Journal of muscle and joint health (근관절건강학회지)

Korean Society of Muscle and Joint Health (대한근관절건강학회)
권호 표지
DOI QR코드

DOI QR Code

Validity Periods of Sterilization Products: Focus on Packing Materials and Storage Environments

멸균물품의 유효기간에 관한 연구: 포장재와 보관환경을 중심으로

  • Park, Hyun Hee (Central Sterile Supply Department, National Health Insurance Service Ilsan Hospital) ;
  • Lee, Kwang Ok (Department of Nursing, Sangmyung University)
  • 박현희 (국민건강보험 일산병원 중앙멸균공급실) ;
  • 이광옥 (상명대학교 간호학과)
  • Received : 2023.12.03
  • Accepted : 2023.12.11
  • Published : 2023.12.31
Download PDF
⟨ Previous Next ⟩

Abstract

Purpose: The aim of this study was to provide a scientific basis for shelf life and re-establish the shelf life in a hospital environment by investigating the validity periods of various packaging materials. Methods: We selected six departments to store sterilized items, prepared 482 sterilized items, and stored them for 12 months. Each sample was tested using a microbiological culture in the laboratory every two weeks. When the result was positive, the sample was considered contaminated. The temperature and relative humidity were measured using an automatic control system to investigate the storage environment during the study period. Results: Except for two samples, which were positive in the 22nd and 28th weeks, 480 samples were negative. The temperature and relative humidity of the sample storage area were measured every week. The annual average temperature was 23.6±1.6℃, and the mean relative humidity was 35.1±15.2%. The cabinets used in this study were the two-open and four-closed types. Conclusion: This study confirmed the validity of the expiration date in a hospital environment. Based on the results, the nonwoven fabric remained sterile for more than nine months. No case of contamination of the paper-plastic pouch packaging was observed, owing to the microbial culture for two months.

Keywords

Acknowledgement

본 연구는 국민건강보험 일산병원의 연구비 지원으로 이루어졌음(NHIMC-2022-CR-031)

