Utilization of the Tyndall Effect for Enhanced Visual Detection of Particles in Compatibility Testing of Intravenous Fluids: Validity and Reliability

References

1. 1.↵
   1. Hill S. E.,
   2. Heldman L. S.,
   3. Goo E. D.,
   4. Whippo P. E.,
   5. Perkinson J. C.

   Fatal microvascular pulmonary emboli from precipitation of a total nutrient admixture solution. JPEN J. Parenter. Enteral Nutr. 1996, 20 (1), 81–87.

   OpenUrlAbstract/FREE Full Text
2. 2.↵
   1. Doessegger L.,
   2. Mahler H-C.,
   3. Szczesny P.,
   4. Rockstroh H.,
   5. Kallmeyer G.,
   6. Langenkamp A.,
   7. Herrmann J.,
   8. Famulare J.

   The potential clinical relevance of visible particles in parenteral drugs. J. Pharm. Sci. 2012, 101 (18), 2635–2644.

   OpenUrlPubMed
3. 3.↵
   1. Walpot H.,
   2. Franke R. P.,
   3. Burchard W. G.,
   4. Agternkamp C.,
   5. Müller F.,
   6. Mittermayer C.,
   7. Klaff G.

   Particulate contamination of intravenous solutions and drug additives during long-term intensive care. Anaesthesist 1989, 38 (10), 544–548.

   OpenUrlPubMedWeb of Science
4. 4.↵
   1. Puntis J. W. L.,
   2. Wilkins K. M.,
   3. Ball P. A.,
   4. Rushton D. I.,
   5. Booth I. W.

   Hazards of parenteral treatment: Do particles count? Arch. Dis. Child. 1992, 67 (12), 1475–1477.

   OpenUrlAbstract/FREE Full Text
5. 5.↵
   1. Hellinger A.,
   2. Piotrowski J.,
   3. Konerding M. A.,
   4. Burchard W. G.,
   5. Doetsch N.,
   6. Peitgen K.,
   7. Erhard J.,
   8. Reidemeister J. C.

   Impact of particulate contamination in crystalloid cardioplegic solutions: studies by scanning and transmission electron microscopy. Thorac. Cardiovasc. Surg. 1997, 45 (1), 20–26.

   OpenUrlPubMedWeb of Science
6. 6.↵
   1. Jack T.,
   2. Brent B. E.,
   3. Boehne M.,
   4. Müller M.,
   5. Sewald K.,
   6. Braun A.,
   7. Wessel A.,
   8. Sasse M.

   Analysis of particulate contaminations of infusion solutions in a pediatric intensive care unit. Intensive Care Med. 2010, 36 (4), 707–711.

   OpenUrlCrossRefPubMed
7. 7.↵
   1. Sherwood L.

   Human Physiology, from Cells to Systems, 6th ed.; Thomson Brooks/Cole: Belmont, CA, 2007.
8. 8.↵
   1. Parikh M. J.,
   2. Dumas G.,
   3. Silvestri A.,
   4. Bistrian B. R.,
   5. Driscoll D. F.

   Physical compatibility of neonatal total parenteral nutrient admixtures containing organic calcium and inorganic phosphate salts. Am. J. Health-Syst. Pharm. 2005, 62 (11), 1177–1183.

   OpenUrlAbstract/FREE Full Text
9. 9.↵
   1. Lehr H. A.,
   2. Brunner J.,
   3. Rangoonwala R.,
   4. Kirkpatrick C. J.

   Particulate matter contamination of intravenous antibiotics aggravates loss of functional capillary density in postischemic striated muscle. Am. J. Respir. Crit. Care Med. 2002, 165 (4), 514–520.

   OpenUrlCrossRefPubMedWeb of Science
10. 10.↵
    1. Ball P. A.

    Intravenous in-line filters: filtering the evidence. Curr. Opin. Clin. Nutr. Metab. Care 2003, 6 (3), 319–325.

    OpenUrlCrossRefPubMedWeb of Science
11. 11.↵
    European Pharmacopoeia. 2.9.20. Particulate Contamination: Visible Particles. In European Pharmacopoeia, 8th ed.; Supplement 8.0., 2014.
12. 12.↵
    United States Pharmacopoeia. <1> Injections. In USP 36–NF 31.
13. 13.↵
    Japanese Pharmacopoeia. 6.06. Foreign Insoluble Matter Test for Injections. In Japanese Pharmacopoeia, 16th ed.
14. 14.↵
    European Pharmacopoeia. 2.9.19. Particulate Contamination: Sub-visible Particles. In European Pharmacopoeia, 8th ed.; Supplement 8.0, 2014.
15. 15.↵
    United States Pharmacopoeia. <788> Particulate Matter in Injections; In USP 36-NF 31.
16. 16.↵
    Japanese Pharmacopoeia. 6.07. Insoluble Particulate Matter Test for Injections. In Japanese Pharmacopoeia, 16th ed.
17. 17.↵
    1. Tran T.,
    2. Kupiec T. C.,
    3. Trissel L. A.

