Evidence map›Paper›PMID 24516786›Full record

ArticleSpringerPlus2014

Evaluation of the Di(2-ethylhexyl)phthalate released from polyvinyl chloride medical devices that contact blood.

Hongyu Luo, Guangyu Sun, Yanping Shi, Yong Shen, Kai Xu

Open access · diamondAbstract read
In one paragraph

Article in SpringerPlus, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Hongyu LuoCFDA 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.
Guangyu SunCFDA 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.
Yanping ShiCFDA 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.
Yong ShenShandong Hengxin Inspection Technology Development Center, 99 Tianluo Road H-T Industrial Development Zone, Jinan, 250000 China.
Kai XuShandong Hengxin Inspection Technology Development Center, 99 Tianluo Road H-T Industrial Development Zone, Jinan, 250000 China.
Shandong Institute for Product Quality Inspection · CNShandong Special Equipment Inspection Institute · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 μg/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.

Indexed as

Blood contactDi(2-ethylhexyl) phthalate (DEHP)Ethanol/water mixtureGas chromatography/mass spectrometry (GC-MS)Medical devicesPolyvinyl chloride (PVC)

Identifiers

PMID24516786
PMCPMC3916584
OpenAlexW2151172953

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.