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TSE: Instrument Management in Surgery and Dentistry
Current CDC Recommendations
Lynne Sehulster, PhD, M(ASCP)
Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention
Atlanta, GA 30333
Information Resources
WHO Infection Control Guidelines for TSEs - 1999:
www.who.int/emc-documents/tse/whocdscsraph2003c.html
CDC Infection control Q & A:
www.cdc.gov/ncidod/diseases/cjd/cjd_inf_ctrl_qa.htm
CDC Guidelines for Infection Control in Dental Health-Care Settings - 2003 www.cdc.gov/mmwr/PDF/RR/RR5217.pdf
Instrument Management Strategy Elements
Patient Status– Confirmed or suspected CJD case– Low or no risk patient
Tissue infectivity level– High-, Low-, or no infectivity
Instruments and surgical procedures– Tissue contact
Tissues and Infectivity:Patients with Confirmed or
Suspected CJD
High infectivity tissues:Brain, spinal cord, eyes
Low infectivity tissues:Cerebrospinal fluid, kidneys, liver, lungs, lymph nodes, spleen, placenta
Based on Table 2, WHO Infection Control Guidelines for TSEs 1999
Neurosurgery: Strategies for Infection Control
Prion-specific reprocessing should be employed for:– Any neurosurgical procedure performed on a
confirmed or suspected TSE patient– Neurosurgery performed for diagnosis– Neurosurgery to obtain non-lesionous biopsy
material Consider demographics of TSE patients
Decontamination Levels for Risk Categories
Patient Category Tissue Category Decon Options*
Confirmed or suspected TSE case
High infectivity
Low infectivity
Annex III
Annex III
Relative of patient with familial TSE
High infectivity
Low infectivity
Annex III
(Annex III**)
All of the above categories No detectable infectivity Routine procedures
Confirmed or suspected vCJD case
All tissue categories Annex III
*WHO Infection Control Guidelines for TSEs: Annex III 1999**WHO guidance is controversial on this topic.
Reprocessing Parameters: TSEHeat-Resistant Instruments
Immerse in 1N sodium hydroxide (NaOH) and heat in a gravity displacement autoclave at 121°C for 30 min, cool, clean, rinse, and follow with conventional autoclaving
WHO Infection Control Guidelines for TSEs: Annex III 1999
Measures to prevent sodium hydroxide spills in autoclaves include use of a container with rim and lid designed to collect condensation. Use caution. Let cool to minimize exposure to hydroxide vapor.
Brown and Merritt. Am J Infect Control 2003; 31: 257-60
Reprocessing Parameters: TSEHeat-Resistant Instruments
Immerse in 1N sodium hydroxide (NaOH) or 20,000 ppm sodium hypchlorite for 1 hr, transfer to water, heat in a gravity displacement autoclave at 121°C for 1 hr, cool, clean, rinse, and follow with conventional autoclaving; OR
Immerse in 1N sodium hydroxide (NaOH) or 20,000 ppm sodium hypochlorite for 1 hr, rinse, heat in gravity displacement autoclave (121°C) or porous load autoclave (134°C) for 1 hr, cool, clean, rinse, and follow with conventional autoclaving.
WHO Infection Control Guidelines for TSEs: Annex III 1999
Reprocessing Parameters: TSEHeat-Sensitive Instruments
Instruments having contact with high- and low-infectivity tissues
– High: brain, spinal cord, eyes– Low: cerebrospinal fluid, kidneys, lungs, liver,
lymph nodes, spleen, placenta Disposable instruments: discard Reusable instruments: soak in 2N NaOH or
undiluted sodium hypochlorite for 1 hr, rinse, clean, reprocess with low-temperature process
Chemicals / Autoclaving: Effects on Instruments
Inexpensive carbon-steel instruments are easily damaged
Gold plating damaged by sodium hypochlorite Soldered and welded joints damaged by
sodium hypochlorite Autoclaving in NaOH discolored instruments NaOH did not affect instrument function
Brown, Merritt, Woods, Busick: J Biomed Mater Res Part B, 2005; 72: 186-90
JCAHO Sentinel Alert No. 20: June 2001
Major points emphasized: Atypical clinical presentations possible Time interval between biopsy and pathology report
should be as short as possible Neurosurgical instruments should not be reused while
diagnosis is pending
JCAHO recommends: Policies and procedures for appropriate reprocessing Quarantine instruments until diagnosis is confirmed
Practical Advice
Quarantine the instruments:– Suitable if the time interval between surgery and
confirmation of the diagnosis is short– Have sufficient instrument inventory to
accommodate this practice– Keep instruments moist while awaiting release
for decontamination and reprocessing
Practical Advice II
To minimize potential exposures to patients in the event that instruments are returned to central sterile units before the diagnosis is confirmed:– Reprocess neurosurgical instruments as
recommended– Consider instrument tracking – Restrict instruments in neurosurgery trays to
those trays only
More Research is Needed
Evaluate decontamination, cleaning, and reprocessing processes as are currently available in health care– Cleaners: enzymatic, alkaline– Terminal reprocessing: peracetic acid, hydrogen
peroxide gas plasma Effects of repeated cycles of cleaning and
conventional autoclaving Potential for prion contamination of other surfaces in
reprocessing areas
CDC- Infection Control for Known CJD or vCJD Dental Patients
Use single-use disposable items and equipment
Consider items difficult to clean (e.g., endodontic files, broaches, carbide and diamond burs) as single-use disposable and discard after one use
CDC- Infection Control for Known CJD or vCJD Dental Patients
Keep instruments moist until cleaned and decontaminated
Clean thoroughly and steam autoclave at 134°C for 18 minutes. This is the least stringent of a list of sterilization methods offered by WHO
Do not use flash sterilization for reprocessing instruments or devices
Risk of transmission of CJD during dental treatment is low
– No documentation of prions in human oral tissues
– No published reports of an association of CJD infection with dental treatment
Additional precautions beyond Standard Precautions might be warranted for known CJD or vCJD patients
Risk of transmission of CJD during dental treatment is low
– No documentation of prions in human oral tissues
– No published reports of an association of CJD infection with dental treatment
Additional precautions beyond Standard Precautions might be warranted for known CJD or vCJD patients
Summary: DentistrySummary: Dentistry
CDC Perspective:At-Risk Patients in the U.S.
Blood relative of patient with inheritable forms of TSEs
Are asymptomatic individuals truly “at risk?”
WHO: no consensus - relatives of familial cases