Decontamination Study Set – Sterile Processing and Infection Control – 2026 – Study and
Practice Guide
What is the purpose of thorough cleaning of a reusable medical device? - ANS✔✔ To remove
soil, including organic matter (blood, protein, feces, mucus and tissue) and other material, prior
to submitting the device toa disinfection or sterilization process.
What may the failure to remove organic matter and residue prior to disinfection or sterilization
impair? - ANS✔✔ the efficacy of disinfection and sterilization process
Will the extension or repetition of the disinfection or sterilization process remove the microbial
load on inadequately cleaned devices? - ANS✔✔ Not necessarilly
Define decontamination - ANS✔✔ The process of reducing the number of microorganisms on a
soiled item to a low level making the item safe to handle and controls the spread of pathogens
in the department
What is the most important step in decontamination? - ANS✔✔ thorough cleaning
Will cleaning adequately decontaminate an item? - ANS✔✔ Maybe not. DIsinfecting further
reduces the number of microorganisms
What are the activities in decontamination directed towards? - ANS✔✔ Keeping staff and
patients safe, and controlling the spread of pathogens. This is done through dress code and
principles of medical asepsis.
What must procedures for disinfection and sterilization include> - ANS✔✔ Statements and
information regarding the type, concentration and testing of chemical products; duration and
temperature of exposure; and physical and chemical properties that might have an impact on
the efficacy of the process.
,what is the goal of a quality system? - ANS✔✔ to provide assurance that the facility's policies,
processes and procedures are in compliance with CSA Z314.8 and the department's products
and services provide the highest possible degree of safety and quality
does the level of responsibility of each individual staff membner or group need to be defined? -
ANS✔✔ yes
how often must the operating procedures be reviewed and updated? - ANS✔✔ at specific
intervals stated in the facility's policies
who must complete the reviews and updates or operating procedures? - ANS✔✔ A
knowledgeable individual who has the authority to make necessary changes to ensure
conformance wqith current or new requirements and/or changes in the practice.
what must an operating procedure be reviewed in response to (in addition to the set-intervals
for reviewing and updating operating procedures)? - ANS✔✔ -any accident, error or adverse
event that is related to a function goverened by the procedure;
-changes in applicable laws or regulatory requirements;
-results obtained from internal or external audits;
-other conditions or situations as defined in the facility's policies
what are accidents or errors? - ANS✔✔ occurences that could adversely effect the safety,
efficacy or quality of the reprocessing system, or the safety of patients or facility personnel.
who must complete audits, how often and according to what? - ANS✔✔ must be completed
according to an established program by trained personnel with well-defined responsibilities and
authority who do not have direct responsibility for the procedures being audited. (yearly or
more often)
,procedures for process control must contain, but not be limited to, the following elements: -
ANS✔✔ change control
proficiency testing program
quality control
true/false: all reusable medical devices should be decontaminated before they are used on a
patient - ANS✔✔ true
what are critical devices and do they need to be sterilized in addition to decontamination? -
ANS✔✔ devices that will invade the blood stream, such as biopsy forceps and cautery devices,
and yes they do.
what must the decision to sterlize semi-critical and non-critical devices be based on? - ANS✔✔
the intended use of the device and associated risks.
true/false: all manufacturer information and manufacturer's instructions must be device
specific. - ANS✔✔ true.
what must manufacturer information and instructions contain? - ANS✔✔ -cleaning and
reprocessing instructions;
-schematic drawings;
-assembly and disassembly instructions;
-information to provide staff in-service on reprocessing the medical device. This in-service must
be performed prior to the device being used on a patient.
-routine maintenance schedulres
what is the purpose of all required information in the manufacturer's instructions? - ANS✔✔ to
prevent risk to patients and ensure that staff performing the reprocessing of medical devices are
properly trained
, When purchasing a reusable medical device, what must the health care facility confirm? -
ANS✔✔ That it is properly licensed and meets applicable standards.
Can devices that are not manufacturered for medical use be used on patients? - ANS✔✔ NO
What must the reprocessing committee consist of at minimum? - ANS✔✔ Risk manager
reprocessing manager
infection prevention and control
user department
finance and purchasing
true/false. Anti-corrrosive and anti-rusting agents (i.e. oils, greases or waxes) may be applied to
the device by the manufacturer and may applied to the device by the manufacturer in order to
protect it during shipping. Such agents will not interfere with sterlization if not removed. -
ANS✔✔ False. they must be removed because they may be removed.
all personnel working in the decontamination area must: (2) - ANS✔✔ 1) be made aware of the
associated hazards;
2) wear appropriate atire, including PPE
When working in the decontamination area, workers must: (4) - ANS✔✔ 1) wear the
appropriate PPE to prevent being exposed to blood, or body fluids or contaminated devices;
2) wash their hands immediately if they have been expoed to potentially infectious material;
3) not eat, drink, smoke, apply cosmetics or lip balm or handle contact lenses
4) not store food, drink or personal belongings in the area
Practice Guide
What is the purpose of thorough cleaning of a reusable medical device? - ANS✔✔ To remove
soil, including organic matter (blood, protein, feces, mucus and tissue) and other material, prior
to submitting the device toa disinfection or sterilization process.
