Sterile Processing Regulations and Standards Guide
Regulations and standards impact every healthcare
1. In what ways do regula- profession- al, including those working in the Sterile
tions and standards Processing department (SPD).
influ- ence healthcare
profession- als?
When regulations and standards are not followed, the
2. What are the potential results can vary from legal consequences to poor
con- sequences when patient outcomes.
regulations 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 A uniform method of defining basic parameters for
of "standard"? processes, products, services, and measurements.
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55
, Sterile Processing Regulations and Standards Guide
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 Generally, standards are not law; however, they may be incorpo-
con- sidered legally rated into law by governmental bodies.
binding, or can they be
incorporated into law
by governmental
bodies?
• Regulations must be followed and failure to comply
7. For what reasons must
with them may result in legal consequences to the
Ster- ile Processing (SP)
healthcare facility.
techni- cians be familiar
• Regulations and standards may include workplace
with applic- able
regulations and stan- safety is- sues, which may help to protect SP
dards? technicians from exposure to infectious agents and
toxic substances.
• Regulations and standards may include disinfecti
and ster-
2/
55
, Sterile Processing Regulations and Standards Guide
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 standards that
Regulations and standards are issued by federal, state, and local
govern vari- ous governing agencies.
sectors?
9. How do professional Standards are also issued by professional organizations and
orga- nizations provide significant assistance to healthcare personnel
contribute to the because
healthcare sector in terms of they are developed according to best practice.
standards development?
10. What is the definition additional items or substances
of "best practice"? does the U.S. Food and Drug
Administra- tion (FDA) regulate?
11. What role does the U.S.
Food and Drug
Administra- tion (FDA)
play in relation to
medical devices and
patient care?
12. Which organization is
re- sponsible for
regulating the
manufacturing of
medical devices?
13. Apart from medical
devices, which
3/
55
, Sterile Processing Regulations and Standards Guide
A method or technique that has
consistently shown results su- perior to The FDA regulates the manufacture of all medical devices.
those achieved by other means.
The U.S. Food and Drug Administration
(FDA) is responsible for ensuring that
medical devices are safe and ettective The FDA also regulates sterilants, high-level
for patient care. disinfectants, pack- aging materials, sterilizers, and
quality monitors such as biolog- ical indicators (BIs).
4/
55
Regulations and standards impact every healthcare
1. In what ways do regula- profession- al, including those working in the Sterile
tions and standards Processing department (SPD).
influ- ence healthcare
profession- als?
When regulations and standards are not followed, the
2. What are the potential results can vary from legal consequences to poor
con- sequences when patient outcomes.
regulations 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 A uniform method of defining basic parameters for
of "standard"? processes, products, services, and measurements.
1/
55
, Sterile Processing Regulations and Standards Guide
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 Generally, standards are not law; however, they may be incorpo-
con- sidered legally rated into law by governmental bodies.
binding, or can they be
incorporated into law
by governmental
bodies?
• Regulations must be followed and failure to comply
7. For what reasons must
with them may result in legal consequences to the
Ster- ile Processing (SP)
healthcare facility.
techni- cians be familiar
• Regulations and standards may include workplace
with applic- able
regulations and stan- safety is- sues, which may help to protect SP
dards? technicians from exposure to infectious agents and
toxic substances.
• Regulations and standards may include disinfecti
and ster-
2/
55
, Sterile Processing Regulations and Standards Guide
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 standards that
Regulations and standards are issued by federal, state, and local
govern vari- ous governing agencies.
sectors?
9. How do professional Standards are also issued by professional organizations and
orga- nizations provide significant assistance to healthcare personnel
contribute to the because
healthcare sector in terms of they are developed according to best practice.
standards development?
10. What is the definition additional items or substances
of "best practice"? does the U.S. Food and Drug
Administra- tion (FDA) regulate?
11. What role does the U.S.
Food and Drug
Administra- tion (FDA)
play in relation to
medical devices and
patient care?
12. Which organization is
re- sponsible for
regulating the
manufacturing of
medical devices?
13. Apart from medical
devices, which
3/
55
, Sterile Processing Regulations and Standards Guide
A method or technique that has
consistently shown results su- perior to The FDA regulates the manufacture of all medical devices.
those achieved by other means.
The U.S. Food and Drug Administration
(FDA) is responsible for ensuring that
medical devices are safe and ettective The FDA also regulates sterilants, high-level
for patient care. disinfectants, pack- aging materials, sterilizers, and
quality monitors such as biolog- ical indicators (BIs).
4/
55
