APPENDIX C. HIGH-LEVEL DISINFECTION PROCEDURE
C.1. Introduction
1. The Exablate 2100V1 (“Exablate”) Prostate probe is considered a semi-critical device, as per
Spaulding classification, and should undergo this cleaning and high-level disinfection (HLD)
procedure, immediately at the point of use after every treatment.
2. Immediately after treatment, all single-use items: (1) probe shell, safety pin and white O-ring, (2) all
drapes and covers, and (3) water pouch must be discarded in marked hazardous material containers
and handled using applicable personal protective equipment (e.g., gloves, protective glasses, etc.),
according to the policies of the medical facility.
3. Used cleaning and disinfection materials should be disposed of according to their manufacturer
instructions and the medical facility policy.
4. Individuals handling cleaning and disinfecting agents must follow the instructions of the agent
manufacturer, including instructions for personal protective equipment.
5. Follow the steps in this procedure consecutively and without delays in between.
6. Users should also refer to professional organizations’ clinical practice guidelines or clinical guidelines
of the Center for Disease Control (CDC).
C.2. List of Materials Required for Cleaning
1. Cleaning and disinfection cart, with four (4) containers:
a. Container #1 for cleaning Solution
b. Container #2 for water
c. Container #3 for disinfectant
d. Container #4 for water
2. Sodium hypochlorite (5.25-6.15%, also known as household bleach)
3. Purified water
4. Enzol® Enzymatic Detergent
5. Revital-Ox™ RESERT® HLD
6. Disposable disinfection wipes containing 0.2-0.4% benzalkonium chloride active ingredient (e.g.,
Clorox® disinfection wipes or equivalent product)
7. Lint free cloth
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