Endoscope Reprocessing

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• About Us
• Module 1. Disease Transmission & Control
  • 1.1 Disease Transmission & Control
  • 1.2 Standard & Transmission-Based Precautions
  • 1.3a Microorganisms
  • 1.3b Normal Flora
  • 1.3c Infectious Agents
  • 1.3d Bacteria
  • 1.3e Viruses
  • 1.3f Other
  • 1.4 Review
• Module 2. Cleaning Disinfection & Sterilisation
  • 2.1 Cleaning, Disinfection & Sterilisation
  • 2.2 Impacting on Sterilisation & Disinfection
  • 2.3 Cleaning
  • 2.4 High-level Disinfectants & Chemical Sterilants
  • 2.5 Review
• Module 3. Workplace Health & Safety
  • 3.1 Workplace Health & Safety
  • 3.2 Biological Hazards
  • 3.3 Hazardous Substances
  • 3.4 Personal Protective Equipment
  • 3.5a Risk Assessment-Glutaraldehyde
  • 3.5b Risk Assessment-Peracetic Acid
  • 3.5c Risk Assessment-OPA
  • 3.6 Review
• Module 4. Endoscope Structure & Function
  • 4.1 Structure & Function
  • 4.2 External Components
  • 4.3 Internal Features
  • 4.4 Review
• Module 5. Reprocessing
  • 5.1 Reprocessing
  • 5.2 Pre-cleaning
  • 5.3 Leak Testing
  • 5.4 Manual Cleaning & Rinsing
  • 5.5 Manual High-level Disinfection
  • 5.6 Final Drying
  • 5.7 Reprocessing Accessories
  • 5.8 Automated Reprocessors
  • 5.9 Damaged Endoscopes
  • 5.10 Review
• Module 6. Quality Assurance
  • 6.1 Quality Assurance
  • 6.2 Proof of Process
  • 6.3 Templates
  • 6.4 Microbiological Testing
  • 6.5 Water Quality
  • 6.6 Recall & Tracking
  • 6.7 Review
• Final Review
• Self-Assessment Tool
• Glossary
• Abbreviations & Acronyms
• References
• Links
• Help

6.6 Recall & Tracking

It may be necessary to recall reprocessed items or track patients on whom particular instruments have been used if:

• a breakdown in the rigorous adherence to the recommended protocol for reprocessing flexible endoscopes is detected
• the transmission of disease via endoscopic equipment is suspected

As well as this the ability of endoscopy units to successfully defend possible litigation following patient infection, which might be traceable to products they have reprocessed, depends in part on the maintenance of suitable and accurate records by the unit. One significant feature that should be present in any system is the ability to recall reprocessed product if necessary.

Australian Standard AS/NZS 4187 establishes minimum criteria governing the monitoring of reprocessing in health care facilities and the associated records which must be kept. Check with your state health department to establish if they have more specific requirements.

Wherever practicable, attempts should be made to link information of an item that has been reprocessed to the patient. This data may be critical in a retrospective investigation about the possible transmission of infectious agents by endoscopy and in the interpretation of cultures from endoscopes and AFERs.

ACCESSORIES

Should accessories be traceable?
The following principles should be followed:

• Accessories which breach sterile surfaces and are difficult to reprocess, such that sterility cannot be regularly achieved, should be single use only, e.g. sclerotherapy needles.
• Accessories which breach sterile surfaces, are not labelled 'single use only' and have documented validated reprocessing systems need only standard indicators, i.e. cleaning by an appropriately certified staff and indicator evidence of sterilisation, e.g. biopsy forceps. They need not be individually traceable.
• Accessories which breach sterile surfaces and are labelled 'single use only' should be discarded after use. Where a facility allows reuse of single use items, there must be an institutionally validated reprocessing protocol which complies with the TGA regulation and these items should be individually traceable.

LOOKBACK INVESTIGATIONS

This refers to the process of identifying, tracing, recalling, counselling and testing patients or health care workers who may be exposed to an infection. Over 90% of incidents will involve the possible risk of transmission of blood-borne viruses. Some 5% - 6% will relate to the possibility of transmission of Pseudomonas or related species at ERCP, and around 2% - 4% will concern issues of possible transmission of Mycobacterium tuberculosis or atypical mycobacteria or the problem of pseudo epidemics related to bronchoscopy. The exact process of investigation may vary depending upon the particular circumstances. For example, the investigation of possible Pseudomonas or related species transmission by ERCP or possible transmission of tuberculosis by bronchoscopy will be significantly different from the process outlined below for blood-borne viruses.

A lookback investigation may be needed if a breakdown in the normal processes of reprocessing flexible endoscopes and their accessories is detected. It may also be required if a claim has been made that a patient has acquired an infection as a consequence of an endoscopy.

Some recommendations in relation to lookback investigations:

• It will be in the best interests of the patient, public health in general, the endoscopy community and your own unit if a prompt, thorough, competent and decisive investigation is undertaken without delay.
• It is not your role to attempt to determine other possible sources of a patient's infection!
• Do not conduct the investigation yourself. You are likely to be involved in emotive disputes regarding the source of infection and your investigation will lack the credibility of an independent body.
• Recognise that a possible conflict of interest exists if the patient is under your continuing care and you have a financial or controlling interest in the centre.
• In most cases the best independent authority will be the public health unit of your State Health Department who will decide whether they will conduct the investigation themselves or allow you to do so under their direction. In addition you may or may not wish to seek advice from an independent microbiologist.

The team responsible for planning the investigation should establish clearly at the outset the procedures that need to be undertaken and how these are presented to patients at risk and the public. These procedures should also clearly set out protocols for tracing, counselling and referral of potentially exposed individuals in a timely manner.

In practice an appropriate protocol in relation to the endoscopy unit will require:

• the endoscope used on the patient in question to be easily and reliably identified
• the endoscope to be inspected by the manufacturer for defects
• patients on whom this instrument has been used following the index case to be tested for the disease in question
• patients endoscoped before the index case to be tested also - this will usually involve the three patients examined prior to the index case
• staff to be tested for the appropriate infection
• an independent assessor to observe the endoscope reprocessing protocols
• an assessment of the anaesthetic technique
• provision of evidence that accessories which penetrated sterile tissue were sterilised

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