WHAT DO YOU KNOW ABOUT CHEMICAL INDICATORS?

1 Volume 22 Issue 3 Page 3. WHAT DO YOU know ABOUT CHEMICAL INDICATORS? By: Pamela H Caudell, RN, CNOR, CSPDS, ACSP. Objectives: labels and load cards are tainers for pack control 1. List the 6 different types of examples of externally visi- monitoring. They can also indicators. ble CHEMICAL indicators that be used as an additional are on the outside on the monitoring tool in order to 2. Describe the differences be- packages. be able to release loads tween indicators and integra- that do not contain im- tors. b. Class 2: Indicators are intended for use in spe- plants based on the ap- 3. Discuss what CHEMICAL indi- cific test procedures as de- propriate Process Chal- cators are. fined in relevant sterilizer/ lenge Device. These indi- sterilization standards.. cators can also be used in CHEMICAL indicators have been Bowie-Dicks are one type of implant loads IF a Biologi- around as long as life itself. For specific testing most are cal indicator is run with example, hydrangeas bloom familiar with.

2 These are the class 5 integrator. blue in acidic soil and pink in used to show the efficacy of The load can NOT be re- basic soil so they are an excel- air removal and steam leased until the BI result is lent indicator of soil conditions. penetration. known except in emergen- That being said, CHEMICAL and cies. biological indicators were not c. Class 3: A single vari- used routinely until the late able indicator that is de- f. Class 6: These are 1940s and early 1950s to moni- signed to solely show the called emulating Indica- tor sterilization processes. At exposure to one sterilization tors which are cycle verifi- that time, it was stated no single process at a stated value cation indicators which quality-assurance monitoring (SV) of the chosen variable. are designed to react to method assures that any item is One example of a single all critical variables for sterile; rather it assures the con- variable is a temperature specified sterilization cy- ditions for sterilization to occur tube that houses a CHEMICAL cles.

3 In other words they have been met. This statement pellet which melts at a spe- are considered to be in- is still true in today's sterilization cific temperature. dicative of a complete cy- practices. cle by showing the pres- d. Class 4: These are ence or absence of spe- considered as multiple vari- cific time and temperature CHEMICAL indicators are either able indicators. They are parameters during a cy- physical or CHEMICAL devices designed to react with two cle. They are currently used to monitor one or more of or more of the critical vari- only available in the US. the process parameters of the ables and are intended to for steam sterilization. sterilization cycle. Currently indicate exposure to a ster- they are divided into 6 classifi- ilization cycle at SVs of the cations. They are as follows: chosen variable. Examples CHEMICAL indicators are of these class 4s would be convenient, are inexpen- a. Class 1: Process the paper strips with a color sive, and indicate that the indicators are intended change CHEMICAL indicator .

4 Item has been exposed to for use with individual These are usually used in- the sterilization process. items, , containers, side each package. In one study, CHEMICAL to indicate that the unit e. Class 5: Integrating indicators were more has been directly ex- indicators are designed to likely than biological indi- posed to the sterilization react with all critical vari- cators to inaccurately indi- process and to distin- ables. These can be used cate sterilization at mar- guish between proc- as internal CHEMICAL indica- ginal sterilization times essed and non- tors in all packs and con- ( , 2 minutes). processed items. Indi- cator tapes, indicator Volume 22 Issue 3 Page 4. CHEMICAL indicators should be monitoring a sterilization used in conjunction with biologi- process. The device is de- cal indicators, but based on cur- signed to respond with a the process. A PCD is a rent studies should not replace characteristic CHEMICAL or challenge test pack or test them because they indicate physical change to one or tray that contains a bio- sterilization at marginal steriliza- more of the physical condi- logic indicator , a Class 5.

5 Tion time and because only a tions within the sterilizing integrating indicator , or an biological indicator consisting of chamber. CHEMICAL indica- enzyme-only indicator . resistant spores can measure tors are intended to detect This is a term now used the microbial killing power of the potential sterilization failures by AAMI in their Recom- sterilization process. CHEMICAL that could result from incor- mended Practices. indicators are affixed on the out- rect packaging, incorrect side of each pack to show that Now that we have discussed all loading of the sterilizer, or the package has been proc- the technical definitions of the malfunctions of the steri- essed through a sterilization cy- different types of indicators, what lizer. The pass response cle, but these indicators do not exactly does that mean to us? of a CHEMICAL indicator does prove sterilization has been Indicators are first put inside not prove the item accom- achieved. Preferably, a chemi- wrapped packs or peel-packs cal indicator also should be These are considered to be placed on the inside of each harder to sterilize to represent a pack to verify sterilant penetra- challenge to the indicator .

