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| Dental Practice Spore Testing Requirements The above chart indicates individual State law for mandating spore testing responsibility. Other States may have county by county regulations. The national monitoring guidelines should supersede the legal requirements for States not mandated by local government. |
| Tattoo and Body Arts Studio's Spore Testing Requirements The above chart indicates individual State law for mandating spore testing responsibility. Other States may have county by county regulations. The national monitoring guidelines should supersede the legal requirements for States not mandated by local government. |
Centers for Disease Control and Prevention (CDC)
Guidelines for Infection Control in Dental Health-Care Settings --- 2003
MMWR December 19, 2003 / 52(RR17); 1-61
Sterilization Monitoring
American Dental Association (ADA)
Monitoring Sterilizers
Biological Indicators
Monitor sterilizers at least weekly with biological (spore) indicators.
1.Check whether your state dental board has different requirements.
Consider using biological (spore) indicators daily if the sterilizer is used frequently (e.g., several loads per
day). Daily monitoring allows for earlier discovery of equipment malfunctions or procedural errors.
A positive spore test result indicates that sterilization was incomplete. Maintain a log of spore test
results. Check your state regulations to determine how long you need to keep spore testing records.
Organization for Safety and Asepsis Procedures (OSAP)
Infection Control Guidelines: September, 1997
Sterilization Monitoring:
The use and functioning of heat sterilizers should be biologically monitored at least weekly, or more often
if the practice demands it, with appropriate spore tests. Place the spore strips or vials inside a pouch,
bag, pack or cassette, and include this package as part of the normal load through a normal sterilizer
cycle. Always use a control spore strip or vial (not heat processed but otherwise treated identically to the
test strips or vials) with each spore test performed. Additionally, chemical indicators should be used on
the inside of each package during every sterilizer load. Accurate records of sterilization monitoring must
be maintained. A chemical indicator from inside each pack may be initialed and dated for each day of
patient care and kept in a file. The weekly spore test for each heat sterilization unit may be kept in the
same file. Biologically monitor whenever there is a change in packaging, following equipment repair;
retest after failure and when training new employees.
Association for the Advancement of Medical Instrumentation (AAMI)
AAMI: Steam Sterilization and Sterility Assurance, 7.5.4 Test Frequency.
"Biological indicators must be used no less than weekly for each sterilizer and, preferably, should be
used for each load. More frequent testing should be carried out on an as needed basis (I.E., after major
sterilizer repairs, when evaluating sterilization of new products, when implantable or intravascular
materials are sterilized, etc.)".
Association of Perioperative Registered Nurses (AORN)
Recommended Practices, Sterilization & Disinfection, 1987.
"For routine monitoring should be used weekly, and as needed; each load of implantables."
Veteran's Administration (VA)
VA Manual G1, MP-2, 1985 and MP-2, Sub-chapter E, Change 159, June 22, 1983.
"Must be monitored no less than weekly, each load of implantables or intravascular materials, following
major sterilizer repairs, new products or packaging material."
Guidelines for Infection Control in Dental Health-Care Settings --- 2003
MMWR December 19, 2003 / 52(RR17); 1-61
Sterilization Monitoring
- Use mechanical, chemical, and biological monitors according to the manufacturer's instructions
to ensure the effectiveness of the sterilization process (IB) (248,278,279). - Monitor each load with mechanical (e.g., time, temperature, and pressure) and chemical indicators
(II) (243,248). - Place a chemical indicator on the inside of each package. If the internal indicator is not visible
from the outside, also place an exterior chemical indicator on the package (II) (243,254,257). - Place items/packages correctly and loosely into the sterilizer so as not to impede penetration of
the sterilant (IB) (243). - Do not use instrument packs if mechanical or chemical indicators indicate inadequate processing
(IB) (243,247,248). - Monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e.,
biological indicator and control from same lot number) (IB) (2,9,243,247,278,279). - Use a biological indicator for every sterilizer load that contains an implantable device. Verify
results before using the implantable device, whenever possible (IB) (243,248).
American Dental Association (ADA)
Monitoring Sterilizers
Biological Indicators
Monitor sterilizers at least weekly with biological (spore) indicators.
1.Check whether your state dental board has different requirements.
Consider using biological (spore) indicators daily if the sterilizer is used frequently (e.g., several loads per
day). Daily monitoring allows for earlier discovery of equipment malfunctions or procedural errors.
