Journal of Korean Clinical Nursing Research (임상간호연구)

Hospital Nurses Association (병원간호사회)
권호 표지
DOI QR코드

DOI QR Code

Study on the Shelf Life of Sterilized Products according to Packaging Materials

포장재에 따른 멸균품의 유효기간에 관한 연구

  • Chang, Song Ja (Department of Nursing, Samsung Medical Center) ;
  • Jeong, Jeong Hee (Graduate School of Clinical Nursing Science, Sungkyunkwan University) ;
  • Choi, Kyoung Mi (Department of Nursing, Samsung Medical Center) ;
  • Kim, Mi Young (Department of Nursing, Samsung Medical Center) ;
  • Park, Joo Hee (Department of Nursing, Samsung Medical Center) ;
  • Jeong, Na Yeon (Office of Infection Prevention and Control, Samsung Medical Center)
  • Received : 2019.09.23
  • Accepted : 2019.10.25
  • Published : 2019.12.31
Download PDF
⟨ Previous Next ⟩

Abstract

Purpose: The purpose of this study was to determine the most appropriate shelf life for sterilized products according to their packaging material. Methods: Samples were prepared to target six nursing units in one general hospital in Seoul. After steam and E.O gas sterilization, sterilized product, samples were supplied to wards. Data collection was conducted for 3 months, after the expiration date of 3 months had passed for samples packaged with crepe paper and nonwoven wraps. For samples packaged with paper-plastic pouches, data collection conducted for 3 months when the expiration date of 9 months had passed. The sterilized products were collected and tested for microbial contamination. Identification of the storage environment was done as samples were collected. Results: This study confirmed that the storage environment met international standards such as CDC, except for temperature. For steam sterilized crepe paper packaging samples and steam and E.O gas sterilized for nonwoven packaging samples no contamination in all products was found for 3 months past the expiration date. However, in the E.O gas sterilized paper-plastic pouch packaging sterile samples, Gram-positive bacilli were detected in one sample from a surgical intensive care unit at 45 weeks and another sample from an operating room at 47 weeks. Furthermore, the results did not show any microorganisms for up to 52 weeks in all products. Conclusion: According to the results of this study, sterilized product packaging made with crepe paper and nonwoven wraps is better able an extended shelf life from 3 months to 6 months, reducing unnecessary costs.

