when u have a bowie dick test

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Education & Training

What To Do

When You Have a

Bowie-Dick Test
By Charles O. Hancock, BSEE, MBA, RAC

Problem

Objectives
Many thanks to the team at 3M Health Care for working with Managing Infection Control to provide the following accredited course. IAHCSMM has awarded 1 contact point for completion of this continuing education lesson toward IAHCSMM recertification. The CBSPD has pre-approved this inservice for 1 contact hour for a period of five (5) years from the date of publication. This inservice is 3M Health Care Provider approved by the California Board of Registered Nurses, CEP 5770 for 1 contact hour. This form is valid up to five years from the date of publication. Instructions for submitting results are on page 78. Managing Infection Control and 3M Health Care will be working collaboratively to provide continuing education courses in monthly editions of Managing Infection Control. 1, 2, 3, 4, After completion of this self-study activity, the learner will be able to: Discuss the process of assessing a Bowie-Dick Test failure. Describe common causes of Bowie-Dick Test failures. Describe the steps to be taken when investigating a Bowie-Dick Test failure. Understand the responsibilities of those involved in investigating a Bowie-Dick Test failure.

Test Questions
True or False 1. The operator is responsible for investigating a Bowie-Dick Test failure. 2. The sterilizer should always be taken out of service immediately upon observing a Bowie-Dick Test failure. 3. The Bowie-Dick Test is the standard test used to evaluate the air removal systems of dynamic air removal steam sterilizers. 4. The Bowie-Dick Test is a visual indication that the air removal system has deteriorated in performance and should be corrected before a sterilization problem is indicated by a positive biological indicator. 5. Bowie-Dick Test failure is indicated when the test sheet result is non-uniform in appearance. 6. Only commercially available Bowie-Dick Test Packs should be used. 7. The maintenance or service technician can always accurately assess the sterilizer controls affecting the outcome of the Bowie-Dick Test. 8. The hospital steam generation and distribution system may influence the outcome of a Bowie-Dick Test. 9. Sterilizers with built in steam generators never experience BowieDick Test failures. 10. All Bowie-Dick Test results should be recorded and saved.

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Introduction
The recommended practice for dynamic air removal steam sterilizers is to evaluate the efficacy of the air removal system daily before the sterilizer is put into service. Dynamic air removal sterilizers use various means, including vacuum and pulsing techniques, to remove air from the load. The Bowie-Dick Test is the standard test used for this evaluation. The Bowie-Dick Test was developed to detect air leaks and to evaluate the ability of the air removal system to reduce air residuals within the sterilization chamber to an acceptable level. It is not an absolute air measurement system. The Bowie-Dick Test is a visual indicator test that may be used as a predictor of future problems in that any unsatisfactory outcome may be anticipated to get worse with continued use of the sterilizer.

The Bowie-Dick Test
The Bowie-Dick Test is a Class 2 Chemical Indicator having the special purpose of evaluating the efficacy of dynamic air removal sterilizer systems. When evaluating

Bowie-Dick Test results according to the Association for the Advancement of Medical Instrumentation (AAMI) ST46 Good Hospital Practice: Steam Sterilization and Sterility Assurance, 2002 document we note that unsatisfactory test results occur when “Any unexpected color change… indicates that there was an air pocket present during the cycle due to sterilizer malfunction. Any indication of a malfunction must be reported to the supervisor on duty, who will determine the disposition of the sterilizer, i.e., whether it should be retested, serviced, or remain in use.” The Bowie-Dick Test is not to be considered a biological performance test. It is intended only to forewarn the user that the air removal system has deteriorated in performance and should be corrected before sterilization problems occur as indicated by a biological indicator failure. For this reason, it may not be necessary to remove a sterilizer from service solely on the basis of an unsatisfactory Bowie-Dick Test result. Rather, a complete investigation of the causes for those results should be undertaken as long as the sterilizer continues to yield satisfactory biological indicator test results.

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The immediate responsibility of the supervisor on duty is to assure that the test results have been interpreted correctly (See Figure 1). This is a judgment call based on experience with the individual sterilizer, the Bowie-Dick Test pack itself, and knowledge and background concerning how that test works and the factors influencing a successful outcome. Some Bowie-Dick Test sheets are easier to interpret than others because the visual assessment of pass/fail criteria is subjective and not quantitative. The colors and patterns presented by the test sheet may influence an individuals’ decision regarding a pass/fail assessment. For some people, different shades of gray (or black) may not be easy to detect. Precise differences in shading and uniformity of the observed results may not be obvious to all readers.

...if the service provider determines that the sterilizer is functioning according to specification, and the Bowie-Dick test results still indicate a problem, the cause of the malfunction must be identified and corrected before the sterilizer is considered free of concern.

