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Volume: 28S5 • November 2002 Infection Control Guidelines
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Table of Contents |
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| Summary | ||
| Health Canada's Infection Control Guidelines Program | ||
| List of Participants | ||
| Steering Committee on Infection Control Guidelines | ||
| Health Canada AD HOC Advisory Committee on Infection Prevention and Control and Creutzfeldt-Jakob Disease | ||
| Acknowledgements | ||
| Introduction | ||
| A. How to Use this Document B. Glossary and Abbreviations (See Appendix II for CJD Surveillance Definitions) C. The Purpose of the Infection Prevention and Control Guidelines for CJD and Other Human TSEs D. Goals of the Guideline |
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Part A. Overview of CJD and Other Human TSEs |
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| Background Information | ||
| A. Etiology B. Clinical Features of CJD C. Diagnosis of CJD D. Epidemiology and surveillance E. Variant CJD |
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| Transmission of CJD | ||
| A. Overview B. Transplantation of Central Nervous System Tissue C. Instruments Used During Invasive Neurological and Neurosurgical Procedures D. Peripheral Administration of Human Pituitary Extracts E. Blood F. Occupational Exposure |
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Part B. Assessment and Management of CJD Risk in Clinical Practice |
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| Risk Assessment for CJD | ||
| A. Patient Risk Assessment for CJD B. Tissue Risk Assessment for CJD |
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| Risk Management for CJD | ||
| A. Infection prevention and control management based
on Risk Assessment for CJD B. Management of Equipment and Environmental Surfaces |
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| Incineration or Decontamination | ||
| Advance Planning | ||
| Instrument Quarantine | ||
| Non-immersible Equipment | ||
| Decontamination | ||
| Cleaning Phase | ||
| Chemical Phase | ||
| Heat/Sterilization Phase | ||
| Combination Methods | ||
| Ineffective or Partially Effective Methods for CJD | ||
Part C. Recommendations |
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| Recommendations for CJD Decontamination Procedures | ||
| Recommendations for the Management of a High Risk or an At Risk Patient for CJD in the Health Care Setting | ||
| A. Administration B. Notification C. General Patient Care D. Medical Procedures E. Surgical Procedures |
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| 1. High risk patient - involving high or low infectivity
tissues, OR at risk patient - involving high infectivity tissues,
including CSF 2. High risk patient - involving no detected infectivity tissues, or at risk patient - involving low infectivity (excluding CSF) or no detected infectivity tissues |
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| F. Pregnancy/Childbirth G. CJD Decontamination Process for Instruments and Equipment H. Environmental Surfaces I. Waste Disposal J. Laboratory |
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| 1. Specimen Collecting and Handling 2. Pathology |
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| K. Autopsy | ||
| 1. General Considerations 2. Transport of a High Risk or At Risk CJD Cadaver 3. Performance of an Autopsy on a High Risk or At Risk CJD Cadaver |
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| Recommendations for The Management of a High Risk or an At Risk Patient for CJD in Community Health Care Settings | ||
| Recommendations for Dentistry for The Management of a High Risk or an At Risk Patient for CJD | ||
| Recommendations for Funeral Service Workers in The Management of Human Remains from a High Risk Patient for CJD | ||
| Recommendations for Occupational Safety | ||
| Recommendations for Protocol Failure | ||
| Appendix I: Guideline Rating System | ||
| Appendix II: Surveillance Definitions for Classic CJD | ||
| Appendix III: Material Safety Data Sheets (MSDS) | ||
| Appendix IV: Instrument Construction | ||
| Appendix V: Example of Hospital CJD Risk Assessment and Management | ||
| Reference List | ||
| List of Tables | ||
| Table 1: Known Iatrogenic Causes of CJD Table 2: Patient Risk for CJD Table 3: Tissue Risk for CJD Table 4: Infection Prevention and Control Management Based on Risk Assessment for CJD Table 5: Ineffective or Partially Effective Processing Methods for CJD Table 6: CJD Decontamination Process |
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| List of Figures | ||
| Figure 1: Algorithm for the Management of Instruments
and Equipment used on a High Risk Patient Diagnosed with CJD Figure 2: Algorithm for the Management of Instruments and Equipment used on a High Risk Patient with Suspected CJD Figure 3: Algorithm for the Management of Instruments and Equipment used on an At Risk Patient for CJD |
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Problem
Transmissible spongiform encephalopathies (TSEs), also known as prion
diseases, are fatal, degenerative brain diseases. The TSE agents are hardy,
remain infectious for years in a dried state, and resist all routine sterilization
and disinfection procedures commonly used in health care facilities. Although
the incidence of Creutzfeldt-Jakob Disease (CJD) and other human TSEs
is rare, there are increasing infection prevention and control concerns
because of the unconventional nature of TSE agents and documented iatrogenic
transmission between humans. The increasing availability of neurological
and neurosurgical procedures has the potential to increase risks for iatrogenic
transmission of the CJD agent if appropriate infection prevention and
control measures are not taken.
Method
This guideline provides a framework within which institutions and agencies
may develop policies and procedures to address their needs. The Health
Canada infection control guidelines provide evidence-based recommendations.
Where scientific evidence is lacking, the consensus of experts is used
to formulate a
recommendation. An overview of CJD and other human TSEs, including modes
of transmission, is presented to provide a background for the recommendations
that follow.
Risk Assessment
Tables and algorithms provide a risk assessment tool for decision making.
