Guide ACTUAL QUESTIONS AND
CORRECT ANSWERS
In addition to testing products and loads, performance qualifications of both products and
loads shall be performed how often? - CORRECT ANSWER At least every 5 years
What process is described as cleaning to remove, inactivate, or destroy, that is followed by
the inactivation of pathogenic micro-organisms? - CORRECT
ANSWER Decontamination
In relation to flexible scope cleaning, which feature is NOT offered by AERs? - CORRECT
ANSWER A drying cycle for flexible endoscope biopsy ports
Potable water is suitable for use in precleaning and rinsing a device immediately after patient
use to remove gross soil. To prevent coagulation of blood and other proteins, the water used
for this purpose should not exceed what temperature? - CORRECT ANSWER 45
degrees C or 113 degrees F
All manufacturer's instructions and related information shall be device-specific and reference
what information - CORRECT ANSWER Device name and model number
Unless otherwise specified by the HLD manufacturer, how many separate rinse(s) shall be
included for manual rinsing of flexible endoscopes? - CORRECT ANSWER At least
three times
What is important for MDRD personnel to identify in relation to the reprocessing areas for
endoscopes? - CORRECT ANSWER The reprocessing area shall be physically
separated from client services areas, patient treatment room and clean storage area
According to CSA standards, which statement is not a protective measure to break chain of
infection?
,1. Receiving appropriate vaccinations
2. Preforming hand hygiene
3. Assuming that all devices received in the decontamination area are contaminated and
potentially infectious
4. Performing manual cleaning of devices above the surface of the cleaning solution -
CORRECT ANSWER 4. Performing manual cleaning of devices above the surface of
the cleaning solution
What does AER stand for? - CORRECT ANSWER Automated Endoscope
Reprocessing
To minimize damage to sensitive medical devices, what should be considered for vehicles
used for transport clean and sterile single use or reprocessed medical devices or supplies? -
CORRECT ANSWER Vehicle pneumatic suspensions
What criteria is not part of manufacturer's time instructions that shall be included in
endoscope procedures?
1. Contact time in cleaning solution
2. standing time in an AER prior to cycle completion
3. Standing time in an AER after cycle cycle completion
4. Waiting time between cleaning, rinsing and disinfection steps - CORRECT
ANSWER 2. Standing time in an AER prior to cycle completion
What does the acronym ABHR stand for? - CORRECT ANSWER Alcohol-based hand
rub
If packages are to be sealed with banding, which statement does NOT apply to the bands?
1. Be of a type that is easy to unfasten without tearing
2. Not be reused
3. Not constrict the middle of the package to create an hourglass effect
4. Be of a type that is not easy to unfasten without tearing - CORRECT ANSWER 4.
Be of a type that is not easy to unfasten without tearing
,If open shelving units are used for storage of clean and sterile single use or reprocessed
medical devices, how high off the follow should the shelves be? - CORRECT
ANSWER 25cm (10 in)
When loading a sterilizer chamber, how much space shall there be between packages away
from the contact point - CORRECT ANSWER 2 cm ( 1 inch)
According to CSA standards in relation to the preparation of medical devices in sterilization
trays or container systems, care shall be used to ensure what with respect to heavier medical
devices? - CORRECT ANSWER They do not damage medical devices
Medical device reprocessing areas shall be designed with the intent to reduce the potential for
adverse health effects by providing all the following expect what?
1. Storing, donning, and removing protective apparel
2. Non automated loading and unloading equipment whenever possible
3. Chemical or Biological monitoring equipment when required
4. Space for improvement of carts between work areas - CORRECT ANSWER 2. Non
automated loading and unloading equipment whenever possible
Which statement applies to off-site vehicles used for the transportation of single use and
reusable medical devices or supplies?
1. Shall be large enough to house clean and soiled medical devices or supplies
2. Shall be approved by the health care facility
3. Shall be inspected daily for cleanliness and maintenance
4. Shall no compromise the condition of the sterile medical device or supplies - CORRECT
ANSWER 4. Shall no compromise the condition of the sterile medical device or
supplies
What is the definition of bioburden? - CORRECT ANSWER Population of visible
micro-organisms on or in the product and/ or sterile barrier system
, When medical devices are exposed to a thermal disinfection phase, What A-O value in a
washer-disinfector process typically achieves thermal disinfecting conditions? - CORRECT
ANSWER 600 or equivalent
How shall reusable medical devices that are sharp or that incorporate sharp components be
handled? - CORRECT ANSWER Shall be segregated to prevent injury to personnel
when manually disinfecting all parts of the medical devices shall - CORRECT
ANSWER Be in complete contact with the solution
If relative humidity exceeds 70% in a sterile storage area, which action is NOT appropriate?
1. Notify the facility's management department to undertake remedial action
2. No action required unless relative humidity exceeds 75%
3. Visual inspection of packages for damage and/or wetness
4. Convening a meeting with stakeholders to determine the transfer of packages to an
alternate site. - CORRECT ANSWER 2. No action required unless humidity exceeds
75%
Following pasteurization, which action shall NOT be performed by MDR personnel
removing medical devices from the washer-pasteurizer?
1. MDR personnel should surface disinfect the exterior of the washer-pasteurizer
2. MDR personnel should remove soiled PPE
3. MDR personnel should perform hand hygiene
4. MDR personnel should surface disinfect the interior of the washer- pasteurizer -
CORRECT ANSWER 4. MDR personnel should surface disinfect the interior fo the
washer pasteurizer
Why should cleaning methods of semi-critical devices be consistent with the medical device
manufacturer's instructions and be appropriate for the type of medical device and amount of
soil to be removed? - CORRECT ANSWER to ensure that any inorganic and organic
matter is removed since they can inhibit the disinfection and sterilization process