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Table 1 Characteristics of medical devices used for pregnant women included in the study and GC-MS analyses results

From: Exposure of hospitalised pregnant women to plasticizers contained in medical devices

Information on the packaging and/or the technical sheets of the MDs

GC-MS Analysis

Medical device (Manufacturer)

References

Batch number

Material

Mention “with DEHP” or “with phthalates”

PVC plasticizers (% of plasticizers: g of plasticizers / 100 g of PVC)a

Catheters

 Venflon™ pro safety (BD Medical Systems)

393228; 393229; 393224; 393226

4114335P47

PU

No

Not analyzedb

 Surshield Versatus™ (Terumo)

SR + DS1845PX

2110058

PU

No

Not analyzedb

 Insyte™ Autoguard™ (BD Medical Systems)

381934; 381944

3225842

PU

No

Not analyzedb

 Epidural catheterization set (Teleflex)

JC05400B

71F14J1867

PU

No

Not analyzedb

 Infusion Sets

 Infusion set perfusend (Sendal)

A64

03501

PVC

No

DiNP (36.39%).

 Multi access infusion set (Doran Int)

Edelvaiss-2

231501Q

PVC/TOTM

No

TOTM (34.99%), DEHP (0.01%), DEHT (0.13%).

 Epidural infusion set (Smiths medical)

21–7039-24

2020–01

PVC/TOTM

DEHP <0.2%

TOTM (34.93%), DEHP (1.19%).

Extension tubes (for electric syringe pump)

 Extension tube (Cair LGL)

PB311 8 M

14H27-T

PE/PVC

No

TOTM (30.87%), DEHP (0.02%), DEHT (0.95%).

 Extension tube (Cair LGL)

PB311 5 M

14G30-T

PE/PVC

No

TOTM (28.79%), DEHP (0.02%), DEHT (0.43%).

 Extension tube (Cair LGL)

PB310 5 M

14F02-T

PE/PVC

No

TOTM (30.01%), DEHP (0.01%), DEHT (0.35%).

 Extension line with 3 way stopcock (Cair LGL)

PES3301M

14I06-T

PE/PVC

No

TOTM (30.03%), DEHP (0.02%), DEHT (0.48%).

Flow Regulator

 Flow regulator (Cair LGL)

SSDF050

14H25-T

PVC

No

DINCH (33.50%), DEHP (0.01%).

SYRINGES (for electric syringe pump)

 BD plastipak syringe (BD Medical Systems)

300865

1407212

PP

No

Not analyzedb

 Urinary catheters

 Intermittent urinary catheter (Coloplast)

275140

4227421

PU

Noc

Not analyzedb

 Indwelling urinary catheter (Teleflex)

170605–000140

144E06

Silicone

No

Not analyzedb

  1. aThe quantity of each plasticizer contained in MDs was expressed in g of plasticizer for 100 g of PVC which corresponds to the percentage (%) of plasticizers contained in the PVC of MDs
  2. bThe MDs which have undergone a GC-MS analysis are only those which may contain phthalates/other plasticizers in their formulation, namely the MDs based on PVC. The other MDs made of unplasticized biomaterial [elastomeric materials (polyurethane and silicone) or polyolefin (polypropylene)] were not analyzed because they are free of plasticizers
  3. cLimits of detection of 10 to 40 μg/g of product
  4. Abbreviations: DEHP di-(2-ethylhexyl) phthalate, DEHT di-(ethylhexyl)-terephthalate, DINCH di(isononyl)-cyclohexane-1,2-dicarboxilic acid, DiNP di-(isononyl) phthalate; GC-MS gas chromatography-mass spectrometry, MDs medical devices, PE Polyethylene, PP Polypropylene, PU Polyurethane, PVC polyvinyl chloride, TOTM tri-octyltrimellitate