Quality and stability evaluation of disposable medical equipment

Autor: Arthur Raskin, Abraham J. Domb, Erwin Sigler, Alexander Tarnopolsky, Ilana Schumacher, Evgeny Tsiperman
Rok vydání: 2007
Předmět:
Zdroj: Polymers for Advanced Technologies. 18:207-212
ISSN: 1099-1581
1042-7147
DOI: 10.1002/pat.856
Popis: The complexity and uniqueness of disposable medical devices (DMDs) requires thorough analytical investigation to ensure their quality and stability upon storage. Infusion sets were studied in this context. Chemical compositions of various parts of these medical devices were analyzed using spectroscopic and chromatographic techniques. Physical properties of the components were tested according to appropriate American Society for Testing and Materials (ASTM) procedures (swelling and leaching test, tensile strength and microhardness). Since degradation of polymers is often accompanied by a color change, the yellowing observed in the chosen items was considered as an indication of degradation. Swelling and microhardness tests indicative of a correlation between the plastics' shelf-life and their degradation extent. Analyses of extracts of the plastics in different solvents confirmed the presense of a common plasticizer diethylhexylphthalate (DEHP) and two widely used antioxidants butylated hydroxytoluene (BHT) and methylenebis(methyl-t-butylphenol) in different parts of the devices. The mentioned compounds were identified by high performance liquid chromatography (HPLC) and gas chromatography and mass spectrometry (GC/MS) techniques. The concentration of these compounds in the extracts may be correlated with aging of the examined parts of the infusion sets. The quality of DMDs may deteriorate due to the field storage conditions. Development of qualititative and quantitative methods for evaluating this deterioration is essential for better quality control of these items. Copyright © 2007 John Wiley & Sons, Ltd.
Databáze: OpenAIRE
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