Specification and Evaluation of Plasticizer Migration Simulants for Human Blood Products: A Delphi Study.
Blood Banks
Blood Cells
/ cytology
Blood Platelets
/ cytology
Blood Preservation
/ instrumentation
Blood Transfusion
/ instrumentation
Delphi Technique
Erythrocytes
/ cytology
Hematology
/ standards
Humans
Hydrogen-Ion Concentration
Interdisciplinary Communication
Materials Testing
Plasma
/ cytology
Plasticizers
/ chemistry
Polyvinyl Chloride
/ chemistry
Surface Properties
Surveys and Questionnaires
Viscosity
labile blood product
migration
plasticizer
simulant
Journal
Biomolecules
ISSN: 2218-273X
Titre abrégé: Biomolecules
Pays: Switzerland
ID NLM: 101596414
Informations de publication
Date de publication:
22 07 2021
22 07 2021
Historique:
received:
16
06
2021
revised:
16
07
2021
accepted:
20
07
2021
entrez:
27
8
2021
pubmed:
28
8
2021
medline:
26
10
2021
Statut:
epublish
Résumé
Potentially toxic plasticizers are commonly added to polyvinyl chloride medical devices for transfusion in order to improve their flexibility and workability. As the plasticizers are not chemically bonded to the PVC, they can be released into labile blood products (LBPs) during storage. Ideally, LBPs would be used in laboratory studies of plasticizer migration from the medical device. However, short supply (i.e., limited stocks of human blood in collection centres) has prompted the development of specific simulants for each type of LBP in the evaluation of new transfusion devices. We performed a Delphi study with a multidisciplinary panel of 24 experts. In the first (qualitative) phase, the panel developed consensus definitions of the specification criteria to be met by each migration simulant. Next, we reviewed the literature on techniques for simulating the migration of plasticizers into LBPs. A questionnaire was elaborated and sent out to the experts, and the replies were synthesized in order to obtain a consensus. The qualitative study established specifications for each biological matrix (whole blood, red blood cell concentrate, plasma, and platelet concentrate) and defined the criteria required for a suitable LBP simulant. Ten criteria were suggested: physical and chemical characteristics, opacity, form, stability, composition, ability to mimic a particular clinical situation, ease and safety of use, a simulant-plastic interaction correlated with blood, and compatibility with analytical methods. The questionnaire data revealed a consensus on the use of natural products (such as pig's blood) to mimic the four LBPs. Opinions diverged with regard to synthetic products. However, an isotonic solution and a rheological property modifier were considered to be of value in the design of synthetic simulants. Consensus reached by the Delphi group could be used as a database for the development of simulants used to assess the migration of plasticizers from PVC bags into LBPs.
Identifiants
pubmed: 34439748
pii: biom11081081
doi: 10.3390/biom11081081
pmc: PMC8392596
pii:
doi:
Substances chimiques
Plasticizers
0
Polyvinyl Chloride
9002-86-2
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Références
Ultrasound Med Biol. 1999 Jan;25(1):105-10
pubmed: 10048807
J Ultrasound Med. 1988 Mar;7(3):137-47
pubmed: 2965254
Lab Chip. 2016 Oct 5;16(20):3919-3928
pubmed: 27714019
IEEE Trans Biomed Eng. 1994 Jan;41(1):29-34
pubmed: 8200665
J Biomech. 1981;14(9):601-11
pubmed: 7334043
J Pediatr Surg. 2000 Dec;35(12):1775-81
pubmed: 11101735
Ultrasound Med Biol. 1995;21(9):1163-76
pubmed: 8849831
Magn Reson Med. 1985 Dec;2(6):555-66
pubmed: 3880097
IEEE Trans Biomed Eng. 1992 May;39(5):462-9
pubmed: 1526637
Ultrasound Med Biol. 1983 Jul-Aug;9(4):347-56
pubmed: 6649152
Cardiovasc Eng Technol. 2018 Dec;9(4):623-640
pubmed: 30291585
J Am Soc Echocardiogr. 1992 Jul-Aug;5(4):385-92
pubmed: 1510854