FIGURE 1 Pass (Top) and Fail (Bottom) Bowie-Dick Test Results

If the supervisor on duty is unsure that the interpretation is correct, comparison with past results for the same sterilizer over a recent period of time of weeks or months can easily be done. Often, subtle air leaks may gradually occur and a pattern may be obvious when test sheet results are reviewed over a period of time. Day to day changes may not be so clear. If the supervisor on duty decides the test results indicate a problem—the sterilizer should be retested immediately to confirm the outcome interpretation. After repeating the Bowie-Dick Test, if the results confirm the existence of a problem, the sterilizer service provider or maintenance engineer should be immediately informed of the problem. Usually the service provider can make a simple adjustment to resolve the problem if the problem is with the sterilizer. Following the maintenance activity, the supervisor on duty may independently run the Bowie-Dick Test to confirm a successful outcome before the sterilizer is used for that day. However, if the service provider determines that the sterilizer is functioning according to specification, and the Bowie-Dick Test results still indicate a problem, the cause of the malfunction must be identified and corrected before the sterilizer is considered free of concern.

Problem Solving Guidance
What to do? The sterilizer appears to be functioning correctly but the sterilizer cannot pass the Bowie-Dick Test. Whom do you call? Where do you turn? What are your options? If you are responsible for this department and your supervisor on duty presents you with this challenge, here is some guidance.

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Bowie-Dick Test Pack Preparation Ensure that you have done all that your department can do to solve this problem. If you make up your own Bowie-Dick Test packs, make sure that they are all uniformly prepared. This may mean assuring that only one skilled individual makes up each and every pack in order to eliminate variations in technique. Ensure that the same brand of Bowie-Dick Test sheet is used exclusively in all tests. Carefully review the preparation of the textile components of the test packs to assure that they are uniformly and repeatedly in the same condition for each use. If commercially available Bowie-Dick Test packs are used, make sure that all tests are conducted with test packs of the same manufacturers’ specification. Do not mix and match brands of test packs! If you are at this point and have not identified the source of the problem, inform and request assistance in resolving the problem by contacting the sterilizer manufacturer, the maintenance or service provider, the test pack manufacturer and the facility engineering department. At this point, all may have a role in resolving the problem. This should be both in writing and verbally to establish a reference in time when the problem is recognized. Sterilizer Control Calibration The sterilizer manufacturer may be of assistance in ensuring that the machine itself is properly calibrated and does in fact meet stated performance criteria. Such performance may need to be independently verified by a third party to assure the actual conditions within the sterilizer chamber are achieved. With modern control systems the sterilizer cycles are usually reliably repeated through control software the manufacturer has validated. However, the calibration of control sensors is critical to ensure the results obtained agree with the intended operation. The service provider may or may not be capable of ensuring this calibration. The maintenance or service provider may or may not have specific factory training and the required instrumentation and tools to accurately calibrate the control system. If informed of the problem they may recognize a need to provide expertise and equipment not currently available to assist in resolving this problem. The test pack/sheet manufacturer may be of assistance by independently verifying the actual conditions within the sterilizer chamber or by relating your circumstances to those of other users with similar situations. Be sure to provide them with lot number identification of the test pack in question. Facility Utilities and Steam Quality Most importantly, the facility engineering department should become involved immediately to assure that the services/utilities provided to the sterilizer are now, have been in the past, and will be in the future adequate to ensure the performance of the sterilizer. Variations in the services/utilities (steam, water, air, electric, etc.) are common in practice. Seasonal variations are to be expected. Variation in the supply systems will also occur due to changes in the demand load throughout the workday. These variations may go beyond normal limits without impacting all users. For example, peak demand for use of steam and water usually occurs simultaneously in departments starting the work day in the same time period. Quite often the HVAC system, Laundry, Food Service and Central Sterilization Services (CSS) may all be demanding steam and water at the same time. Steam (and/or feedwater) chemistry variations may be transparent to the

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Sterile Process and Distribution CEU Information
CEU Applicant Name ______________________________________________ Address________________________________________________________ City__________________________________________ _ _ _ _ _ _ _ ___________ State_________________________ Zip Code ______ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___ The CBSPD (Certification Board for Sterile Processing and Distribution) has pre-approved this inservice for one (1) contact hour for a period of five (5) years from the date of publication. Successful completion of the lesson and post test must be documented by facility management and those records maintained by the individuals until re-certification is required. DO NOT SEND LESSON OR TEST TO CBSPD. For additional information regarding CBSPD certification, contact: CBSPD, 121 State Hwy 31N, Suite 500, Flemington, NJ 08822 or call (908) 788-3847 or visit www.sterileprocessing.org. IAHCSMM has awarded 1 Contact Points for completion of this continuing education lesson toward IAHCSMM recertification.

