Quality and stability evaluation of disposable medical equipment

Abstract

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.

Storage stability study of salicylate-based Poly(anhydride-esters)

“…[29] Specifically, color change can indicate the loss of specific functional groups or changes in glass transition. [29,30] In this study, all polymer powders were initially off-white in color. Samples stored at −12 °C and 4 °C, retained their original off-white coloration throughout the experiment, indicating the polymer had not significantly degraded (Figure 2A).…”

Mechanisms of cell death induced by infusion sets leachables in in vitro experimental settings

“…Unfortunately, the composition and the manufacturing process of the DMDs are usually not disclosed by their manufacturers, and it cannot be easily revealed using existing analytical techniques (e.g., by liquid chromatography or gas chromatography with mass-spectrum detection (Schumacher et al, 2007)). Detailed analytical analysis of DMDs leachates is needed to identify the individual toxic leachables, and we urge analytical chemists to invest efforts in this field of study, which has not received appropriate attention during the last decades.…”

“…We as well as others have revealed alterations in the physical and chemical properties of infusion sets with storage time that lead to color change (yellowing; see Fig. 1), release of toxic chemicals and particles into the leachate, and prominent in vitro toxicity of the flashball part (also called the injection site; usually composed of latex or its synthetic substitutes) and sometimes also the tube and the drip chamber (called the 'cup' in our previous publication) parts of the infusions sets (Dakwar et al, 2012;Schumacher et al, 2007). The individual studied cell lines varied in their sensitivity to the infusion sets leachates, suggesting differences in the interaction of the leachables with cells of different type and in the subsequent intracellular events.…”