Benchmarking different brands of perfluorocarbon liquids

Area of Science:

• Ophthalmology
• Materials Science
• Analytical Chemistry

Background:

• Perfluorocarbon liquids (PFCL) are crucial intraoperative tools in vitreoretinal surgery.
• Ensuring the analytical quality of PFCL is essential for patient safety and surgical efficacy.
• Variability in PFCL purity can impact surgical outcomes and complicate interpretation of results.

Purpose of the Study:

• To compare the analytical quality characteristics of CE-marked perfluorocarbon liquids (PFCL).
• To assess the purity profiles of perfluorooctane (PFO) and perfluorodecalin (PFD) used in vitreoretinal surgery.
• To identify potential contaminants and packaging leachables affecting PFCL quality.

Main Methods:

• Analysis of 21 perfluorooctane (PFO) and 25 perfluorodecalin (PFD) samples from 8 and 13 brands, respectively.
• Gas chromatography-mass spectrometry (GC/MS) for main product content determination.
• Fluoride selective potentiometry to quantify reactive impurities (H-value) and UV-active substances for packaging integrity assessment.

Main Results:

• Significant variations in purity profiles were observed across PFO and PFD batches and brands.
• PFO batches showed H-values from <10 to 1230 ppm and 1H-PFO from <1 to 376 ppm.
• PFD batches exhibited H-values from <10 to 70 ppm, with leachables detected in both types of PFCL.

Conclusions:

• The analytical quality of intraoperative PFCLs is highly variable, even within the same manufacturer's batches.
• Clearer communication of product purity by manufacturers is essential.
• Standardized certificates of analysis are needed to help surgeons differentiate PFCL effects from impurity-related complications.