Rapid Analytical Method for Assessing the Quality of Medical Equipment Components Using Multiple Data (Big-Data)

Igal Bar Ilan, Analytical Chemistry & Special Project Dep., Bioforum, Ness Ziona, Israel

Medical devices consist of various polymers sometimes combined with metals. The production of polymers requires working with various ingredients including organic solvents. The diversity of reactions to create polymers is accompanied by the production of additional compounds, leaving residues of raw materials and their impurities, which later become the fingerprint of the material. These phenomena create different qualities of polymers.

Medical devices are used for drugs delivery, physiological solutions transfer, and for applications inside and outside the body. To evaluate the quality of medical devices, various extracts in different conditions are made (Leaching and Extracting techniques). Most of the devices release many substances into the extraction solvents.

The analysis of the leaching and extracting compounds is made by using chromatographic and mass spectrometric techniques (GC, GCMS, HPLC, LCMS, ICP).

Because medical equipment manufacturers use many types of polymers, many tests are needed, which creates an enormous amount of data.

This work presents an interesting and original way of looking at a large database of the analyses' results, which easily allows the evaluation of the quality of many medical devices and their parts simultaneously. This way enables finding the right components with low leaching, leading to making the right decisions more easily.