A positive spore test result indicates that sterilization was incomplete. Maintain a log of spore test
results. Check your state regulations to determine how long you need to keep spore testing records.
Organization for Safety and Asepsis Procedures (OSAP)
Infection Control Guidelines: September, 1997
Sterilization Monitoring:
The use and functioning of heat sterilizers should be biologically monitored at least weekly, or more often
if the practice demands it, with appropriate spore tests. Place the spore strips or vials inside a pouch,
bag, pack or cassette, and include this package as part of the normal load through a normal sterilizer
cycle. Always use a control spore strip or vial (not heat processed but otherwise treated identically to the
test strips or vials) with each spore test performed. Additionally, chemical indicators should be used on
the inside of each package during every sterilizer load. Accurate records of sterilization monitoring must
be maintained. A chemical indicator from inside each pack may be initialed and dated for each day of
patient care and kept in a file. The weekly spore test for each heat sterilization unit may be kept in the
same file. Biologically monitor whenever there is a change in packaging, following equipment repair;
retest after failure and when training new employees.
Association for the Advancement of Medical Instrumentation (AAMI)
AAMI: Steam Sterilization and Sterility Assurance, 7.5.4 Test Frequency.
"Biological indicators must be used no less than weekly for each sterilizer and, preferably, should be
used for each load. More frequent testing should be carried out on an as needed basis (I.E., after major
sterilizer repairs, when evaluating sterilization of new products, when implantable or intravascular
materials are sterilized, etc.)".
Association of Perioperative Registered Nurses (AORN)
Recommended Practices, Sterilization & Disinfection, 1987.
"For routine monitoring should be used weekly, and as needed; each load of implantables."
Veteran's Administration (VA)
VA Manual G1, MP-2, 1985 and MP-2, Sub-chapter E, Change 159, June 22, 1983.
"Must be monitored no less than weekly, each load of implantables or intravascular materials, following
major sterilizer repairs, new products or packaging material."
News Update
AAAASF Underscores Importance of
Spore Testing as Part of its Patient
Safety Initiatives
OR Today Magazine
January 2006 Issue
With the renewed industry-wide initiative to reduce the
incidence of infections resulting from improperly sterilized
equipment, the American Association for Accreditation of
Ambulatory Surgery Facilities’ (AAAASF) is reiterating the role
of its Standard 220-040 in promoting patient safety. The
AAAASF Standard mandates that a “weekly spore test is
performed and the results filed for each autoclave”. AAAASF
maintains that despite some industry discussion about how
often spores should be tested, the Association’s
recommendations for weekly spore testing conform with the
recommendations of OSHA, AAMI, CDC, JCAHO, AORN, ADA,
AHA and many insurance companies.
“We recognize that our Gold Standard of 100% compliance may
seem overly stringent at times, but health care professionals
should not compromise on patient safety. While it may seem
unrealistic to smaller facilities, like fertility clinics that make
less frequent use of the autoclave, to conform with the
standard, the AAAASF Board has continually supported strict
regulations to verify that every facility’s sterilization process is
destroying microorganisms and spores,” said James A. Yates,
MD President of AAAASF.
HEALTHIER HOSPITALS
New Law To Make Infection Rates Public
Timothy Bolger 08/04/2005 12:01 am
For more than 2 million Americans each year, a hospital visit
ends not in health but in sickness.
A new state law will now make statistics on infection rates at
every hospital in the state available to the public, so that
patients—and workers and insurers—can avoid facilities with
a history of high infections. Gov. George Pataki signed the bill a
week after the Press published a story on the subject
["Hospital Hell," July 14].
Details of the data gathering are yet to be ironed out, but the
law establishes a statewide database of all hospital-acquired
infection cases. In part, the idea is to push hospitals to enact
stricter patient-safety measures by revealing the worst
offenders.
"I am just very pleased that the bill has passed and been
signed by the governor, and we hope that it will be an important
first step towards improving cleanliness in New York's
hospitals," says Betsy McCaughey, founder and chair of the
Committee to Reduce Infection Deaths. Her organization, the
chief proponent of this potentially lifesaving legislation, is
already moving for similar laws to be enacted in other states.
NY's law puts it in league with Texas, Virginia, Florida, Illinois,
Missouri and Pennsylvania.
Infections acquired in hospitals account for approximately
103,000 deaths nationally each year, making it the fourth most
common cause of death. In New York State alone, hospital
infections kill at least 7,000 people annually.
