PMID- 24516786
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140211
LR  - 20220410
IS  - 2193-1801 (Print)
IS  - 2193-1801 (Electronic)
IS  - 2193-1801 (Linking)
VI  - 3
DP  - 2014
TI  - Evaluation of the Di(2-ethylhexyl)phthalate released from polyvinyl chloride 
      medical devices that contact blood.
PG  - 58
LID - 10.1186/2193-1801-3-58 [doi]
LID - 58
AB  - Extraction methods that simulate those used in the clinic are recommended for 
      obtaining extraction solutions. For polyvinyl chloride (PVC) medical devices that 
      have contact with human blood, an alternative medium (ethanol/water mixture) is 
      suggested as an extraction screening vehicle to evaluate the 
      di(2-ethylhexyl)phthalate (DEHP) released. A test comparing the extraction 
      ability between the alternative medium and whole blood from three healthy 
      volunteers has been conducted. An experimental method is provided outlining the 
      chemical analysis of the DEHP released from medical devices made with polyvinyl 
      chloride (PVC). Gas chromatography-mass spectrometry (GC-MS) in the selective ion 
      monitoring (SIM) mode was used to analyze and quantify the extracted DEHP. The 
      linear range of the SIM method was 0.1-200 mug/mL, and the recoveries were 
      89.6-101.5% and 91.0-98.9% when using the ethanol/water mixture and whole blood 
      as the extraction media, respectively. The validated method demonstrates that it 
      is suitable for the determination of the DEHP released from PVC medical devices 
      that have contact with blood. The results from the determination of the DEHP 
      released will be compared with the limits derived from toxicological data for the 
      parenteral exposure route and certain population groups, and the results will be 
      used in the risk assessment of medical devices.
FAU - Luo, Hongyu
AU  - Luo H
AD  - CFDA Jinan Quality Inspection Center for Medical Devices, 99 Tianluo Road H-T 
      Industrial Development Zone, Jinan, 250000 China ; Shandong Provincial Key 
      Laboratory of Biological Evaluation of Medical Device, 99 Tianluo Road H-T 
      Industrial Development Zone, Jinan, 250000 China.
FAU - Sun, Guangyu
AU  - Sun G
AD  - CFDA Jinan Quality Inspection Center for Medical Devices, 99 Tianluo Road H-T 
      Industrial Development Zone, Jinan, 250000 China ; Shandong Provincial Key 
      Laboratory of Biological Evaluation of Medical Device, 99 Tianluo Road H-T 
      Industrial Development Zone, Jinan, 250000 China.
FAU - Shi, Yanping
AU  - Shi Y
AD  - CFDA Jinan Quality Inspection Center for Medical Devices, 99 Tianluo Road H-T 
      Industrial Development Zone, Jinan, 250000 China ; Shandong Provincial Key 
      Laboratory of Biological Evaluation of Medical Device, 99 Tianluo Road H-T 
      Industrial Development Zone, Jinan, 250000 China.
FAU - Shen, Yong
AU  - Shen Y
AD  - Shandong Hengxin Inspection Technology Development Center, 99 Tianluo Road H-T 
      Industrial Development Zone, Jinan, 250000 China.
FAU - Xu, Kai
AU  - Xu K
AD  - Shandong Hengxin Inspection Technology Development Center, 99 Tianluo Road H-T 
      Industrial Development Zone, Jinan, 250000 China.
LA  - eng
PT  - Journal Article
DEP - 20140129
PL  - Switzerland
TA  - Springerplus
JT  - SpringerPlus
JID - 101597967
PMC - PMC3916584
OTO - NOTNLM
OT  - Blood contact
OT  - Di(2-ethylhexyl) phthalate (DEHP)
OT  - Ethanol/water mixture
OT  - Gas chromatography/mass spectrometry (GC-MS)
OT  - Medical devices
OT  - Polyvinyl chloride (PVC)
EDAT- 2014/02/12 06:00
MHDA- 2014/02/12 06:01
PMCR- 2014/01/29
CRDT- 2014/02/12 06:00
PHST- 2013/11/18 00:00 [received]
PHST- 2014/01/27 00:00 [accepted]
PHST- 2014/02/12 06:00 [entrez]
PHST- 2014/02/12 06:00 [pubmed]
PHST- 2014/02/12 06:01 [medline]
PHST- 2014/01/29 00:00 [pmc-release]
AID - 799 [pii]
AID - 10.1186/2193-1801-3-58 [doi]
PST - epublish
SO  - Springerplus. 2014 Jan 29;3:58. doi: 10.1186/2193-1801-3-58. eCollection 2014.