title: Multidisciplinary evaluation for severity of hazards applied to hemodialysis devices: an original risk analysis method.
abstract: OBJECTIVE
  Risk analysis for medical devices is a crucial process to grant adequate levels of safety. Identification of device exposure-related hazards is one of the main objectives.
  
  
  METHODS
  Hazard analysis for hemodialysis devices has been performed by a multidisciplinary team involving engineers and clinical experts. A potential harm list was identified from clinical and technical experience, postproduction information, and literature. Various hazardous situations (circumstances when the use of the dialysis device may lead to described harms) were described. Such hazardous situations were correlated to the extent of the deviation of a specific device parameter from expected ranges. The clinical severity that was relevant to any specific harm was categorized for each hazardous situation using a descriptive and numerical scale with five levels (from negligible [i.e., discomfort only] to catastrophic [i.e., potentially lethal]).
  
  
  RESULTS
  Harms in which the deviation of a parameter strictly coincides with the clinically measured effect on the patient are defined as "direct." Otherwise, when another clinical parameter must be involved to quantify severity, the related harm is considered "indirect." Two complete examples of multidisciplinary evaluation for severity of hazards (MESH) are given for a direct harm (air embolism) and for an indirect harm (hypothermia). For other harms, the maximum value of severity involved is provided.
  
  
  CONCLUSIONS
  MESH represents a possible example of risk management for dialysis equipment in which, although the manufacturer is directly responsible, a multidisciplinary task force may contribute to a better link between engineering and clinical perspectives.
authors.affiliation: Research & Development, Gambro Dasco SpA, Medolla, Italy. carlo.lodi@gambro.com
authors.forename: Carlo Alberto
authors.initials: CA
authors.lastname: Lodi
authors.forename: Alessandro
authors.initials: A
authors.lastname: Vasta
authors.forename: Maria Alquist
authors.initials: MA
authors.lastname: Hegbrant
authors.forename: Juan P
authors.initials: JP
authors.lastname: Bosch
authors.forename: Francesco
authors.initials: F
authors.lastname: Paolini
authors.forename: Francesco
authors.initials: F
authors.lastname: Garzotto
authors.forename: Claudio
authors.initials: C
authors.lastname: Ronco
mesh_terms: D002388:Catastrophic Illness; D016638:Critical Illness; D004618:Embolism, Air / Q000209:etiology* / Q000517:prevention & control; D004867:Equipment Design; D004868:Equipment Failure; D004869:Equipment Safety; D006801:Humans; D007035:Hypothermia / Q000209:etiology* / Q000517:prevention & control; D033183:Interdisciplinary Communication; D006435:Renal Dialysis / Q000009:adverse effects* / Q000295:instrumentation* / Q000401:mortality; D018570:Risk Assessment; D012307:Risk Factors; D017751:Safety Management; D009626:Terminology as Topic
references.citation: Nephrol Dial Transplant. 2001 Nov;16(11):2138-42
references.pmid: 11682657
references.citation: Semin Dial. 2008 May-Jun;21(3):232-8
references.pmid: 18363602
references.citation: MMWR Recomm Rep. 2001 Apr 27;50(RR-5):1-43
references.pmid: 11349873
references.citation: Chest. 2005 Oct;128(4):2918-32
references.pmid: 16236969
references.citation: Hemodial Int. 2006 Apr;10(2):162-7
references.pmid: 16623668
references.citation: Clin Chem Lab Med. 2000 May;38(5):433-6
references.pmid: 10952227
references.citation: BMC Health Serv Res. 2007 Jun 18;7:89
references.pmid: 17577401
references.citation: Biomed Instrum Technol. 2008 Mar-Apr;42(2):150-9
references.pmid: 18397140
references.citation: Nephrol Dial Transplant. 1990;5 Suppl 1:109-14
references.pmid: 2129438
references.citation: Biomed Instrum Technol. 2004 Mar-Apr;38(2):119-21
references.pmid: 15106429
references.citation: Crit Care. 2009;13(6):1007
references.pmid: 20053299
references.citation: Am J Kidney Dis. 2001 Feb;37(2):276-86
references.pmid: 11157367
references.citation: Nephrol News Issues. 2006 Nov;20(12):57-8, 60-1, 63 passim
references.pmid: 17125098
references.citation: Am J Kidney Dis. 2006 Jul;48 Suppl 1:S2-90
references.pmid: 16813990
references.citation: Nephrol Dial Transplant. 2003 Nov;18(11):2377-81
references.pmid: 14551369
references.citation: Artif Organs. 2007 Jun;31(6):483-8
references.pmid: 17537063
references.citation: Clin Chim Acta. 2010 Feb;411(3-4):135-9
references.pmid: 19945449
references.citation: J Nephrol. 2010 Jan-Feb;23(1):111-8
references.pmid: 20091494
references.citation: Artif Organs. 2007 Feb;31(2):132-9
references.pmid: 17298402
references.citation: Nephrol Dial Transplant. 2001 Sep;16(9):1863-9
references.pmid: 11522871
references.citation: Infect Dis Clin North Am. 2001 Sep;15(3):797-812, viii
references.pmid: 11570142
references.citation: Semin Dial. 2009 Sep-Oct;22(5):524-31
references.pmid: 19558629
references.citation: Artif Organs. 1999 Jan;23(1):37-43
references.pmid: 9950177
references.citation: Adv Ren Replace Ther. 2001 Apr;8(2):131-7
references.pmid: 11349254
references.citation: Clin Chim Acta. 2009 Jun;404(1):75-8
references.pmid: 19298799
references.citation: Blood Purif. 2010;29(2):81-5
references.pmid: 20093808
references.citation: Artif Organs. 2007 Dec;31(12):911-2; author reply 913-4
references.pmid: 18039272
references.citation: Blood Purif. 2009;27(1):6-10
references.pmid: 19169010