Med Biol Eng Comput. 1987 Sep;25(5):543-50
pubmed: 3446976
Ultrasound Med Biol. 1990;16(2):141-7
pubmed: 1691560
Ultrasound Med Biol. 1995;21(1):59-70
pubmed: 7538706
Ultrasound Med Biol. 2000 Sep;26(7):1177-89
pubmed: 11053753
Ann Biomed Eng. 1978 Jun;6(2):83-92
pubmed: 152591
IEEE Trans Biomed Eng. 1994 Jan;41(1):91-5
pubmed: 8200673
Expert Rev Med Devices. 2018 May;15(5):377-383
pubmed: 29658331
Ultrasound Med Biol. 1996;22(7):883-94
pubmed: 8923707
Biorheology. 1986;23(4):359-70
pubmed: 3779061
Ultrasound Med Biol. 2001 May;27(5):655-64
pubmed: 11397530
Vox Sang. 2014 Jan;106(1):1-13
pubmed: 24102543
Methods Mol Biol. 2012;788:43-57
pubmed: 22130699
Ultrasound Med Biol. 1988;14(1):21-31
pubmed: 3279685
J Biomech Eng. 1996 Aug;118(3):318-25
pubmed: 8872253
IEEE Trans Ultrason Ferroelectr Freq Control. 1990;37(3):176-89
pubmed: 18285030
Biorheology. 1991;28(5):383-400
pubmed: 1838287
J Med Phys. 2006 Oct;31(4):275-8
pubmed: 21206644
Biorheology. 1991;28(5):421-7
pubmed: 1782394
IEEE Trans Biomed Eng. 1993 Sep;40(9):953-62
pubmed: 8288287
J Biomech. 1984;17(5):299-315
pubmed: 6736066
J Biomech. 1985;18(12):927-38
pubmed: 2934393
Int J Pharm. 2015 May 15;485(1-2):341-7
pubmed: 25796128
Ultrasound Med Biol. 1986 Mar;12(3):245-9
pubmed: 2938324
Biorheology. 1983;20(6):745-59
pubmed: 6661526
Acta Clin Belg. 2021 Jun;76(3):184-189
pubmed: 31787034
Ultrasound Med Biol. 2007 Aug;33(8):1269-76
pubmed: 17466441
Ultrasound Med Biol. 1998 Mar;24(3):451-9
pubmed: 9587999
J Acoust Soc Am. 2008 Sep;124(3):1803-10
pubmed: 19045670
IEEE Trans Biomed Eng. 1992 Nov;39(11):1111-22
pubmed: 1487274
Biorheology. 1996 Jul-Oct;33(4-5):365-77
pubmed: 8977661
Int J Pharm. 2017 Mar 30;520(1-2):119-125
pubmed: 28126549
IEEE Trans Ultrason Ferroelectr Freq Control. 1999;46(6):1591-6
pubmed: 18244358
BMJ. 1995 Aug 5;311(7001):376-80
pubmed: 7640549
IEEE Trans Ultrason Ferroelectr Freq Control. 1993;40(6):786-95
pubmed: 18263247
Circulation. 1999 Apr 13;99(14):1780-7
pubmed: 10199872
Ultrasound Med Biol. 1995;21(4):527-32
pubmed: 7571145
J Biomech Eng. 1986 Aug;108(3):228-31
pubmed: 2943937
Ultrasound Med Biol. 1996;22(8):1059-69
pubmed: 9004430
Phys Med Biol. 1991 Nov;36(11):1433-42
pubmed: 1754614
Ultrasound Med Biol. 1993;19(8):649-59
pubmed: 8134969
Biorheology. 1993 Sep-Dec;30(5-6):443-61
pubmed: 8186410
Ultrasound Med Biol. 1995;21(8):1029-35
pubmed: 8553497
Ultrasonics. 1998 Feb;36(1-5):653-60
pubmed: 9651595
J Biomech. 1976;9(7):439-48
pubmed: 939765
Radiology. 1991 Mar;178(3):701-4
pubmed: 1994406
Ultrasound Med Biol. 2014 Sep;40(9):2151-61
pubmed: 25023095
Am J Public Health. 1984 Sep;74(9):979-83
pubmed: 6380323
JPEN J Parenter Enteral Nutr. 2002 Sep-Oct;26(5):305-9
pubmed: 12216711
Biorheology. 1984;21(4):571-86
pubmed: 6487768
J Acoust Soc Am. 1984 Apr;75(4):1265-72
pubmed: 6725778
Biorheology. 1990;27(5):711-33
pubmed: 2271763
J Biomech. 1983;16(7):505-16
pubmed: 6619168
Ultrasound Med Biol. 2001 Jan;27(1):135-41
pubmed: 11295279
J Acoust Soc Am. 1987 Sep;82(3):794-9
pubmed: 3655112
J Biomech. 1981;14(5):279-96
pubmed: 7263720
J Pediatr Gastroenterol Nutr. 2008 Jul;47(1):81-6
pubmed: 18607273
J Pharm Pharmacol. 1977 Jul;29(7):407-10
pubmed: 19578
Phys Med Biol. 1989 Nov;34(11):1709-17
pubmed: 2479955
JPEN J Parenter Enteral Nutr. 1989 Jan-Feb;13(1):59-62
pubmed: 2494368
J Acoust Soc Am. 1991 Mar;89(3):1394-401
pubmed: 2030227
J Biomech. 1979;12(3):185-96
pubmed: 422585
Ultrason Sonochem. 2019 Sep;56:114-124
pubmed: 31101245
Magn Reson Imaging. 1989 Jan-Feb;7(1):69-77
pubmed: 2918821
Biorheology. 1991;28(6):569-87
pubmed: 1818745
Eur J Ultrasound. 1999 Jul;9(3):267-76
pubmed: 10657601
Ultrasound Med Biol. 1982;8(4):427-37
pubmed: 7112729
J Acoust Soc Am. 1988 Jul;84(1):52-8
pubmed: 3411055
Ultrasound Med Biol. 2002 Apr;28(4):495-506
pubmed: 12049963
J Acoust Soc Am. 1988 Oct;84(4):1195-200
pubmed: 3058769