Journal of Korean Academy of Fundamentals of Nursing (기본간호학회지)

Korean Academy of Fundamentals of Nursing (기본간호학회)
권호 표지

Influence of Different Methods of Cutting Ampules on Drug Contamination by Glass Flakes from the Ampule

유리앰플 주사제 개봉방법이 유리조각 혼입 및 약물오염에 미치는 영향

  • Published : 2009.05.31
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Abstract

Purpose: This study was done to examine how medication contamination in a single-dose glass ampule is affected by minute glass flakes generated in different methods of cutting the ampule. Method: Sixty medication-containing glass ampules were randomly assigned to two groups. The number of glass flakes, resulting from two different cutting methods (with cotton and without cotton), were counted under the microscope. Contamination was evaluated by extracted the medication with a syringe and culturing it in E. coli, coliform, and aerobic bacteria culture media. Result: Fewer glass flakes were found in the ampules when the ampule was cut with cotton. The use of cotton, however, did not significantly change the degree of drug contamination. Conclusion: Although minute glass flakes generated in the ampule cutting operation did not significantly contaminate the medication and the use of cotton decreased the number of glass flakes in the ampules, glass flakes injected into the blood and tissues of the patient remain a risk factor. Therefore, pre-filled syringes or syringes with filters would be alternative methods and safeguards against the possible injection of glass flakes generated while cutting the ampule.

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References

  1. Bernadette, E. B., Thomas, J., & Michael, S. (2007). In-line filtration of intravenous fluids retains 'spearhead'-shaped particles from the vascular system after open-heart surgery. European Heart Journal. 28(10), 1192. https://doi.org/10.1093/eurheartj/ehl398
  2. Brewer, J. H., & Dunning, J. H. (1947). An in vitro and in vivo study of glass particles in ampules. Journal of the American Pharmaceutical Association. 36(10), 289-293.
  3. Carbone-Traber, K. B., & Shanks, C. A. (1986). Glass particle contamination in single dose ampules. Anesthesia & Analgesia, 65(12), 1361-1363.
  4. Chae, J. H., Kim, W. O., Kil, H. K., & Kim, J. R. (1990). Glass particle contamination in single dose ampules upon opening. Korean Journal of Anesthesiology, 23(5), 668-691.
  5. Cohen, J. (1988). Statistical power analysis for the behavioral science (2nd ed.). Hillsdale, NJ: Lawrence Erlbaum Association Publishing.
  6. Crichton, E. P. (1973). Infusion fluids as culture media. American Journal of Clinical Pathology, 59(2), 199-202.
  7. Hemingway, C. J., Malhotra, S., Almeida, M., Azadian, B., & Yentis, S. M. (2007). The effect of alcohol swabs and filter straws on reducing contamination of glass ampoules used for neuroaxial injections. Anaesthesia, 62(3), 286-288. https://doi.org/10.1111/j.1365-2044.2007.04977.x
  8. Kenneth, E. A., Herbert, A. L., & Leen, L. (Eds.). (1993). Pharmaceutical dosage form: Parenteral medications, Vol 3 (2nd ed.). London: Informa Healthcare.
  9. Kim, D. S. (1982). A study on the contamination rates of hospital in-use intravenous fluids. Unpublished master's thesis, Seoul National University, Seoul.
  10. Kim, I. W. (1986). A study on the relationship between length of time and contamination in open intravenous solutions. Journal of Korean Academy of Nursing, 16(1), 67-80.
  11. Kohan, S., Carlin, H., & Whitehead, R. (1962). A study of contamination of multiple-dose medication vials. Hospitals. 36, 78.
  12. Korea Food & Drug Administration. (2008). Korean Pharmacopoeia (9th ed.). Seoul: Shinil publishing.
  13. Park, J. S., Oh, H. R., Seo, B. H., & Bhang, J. H. (2006). Comparison of glass particle contamination according to method of ampule cutting and needle aspiration. Journal of Korean Academy of Nursing, 36(6), 1033-1041.
  14. Park, K. J. (2002). Issues of injection on children' hospital. Journal of Korean Society of Hospital Pharmacists, 19(2), 153-156.
  15. Park, K, J. (2005). Evaluation of risks caused by glass particles and an investigation of the actual use of glass ampules in the local medical institutions, Korea Food & Drug Administration Research Report.
  16. Preston, S. T., & Hegadoren, K. (2004). Glass in parenterally administered medication. Advanced Nursing, 48(3), 266-270. https://doi.org/10.1111/j.1365-2648.2004.03195.x
  17. Ravnik, A., & Yatsco, J. (1962). A study of the sterility of multiple dose injectables after repeated withdrawals. American Journal of Hospital Pharmacy. 19, 469-471.
  18. Ro, Y. J., & Hahm, Y. B. (1975). Contamination of multiple dose solutions for injection distilled water and procaine. Journal of Korean Academy of Nursing, 5(1), 87-92.
  19. Shaw, N. J., & Lyall, E. G. (1985). Hazards of glass ampoules. British Medical Journal. 291(6506), 1390.
  20. Shim, C. K., Han, Y. H., & Kwon, D. S. (1991). Comparative study of particulate contamination from ampoule and prefilled syringe. Journal of Korean Pharmaceutical Sciences, 21(3), 155-160.
  21. Song, J. Y. (2007). The factors influencing glass particles in single dose glass ampules upon opening. Unpublished master's thesis, Pusan National University, Pusan
  22. Song, J. Y., & Kim, D. H. (2007). The factors influencing glass particles in single dose glass ampules upon opening. Journal of Korean Academy of Fundamentals of Nursing. 14(2), 166-172.
  23. Turco, S., & Davis, N. M. (1972). Glass particles in intravenous injections. The New England Journal of Medicine, 287(23), 1204-1205.
  24. Yun, E. M. (2004). Investigation of foreign guidelines for glass ampule use and the current situation of injectable drug use. Unpublished master's thesis, Sookmyung Women's University, Seoul.
  25. Walpot, H., Franke, R. P., Burchard, W. G., Agternkamp, C., Muller, F. G., & Kalff, G. (1989). Particulate contamination of infusion solutions and drug additives within the scope of long-term intensive therapy. 1. Energy dispersion electron images in the scanning electron microscope-REM/EDX. Anaesthesist. 38(10), 544-548.
  26. Zacher, A. N.,Zornow, M. H., Evans, G. (1991). Drug contamination from opening galss ampules. Anesthesiology. 75(5), 893-895. https://doi.org/10.1097/00000542-199111000-00022