Sterile Processing Technical Manual - Chapter 6: Regulations and Standard
*Need to review and/or update to HSPA 9th Edition.
Study online at https://quizlet.com/_eax6tp
1. In what ways do regula- Regulations and standards impact every healthcare profession-
tions and standards influ- al, including those working in the Sterile Processing department
ence healthcare profession- (SPD).
als?
2. What are the potential con- When regulations and standards are not followed, the results
sequences when regulations can vary from legal consequences to poor patient outcomes.
and standards are not ad-
hered to?
3. What is the definition of "reg- Rules issued by administrative agencies that have the force of
ulation"? law.
4. What is the definition of A uniform method of defining basic parameters for processes,
"standard"? products, services, and measurements.
5. Who are the entities involved Industry, nonprofit organizations, trade associations, and others
in the development of stan- develop standards.
dards?
6. Are standards typically con- Generally, standards are not law; however, they may be incorpo-
sidered legally binding, or rated into law by governmental bodies.
can they be incorporated
into law by governmental
bodies?
7. For what reasons must Ster- • Regulations must be followed and failure to comply with them
ile Processing (SP) techni- may result in legal consequences to the healthcare facility.
cians be familiar with applic- • Regulations and standards may include workplace safety is-
able regulations and stan- sues, which may help to protect SP technicians from exposure
dards? to infectious agents and toxic substances.
• Regulations and standards may include disinfection and ster-
, Sterile Processing Technical Manual - Chapter 6: Regulations and Standard
*Need to review and/or update to HSPA 9th Edition.
Study online at https://quizlet.com/_eax6tp
ilization practices.
• With careful compliance with regulations and standards, pa-
tient safety is at its highest level of quality care.
8. Who issues regulations and Regulations and standards are issued by federal, state, and local
standards that govern vari- governing agencies.
ous sectors?
9. How do professional orga- Standards are also issued by professional organizations and
nizations contribute to the provide significant assistance to healthcare personnel because
healthcare sector in terms of they are developed according to best practice.
standards development?
10. What is the definition of A method or technique that has consistently shown results su-
"best practice"? perior to those achieved by other means.
11. What role does the U.S. The U.S. Food and Drug Administration (FDA) is responsible for
Food and Drug Administra- ensuring that medical devices are safe and effective for patient
tion (FDA) play in relation to care.
medical devices and patient
care?
12. Which organization is re- The FDA regulates the manufacture of all medical devices.
sponsible for regulating the
manufacturing of medical
devices?
13. Apart from medical devices, The FDA also regulates sterilants, high-level disinfectants, pack-
which additional items or aging materials, sterilizers, and quality monitors such as biolog-
substances does the U.S. ical indicators (BIs).
Food and Drug Administra-
tion (FDA) regulate?
, Sterile Processing Technical Manual - Chapter 6: Regulations and Standard
*Need to review and/or update to HSPA 9th Edition.
Study online at https://quizlet.com/_eax6tp
14. What factor determines the The level of regulation placed on any device depends upon how
level of regulation imposed the FDA classifies that device.
on a medical device?
15. What level of risk is associat- Low-risk devices, such as most handheld surgical instruments,
ed with Class I devices and hospital beds, and ultrasonic cleaners.
what are some examples of
Class I medical devices?
16. What specific regulatory con- These items are subject to "general controls", which include
trols are applied to Class I de- registration and device listing, medical device reporting, and
vices by the FDA? quality system regulation and labeling.
17. What level of risk is associat- Devices considered to pose potential risks great enough to
ed with Class II devices and warrant a higher level of regulation. Class II devices include most
what are some examples of types of sterilization equipment, BIs, and chemical indicators
Class II medical devices? (CIs).
18. What additional regulatory Class II devices are usually subjected to performance standards,
measures are typically im- postmarket surveillance studies, and specific guidelines or spe-
posed on Class II devices? cial labeling.
19. What is the classification of The most stringently regulated devices include heart valves,
devices that undergo the pacemakers, and other life-sustaining devices.
highest level of regulation
and what are some examples
of such devices?
20. What is the requirement for Manufacturers of new Class III devices must obtain a premarket
manufacturers of new Class approval (PMA) from the FDA to demonstrate product safety and
III devices? efficacy.
