CAD---for-websiteRecommendations & Regulations for Biological Indicator (Spore) Testing

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ALBERTA

ALBERTA DENTAL ASSOCIATION & COLLEGE (ADA+C)   www.alberta.ca

Biological Indicator monitoring   “A biologic monitor must be used with each load of surgical instruments if implantable dental or medical devices (for example, dental implants, bone grafting screws,
temporary anchorage devices, bone plates, etc.) are being placed. These instrument packs and implantable devices or materials must not be used until the results of the biologic monitor test are known, and must be tracked for date, load and sterilizer used, and this information must be recorded in the patient’s record at the time of placement.”

Chemical Indicator monitoring   “Each instrument pack or cassette must have an external Class 1 process indicator applied to, or visible from, the exterior of the package, and an internal chemical indicator that is a Class 4 multi-parameter indicator or a Class 5 integrating indicator. Class 5 integrating indicators must be used inside the material and/or instrument packs whenever implantable devices are used.”

Bowie-Dick Test monitoring  “…A Bowie-Dick test must be performed for all prevacuum capable sterilizers in an empty chamber daily.”

 

COLLEGE OF ALBERTA DENTURISTS  www.collegeofabdenturists.ca

Section Q (“Sterilization of Reusable Instruments and Devices”)

The sterilization process must be tested, monitored and recorded. For all sterilizers, the following is required to be completed to ensure that effective sterilization has been achieved:

• Mechanical monitoring: mechanical or electronic failure alarms for time, temperature and pressure must be in place, and their correct functioning recorded daily.

• Chemical monitoring: each instrument/device package/cassette must have an external Class 1 process indicator applied to, or visible from, the exterior of the package, and an internal chemical indicator that is a Class 4 multi-parameter indicator or a Class 5 integrating indicator. Class 5 integrating indicators must be used inside the material and/or instrument packs whenever implantable devices are used.

• A biologic monitor must be utilized for each sterilizer each day the sterilizer is used.

• A biologic monitor must be used with each load if implantable medical devices are being sterilized.

• In addition to routine biological monitoring, a Bowie-Dick test must be performed in an empty chamber for all pre-vacuum capable sterilizers, every day the sterilizer is used.

 

BRITISH COLUMBIA

COLLEGE OF DENTAL SURGEONS OF BRITISH COLUMBIA (CDSBC)   www.cdsbc.org

Biological Indicator monitoring   “Biological indicators (BIs or spore tests) are the most accepted means for monitoring sterilization because they directly assess the procedure’s effectiveness in killing the most resistant microorganisms. The spores used are more resistant and present in greater numbers than the common microbial contaminants found on patient care items. Therefore, an inactivated BI signifies that other potential pathogens in the load have been killed. BIs must be used at least once a week for each sterilizer used. Spore tests may be conducted using an in-office system available through most dental suppliers or by submitting the indicator to a testing facility. In addition, if a load contains implantable devices, it must be monitored with a BI, and these items should be quarantined until the test results are known. Follow the manufacturer’s directions concerning the appropriate placement of the BI in the sterilizer.”

Chemical Indicator monitoring   “…each package must have external chemical indicators. In addition, it is recommended that both internal and external chemical indicators be used to detect penetration into the package.”

RecordKeeping   “The daily operation of every sterilizer must be reviewed and documented. A record must be kept for this purpose indicating “operating as required”, or noting any malfunctions and followup action taken.”

ONTARIO

ROYAL COLLEGE OF DENTAL SURGEONS OF ONTARIO (RCDSO) www.rdcso.org

Biological Indicator monitoring  “3. Biological indicators (BIs or spore tests) are the most accepted means for monitoring of sterilization, because they directly assess the procedure’s effectiveness in killing the most resistant micro-organisms. The spores used are more resistant and present in greater numbers than the common microbial contaminants found on patient care items. Therefore, an inactivated BI signifies that other potential pathogens in the load have been killed. Include a BI each day a sterilizer is used. In addition, if a load contains implantable devices, it must be monitored with a BI, and these items should be quarantined until the test results are known. Follow the manufacturer’s directions concerning the appropriate placement of the BI in the sterilizer.”

Chemical Indicator monitoring  “For these reasons, each package must have external chemical indicators. In addition, it is recommended that both internal and external chemical indicators be used to detect penetration into the package.”