References

  1. Association for the Advancement of Medical Instrumentation. (2013). ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Arlington: Association for the Advancement of Medical Instrumentation.
  2. Barrett, R., Stevens, J., & Taranter, J. (2003). A shelf-life trial: examining the efficacy of event related sterility principles and its implications for nursing practice. Australian Journal of Advanced Nursing, 21(2), 8-12.
  3. Bhumisirikul, W., Bhumisirikul, P., & Pongchairerks, P. (2003). Long-term storage of small surgical instruments in autoclaved packages. Asian Journal of Surgery, 26(4), 202-204. https://doi.org/10.1016/S1015-9584(09)60303-1
  4. Bruna, C. Q., Pinto, F. M., & Graziano, K. U. (2012). The influence of environmental temperature and air humidity on the maintenance of sterility of surgical instruments sterilized in different wraps. Infection Control & Hospital Epidemiology, 33(12), 1278-1280. https://doi.org/10.1086/668440
  5. Chang, S. J., Jeong, J. H., Choi, K. M., Kim, M. Y., Park, J. H., & Jeong, N. Y. (2019). Study on the Shelf Life of Sterilized Products according to Packaging Materials. Journal of Korean Clinical Nursing Research, 25(3), 333-341. https://doi.org/10.22650/JKCNR.2019.25.3.333
  6. Cho, S. S., & Kim, M. A. (1999). The measurement of the contamination period about the storage environment of ethylene oxide gas sterilized packs using in the operating room. The Journal of Korean Academic Society of Adult Nursing, 11(2), 343-357.
  7. Choi, J. S., & Kim, K. S. (2004). A study for safe storage time and cost analysis for sterilized products. Korean Journal of Nosocomial Infection Control, 9(2), 131-138.
  8. Graybill, -D. P. (2013). Implementing aorn recommended practices for sterilization. AORN Journal, 97(5), 521-533. https://doi.org/10.1016/j.aorn.2013.03.002
  9. Jeong, S. Y., Choi, J. H., Kim, E. K., Kim, S. M., Son, H. J., Cho, N. H., et al. (2014). Actual disinfection and sterilization control in Korean healthcare facilities. Journal of Korean Academy of Fundamentals of Nursing, 21(4), 392-402. https://doi.org/10.7739/jkafn.2014.21.4.392
  10. Joo, H., Jo, S., Jeong, J., Shin, D., Lim, B., Roh, E., et al. (2003). Effect of a long-term storage on contamination status of the sterile packs. Korean Journal of Nosocomial Infection Control, 8(1), 47-55.
  11. Kim, G. S., Kim, G. J., Park, D. M., Park, M. O., & Choi, M. G. (2001). A study on validity periods of steam sterilization products-centering around packing materials and storage environments. Journal of Korean Clinical Nursing Research, 6(1), 73-90.
  12. Kim, Y. A., Lee, H., & Lee, K . (2015). Contamination of the Hospital Environmental by Pathogenic Bacteria and Infection Control. Korean Journal of Nosocomial Infection Control, 20(1), 1-6. https://doi.org/G704-SER000008654.2015.20.1.001
  13. Kim, Y. K. (2019). Perspective of nationwide surveillance system for surgical site infections. Korean Journal of Healthcare-Associated Infection Control and Prevention, 24(2), 46. https://doi.org/10.14192/kjicp.2019.24.2.46
  14. Lakhan, P., Faoagali, J., Steinhardt, R., & Olesen, D. (2013). Shelf life of sterilized packaged items stored in acute care hospital settings: Factors for consideration. Healthcare Infection, 18(3), 121-129. https://doi.org/10.1071/hi13002
  15. Ling, M. L., Ching, P., Widitaputra, A., Stewart, A., Sirijindadirat, N., & Thu, L. T. (2018). APSIC guidelines for disinfection and sterilization of instruments in health care facilities. Antimicrobial Resistance & Infection Control, 7(1), 25. https://doi.org/10.1186/s13756-018-0308-2
  16. Magill, S. S., Hellinger, W., Cohen, J., Kay, R., Bailey, C., Boland, B., et al. (2012). Prevalence of healthcare-associated infections in acute care hospitals in Jacksonville, Florida. Infection Control & Hospital Epidemiology, 33(3), 283-291. https://doi.org/10.1086/664048
  17. Mayworm, D. (1984). Sterile shelf life and expiration dating. Journal of Hospital Supply, Processing, and Distribution, 2(6), 32-35.
  18. Puangsa-Ard, Y., Thaweboon, S., Jantaratnotai, N., & Pachimsawat, P. (2018). Effects of resterilization and storage time on sterility of paper/plastic pouches. European Journal of Dentistry, 12(3), 417-421. https://doi.org/10.4103/ejd.ejd_351_17
  19. Rutala, W. A., Weber, D. J., & Healthcare Infection Control Practices Advisory Committee. (2019). Guideline for disinfection and sterilization in healthcare facilities, 2008 Update: Update: May 2019. Centers for Disease Control and Prevention.
  20. Son, J. S., & Yu, I. K. (2014). A study on expiration date on ethylene oxide gas sterilization products - related to storage environment. Journal of Korean Academy of Fundamentals of Nursing, 21(2), 141-150. doi:10.7739/jkafn.2014.21.2.141
  21. Van, D. J., & Kopinga, K. (2008). Review of surface steam sterilization for validation purposes. American Journal of Infection Control, 36(2), 86-92. https://doi.org/10.1016/j.ajic.2007.02.002
  22. Webster, J., Lloyd, W., Ho, P., Burridge, C., & George, N. (2003). Rethinking sterilization practices: evidence for event-related outdating. Infection Control & Hospital Epidemiology, 24(8), 622-624. https://doi.org/10.1086/502264