CENTRAL STERILE PROCESSING
CHAPTER #5 EXAM QUESTIONS AND
ANSWERS
Third Party Re-processors are regulated by the FDA. - Answer-True
Recommendations regarding sterilization practices are provided by AAMI. - Answer-
True
ANSI is a voluntary association dedicated to infection control and prevention. -
Answer-False
The organization that conducts on-site surveys to evaluate healthcare organizations
is the ISO. - Answer-False
Failure to receive accreditation from the Joint Commission can result in the loss of
Medicare and Medicaid payments. - Answer-True
The SGNA is a good source of information about the proper procession of flexible
endoscopes. - Answer-True
Class III medical devices are identified as High Risk. - Answer-True
Re-use of single use medical devices is less regulated now than it was in the 1990's.
- Answer-False
Agency which may intervene in a matter of worker protection even if there are not
specific regulations covering the situation. - Answer-OSHA
Regulations under the Clean Air Act are administered by - Answer-EPA
Agency which imposes very strict labeling requirements on manufacturers of
chemicals used by Central Service departments. - Answer-EPA
Healthcare Regulations and Standards provide consistency of departmental activities
by outlining - Answer-minimal performance standards
Established national emissions standards for EO used by hospitals are regulated -
Answer-there are no established national emission standards
Chemical indicators are FDA __________ devices. - Answer-Class II
Heart valves and pacemakers are examples of FDA _____ medical devices. -
Answer-Class III
Under current regulations who is required to report suspected medical device-related
deaths to the FDA? - Answer-Device manufacturers and hospitals
CHAPTER #5 EXAM QUESTIONS AND
ANSWERS
Third Party Re-processors are regulated by the FDA. - Answer-True
Recommendations regarding sterilization practices are provided by AAMI. - Answer-
True
ANSI is a voluntary association dedicated to infection control and prevention. -
Answer-False
The organization that conducts on-site surveys to evaluate healthcare organizations
is the ISO. - Answer-False
Failure to receive accreditation from the Joint Commission can result in the loss of
Medicare and Medicaid payments. - Answer-True
The SGNA is a good source of information about the proper procession of flexible
endoscopes. - Answer-True
Class III medical devices are identified as High Risk. - Answer-True
Re-use of single use medical devices is less regulated now than it was in the 1990's.
- Answer-False
Agency which may intervene in a matter of worker protection even if there are not
specific regulations covering the situation. - Answer-OSHA
Regulations under the Clean Air Act are administered by - Answer-EPA
Agency which imposes very strict labeling requirements on manufacturers of
chemicals used by Central Service departments. - Answer-EPA
Healthcare Regulations and Standards provide consistency of departmental activities
by outlining - Answer-minimal performance standards
Established national emissions standards for EO used by hospitals are regulated -
Answer-there are no established national emission standards
Chemical indicators are FDA __________ devices. - Answer-Class II
Heart valves and pacemakers are examples of FDA _____ medical devices. -
Answer-Class III
Under current regulations who is required to report suspected medical device-related
deaths to the FDA? - Answer-Device manufacturers and hospitals