 

THE COLLEGE OF PHYSICIANS AND SURGEONS OF ONTARIO  www.cpso.on.ca

Infection Control in the Physician’s Office -2004 Edition

http://www.cpso.on.ca/uploadedFiles/policies/guidelines/office/Infection_Controlv2.pdf

 

SASKATCHEWAN

Saskatchewan Dental Hygienists’ Association (SDHA)  www.sdha.ca

“IPC-04-04 – Monitoring Sterilization

Monitoring of sterilization procedures and equipment, utilizing mechanical, chemical and biological monitors, ensures the condition of sterility.

Mechanical techniques for monitoring sterilization include assessing cycle time, temperature, and pressure by observing the gauges or displays on the sterilizer and noting these parameters for each load. Correct readings do not ensure sterilization; however, incorrect readings may be an early indication of a problem with the sterilization cycle. New sterilizers have printouts or USB data devices for documentation.

Chemical indicators use sensitive chemicals to assess physical conditions (e.g., time, temperature or the presence of steam) during the sterilization process. Even though chemical indicators do not prove sterilization has been achieved, they allow detection of certain equipment malfunctions, and they can help identify procedural errors. Internal and external chemical indicators (e.g., chemical indicator tape or special markings) change colour rapidly when a specific parameter is reached. This verifies that the package has been exposed to the sterilization process. Chemical indicators should be used inside and on the outside of each package to signify that the package has undergone a sterilization cycle.

If either internal or external chemical indicators indicate inadequate processing, items in the load should not be used until reprocessed.

Biological monitors (i.e., spore tests) verify the sterilization process directly by assessing the killing of known highly resistant microorganisms. As spores used in biological monitors are the most resistant and present in greater numbers than the common microbial contaminants found on patient-care equipment, a negative spore test signifies that other potential pathogens in the load have been killed. The date and time or cycle number should be documented and signed.

Correct functioning of sterilization cycles must be verified for each sterilizer by weekly use of biological monitors.

Every load containing implantable devices and/or the standard instruments used to place implantable devices must be biologically monitored with spore-test strips. These items must be quarantined until the test results are known. In-house testing is recommended for offices placing implantable devices; timing is based on manufacturer’s recommendations and can be as short as one hour.

Manufacturer’s directions should determine the placement and location of the biological monitors in the sterilizer. In-house biological monitoring systems, processed by the facility SOHCP, are available, and may be preferable to mail-in services, given the increased safety provided by decreasing turn-around time. If in-house testing is done, a control biological monitor from the same lot as the test indicator that is not processed through the sterilizer should be incubated with the test biological monitors. The control biological monitors should yield positive results for bacterial growth. It is prudent to have control biological monitors for every test to assure the incubator is working.

Mail-in sterilization monitoring services (e.g., from private companies or dental schools) should be used to test both the test biological monitors and the control biological monitors.

In the event of a positive spore test, the biological monitors test MUST be repeated immediately after correctly loading the sterilizer and using the same cycle that produced the failure and all records reviewed of chemical and mechanical monitoring since the last negative biological monitors test.

The sterilizer operating procedures must be IMMEDIATELY reviewed, including packaging, loading and spore testing, with all SOHCPs or other personnel who work with the sterilizer to determine whether operator error could be responsible. Common reasons for a positive biological monitor in the absence of mechanical failure of the sterilizer include:

  • Improper packaging
  • Improper loading
  • Improper timing
  • Improper temperature
  • Improper method of sterilization in regard to the item

The sterilizer must be immediately removed from service. A second monitored sterilizer in the oral health care facility can be used, or a loaner from a sales or repair company obtained, to minimize facility disruption while waiting for the repeat biological monitor results. All “sterilized” packages must be reprocessed as a precaution. If the repeat biological monitor test is negative and chemical and mechanical monitoring indicates adequate processing, the sterilizer may be put back into service.

If the repeat biological monitor test is positive, and packaging, loading, and operating procedures have been confirmed as performing correctly, the sterilizer should remain out of service until it has been inspected, repaired, and re-challenged with biological monitor tests in three consecutive empty chamber sterilization cycles. Whenever possible, items from suspect loads dating back to the last negative biological monitor test should be recalled, re-wrapped, and re-sterilized.

Results of biological monitoring should be recorded and retained.

In the event of a sterilizer failure, a facility should be reasonably aware of what sort of instruments have gone through the sterilizer in the past few days/weeks, and whether or not those instrument packs have been used. Reviewing the day sheets of those days would provide information on who was treated, and decisions can be made from there.