Nursing CEU Application Form
This inservice is 3M Health Care Provider approved by the California Board of Registered Nurses, CEP 5770 for one (1) contact hour. This form is valid up to five years from the date of publication. 1. Make a photocopy of this form. 2. Print your name, address and daytime phone number and position/title. 3. Add your social security number or your nursing license number. 4. Date the application and sign. 5. Answer the CE questions. 6. Submit this form and the answer sheet to: Workhorse Publishing Managing Infection Control PO Box 25310, Scottsdale, AZ 85255-9998 7. Participants who score at least 70% will receive a certificate of completion within 30 days of Managing Infection Control’s receipt of the application.

Application
Please print or type. Name____________________________________ _ _ _ _ _ _ ____________ _ ___ Mailing Address________________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ City, State, Country, Zip ________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___ Daytime phone ( )___________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ______

other users while severe out of specifications conditions may be present for the sterilizer user. Recognize that any change in steam and/or water chemistry may be problematic. Drastic changes in steam chemistry as required for steam sterilizers may occur as the result of changes in feedwater treatment. Feedwater conditions may change radically under peak demand conditions for steam within the overall steam distribution system. Periodic review of the steam distribution system in installations using an in-house steam supply may reveal inherent potential problems that can be caused when changes are made to the piping system without careful consideration of the impact those changes may have on low volume users such as CSS. Steam distribution piping systems have installation requirements, which differ significantly from hot water piping distribution systems, yet in many instances one contractor may install both. If the mechanical contractor lacks steam-piping installation and repair expertise, serious problems may ensue. For those installations having a self-contained steam generator (usually the steam generator is integral to the sterilizer enclosure), a maintenance or service provider can verify the performance of the steam generator.

Answer Key
1. 3. 5. 7. 9. F T T F F 2. 4. 6. 8. 10. F T F T T

Position/Titile____________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ Social Security or Nursing License Number _______ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___ Date application submitted _________________________________________ Signature _______________________________________________________
Offer expires January 2010

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In either case, when problems with Bowie Dick test packs are encountered a comprehensive examination should be conducted. Such an examination should include: determination of steam quality (dryness), measurement of superheated steam, and accurate determination of non-condensable gasses (air) in the steam supplied to the sterilizer. Additionally, an investigation should be conducted of the steam boiler feedwater system including complete water chemistry measurements and an accurate record of any and all water conditioning or treatment processes. Detailed water treatment investigation may be in order particularly if the source of water (i.e., municipal water authority) has multiple sources. It may be necessary to obtain independent steam sterilization and water chemistry expertise to make these determinations.

Summary
Ultimately, it is your responsibility to use all or part of the information gathered using the preceding sources to make an appropriate decision regarding the resolution of the problem. In all probability no one item will uniquely solve the problem. It is likely that there is a combination of factors contributing to the cause. Some items may be dealt with immediately at little cost. Other factors may require substantial outlays in time, effort and money to resolve. Document Bowie-Dick Test results, the issues investigated and the results as they surface over time. Prioritize solutions on whatever basis fits your circumstances (cost, timing, future planning, etc). Understand that you have options considering the predictive nature of Bowie-Dick Tests. Understand also that the Bowie-Dick Test is intended to get you to take action before a catastrophic failure occurs. Do not delay. Correct the problem now before you have to deal with a sterilization failure!

References
1. 2. Association for the Advancement of Medical Instrumentation. Steam Sterilization and Sterility Assurance in Health Care Facilities, ANSI/AAMI ST46, 2002. Association for the Advancement of Medical Instrumentation. Chemical Indicators-Guidance for Selection, Use and Interpretation of Results. ANSI/AAMI ST60, 1996.

Charles O. Hancock, founder and president of Charles O. Hancock Associates Inc., is a consultant to industry, hospitals, and government in the field of Sterilization Science. He is recognized as an international expert on a broad range of sterilization issues impacting the medical device sector and has been involved with sterilization issues since joining the Old Castle Company in 1967. Mr. Hancock is a member of AAMI, currently serving on various sterilization subcommittees for Thermal and Chemical Sterilization Standards, and he co-chairs the Hospital Steam Sterilizer Working Group. He is also the Vice-Chairman of the Canadian Standards Association (CSA) Technical Committee for Sterilization and, in 1994, received the CSA Award of Merit for leadership in bi-national and international standards development. He chairs the CSA working group on steam sterilization. Mr. Hancock is board certified in regulatory affairs dealing with the U.S. Food and Drug Administration and is an author of various professional articles, chapters and texts as well as being a speaker at numerous professional meetings and seminars both nationally and internationally on sterilization and related topics. Mr. Hancock can be reached at [email protected].
70-2009-6420-6

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