What may the failure to remove organic matter and residue prior to disinfection or sterilization
impair? - ANS✔✔ the efficacy of disinfection and sterilization process
Will the extension or repetition of the disinfection or sterilization process remove the microbial
load on inadequately cleaned devices? - ANS✔✔ Not necessarilly
Define decontamination - ANS✔✔ The process of reducing the number of microorganisms on a
soiled item to a low level making the item safe to handle and controls the spread of pathogens
in the department
What is the most important step in decontamination? - ANS✔✔ thorough cleaning
Will cleaning adequately decontaminate an item? - ANS✔✔ Maybe not. DIsinfecting further
reduces the number of microorganisms
What are the activities in decontamination directed towards? - ANS✔✔ Keeping staff and
patients safe, and controlling the spread of pathogens. This is done through dress code and
principles of medical asepsis.
What must procedures for disinfection and sterilization include> - ANS✔✔ Statements and
information regarding the type, concentration and testing of chemical products; duration and
temperature of exposure; and physical and chemical properties that might have an impact on
the efficacy of the process.
,what is the goal of a quality system? - ANS✔✔ to provide assurance that the facility's policies,
processes and procedures are in compliance with CSA Z314.8 and the department's products
and services provide the highest possible degree of safety and quality
does the level of responsibility of each individual staff membner or group need to be defined? -
ANS✔✔ yes
how often must the operating procedures be reviewed and updated? - ANS✔✔ at specific
intervals stated in the facility's policies
who must complete the reviews and updates or operating procedures? - ANS✔✔ A
knowledgeable individual who has the authority to make necessary changes to ensure
conformance wqith current or new requirements and/or changes in the practice.
what must an operating procedure be reviewed in response to (in addition to the set-intervals
for reviewing and updating operating procedures)? - ANS✔✔ -any accident, error or adverse
event that is related to a function goverened by the procedure;
-changes in applicable laws or regulatory requirements;
-results obtained from internal or external audits;
-other conditions or situations as defined in the facility's policies
what are accidents or errors? - ANS✔✔ occurences that could adversely effect the safety,
efficacy or quality of the reprocessing system, or the safety of patients or facility personnel.
who must complete audits, how often and according to what? - ANS✔✔ must be completed
according to an established program by trained personnel with well-defined responsibilities and
authority who do not have direct responsibility for the procedures being audited. (yearly or
more often)
,procedures for process control must contain, but not be limited to, the following elements: -
ANS✔✔ change control
proficiency testing program
quality control
true/false: all reusable medical devices should be decontaminated before they are used on a
patient - ANS✔✔ true
what are critical devices and do they need to be sterilized in addition to decontamination? -
ANS✔✔ devices that will invade the blood stream, such as biopsy forceps and cautery devices,
and yes they do.
what must the decision to sterlize semi-critical and non-critical devices be based on? - ANS✔✔
the intended use of the device and associated risks.
true/false: all manufacturer information and manufacturer's instructions must be device
specific. - ANS✔✔ true.
what must manufacturer information and instructions contain? - ANS✔✔ -cleaning and
reprocessing instructions;
-schematic drawings;
-assembly and disassembly instructions;
-information to provide staff in-service on reprocessing the medical device. This in-service must
be performed prior to the device being used on a patient.
-routine maintenance schedulres
what is the purpose of all required information in the manufacturer's instructions? - ANS✔✔ to
prevent risk to patients and ensure that staff performing the reprocessing of medical devices are
properly trained
, When purchasing a reusable medical device, what must the health care facility confirm? -
ANS✔✔ That it is properly licensed and meets applicable standards.
Can devices that are not manufacturered for medical use be used on patients? - ANS✔✔ NO
What must the reprocessing committee consist of at minimum? - ANS✔✔ Risk manager
reprocessing manager
infection prevention and control
user department
finance and purchasing
true/false. Anti-corrrosive and anti-rusting agents (i.e. oils, greases or waxes) may be applied to
the device by the manufacturer and may applied to the device by the manufacturer in order to
protect it during shipping. Such agents will not interfere with sterlization if not removed. -
ANS✔✔ False. they must be removed because they may be removed.
all personnel working in the decontamination area must: (2) - ANS✔✔ 1) be made aware of the
associated hazards;
2) wear appropriate atire, including PPE
When working in the decontamination area, workers must: (4) - ANS✔✔ 1) wear the
appropriate PPE to prevent being exposed to blood, or body fluids or contaminated devices;
2) wash their hands immediately if they have been expoed to potentially infectious material;
3) not eat, drink, smoke, apply cosmetics or lip balm or handle contact lenses
4) not store food, drink or personal belongings in the area
