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VOLUME 15 , ISSUE 5 ( September-October, 2014 ) > List of Articles

RESEARCH ARTICLE

A Preliminary Evaluation of a Reusable Digital Sterilization Indicator Prototype

R Puttaiah, J Griggs, M D'Onofrio

Citation Information : Puttaiah R, Griggs J, D'Onofrio M. A Preliminary Evaluation of a Reusable Digital Sterilization Indicator Prototype. J Contemp Dent Pract 2014; 15 (5):626-635.

DOI: 10.5005/jp-journals-10024-1591

Published Online: 01-10-2014

Copyright Statement:  Copyright © 2014; Jaypee Brothers Medical Publishers (P) Ltd.


Abstract

Background

Sterilization of critical and semicritical instruments used in patient care must undergo a terminal process of sterilization. Use of chemical and physical indicators are important in providing information on the sterilizer's performance during each cycle. Regular and periodic monitoring of sterilizers using biological indictors is necessary in periodically validating performance of sterilizers. Data loggers or independent digital parametric indicators are innovative devices that provide more information than various classes chemical indicators. In this study we evaluated a prototype of an independent digital parametric indicator's use in autoclaves.

Aim

The purpose of this study was to evaluate the performance of an independent digital indictor/data logger prototype (DS1922F) that could be used for multiple cycles within an autoclave. MG

Materials and methods

Three batches of the DS1922F (150 samples) were used in this study that was conducted in a series. The first batch was challenged with 300 sterilization cycles within an autoclave and the data loggers evaluated to study failures and the reason for failure, make corrections and improve the prototype design. After changes made based on studying the first batch, the second batch of the prototype (150 samples) were challenged once again with 300 sterilization cycles within an autoclave and failure studied again in further improvement of the prototype. The final batch (3rd batch) of the prototype (150 samples) was challenged again but with 600 cycles to see how long they would last. Kaplan-Meier survival analysis analyses of all three batches was conducted (α = 0.05) and failed samples qualitatively studied in understanding the variables involved in the failure of the prototype, and in improving quality.

Results

Each tested batch provided crucial information on device failure and helped in improvement of the prototype. Mean lifetime survival of the final batch (Batch 3) of prototype was 498 (480, 516) sterilization cycles in an autoclave.

Conclusion

In this study, the final batch of the DS1922F prototype data logger was found to be robust in withstanding the challenge of 600 autoclave cycles, with a mean lifetime of more than 450 cycles, multiple times more than prescribed number of cycles.

Clinical significance

Instrument reprocessing is among the important aspects of infection control. While stringent procedures are followed in instrument reprocessing within the clinic in assuring patient safety, regular use of sterilization process indicators and periodic biological validation of the sterilizer's performance is necessary. Chemical indicators for use in Autoclaves provide information on whether the particular cycle's parameters were achieved but do not provide at what specific point in time or temperature the failure occurred. Data loggers and associated reader software as the tested prototype in this evaluation (DS1922F), are designed to provide continuous information on time and temperature of the prescribed cycle. Data loggers provide immediate information on the process as opposed to Biological Indicators that take from days to a week in obtaining a confirmatory result. Further, many countries do not have the sterilization monitoring service infrastructure to meet the demands of the end users. In the absence of sterilization monitoring services, use of digital data loggers for each sterilization cycle is more pragmatic.

How to cite this article

Puttaiah R, Griggs J, D'Onofrio M. A Preliminary Evaluation of a Reusable Digital Sterilization Indicator Prototype. J Contemp Dent Pract 2014;15(5):626-635.


