Analysis: Particulate Limits for Intravascular Devices: Considerations for Polymer Coating Embolism

Lubricious polymer coatings are increasingly used on intravascular devices to facilitate easier access and navigation through tortuous blood vessels. Recent reports highlight the separation and downstream embolism of polymer particles affecting the vasculature and various organs. The Food and Drug Administration (FDA) acknowledges polymer coating embolism as an iatrogenic complication of intravascular devices and continues to close gaps in standards related to coating integrity. The Association for the Advancement of Medical Instrumentation established particulate testing as an industry standard for evaluating coating integrity of intravascular devices. The FDA recognizes this standard; however, challenges exist in setting particulate limits that may compromise device function without sufficient clinical data. The microscopic nature of polymer emboli not visible with available imaging modalities has impacted reporting. This has also resulted in a reduced number of manufacturer-driven product development projects related to coating integrity. On the other hand, recent procedural trends have supported the innovation of coated devices with expanded indications, requiring particulate evaluations and release limits. This article proposes a methodology to set particulate limits for intravascular devices given existing clinical, regulatory, and manufacturing challenges. The approach with standardization requirements enables characterization, comparison, and evaluation of lubricious coatings from various manufacturers. It incorporates a step-by-step procedure that adds scrutiny to the application of coatings while ensuring device function is not impacted. Together with particulate assessments, clinicopathologic and animal studies permit an understanding of particulate ranges from commercially available devices and setting of particulate limits for new device evaluations.

Antimony(III/V) removal from industrial wastewaters: treatment of spent catalysts formally used in the SOHIO acrylonitrile process

A treatment and volume reduction process for a spent uranium–antimony catalyst has been developed. Targeted removal, immobilization and disposal of the uranium component has been confirmed, thus eliminating the radiological hazard. However, significant concentrations of antimony ([Sb] ≥ 25–50 mg L−1) remain in effluent from the process, which require removal in compliance with Korean wastewater regulations. Antimony(III/V) removal via co-precipitation with iron has been considered with optimal pH, dose and kinetics being determined. The effect of selected anions – Cl−, SO42− and PO43− – have also been considered, the latter present due to a prior uranium removal step. Removal of Sb(III) from both Cl− and SO42− media and Sb(V) removal from Cl− media to below release limits were found to be effective within 5 minutes at an iron dose of 8 mM (molar ratio, [FeIII]/[Sb] = 20) and a target pH of 5.0. However, Sb(V) removal from SO42− was significantly hampered requiring significantly higher iron dosages for the same removal performance. Phosphate poses significant challenges for the removal of Sb(V) due to competition between PO43− and Sb(OH)6− species for surface binding sites, attributed to similarities in chemistries and a shared preference for an inner vs outer binding mechanism.