Assessment of parameters associated to the risk of PVC catheter reuse.
The practice of single use devices (SUD) recycling raises public health concerns, primarily with regard to the potential risks of infection and device malfunction. These concerns have led to a Food and Drug Administration (FDA) revision of the present regulations. The purpose of our work is to identify different material parameters that could contribute to the health risks associated with the practice of reprocessing PVC catheters for use in other patients. Ethylene oxide hospital-reprocessed central venous catheter samples were obtained from the stock of a health-care institution. One device trademark was selected, and samples that had been used 8 and 24 times were compared with new ones. In order to determine the total percentage of extractables, supercritical fluid extraction (SFE) was used, and off-line gas-chromatography-flame-ionization detection (GC-FID) was employed for identification and quantitation of bis-(2-ethyl hexil)phthalate (DEHP). Storage modulus (E') and dissipation factor (tan delta curves were obtained by dynamic mechanical analysis (DMA). Successive catheter recycles produced increased plasticizer loss, increased glass transition temperature (T(g)) and E', widening of tan delta curve with a simultaneous shift to higher temperature, small decrease of weight average molecular weight (M(w)), increased surface roughness, and increased appearance of surface grooves (severe damage). The magnitude of biomaterial parameter changes measured suggests that reuse could alter the original device performance. Examples of possible adverse clinical events include leaching of toxic agents, device rigidization or breakage, increased catheter protein retention, or the promotion of bacterial adhesion by device topography modification.
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National University of San Juan, Institute of Chemical Engineering, Avenida San Martín 1109 Oeste (5400), San Juan, Argentina.
Jiménez
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Cuadrado
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D001672:Biocompatible Materials / Q000009:adverse effects*; D002408:Catheters, Indwelling / Q000600:supply & distribution; D002849:Chromatography, Gas / Q000379:methods; D002850:Chromatography, Gel / Q000379:methods; D025924:Chromatography, Supercritical Fluid / Q000379:methods; D003080:Cold Temperature; D004051:Diethylhexyl Phthalate / Q000032:analysis*; D004868:Equipment Failure; D017743:Equipment Reuse; D005027:Ethylene Oxide / Q000737:chemistry*; D005410:Flame Ionization / Q000379:methods; D006358:Hot Temperature; D006801:Humans; D017053:Infection Control; D008855:Microscopy, Electron, Scanning; D011143:Polyvinyl Chloride / Q000737:chemistry*; D018570:Risk Assessment; D012307:Risk Factors; D013242:Sterilization
D001672:Biocompatible Materials; D011143:Polyvinyl Chloride; D004051:Diethylhexyl Phthalate; D005027:Ethylene Oxide