    Particulate matter in injections: What is it and what are the concerns? Int. J. Pharm. Compd. 2006, 10 (3), 202–204.

    OpenUrlPubMed
18. 18.↵
    1. Mahler H.-C.,
    2. Jiskoot W.

    1. Smulders R.,
    2. Vos H.,
    3. Mahler H.-C.

    Detection of Visible Particles in Parenteral Products. In Analysis of Aggregates and Particles in Protein Pharmaceuticals, 1st ed.; Mahler H.-C., Jiskoot W., Eds.; John Wiley & Sons, Inc.: Hoboken, NJ, 2012; pp 117–132.
19. 19.↵
    1. Newton D. W.

    Drug incompatibility chemistry. Am. J. Health-Syst. Pharm. 2009, 66 (4), 348–357.

    OpenUrlAbstract/FREE Full Text
20. 20.↵
    1. Newton D. W.

    Y-site compatibility of intravenous drugs with parenteral nutrition. Commentary. JPEN J. Parenter. Enteral Nutr. 2013, 37 (3), 297–299.

    OpenUrlFREE Full Text
21. 21.↵
    1. Newton D. W.,
    2. Driscoll D. F.

    Calcium and phosphate compatibility: revisited again. Am. J. Health-Syst. Pharm. 2008, 65 (1), 73–80.

    OpenUrlFREE Full Text
22. 22.↵
    1. Veggeland T.,
    2. Brandl M.

    Evaluation of a simple method for visual detection of microprecipitates in blends of parenteral drug solutions using a focused (Tyndall) light beam. Int. J. Pharm. Compd. 2010, 14 (1), 78–81.

    OpenUrlPubMed
23. 23.↵
    1. Minton A. R.,
    2. Barnett M. I.,
    3. Cosslett A. G.

    Detection of particulate material in parenteral nutrition admixtures. Commentary. Nutrition 1998, 14 (2), 251–252.

    OpenUrlPubMed
24. 24.↵
    1. Trissel L. A.,
    2. Gilbert D. L.,
    3. Martinez J. F.,
    4. Baker M. B.,
    5. Walter W. V.,
    6. Mirtallo J. M.

    Compatibility of parenteral nutrient solutions with selected drugs during simulated Y-site administration. Am. J. Health-Syst. Pharm. 1997, 54 (11), 1295–1300.

    OpenUrlAbstract/FREE Full Text
25. 25.↵
    1. Trissel L. A.,
    2. Gilbert D. L.,
    3. Martinez J. F.,
    4. Baker M. B.,
    5. Walter W. V.,
    6. Mirtallo J. M.

    Compatibility of medications with 3-in-1 parenteral nutrition admixtures. JPEN J. Parenter. Enteral Nutr. 1999, 23 (2), 67–74.

    OpenUrlAbstract/FREE Full Text
26. 26.↵
    1. Husson E.,
    2. Crauste-Manciet S.,
    3. Hadj-Salah E.,
    4. Seguier J.,
    5. Brossard D.

    Compatibility of parenteral drugs with commercialized total parenteral admixtures during simulated Y-site infusion. Nutr. Clin. Métabol. 2003, 17 (2), 72–79.

    OpenUrl
27. 27.↵
    1. Bouchoud L.,
    2. Fonzo-Christe C.,
    3. Klingmüller M.,
    4. Bonnabry P.

    Compatibility of intravenous medications with parenteral nutrition: in vitro evaluation. JPEN J. Parenter. Enteral Nutr. 2013, 37 (3), 416–424.

    OpenUrlAbstract/FREE Full Text
28. 28.↵
    1. Garvan J. M.,
    2. Gunner B. W.

    The harmful effects of particles in intravenous fluids. Med. J. Aust. 1964, 2, 1–6.

    OpenUrlPubMedWeb of Science
29. 29.↵
    1. Trissel L. A.,
    2. Martinez J. F.

    Physical compatibility of melphalan with selected drugs during simulated Y-site administration. Am. J. Hosp. Pharm. 1993, 50 (11), 2359–2363.

    OpenUrlAbstract
30. 30.↵
    1. Singh B. N.,
    2. Dedhiya M. G.,
    3. DiNunzio J.,
    4. Chan P.,
    5. Kupiec T. C.,
    6. Trissel L. A.,
    7. Laudano J. B.

    Compatibility of ceftaroline fosamil for injection with selected drugs during simulated Y-site administration. Am. J. Health-Syst. Pharm. 2011, 68 (22), 2163–2169.

    OpenUrlAbstract/FREE Full Text
31. 31.↵
    1. Knapp J. Z.,
    2. Kushner H. K.

