Skip to main content

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