Design and Process
Who should be contacted when there is no specific written IFU in the device labeling?
Device manufacturer
ANSI/AAMI ST79,
Section 7.3, Page 40
Name the chemical that can contribute to adverse patient events, such as device malfunction, toxic effects and tissue irritation, patient infection, ineffective cleaning, and noncondensable gases when left untreated.
Water
AAMI TIR34, Section 3.2.1,
Page 8
Proper Attire in Sterile Processing Prep and Pack
Clean scrubs, hair covering, jacket, hospital shoes
When testing the MEC on the OER-Pro how much must you wait before reading the test strip?
7 seconds
__________ can contribute to corrosion, staining, and increased microbial levels after reprocessing, if not monitored.
Water Quality
AAMI TIR34, Section 7.2,
Page 30
What area should be physically separate from all other processing areas in which clean or sterilization procedures are carried out?
Decontamination Area/Room
ANSI/AAMI ST79,
Section 3.3.6.1.1, Page 21
There are two categories of water quality; name the category of water mainly used for the final rinse or steam generation.
Critical water
AAMI TIR34, Section 4.2,
Page 15
what testing material is used for a 4'' Iris Scissor
Yellow ThereaBand
When testing the MEC (Minimum Effective Concentration) of OPA Cidex how long must you wait before reading the test strip?
90seconds or 1min 30secons
There should be a planned, systematic, and ongoing process for verifying compliance and procedures. Quality processes can be enhanced by ______ that are conducted on a regular basis.
Audits
AAMI TIR34, Section 10,
Page 33
Microbicidal processes could be a _____ or ____ process. What are the two processes?
Disinfection or
sterilization
ANSI/AAMI ST79,
Section 7.1, Page 39
Name a substance found in a solution, such as Protease, Lipase, and Amylase that initiates chemical changes.
Enzyme
IAHCSMM CS Tech Manual,
Chapter 8, Page 146, 488
How often should the Prep and Pack side be cleaned?
Terminally Cleaned Everyday
What type of Flexible Endoscope has an Elevator?
The ERCP
Attire worn to protect oneself from contact with blood and bodily fluid of any patient.
PPE
IAHCSMM CS Tech
Manual, Chapter 18. Page
387
Ventilation characteristics, including air exchanges per hour and airflow pattern should be included in?
Performance measures for aspects of design
ANSI/AAMI ST79,
Section 14.2.3.2, Page
Name a cleaning agent containing emulsifiers, surfactants, and chelating agents to increase cleaning efficacy.
Detergent
IAHCSMM CS Tech Manual,
Chapter 8, Page 147
What is the maximum amount of relative humidity for assembly side?
Cannot exceed 60%
Following the Cidex OPA Disinfection what phase requires 3 repeated processes?
Rinsing phase
A list of actions to be performed in a given process or technical setting, the goal being to ensure that no step will be forgotten
Checklists
Article: The checklist – a
tool for error management
and performance
improvement
Piece of equipment that makes use of energy creating tiny gas bubbles that implode on the device surface whereby loosening fine soil.
Ultrasonic
IAHCSMM CS Tech Manual,
Chapter 8, Page 139
What is acronym for the “potential of Hydrogen”?
pH
IAHCSMM CS Tech Manual,
Chapter 8, Page 136
Water that has been heated to boiling point, vaporized, cooled and condensed into liquid form whereby removing impurities and like gases and organic material, it also removes some bacteria.
Distilled Water
IAHCSMM CS Tech Manual,
Glossary, Page 486;
ANSI/AAMI ST79,
Section 335, Page 9
Verification and documentation of automated cleaning processes through objective means is an important aspect of?
Quality Control
ANSI/AAMI ST79, Section
7.6.4.5, Page 48
At a minimum, what should occur within two (2) years of hire and be maintained throughout employment.
Certification
ANSI/AAMI ST79, Section
4.2.2, Page 26