Analysis of plasticizers in PVC medical devices: Performance comparison
1. Introduction. Polyvinylchloride (PVC) is a common plastic material used in disposable medical devices (MDs) in hospitals. Most of these MDs (e.g. tubing for infusion, dialysis, endotracheal intubation, and feeding) are made of flexible PVC due to its numerous benefits, which include chemical stability, biocompatibility, clarity and transparency, flexibility, durability, chemical and
A Comparison of Plasticizers for Use in Flexible Vinyl Medical Product
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Analysis of plasticizers in PVC medical devices: Performance comparison
Analysis of plasticizers in PVC medical devices: Performance comparison of eight analytical methods Analysis of plasticizers in PVC medical devices: Performance comparison of eight analytical methods Authors
Analysis of plasticizers in PVC medical devices: Performance comparison
A wide variety of medical devices (MDs) used in hospitals are made of flexible plasticized polyvinylchloride (PVC). Different plasticizers are present in variable amounts in the PVC matrix of...
What is the best alternative to DEHP for medical-grade
By comparison, DOTP is listed at 500-700 milligrams, making it 100 to 140 times safer than DEHP for rodents and five to seven times safer than TOTM. The same study listed NOAELs for ATBC (acetyl tributyl citrate), DINCH (di-isononyl cyclohexanoate), and DOA (di-octyl adipate) plasticizers at 100, 107, and 200, respectively.
- Can plasticizers be quantified in medical devices?
- For plasticizer quantification in MDs we chose to limit the sample quantity considering that the limit of quantification obtained on 10 mg was enough. Indeed we wanted to be able to analyze very small PVC samples from medical devices, so the less we used for extraction, the better. 3.4. Medical device tests
- What are the alternative plasticizers for PVC MDS?
- This resulted in the commercialization of PVC MDs plasticized with the DEHP alternative plasticizers tri-octyl trimellitate (TOTM), di- (2-ethylhexyl) terephthalate (DEHT), di-isononyl cyclohexane-1,2-dicarboxylate (DINCH), di-isononyl phthalate (DINP), di- (2-ethylhexy) adipate (DEHA), and Acetyl tri- n -butyl citrate (ATBC).
- Which plasticizer is most commonly used in medical devices?
- TOTM is the plasticizer most frequently used in the MDs studied (45%) followed by DEHP (29%), DINCH (16%), DINP (7%), ATBC (3%), and DEHA (3%). But the repartition is very disparate according to the types of MD. Fig. 4. Distribution of the majority plasticizers in the 32 medical devices analyzed according to the type of MD.
- Does plasticizer release a PVC MD into a simulant solution?
- We then tested the developed method on 32 PVC MDs used in our hospital and evaluated the plasticizer release from a PVC MD into a simulant solution during a 24 h migration test. The results showed a predominance of TOTM in PVC MDs accompanied by DEHP (<0.1% w/w), DEHT, and sometimes DEHA.
- Are there alternatives to DEHP plasticizers in MDS?
- Among the most widely used alternatives to DEHP plasticizers in MDs for infusion and artificial nutrition, TOTM and, to a lesser extent, DEHT, show much lower migration capabilities than DEHP, thus leading to a lesser exposure risk for the patients.
- Can a low molecular weight plasticizer be used as a secondary plasticizer?
- Noteworthy research focused on the introduction of a low molecular weight plasticizer as a secondary plasticizer and was carried out by Matos et al. DEHT was partially (5, 10, 15, 20 phr) replaced by di (ethylhexyl)-2,5-furandicarboxylate (DEHF) in PVC plastics (with whole plasticizer content of 55 phr).