Known iatrogenic sources of CJD are contaminated corneal and dura mater
grafts, stereotactic electroencephalography electrodes and neurosurgical
instruments, and human growth hormone and human pituitary gonadotropin.
It is important to
assess the patient and tissue risk for CJD to determine the infection
prevention and control precautions necessary to prevent the transmission
of CJD from one patient to other patients or care providers. Patients
who are classified as high risk are those who are diagnosed with CJD and
those who are suspected of having CJD on the basis of clinical signs and
symptoms indicating progressive neurological disease. Patients at risk
for CJD are those who have received human dura mater grafts, corneal grafts,
and human pituitary hormones. Members of families with familial CJD, Gerstmann-Sträussler-Scheinker
syndrome (GSS), and fatal familial insomnia (FFI) are also considered
to be at risk for prion disease. Assignment of different organs and tissues
to categories of high and low infectivity is based upon the frequency
with which infectivity has been detected under experimental conditions.
High infectivity tissues are the brain, spinal cord, dura
mater, pituitary, and eye (including optic nerve and retina). Low infectivity
tissues are cerebrospinal fluid (CSF), kidney, liver, lung, lymph nodes,
spleen, and placenta. There is no detected infectivity in adipose tissue,
skin, adrenal gland, heart muscle, intestine, peripheral nerve, prostate,
skeletal muscle, testis, thyroid gland, feces, milk, nasal mucus, saliva,
serous exudate, sweat, tears, urine, blood, bone marrow, or semen. Although
CSF is classified as low infectivity and is lessinfectious than high infectivity
tissues, it is felt that instruments ontaminated by CSF should be handled
in the same manner as those contacting high infectivity tissues in high
risk and at risk patients. Three algorithms have been developed to assist
with decision making regarding the management of instruments and equipment
used on a high risk or an at risk patient, depending on hether the instruments
came into contact with tissues of high, low, or no detected infectivity.
Risk Management
The results of the risk assessment for CJD should be used to determine
the appropriate infection prevention and control precautions required.
The following table summarizes CJD decontamination processes that must
be initiated for a high risk patient when exposure to high or low infectivity
tissues is anticipated and for an at risk patient when exposure to high
infectivity tissues (including CSF) is anticipated.
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Table 6: CJD Decontamination Processes(1)
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| These recommendations are based on the best available evidence at this time and are in decreasing order of effectiveness. They must be followed, without exception, when there is exposure to high and low infectivity tissues from a high risk patient and high infectivity tissues and CSF from an at risk patient (see Tables 2 and 3). NOTE: If the instrument or surface cannot be fully immersed or flooded with the chemical disinfectant, then the item must be incinerated. | ||
| 1. Incineration: Use for all instruments, effluent materials, and solid waste. | ||
| 2. Instrument Decontamination for heat-resistant
reusable instruments that an institution is unwilling or unable to incinerate. |
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| 2.1 | Cleaning: Removal of adherent particles through mechanical or manual cleaning must be completed prior to any chemical/sterilizer decontamination of instruments. Instruments and other materials to be decontaminated should be kept moist between the time of exposure to infectious materials and subsequent decontamination; then | |
| 2.2 | Immerse instruments in 1N sodium hydroxide (NaOH) or sodium hypochlorite* solution for 1 hour; remove from chemical solution; rinse instruments well; then immerse instruments in water and place in a sterilizer selecting the liquid cycle and heat to 121° C for 1 hour; or | |
| 2.3 | Immerse instruments in 1N NaOH or sodium
hypochlorite* for 1 hour; remove instruments from chemical solution; thoroughly rinse instruments in water; then transfer to an open pan, place in prevacuum sterilizer, and heat to 134°C for 1 hour or to 121°C in a gravity displacement sterilizer for 1 hour. |
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| 3. Hard Surface Decontamination | ||
| 3.1 | Remove visible soil. | |
| 3.2 | Flood with 2N NaOH or undiluted sodium hypochlorite; let stand for 1 hour; then mop up and rinse with water; or | |
| 3.3 | If surfaces cannot tolerate NaOH or undiluted
sodium hypochlorite, thorough cleaning will remove most infectivity by dilution, and some additional benefit may be derived from the use of one or another of the partially effective methods listed in Table 5. |
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| 4. Chemical/Sterilizer Process for Dry Goods | ||
| 4.1 | Small dry goods that can withstand either NaOH or sodium hypochlorite should first be immersed in one or the other solution (as described in 2.3 above) and then heated in a prevacuum steam sterilizer to 134°C for 1 hour. | |
| 4.2 | Bulky dry goods or dry goods of any size that cannot withstand exposure to NaOH or sodium hypochlorite should be heated in a prevacuum steam sterilizer to 134° C for 1 hour. | |
| *20,000 ppm available chlorine | ||
Recommendations
The recommendations in this guideline represent a conservative approach
to the management of classic CJD in health care and public service settings
in Canada. Recommendations on the management of a high risk or an at risk
patient for CJD in the health care setting include medical and surgical
procedures and, for high risk patients, precautions during childbirth
and dentistry. The recommendations elaborate on the CJD decontamination
process for instruments and equipment. The use of single-use instruments
and equipment is recommended wherever possible for high infectivity tissue
and CSF when CJD is a concern. Other recommendations deal with laboratory
specimen collection and handling, and pathology; autopsy and mortuary
procedures; and issues related to occupational safety.
Classic Creutzfeldt-Jakob
Disease in Canada
110 Pages - 403KB in PDF Format 
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Last Updated: 2003-01-15 |  |
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