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  1. Definition of terms. In: Block SS (4th ed). Disinfection, sterilization and preservation. Philadelphia: Lea & Febiger; 1991. p. 18-25.
  2. Sterilization. In Husa's Pharmaceutical dispensing. In: Martin EW, Easton PA, editors. Mack Publishing Company; 1971. p. 592-623.
  3. Chemical disinfection of medical and surgical materials. In: Lawrence C, Block SS, editors. Disinfection, sterilization, and preservation. Philadelphia: Lea and Febiger; 1968. p. 517-531.
  4. Chemical disinfection of medical and surgical materials. In: Block S (4th ed.). Disinfection, sterilization and Preservation. Philadelphia, Lea and Febiger, 1991. p. 617-641.
  5. Recommended infection-control practices for dentistry. MMWR 1993;42 (No. RR-8).
  6. J Am Dent Assoc 1992;123(8) Suppl 1.
  7. Guidelines for Infection Control in Dental Health-Care Settings, 2003. MMWR 2003;52(No. RR-17):1-76.
  8. The healthcare infection control practices advisory committee (HICPAC). Guideline for disinfection and sterilization in healthcare facilities, 2008. CDC/Department of Health and Human Services. Available at: http://www.cdc.gov/hicpac/pdf/guidelines/disinfection_Nov_2008.pdf
  9. Sterilization by heat. In: Block SS (4th ed). Disinfection, sterilization and preservation. Philadelphia: Lea & Febiger; 1991. p. 495-556.
  10. Glutaraldehyde. In: Block SS (4th Ed.) Disinfection, sterilization and preservation. Philadelphia: Lea & Febiger; 1991. p. 596-614.
  11. How well does the Chemiclave sterilize handpieces? J Am Dent Assoc 1998;129(7):985-991.
  12. Sterilization and preservation by ionizing radiation. In: Block SS (4th ed.) Disinfection, sterilization and preservation. Philadelphia: Lea & Febiger; 1991. p. 566-579.
  13. Cleaning, sterilization and disinfection: the basics of microbial killing for infection control. J Am Dent Assoc 1993;124:48-56.
  14. Sterilization, disinfection and asepsis in dentistry. In: Block SS (5th ed.) Disinfection, sterilization and preservation. Philadelphia: Lippincott Williams and Wilkins: 2001. p. 1049-1068.
  15. Instrument processing. In: Miller CH (5th Ed.) Infection control and management of hazardous materials for the dental team. Elsevier, St. Louis MO; 2014. p. 120-151.
  16. Sterilization effect analysis of Bclass pulsation table top vacuum sterilizer to dental handpieces. West China J Stomatol 2007 Jun;25(3):269-271.
  17. Sterilization. Disciplined microbial control. Dent Clin North Am 1991 Apr;35(2):339-355.
  18. Sterilization of healthcare products—Chemical indicators—Part 1: General requirements. Association for the Advancement of Medical Instrumentation. Arlington VA. Available at: http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/11140011006_preview.pdf
  19. Understanding and monitoring the sterilization process: Inside the ‘Black Box’. Infection Control. Australasian Dent Pract 2008 Jan/Feb, p. 110-116.
  20. 3MTM Sterilization (Digital Brochure). Available at: http://multimedia.3m.com/mws/media/600678O/scic-tutorial-pdf.pdf?&fn=SCIC_Tutorial.pdf.
  21. Australian Dental Association. August 2008. Authorized by JE Matthews-Federal President, Australian Dental Association Inc. St. Leonards, NSW, Australia. Available at: http://www.ada.org.au/app_cmslib/media/lib/1011/m274408_v1_infection%20control%20guidelines.pdf.
  22. Sterilization and Validation. Power Point Program (Slides 63 and 80). Available at: http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CCAQFjAA&url=http%3A%2F%2Fcsao.net%2Ffiles%2Fppt%2FSterilization%2520and%2520validationby%2520Dr.%2520Marchand.ppt&ei=WNFpVKSuBo72yQTP8IK4Aw&usg=AFQjCNGFdPN89KFghGr3rz697GOyqAappA&sig2=Y4Av4Q3apAZPLreZNUwIBg&bvm=bv.79142246,d.aWw
  23. Biological monitoring of sterilizers and sterilization failures in Norwegian dental offices in 1985 and 1996. Acta Odontol Scand 1999 Aug;57(4):175-180.
  24. Instrument reprocessing and sterilization monitoring. In: Kohli A, Puttaiah R. Dental infection control and occupational safety for oral health professionals. Publication of the Dental Council of India; 2007. p. 46-51.
  25. Biologic monitoring of dental office sterilizers in Mexico. Am J Infect Control 2002 May;30(3):153-157.
  26. Health technical memorandum 01-05 — a view from north of the border. J Infection Prevention 2010;11(6):212-216.
  27. Dental safety knowledge, attitudes and practice among Indian dentists. Abstract #708. IADR General Session, 2009. San Diego CA. Available at: https://iadr.confex.com/iadr/2011sandiego/webprogram/paper147988.html
  28. Evaluation of a new rapid readout biological indicator for use in 132°C and 135°C vacuum-assisted steam sterilization cycles. Am J Infect Control 2014;42(2):e17-e21.
  29. Available at: http://www.wh.com/en_global/dental-products/sterilization-hygienicmaintenance/sterilizers/lisa-autoclave/
  30. Available at: http://www.scicanusa.com/index.cfm?pagepath=Autoclaves/BRAVO&id=17963.
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