Analysis of plasticizers in poly(vinyl chloride) medical devices
The identification of plasticizers in plastics is carried out in two steps: (i) sample treatment, in which the additives must be separated from the polymer and isolated from other compounds that are present in plastic matrix, and (ii) quantification, in which additives are quantified using a suitable technique, mainly by chromatography.
Analysis of plasticizers in poly(vinyl chloride) medical devices
Analysis of plasticizers in poly (vinyl chloride) medical devices for infusion and artificial nutrition: comparison and optimization of the extraction procedures, a pre-migration test step Authors Lise Bernard 1 , Régis Cueff , Daniel Bourdeaux , Colette Breysse , Valérie Sautou , Armed Study Group Collaborators Armed Study Group :
Analysis of PVC plasticizers in medical devices and infused solutions
1. Introduction. In 2008, di- (2-ethylhexyl) phthalate (DEHP), widely used as a plasticizer in flexible polyvinyl chloride medical devices (PVC MDs), was categorized as CMR 1B (carcinogenic, mutagenic or toxic to reproduction) under the CLP regulations [1]. As a result, its use in PVC MDs was called into question by the European authorities [2
Analysis of plasticizers in poly(vinyl chloride) medical devices
plasticizers from the PVC matrix of medical devices has not been extensively studied, and there is very little data on the extraction yields for each technique. The aim of the present work was to set up a simple, rapid, and widely applicable analysis method suitable for the quan-tification of four plasticizers used in current medical devices
Analysis of plasticizers in poly(vinyl chloride) medical devices
It was found that simple room temperature chloroform extraction under optimized conditions gave the best separation of plasticizers from the PVC matrix, with extraction yields ranging from 92 to 100 % for all plasticizers. Medical devices (MDs) for infusion and enteral and parenteral nutrition are essentially made of plasticized polyvinyl chloride (PVC). The first step in assessing patient
- Are PVC plasticizers harmful to patients?
- The plasticizers in the PVC matrix can leach out into the infused solutions and may enter into contact with the patients. In order to assess the risk of patient exposure to these plasticizers we evalu … Migrability of PVC plasticizers from medical devices into a simulant of infused solutions Int J Pharm.
- Are plasticizers in the PVC matrix a risk factor for patient exposure?
- The plasticizers in the PVC matrix can leach out into the infused solutions and may enter into contact with the patients. In order to assess the risk of patient exposure to these plasticizers we evaluated the migration performance of DEHP, DEHT, DINCH, and TOTM using a model adapted to the clinical use of the MDs.
- 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.
- 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
- How many plasticizers are found in medical devices analyzed?
- Distribution of the majority plasticizers in the 32 medical devices analyzed according to the type of MD. Moreover, in the MDs tested, trace levels of minority plasticizers are often found. Table 5 shows the quantities of the different plasticizers recovered from the MDs. Table 5. Plasticizer content of the 31 MDs analyzed.
- 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).