    Generalized methodology for evaluation of parenteral inspection procedures. PDA J. Pharm. Sci. Technol. 1980, 34 (1), 14–61.

    OpenUrlAbstract/FREE Full Text
32. 32.↵
    1. Faesen A. C.

    Reproducibility in visual inspection of parenterals. J. Parenter. Drug Assoc. 1978, 32 (2), 75–83.

    OpenUrlPubMed
33. 33.↵
    1. Borchert S. J.,
    2. Maxwell R. J.,
    3. Davison R. L.,
    4. Aldrich D. S.

    Standard particulate sets for visual inspection systems: their preparation, evaluation, and applications. PDA J. Pharm. Sci. Technol. 1986, 40 (6), 265–276.

    OpenUrlAbstract/FREE Full Text
34. 34.↵
    1. Sadeghipour F.,
    2. Bugmann A.,
    3. Herrera V.,
    4. Bonnabry P.

    The reliability of operators when visually inspecting parenteral drugs. Pract. Res. Innov. 2007, 13, 41–45.

    OpenUrl
35. 35.↵
    1. Knapp J. Z.

    The scientific basis for visible particle inspection. PDA J. Pharm. Sci. Technol. 1999, 53 (6), 291–302.

    OpenUrlAbstract/FREE Full Text
36. 36.↵
    1. Gerstman B. B.

    Epidemiology Kept Simple: An Introduction to Traditional and Modern Epidemiology, 2nd ed.; Wiley-Liss: Hoboken, NJ, 2003.
37. 37.↵
    1. Akobeng A. K.

    Understanding diagnostic tests 2: likelihood ratios, pre- and post-test probabilities and their use in clinical practice. Acta Paediatr. 2006, 96 (4), 487–491.

    OpenUrlCrossRef
38. 38.↵
    1. Egger M.,
    2. Smith G. D.,
    3. Altman D. G.

    1. Deeks J. J.

    Systematic Reviews of Evaluations of Diagnostic and Screening Tests. In Systematic Reviews in Health Care Meta-analysis in Context, 2nd ed.; Egger M., Smith G. D., Altman D. G., Eds.; BMJ Publishing Group: London, 2001; pp 248–282.
39. 39.↵
    1. Fleiss J. L.

    Measuring nominal scale agreement among many raters. Psychol. Bull. 1971, 76 (5), 378–382.

    OpenUrlCrossRef
40. 40.↵
    1. Gwet K. L.

    Handbook of Inter-rater Reliability, 3rd ed.; Advanced Analytics, LLC: Gaithersburg, MD, 2012.
41. 41.↵
    1. Landis J. R.,
    2. Koch G. G.

    The measurement of observer agreement for categorical data. Biometrics 1977, 33 (1), 159–174.

    OpenUrlCrossRefPubMedWeb of Science
42. 42.↵
    1. Trissel L. A.,
    2. Bready B. B.

    Turbidimetric assessment of the compatibility of taxol with selected other drugs during simulated Y-site injection. Am. J. Hosp. Pharm. 1992, 49 (7), 1716–1719.

    OpenUrlAbstract
43. 43.↵
    European Pharmacopoeia. 2.2.1. Clarity and Degree of Opalescence of Liquids. In European Pharmacopoeia, 8th ed.; Supplement 8.0, 2014.
44. 44.↵
    1. Jaeschke R.,
    2. Guyatt G. H.,
    3. Sackett D. L.

    Users' guide to the medical literature. III How to use an article about a diagnostic test. B. What are the results and will they help me in caring for my patients? JAMA 1994, 271 (9), 703–707.

    OpenUrlCrossRefPubMedWeb of Science
45. 45.↵
    Filter Manufacturers Council. Technical Service Bulletin 89-5. The Micron Rating for Media in Fluid Filters. www.aftermarketsuppliers.org/Councils/Filter-Manufacturers-Council/TSBs-2/English/89-5R3.pdf (accessed Mar 10, 2014).
46. 46.↵
    1. Vessey I.,
    2. Kendall C. E.

    Determination of particulate matter in intravenous fluids. Analyst 1966, 91 (1081), 273–279.

    OpenUrlCrossRefPubMed
47. 47.↵
    1. Migaki E. A.,
    2. Melhart B. J.,
    3. Dewar C. J.,
    4. Huston R. K.

    Calcium chloride and sodium phosphate in neonatal parenteral nutrition containing TrophAmine: precipitation studies and aluminum content. JPEN J. Parenter. Enteral Nutr. 2012, 36 (4), 470–475.

    OpenUrlAbstract/FREE Full Text
48. 48.↵
    1. Driscoll D. F.,
    2. Newton D. W.,
    3. Bistrian B. R.

    Potential hazards of precipitation associated with calcium chloride in parenteral nutrition admixtures: response to Migaki et al. JPEN J. Parenter. Enteral Nutr. 2012, 36 (5), 497–498.

    OpenUrlFREE Full Text