The sterilizer in question should immediately be pulled from service, the dental service people should be called, instrument packs should be (re-)sterilized in a sterilizer known to be functioning properly and the Medical Health Officer for the Regional Health Authority should be consulted for recommendations.”

SOHP Infection Prevention and Control Standards in the Oral Health Care Facility

VISIT:  http://www.sdha.ca/index.php/infection-prevention-and-control-standards/

 

 

 

OTHER ASSOCIATIONS & GOVERNMENT AGENCIES:

CANADIAN STANDARDS ASSOCIATION (CSA)

CANADIAN STANDARDS ASSOCIATION (CSA)  www.csa.ca

Plus 1112, March 2004 – Infection prevention and control in office-based health care and allied services.

Biological Indicator Monitoring  “4.8 Using BIs with steam sterilizers: BIs used with steam sterilizers are impregnated with Geobacillus stearothermophilus spores. For the best assurance that a sterilizer is working correctly, it should be tested with a BI every day that it is to be used and with every cycle that will be used that day.”

Chemical Indicator monitoring “An internal chemical indicator shall be placed inside each package, rigid sterilization container, or bundle that is undergoing sterilization. The class of indicator shall be chosen based on the parameters being measured and the degree of precision that is needed.”

CDC (Center for Disease Control and Prevention)

The CDC (Center for Disease Control and Prevention)  www.cdc.gov

– Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

“Biological indicators are the only process indicators that directly monitor the lethality of a given sterilization process. Spores used to monitor a sterilization process have demonstrated resistance to the sterilizing agent and are more resistant than the bioburden found on medical devices. B. atrophaeus spores are used to monitor ETO and dry heat, and G. stearothermophilus spores are used to monitor steam sterilization, hydrogen peroxide gas plasma, and liquid peracetic acid sterilizers. G. stearothermophilus is incubated at 55-60°C, and B. atrophaeus is incubated at 35-37°C. Steam and low temperature sterilizers (e.g., hydrogen peroxide gas plasma, peracetic acid) should be monitored at least weekly with the appropriate commercial preparation of spores. If a sterilizer is used frequently (e.g., several loads per day), daily use of biological indicators allows earlier discovery of equipment malfunctions or procedural errors and thus minimizes the extent of patient surveillance and product recall needed in the event of a positive biological indicator. Each load should be monitored if it contains implantable objects. If feasible, implantable items should not be used until the results of spore tests are known to be negative.”
See also: www.CDC.gov/oralhealth/infectioncontrol/faq/sterilization_monitoring.htm

AORN (Association of Perioperative Registered Nurses)

AORN (Association of Perioperative Registered Nurses)  www.aorn.org

“For routine monitoring should be used weekly, and as needed; each load of implantables.”

Recommended Practices, Sterilization & Disinfection, 1987

AAP (American Academy of Pediatrics)

AAP (American Academy of Pediatrics)   www.aap.org

Biological indicators are necessary to ensure sterility. A variety of indicator systems are available. The procedure recommended by the manufacturer to document sterility should be done at least weekly and results should be recorded.” (from June 2000 Policy Statement)

ANSI / AAMI

ANSI / AAMI
(American National Standards Institute Inc. / Association for the Advancement of Medical Instrumentation) – www.aami.org

“Biological indicators should be used within PCDs for routine sterilizer efficacy monitoring at least weekly, but preferably every day that the sterilizer is in use.” ANSI/AAMI ST79:2006, Section 10.5.3.2

VA (Veteran’s Administration)

VA (Veteran’s Administration)   www.va.gov

“…must be sterilizer monitored no less than weekly, each load of implantables or intravascular materials, following major sterilizer repairs, new products or packaging material.” VA Manual G1, MP-2, Sub-chapter E, Change 159, June 22, 1983

OSAP (Organization for Safety & Asepsis Procedures)

OSAP (Organization for Safety & Asepsis Procedures) – www.osap.org

“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.” Infection Control in Dentistry Guidelines, September 1997

ADA (American Dental Association)

ADA (American Dental Association)   www.ada.org
“This report is based on the recommendations of the Centers for Disease Control and Prevention (see the CDC recommendations above) and other publications in the medical and dental literature. The recommendations in this document have been accepted by the Council on Scientific Affairs and the Council on Dental Practice. The Councils strongly urge practitioners and dental laboratories to comply with these infection control practices… Since this document is not intended to cover every aspect of infection control compliance, the dentist, his or her staff and that of dental laboratories should refer to the referenced publications.”
Infection Control Recommendations for the Dental Office and the Dental Laboratory