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5/31/2018 » 6/3/2018
2018 OSAP Annual Conference

FAQ - Sterilization - 2016
FAQ - Sterilization - 2016



Are class 5 integrators mandatory if you are doing BIs once a week? Also must it be a class 5 integrator. We are using sterile pouches with internal & external indicators.

Ask OSAP can provide you with some general information on this topic. 

In a prior communication on this subject, Eve Cuny has stated:

The AAMI/ANSI standard recommends BI at least weekly (and with any load of implantables) and a challenge pack with each load in addition to a CI in each pack.  The challenge pack may consist of either a BI and a Class 5 CI or just a Class 5 CI.  I am attaching an article describing how this can be done in a table top sterilizer. 1

This article is entitled The use of a process challenge device in dental office gravity displacement tabletop sterilizers.2

The specific CDC recommendations for internal chemical indicators and BI monitoring from the 2003 Guideline and 2008 CDC Disinfection and Sterilization Guideline may also be of interest. The 2003 CDC guidelines for infection control in dentistry states in part:

Internal chemical indicators should be used inside each package to ensure the sterilizing agent has penetrated the packaging material and actually reached the instruments inside. A single-parameter internal chemical indicator provides information regarding only one sterilization parameter (e.g., time or temperature). Multiparameter internal chemical indicators are designed to react to>2 parameters (e.g., time and temperature; or time, temperature,and the presence of steam) and can provide a more reliable indication that sterilization conditions have been met(254). Multiparameter internal indicators are available onlyfor steam sterilizers (i.e., autoclaves). 3


Biological indicators (BIs) (i.e., spore tests) are the most accepted method for monitoring the sterilization process (278,279) because they assess it directly by killing known highly resistant microorganisms (e.g., Geobacillus or Bacillus species), rather than merely testing the physical and chemical conditions necessary for sterilization (243). Because spores used in BIs are more resistant and present in greater numbers than the common microbial contaminants found on patient-care equipment, an inactivated BI indicates other potential pathogens in the load have been killed (280).

Correct functioning of sterilization cycles should be verified for each sterilizer by the periodic use (at least weekly) of BIs (2,9,134,243,278,279). Every load containing implantable devices should be monitored with such indicators (248), and the items quarantined until BI results are known. However, in an emergency, placing implantable items in quarantine until spore tests are known to be negative might be impossible. Manufacturer’s directions should determine the placement and location of BI in the sterilizer. A control BI, from the same lot as the test indicator and not processed through the sterilizer, should be incubated with the test BI; the control BI should yield positive results for bacterial growth. 3

The 2008 CDC guidelines for disinfection and sterilization can be accessed here:    4

This publication contains sections on sterilization, sterilizing practices and monitoring.


1)     E-mail communication from Eve Cuny dated February 10, 2016

2)     Cuny E. The use of a process challenge device in dental office gravity displacement tabletop sterilizers. Am J Infect Control 2015; 43:1131-3 3)    
3)     US Centers for Disease Control and Prevention. Guidelines for Infection Control in Dental Health-Care Settings — 2003. MMWR 2003; 52 No. (RR-17)
4) US Centers for Disease Control and Prevention. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008.   Accessed on June 14, 2016. 






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