Medical Device Defects

Addressing Medical Device Issues

Through Microscopy: A Case Study

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THE PROBLEM: A medical device manufacturer had trouble keeping the delivery dosage constant and reproducible with this particular radiation implant device known as a “seed.” MVA was asked to diagnose the problem.

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THE ANALYSIS: The manufacturer reported that nothing in the process had changed. However, MVA examined the implant at very high magnification, and observed structural differences on the surface of the wire substrates used to produce the “seeds.” These differences on the surface affected the surface area available to the radioactive isotope, and therefore the radiation dose delivered.

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THE IMAGE: The image to the right shows a polarized light micrograph of one of many fibers found in the back half of one sample, and these fibers made up the majority of material present. Further analysis by micro-FTIR confirmed their identity as paper fibers.

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THE OUTCOME: MVA reported the observed differences to the manufacturer. They were able to back track the production process and pin point the problem to the electro-polishing process at a supplier.