WHAT DO YOU KNOW ABOUT CHEMICAL …

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.

2 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. 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.

3 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. 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.

4 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 . item has been exposed to for use with individual These are usually used in- the sterilization process.

5 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.

6 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. 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.

7 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 . 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?)

8 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? If so, what are the be used815. An air-removal test classes of CHEMICAL indica- (Bowie-Dick Test) must be per- specifics?

9 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.

10 CHEMICAL indicator : device for the effective performance of AAMI Standards 2005. 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.