6 What tion. CHEMICAL indicators usually are the needs of the department are either heat-or CHEMICAL - based on the types of equipment sensitive inks that change color being sterilized? when one or more sterilization Other questions to ask are: parameters ( , steam-time, temperature, and/or saturated a. Are the indicator results steam; ETO-time, temperature, easy to interpret? relative humidity and/or ETO b. Can the indicators be eas- concentration) are present. ily stored for a set period CHEMICAL indicators have been of time without damage? grouped into five classes based Is there a shelf life? on their ability to monitor one or panied by the indicator is c. What sterilization perame- multiple sterilization parameters. necessarily sterile. The As- ters will the indicator de- If the internal and/or external sociation for the Advance- tect? indicator suggests inadequate ment of Medical Instrumen- processing, the item should not d. Is it biologically corre- tation has defined five lated?

7 If so, what are the be used815. An air-removal test classes of CHEMICAL indica- (Bowie-Dick Test) must be per- specifics? tors: Class 1 (process indi- formed daily in an empty dy- cator); Class 2 (Bowie-Dick namic-air-removal sterilizer test indicator ); Class 3 Only by understanding the needs ( , prevacuum steam steri- (single-parameter indicator ); of the department as well as the lizer) to ensure air removal. Class 4 (multi-parameter composition of the individual indicator ); and Class 5 CHEMICAL indicators/integrators (integrating indicator ). can the department make an in- The definitions listed Process challenge device (PCD): formed choice as to the indicator above were taken from item designed to simulate best for them. the ANSI/AAMI/ISO. 11140-1:2005 defini- product to be sterilized and tions. to constitute a defined chal- lenge to the sterilization Resources: Definitions: process and used to assess ANSI/AAMI/ISO 11140-1:2005. CHEMICAL indicator : device for the effective performance of AAMI Standards 2005.

8 Volume 22, Issue 3 Page 5. What Do You know ABOUT CHEMICAL Indicators? Summer 2010. 1. CHEMICAL Indicators have been in use since the early 1900's. True False EVALUATION--Please evaluate this in-service by select- 2. There are 8 different classifications of CHEMICAL ing a rating between 0 and 4. indicators. True False 0=Not Applicable, 1=Poor, 4=Excellent 3. CHEMICAL indicators are either physical or Author's Knowledge of the Subject 0 1 2 3 4. CHEMICAL devices used to monitor one or Author's Presentation, Organization, Content 0 1 2 3 4. more of the process parameters of the Author's Methodology, Interesting/Creativity 0 1 2 3 4. sterilization cycle. Program Met Objectives 0 1 2 3 4. True False 4. Class 3 CHEMICAL indicators are considered as To receive contact hours toward certification from multiple variable indicators. CBSDP, complete the in-service quiz after reading the True False article. Send the entire page with the completed quiz to: 5. CHEMICAL indicators can be used to replace Lana Haecherl biological indicators.

9 Box 568. True False Pineville, NC 28134. 6. The pass response on a CHEMICAL indicator does not prove the item accompanied by the Lana will issue a certificate if your score is greater than indicator is necessarily sterile. 70%. Please be sure to fill in the information requested True False below. 7. CHEMICAL integrators can be used as an addi- If you are NOT a member of NCAHCSP, please include a tional monitoring tool in order to be able to fee of $ for instate membership and $ for out release loads that do not contain implants of state membership. Your fee will provide you a 1-year based on the appropriate Challenge Device. membership in the Association and will also entitle you to submit the next in-service offerings for the cost of a post- True False age stamp. That is potentially six in-service programs for 8. Process Challenge Devices are items designed your registration fee. Remember you will not be issued a to simulate the product to be sterilized and certificate unless you are a member of NCAHCSP.

10 Are used to assess the effective performance of CEU credits pending from CBSDP. the process. CLEARLY print your name as you wish it to appear on True False the certificate. Enter the address where you want the cer- tificate sent. 9. A class one (1) CHEMICAL indicator is only used to indicate the item has been exposed to the NAME: _____. sterilization process and to differentiate be- tween processed and non-processed. Address: _____. True False 10. A CHEMICAL indicator can be used to indicate City: _____ State: _____ Zip: _____. sterilization has occurred. True False E-mail address: _____.