Chpt 5 Quiz/Test Flashcards
This organization specializes in endoscopy issues and has established standards for the effective processing of flexible endoscopes
Society of gastroenterology and health admin
Voluntary
Furthers international cooperation in improving health conditions
world health org
Voluntary
Develops nationally recognized guidelines for the perioperative setting
association of perioperative registered nurses
Voluntary
Protects workers from occupationally-caused illnesses and injuries
occupational safety and health admin
Regulatory
Proposed standards are submitted from members such as the Association for the Advancement of Medical Instrumentation
american national standards institute
Voluntary
Provides standards and evaluations for healthcare facilities. These evaluations are in the form of onsite surverys at least every 3 years
the joint commission
Voluntary
Creates and revises standards for processing water for irrigation
united states pharmacopeia - national nurses
voluntary
Enforces laws relating to the transportation of medical waste
department of transportation
regulatory
Creates and enforces laws relating to cleaner water, air, and land
environmental protection agency
regulatory
A voluntary international org. dedicated to the prevention and control of infections and related outcomes
assoc. for profs. in infections control and epidemiology
voluntary
Is considered one of the major resources for healthcare guidelines
assoc. for the advancement of medical instrumentation
voluntary
International standards to reduce the burden of fire and other hazards
national fire protection association
voluntary
Promotes health by preventing and controlling disease
centers for disease control
voluntary
Responsible for pre- and post-market medical device requirments. medwatch, medical device classification and medical device recall
u.s food and drug admin.
regulatory
Enhances the global competitiveness and quality of life by promoting standards and ensuring their integrity
american national standards institute
voluntary
Agencies responsible for regulating ethylene oxide
occupational safety and health admin, environmental protection agency
regulatory
Agency responsible for the medwatch program
u.s. food and drug admin.
regulatory
Agency which may intervene in a matter of worker protection even if there are no specific regulations covering the situation
occupational safety and health admin.
regulations under the clean air act are administered by
encironmental protection agency
the agency which imposes very strict labeling requirements on manufacturers of disinfectants used by cs departments
environmental protection agency
healthcare regulations and standards establish
minimal levels of quality and safety
chemical indicators are classified as
fda class 2 medical devices
heart valves and pacemakers are examples of
fda class 3 medical devices
under current regulations, who are required to report suspected medical device-related deaths to the u.s. food and drug admin.
-device manufacturer
-hospitals
standards and regulations help set levels of ___ in our departments
both quality and safety
medical device reporting is regulated by the
u.s. food and drug admin.
the department of transportation enforces statutes relating to the
transportation of unclean, damaged flexible endoscopes
sometimes state or local regulations differ from federal regulations and when that happens the most stringent regulations apply. (T/F)
True
following the occupational safety and health admins regulations for wearing ppe in the cs decontam area is option (T/F)
False
3rd party reprocessors are regulated by the u.s. food and drug admin. (T/F)
True
recommendations regarding sterilization practices are provided by the association for the advancement of medical instrumentation (T/F)
True
the american national standards institute is a voluntary assoc. dedicated to infection control and prevention (T/F)
false
failure to receive accreditation from tjc can result in the loss of medicare and medicaid payments
true
the society of gastroenterology nurses and assocs. is a source for infor about the proper processing of flexible endoscopes (T/F)
true
class 3 medical devices are identified as high risk (T/F)
true
reuse of single-use medical devices is less regulated now than it was in the 1990s (T/F)
false
the u.s. food and drug admin recalls may be either mandatory or voluntary
true
the u.s. food and drug admin is responsible for
ensuring food, drugs, and cosmetics are safe to use
the federal program designed for the voluntary reporting of device-related problems is called
medwatch
Which org. conducts onsite survery
tjc
chemical indicators are what fda class devices?
2
healthcare regulations and standards provide consistency of departmental activities by outlining
minimal levels of quality and safety
regulations and standards provide info to help ensure
quality and safety
Sterrad
low temp sterilizer 4 types
Duo
Standard
Express
Flex