"Making risk-adjusted data available to the hospital community
and the public will promote improvement and patient safety,"
says Sen. Kemp Hannon (R-Garden City), chair of the Senate
Health Committee.
The reporting system will require hospitals to inform the New
York State Department of Health as to the number of infections
acquired from surgical wounds, central line placements,
ventilators and urinary tract catheters.
"The governor will establish an advisory work group
comprised of government, industry and community leaders to
develop guidelines," says Robert Kenny, spokesperson for the
state health department, adding that hospitals won't begin
reporting until January 2007 and results won't be public until
2008.
Eliminating infections acquired in hospitals is not unachievable,
McCaughey says. Her group hosts annual forums for hospital
administrators to learn how infection rates can be reduced and
how improving hospital hygiene not only saves lives, but also
millions of dollars in treatment fees and lawsuits.
"It doesn't cost more per year to prevent infections," she says.
"It costs much less."
Clean hospitals: one step closer
AAAASF Underscores Importance of
Spore Testing as Part of its Patient
Safety Initiatives
OR Today Magazine
January 2006 Issue
With the renewed industry-wide initiative to reduce the
incidence of infections resulting from improperly sterilized
equipment, the American Association for Accreditation of
Ambulatory Surgery Facilities’ (AAAASF) is reiterating the role
of its Standard 220-040 in promoting patient safety. The
AAAASF Standard mandates that a “weekly spore test is
performed and the results filed for each autoclave”. AAAASF
maintains that despite some industry discussion about how
often spores should be tested, the Association’s
recommendations for weekly spore testing conform with the
recommendations of OSHA, AAMI, CDC, JCAHO, AORN, ADA,
AHA and many insurance companies.
“We recognize that our Gold Standard of 100% compliance may
seem overly stringent at times, but health care professionals
should not compromise on patient safety. While it may seem
unrealistic to smaller facilities, like fertility clinics that make
less frequent use of the autoclave, to conform with the
standard, the AAAASF Board has continually supported strict
regulations to verify that every facility’s sterilization process is
destroying microorganisms and spores,” said James A. Yates,
MD President of AAAASF.
HEALTHIER HOSPITALS
New Law To Make Infection Rates Public
Timothy Bolger 08/04/2005 12:01 am
For more than 2 million Americans each year, a hospital visit
ends not in health but in sickness.
A new state law will now make statistics on infection rates at
every hospital in the state available to the public, so that
patients—and workers and insurers—can avoid facilities with
a history of high infections. Gov. George Pataki signed the bill a
week after the Press published a story on the subject
["Hospital Hell," July 14].
Details of the data gathering are yet to be ironed out, but the
law establishes a statewide database of all hospital-acquired
infection cases. In part, the idea is to push hospitals to enact
stricter patient-safety measures by revealing the worst
offenders.
"I am just very pleased that the bill has passed and been
signed by the governor, and we hope that it will be an important
first step towards improving cleanliness in New York's
hospitals," says Betsy McCaughey, founder and chair of the
Committee to Reduce Infection Deaths. Her organization, the
chief proponent of this potentially lifesaving legislation, is
already moving for similar laws to be enacted in other states.
NY's law puts it in league with Texas, Virginia, Florida, Illinois,
Missouri and Pennsylvania.
Infections acquired in hospitals account for approximately
103,000 deaths nationally each year, making it the fourth most
common cause of death. In New York State alone, hospital
infections kill at least 7,000 people annually.
"Making risk-adjusted data available to the hospital community
and the public will promote improvement and patient safety,"
says Sen. Kemp Hannon (R-Garden City), chair of the Senate
Health Committee.
The reporting system will require hospitals to inform the New
York State Department of Health as to the number of infections
acquired from surgical wounds, central line placements,
ventilators and urinary tract catheters.
"The governor will establish an advisory work group
comprised of government, industry and community leaders to
develop guidelines," says Robert Kenny, spokesperson for the
state health department, adding that hospitals won't begin
reporting until January 2007 and results won't be public until
2008.
Eliminating infections acquired in hospitals is not unachievable,
McCaughey says. Her group hosts annual forums for hospital
administrators to learn how infection rates can be reduced and
how improving hospital hygiene not only saves lives, but also
millions of dollars in treatment fees and lawsuits.
"It doesn't cost more per year to prevent infections," she says.
"It costs much less."
Clean hospitals: one step closer
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