21.
*Need to review and/or update to HSPA 9th Edition.
Study online at https://quizlet.com/_eax6tp
1. In what ways do regula- Regulations and standards impact every healthcare profession-
tions and standards influ- al, including those working in the Sterile Processing department
ence healthcare profession- (SPD).
als?
2. What are the potential con- When regulations and standards are not followed, the results
sequences when regulations can vary from legal consequences to poor patient outcomes.
and standards are not ad-
hered to?
3. What is the definition of "reg- Rules issued by administrative agencies that have the force of
ulation"? law.
4. What is the definition of A uniform method of defining basic parameters for processes,
"standard"? products, services, and measurements.
5. Who are the entities involved Industry, nonprofit organizations, trade associations, and others
in the development of stan- develop standards.
dards?
6. Are standards typically con- Generally, standards are not law; however, they may be incorpo-
sidered legally binding, or rated into law by governmental bodies.
can they be incorporated
into law by governmental
bodies?
7. For what reasons must Ster- • Regulations must be followed and failure to comply with them
ile Processing (SP) techni- may result in legal consequences to the healthcare facility.
cians be familiar with applic- • Regulations and standards may include workplace safety is-
able regulations and stan- sues, which may help to protect SP technicians from exposure
dards? to infectious agents and toxic substances.
• Regulations and standards may include disinfection and ster-
, Sterile Processing Technical Manual - Chapter 6: Regulations and Standard
*Need to review and/or update to HSPA 9th Edition.
Study online at https://quizlet.com/_eax6tp
ilization practices.
• With careful compliance with regulations and standards, pa-
tient safety is at its highest level of quality care.
8. Who issues regulations and Regulations and standards are issued by federal, state, and local
standards that govern vari- governing agencies.
ous sectors?
9. How do professional orga- Standards are also issued by professional organizations and
nizations contribute to the provide significant assistance to healthcare personnel because
healthcare sector in terms of they are developed according to best practice.
standards development?
10. What is the definition of A method or technique that has consistently shown results su-
"best practice"? perior to those achieved by other means.
11. What role does the U.S. The U.S. Food and Drug Administration (FDA) is responsible for
Food and Drug Administra- ensuring that medical devices are safe and effective for patient
tion (FDA) play in relation to care.
medical devices and patient
care?
12. Which organization is re- The FDA regulates the manufacture of all medical devices.
sponsible for regulating the
manufacturing of medical
devices?
13. Apart from medical devices, The FDA also regulates sterilants, high-level disinfectants, pack-
which additional items or aging materials, sterilizers, and quality monitors such as biolog-
substances does the U.S. ical indicators (BIs).
Food and Drug Administra-
tion (FDA) regulate?
, Sterile Processing Technical Manual - Chapter 6: Regulations and Standard
*Need to review and/or update to HSPA 9th Edition.
Study online at https://quizlet.com/_eax6tp
14. What factor determines the The level of regulation placed on any device depends upon how
level of regulation imposed the FDA classifies that device.
on a medical device?
15. What level of risk is associat- Low-risk devices, such as most handheld surgical instruments,
ed with Class I devices and hospital beds, and ultrasonic cleaners.
what are some examples of
Class I medical devices?
16. What specific regulatory con- These items are subject to "general controls", which include
trols are applied to Class I de- registration and device listing, medical device reporting, and
vices by the FDA? quality system regulation and labeling.
17. What level of risk is associat- Devices considered to pose potential risks great enough to
ed with Class II devices and warrant a higher level of regulation. Class II devices include most
what are some examples of types of sterilization equipment, BIs, and chemical indicators
Class II medical devices? (CIs).
18. What additional regulatory Class II devices are usually subjected to performance standards,
measures are typically im- postmarket surveillance studies, and specific guidelines or spe-
posed on Class II devices? cial labeling.
19. What is the classification of The most stringently regulated devices include heart valves,
devices that undergo the pacemakers, and other life-sustaining devices.
highest level of regulation
and what are some examples
of such devices?
20. What is the requirement for Manufacturers of new Class III devices must obtain a premarket
manufacturers of new Class approval (PMA) from the FDA to demonstrate product safety and
III devices? efficacy.
21.
