American Journal of Kidney Diseases
Volume 55, Issue 1 , Pages 11-14 , January 2010

Recognizing and Reacting to Product-Related Adverse Events in Hemodialysis

  • Richard A. Ward, PhD

      Affiliations

    • Corresponding Author InformationAddress correspondence to Richard A. Ward, PhD, Kidney Disease Program, University of Louisville, 615 S Preston Street, Louisville, KY 40202
    • ,
  • George R. Aronoff, MD

References 

  1. Cameron JS. Practical haemodialysis began with cellophane and heparin: The crucial role of William Thalhimer (1884-1961). Nephrol Dial Transplant. 2000;15:1086–1091
  2. Petitou M, Hérault J-P, Bernat A, et al. Synthesis of thrombin-inhibiting heparin mimetics without side effects. Nature. 1999;398:417–422
  3. Blossom DB, Kallen AJ, Patel PR, et al. Outbreak of adverse reactions associated with contaminated heparin. N Engl J Med. 2008;359:2674–2684
  4. Guerrini M, Beccati D, Shriver Z, et al. Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events. Nat Biotech. 2008;26:669–675
  5. Kishimoto TK, Viswanathan K, Ganguly T, et al. Contaminated heparin associated with adverse clinical events and activation of the contact system. N Engl J Med. 2008;358:2457–2467
  6. Marshall CP, Pearson FC, Sagona MA, et al. Reactions during hemodialysis caused by allergy to ethylene oxide gas sterilization. J Allergy Clin Immunol. 1985;75:563–567
  7. Hutter JC, Kuehnert MJ, Wallis RR, et al. Acute onset of decreased vision and hearing traced to hemodialysis treatment with aged dialyzers. JAMA. 2000;283:2128–2134
  8. Canaud B. Performance liquid test as a cause for sudden deaths of dialysis patients: Perfluorohydrocarbon, a previously unrecognized hazard for dialysis patients. Nephrol Dial Transplant. 2002;17:545–548
  9. Ward RA. Water processing for hemodialysis (Part I: A historical perspective). Semin Dial. 1997;10:26–31
  10. Verresen L, Fink E, Lemke H-D, et al. Bradykinin is a mediator of anaphylactoid reactions during hemodialysis with AN69 membranes. Kidney Int. 1994;45:1497–1503
  11. Villarreol F. Incidence of hypersensitivity in hemodialysis. Artif Organs. 1984;8:278–280
  12. Turabelidze G, Elward A, Jones M, et al. Acute allergic-type reactions among patients undergoing hemodialysis—Multiple states, 2007–2008. MMWR Morbid Mortal Wkly Rep. 2008;57:124–125
  13. US Food and Drug Administration. Baxter's Multiple-Dose Vial Heparin Linked to Severe Allergic Reactions (FDA News Release). http://www.fda.gov/bbs/topics/NEWS/2008/NEW01797.htmlFebruary 11, 2008;Accessed June 21, 2009
  14. WHO. Contaminant Detected in Heparin Material of Specified Origin in the USA and in Germany; Serious Adverse Events Reported; Recall Measures Initiated. World Health Organization Alert No. 118 http://www.who.int/medicines/publications/drugalerts/Alert_118_Heparin.pdfMarch 7, 2008;Accessed June 21, 2009
  15. ISO. Medical Devices—Coding Structure for Adverse Event Type and Cause (ISO 19218:2005). Geneva, Switzerland: International Organization for Standardization; 2005;
  16. Global Harmonization Task Force. Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices (GHTF/SG2/N54R8:2006). http://www.ghtf.org/documents/sg2/SG2-N54-R8-2006-Proposed.pdfAccessed June 21, 2009
  17. Bhalla V, Grimm PC, Chertow GM, et al. Melamine nephrotoxicity: An emerging epidemic in an era of globalization. Kidney Int. 2009;75:774–779

 Originally published online as doi:10.1053/j.ajkd.2009.06.001 on July 14, 2009.

PII: S0272-6386(09)00831-2

doi: 10.1053/j.ajkd.2009.06.001

American Journal of Kidney Diseases
Volume 55, Issue 1 , Pages 11-14 , January 2010

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