Chemical Indicators. Biological Indicators. Physical Monitors. Welcome! How do I get a CE Certificate? Learning Objectives

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1 3M Infection Prevention Solutions 3M Sterile U Web Meeting July 17, 2014 The Science of Speed The Evolution of Biological Indicators Welcome! Topic: The Science of Speed The Evolution of Biological Indicators Facilitators: Christophe de Campeau, 3M Sandra Velte, 3M Speakers: Craig Wallace Senior Technical Specialist 3M Housekeeping Questions Today s meeting times are 9:00 a.m., 11:00 a.m. and 1:00 p.m. CST How do I get a CE Certificate? difficulties Craig Wallace 3M follow-up For22 more information: Learning Objectives Next week, all of today s meeting participants will be sent an containing instructions for obtaining a CE Certificate for today s meeting. 1. Describe the design and function of biological indicators 2. Discuss how biological indicator incubation time is determined The will be sent to the address you provided when you logged-in to today s meeting. If there are others listening with you today who did not log-on, you may forward the CE certificate to them. 3 Chat feature Post session 2 3 Mute feature (*7 = unmute; *6 = mute) Technical To hear audio, call and enter access code Phone lines are muted. Audio will commence when the webinar begins. 3 Sterilization Monitoring - Quality Control 3. Understand how rapid readout biological indicator systems work 4 Sterilization Process Monitoring Tools Load Control Biological Indicators Pack Control Equipment Control 5 Chemical Indicators Physical Monitors Exposure Control 6 1

2 The history of biological indicators Late 1800s First biological indicators... National Institutes of Health (NIH) 1955 Robert Koch 1881 Recommends Bacillus stearothermophilus* as the test organism for steam sterilization Forms spores - challenges process Inoculated carriers No threat of pathogenicity, pyrogenicity, or toxicity * Now known as Geobacillus stearothermophilus 9 10 The basic principle of biological indicators BI Basics.... Direct measurement of lethality Large number of test organisms Test organisms that are very resistant to the process (hard to kill) If the process can kill the BI, it will kill the lower numbers of less resistant organisms on the medical devices

3 Bacterial Spores Bacterial Spores Some types of bacteria can form spores to protect themselves from a hostile environment, such as lack of nutrients e.g. some Bacillus sp., Clostridium sp. Protective shell around DNA, almost no water No biological activity - dormant Geobacillus stearothermophilus Bacillus atropheus 13 Google Images 14 Bacterial Spores - Formation Bacterial Spores Activation and germination Many complex steps driven by enzymes Google Images Google Images Bacterial Growth Bacterial Growth If we had a starting count of 10 contaminating bacteria that can grow and double every 20 minutes, you will have: Types of BIs Inoculated devices Elapsed Time # of Bacteria 0: : : : : : : :20 1,440 2:40 2,880 3:00 5,760 3:20 11,520 3:40 23,040 4:00 46,080 4:20 92,160 4:40 184,320 5:00 368,640 5:20 737,280 5:40 1,474,560 6:00 2,949, Cycle time: 20 minutes - 3 hours 18 3

4 Types of BIs Spore Strips Types of BIs Spore Ampoules Types of BIs Self-contained (SCBI) Self-contained BIs color change Growth of the test organisms produces acid ph of the growth media drops Cap Filter Growth Media with ph Indicator Spore Strip Sleeve ph indicator changes color positive BI Negative Positive Biological indicator testing - resistometer Biological indicator performance requirements ANSI/AAMI/ISO series

5 Key performance parameters Population (number of test organisms) Number of organisms that must be killed to get a negative BI The more organisms, the longer it takes to inactive the BI Measured by distributing the spores on plates and counting Expressed in exponents (e.g = 1,000,000) D-value (resistance) A measure of how resistant the organisms are to the process (how hard to kill) Measured as the time to reduce the population by 90% Expressed in time units (usually minutes) Biological indicators key specifications Moist heat D-value: 1.5 minute minimum (121 C) Population: 1 x 10 5 CFU (minimum) Ethylene oxide D-value: 2.5 minutes minimum Population: 1 x 10 6 CFU minimum ISO 11138: The evolution of BI technology BI evolution Consistency Purified cultures of carefully selected test organisms Convenience Self-contained designs eliminate transfers to growth media Biological indicator readout time Readout (or incubation) time: Time required to decide that a biological indicator is NEGATIVE 7 days is the accepted readout time for BIs for established sterilization processes, with known test organisms Readout time 7 days reduced to minutes ISO/ANSI/AAMI :

6 Reduced incubation time (RIT) A BI readout time of less than 7 days, which has been validated to an appropriate level of accuracy as compared to the 7 day result. FDA Guidance Reduced Incubation Time How is that done? standard seven or more days more than 97% Evolution of readout times????? Rapid biological indicator technologies* 7 days hours 1-4 hours minutes *Less than 24 hours Bacterial Growth Bacterial Growth If we had a starting count of 10 contaminating bacteria that can grow and double every 20 minutes, you will have: Elapsed Time # of Bacteria 0: : : : : : : :20 1,440 2:40 2,880 3:00 5,760 3:20 11,520 3:40 23,040 4:00 46,080 4:20 92,160 4:40 184,320 5:00 368,640 5:20 737,280 5:40 1,474,560 6:00 2,949,120 Mesa Labs Smart-Read Technology Standard SCBI growth media color change Colorimeter reads color shift and declares a positive when certain color change criteria are met Readout time is 10 hours Cycle time: 20 minutes - 3 hours Smart-Read is a registered trademark of Mesa Labs, Inc

7 Bacterial spores activation and germination Spore start up... Computer start up Many complex steps driven by enzymes Google Images Technology: 3M Rapid Attest and Super Rapid Attest Technology 3M Rapid Attest and Super Rapid Attest SCBIs Detects biological activity very early in the spore s activation and germination process Takes advantage of the activity of enzymes used by the cell to germinate and grow Detects the end product of the enzyme reactions Super Rapid Attest Cap Growth Media with ph Indicator and fluorescent indicator Spore carrier Sleeve Glucosidase enzymes - carbohydrate metabolism Geobacillus stearothermophilus: alpha-glucosidase Bacillus atrophaeus: beta-glucosidase Rapid Attest M Rapid Readout Technology 3M Rapid Readout Technology Non-fluorescent substrate in growth media Non-fluorescent substrate in growth media Fluorescent by-product (4-MU) detected in Auto-reader Fluorescent by-product (4-MU) detected in Auto-reader

8 Readout Times Rapid Attest hours Rapid Attest and Super Rapid Attest also can provide a conventional outgrowthbased ph color change response Super Rapid Attest 1492V 1 hour Summary Biological indicators provide a direct microbial challenge (large number of spores) to the sterilization process, so they are the only sterilization indicator that provides a direct measure of lethality. Biological indicators have evolved in consistency, convenience, and speed (readout time). Different technologies have been developed to detect a earlier signals from the spores, allowing faster readout times Next Month s 3M Sterile U Webinar Questions? August 21, 2014: The Nuts and Bolts of Washer-Disinfectors

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