Keywords

References

  1. Ministry of Health and Welfare. Comprehensive measures for the prevention and control of medical-related infections [Internet]. Ministry of Health and Welfare; 2018 [cited 2019 Sep 4]. Available from: http://www.mohw.go.kr/react/al/sal0301vw.jsp?PAR_MENU_ID=04&MENU_ID=0403&CONT_SEQ=345237.
  2. Yoon GS, Kim JH, Yang SH, Chae JY, Lee YM, Cho GS. A study for safe storage time for in-house sterilized products in a Korean hospital. Journal of Korean Society of Quality Assurance in Health Care. 1999;5(2):258-276.
  3. Kim KS, Kim GJ, Park DI, Park BO, Choi MG. A study on validity periods of steam sterilization products-centering around packing materials and storage environments. Journal of Korean Clinical Nursing Research. 2000;6(1):73-90.
  4. Ministry of Food and Drug Safety. Medical device packaging process validation guideline [Internet]. Cheongju: Ministry of Food and Drug Safety; 2013 [cited 2015 Mar22]. Available from: https://www.mfds.go.kr/brd/m_210/view.do?seq=12662.
  5. Centers for Disease Control and Prevention. Guideline for disinfection and sterilization in healthcare facilities, 2008 [Internet]. Atlanta: Centers for Disease Control and Prevention; 2008 [cited 2019 Sep 4]. Available from: https://www.cdc.gov/infectioncontrol/guidelines/disinfection/.
  6. Joo HS, Jo SD, Jeong JS, Shin DB, Lim BO, Roh EJ, et al. Effect of a long-term storage on contamination status of the sterile packs. Korean Journal of Nosocomial Infection Control. 2003;8(1):47-55.
  7. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79:Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Arlington, VA: Association for the Advancement of Medical Instrumentation; 2013. p. 87-88.
  8. Choi JS, Kim KS. A study for safe storage time and cost analysis for sterilized products. Korean Journal of Nosocomial Infection Control. 2004;9(2):131-138.
  9. Lee SW. A study on the safe storage period of steam- sterilized materials [master's thesis]. Seoul: Kyung Hee University; 2001. p. 1-42.
  10. Son JS, Yu IK. A study on expiration date on ethylene oxide gas sterilization products - related to storage environment. Journal of Korean Academy of Fundamentals of Nursing. 2014;21(2):141-150. https://doi.org/10.7739/jkafn.2014.21.2.141
  11. Gwon YH. A study on the contamination period about the storage environment of sterilized materials[master's thesis]. Seoul: Yonsei University; 1995. p. 1-61.
  12. Kim HJ. The validity of expiration date on extension of sterilization products. Incheon: The Nursing Department, Gachon University Gil Mecical Center; 2010.
  13. Lakhan P, Faoagali J, Steinhardt R, Olesen D.Shelf life of sterilized packaged items stored in acute care hospital settings: Factors for consideration. Healthcare Infection. 2013;18(3):121-129. https://doi.org/10.1071/HI13002
  14. Jeong MW. Extension of shelf life of sterilized products in central supply department. The22ndconference. Korea Association of Central Supply Department Nurse. 2013. p. 178.
  15. Kim JO.Survey on the current status of operation of the central supply department. The 32nd spring conference, Korea Association of Central Supply Department Nurse. 2018. p. 86-89.
  16. Chao RH, Chang FC, Liu CP. Using crepe paper to substitute cotton in sterilization. Antimicrobial Resistance and Infection Control. Abstracts from the 8th International Congress of the Asia Pacific Society of Infection Control(APSIC) Volume 6, Supplement 2;DS6; 2017Feb12-15; Bangkok, Thailand.
  17. Korea Center for Disease Control & prevention. Development guidelines for disinfection and sterilization in healthcare facilities. 2014. p. 4.
  18. Lee SJ, Shim MS, Kim SH, Kim GJ. Principle &truth reality of sterilization. Seoul: Hyunmoonsa; 2004. p. 64, 104-107, 328, 331.
  19. Standard Korean Dictionary [Internet]. Seoul: National Institute of Korean Language; c2019 [cited 2019 Sep 4]. Available from: https://stdict.korean.go.kr/search/searchView.do.
  20. van Doornmalen J, Kopinga K. Review of surface steam sterilization for validation purpose. American Journal of Infection Control. 2008;36(2):86-92. https://doi.org/10.1016/j.ajic.2007.02.002
  21. Barrett R, Stevens J, Taranter J. A shelf-life trial: Examining the efficacy of event related sterility principles and its implications for nursing practice. Austrlian Journal of Advanced Nursing. 2003-2004;21(2):8-12.
  22. Association of periOperative Registeted Nurses. Recommended practices for selection and use of packaging systems for sterilization. AORN Journal. 2007;85(4):804. https://doi.org/10.1016/S0001-2092(07)60155-0
  23. Lee KB, Kim YI, Chung KS. Improvement of hospital sickroom thermal environment through reestablishment of fiducial temperature. Proceedings of the SAREK 2018 Summer Annual Conference. 2009:573-578.
  24. Biological and Environmental Control Laboratories. Post-sterilizationmicrobial barrier challenge test: A 12Month shelf life sterility maintenance study of KIMGUARD sterilization wrap and muslin. Toledo, OH: Biological and Environmental Control Laboratories; 2006.
  25. Brusca MI, Nastri N, Mosca CO, Nastri ML, Rosa AC. Long-term sterility of orthodontic-surgical appliances. Acta odontologica Latinoamericana. 2004;17(1-2):23-27.
  26. Schwartz R, Davis R. Safe storage times of sterile dental packs. Oral Surgery, Oral Medicine, Oral Pathology. 1990;70(3):297-230. https://doi.org/10.1016/0030-4220(90)90144-H