1. Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants and High Level Disinfectants; Final (2003).
    2. Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants and High Level Disinfectants; Draft (1997).
    3. Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities (1993).
    4. Labeling reusable medical devices for reprocessing in health care facilities:  FDA reviewer guidance. April 1996.
    5. Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities (1993).
    6. Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities (1995).
    7. Information for Manufacturers seeking Market Clearance for Diagnostic Ultrasound Systems and Transducers, 1997
    8. Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers, 2000
    9. Content of a 510(k) Submission (Updated 2005).
    10. A 510(k) Primer:  FDA's Premarket Noptification Process.
    11. Premarket Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers (2001).
    12. CDRH Regulatory Guidance for Washers and Washer-Disinfectors Intended for use in Processing Reusable Medical Devices (1998).
    13. Premarket Notification [510(k)] Submissions for Chemical Indicators:  Gudiance for Indistry and FDA Staff (2003).
    14. FDA Revises Guidance on the Reprocessing of Single-Use Devices
    15. What are guidance documents?
    16. Search FDA's (CDRH) on-line guidance database
    17. Search FDA's (CDRH) on-line 510(k) clearance database  
    1. The Endocheck biopsy channel test
    2. Microbiologcal surveillance of flexible endoscopes.
    3. Sampling endoscopes, automated reprocessors
    4. ESGE-ESGENA guideline for quality assurance in reprocessing:  Microbiological surveillance testing in endoscopy
    5. Should we be sampling endoscopes?
    6. How to sample an endoscope (Australia)
    7. Procedure for sampling and bacteriological monitoring (HIS)
    8. How to monitor GI endoscope reprocessing
    9. How to sample an endoscope (see Appendix 1) (Canada)
    10. Procedure for sampling bronchoscopes
    11. Microbiological testing for sampling endoscopes and AERs
    12. Should we be doing endoscope surveillance cultures?  Journal of the New Zealand Medical Association, 26-July-2002, Vol 115 No 1158.
    13. Principles of specimen collection.
    1. A policy and procedure for monitoring the rinse water (criteria are provided)
    2. Abstract: Sampling the rinse water used during endoscope reprocessing
    3. A water sampling method applicable to the endoscopic setting
    4. Culturing environmental specimens for Legionella sp. (CDC)
    5. CDC: Water Sampling Strategies and Culture Techniques for Detecting Legionellae
    1. CHECKLIST for reprocessing GI endoscopes.
    2. A 4 part competency evaluation (page 22 of 44).
    3. Kaiser Permanente's "Endoscope Reprocessing Competency Package."
    4. Sterilization and Disinfection Core Competencies.
    5. Endoscope cleaning and reprocessing competency verification checklist. 
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