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MANUFACTURING MEDICAL DEVICES IN THE USA SINCE 1935

MANUFACTURING MEDICAL DEVICES IN THE USA SINCE 1935

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Sterilizer Monitoring Guidance

Propper's mail-in spore testing programs are designed to help keep you compliant with federal, state and local requirements for sterilizer monitoring. Below you will find references to regulatory & standards organizations.

Contact our sterilization monitoring experts and get your questions answered!

The Center for Disease Control and Prevention (CDC)

Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
“The effectiveness of steam sterilization is monitored with a biological indicator containing spores of Geobacillus stearothermophilus (formerly Bacillus stearothermophilus). Positive spore test results are a relatively rare event and can be attributed to operator error, inadequate steam delivery, or equipment malfunction."

Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Guidelines for Infection Control in Dental Health-Care Settings - 2003
“Correct functioning of sterilization cycles should be verified for each sterilizer by the periodic use (at least weekly) of BIs. Every load containing implantable devices should be monitored with such indicators, 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."

Morbitity and Mortality Weekly Report. December 19, 2003 / Vol. 52 / No. RR-17

Association for the Advancement of Medical Instrumentation (AAMI)

“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."

AAMI ST79:2010, Section 10.5.3.2

Mail-in Spore Test Instructions for Use

Our Mail-in Spore Test Instructions for Use are included with every box of our product SKU# 269067.

Positive Spore Test Troubleshooting

Our Positive Spore Test Troubleshooting Guide will provide additional insight into possible solutions if your steam sterilizer test result comes back positive.