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Extraction of Tissue Antigens for Functional Assays

Extraction of Tissue Antigens for Functional Assays

Published on: September 10, 2012

Inter-laboratory study for extraction testing of medical devices.

David M Saylor¹, Robert M Elder¹, Kaleb Duelge¹

¹Center for Devices and Radiological Health, FDA, Silver Spring, MD 20993, United States.

Journal of Pharmaceutical and Biomedical Analysis

|October 15, 2024

Summary

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Chemical testing for medical device biocompatibility shows significant variability. Repeatability and reproducibility assessments reveal potential differences up to 240% between laboratories, impacting risk evaluations.

Area of Science:

Medical device manufacturing
Analytical chemistry
Materials science

Background:

Biocompatibility evaluation of medical devices is crucial.
Chemical testing per ISO 10993-18 is a key component.
Precision of non-targeted chemical characterization is not well-established.

Purpose of the Study:

To characterize intra-laboratory (repeatability) and inter-laboratory (reproducibility) variability in chemical testing of medical device extractables.
To assess the precision of chemical characterization methods used in biocompatibility assessments.

Main Methods:

Two polymers with nine intentionally compounded chemicals were used.
Eight laboratories performed extraction testing in two solvents.
Gas chromatography and liquid chromatography methods were employed for extract characterization.

Keywords:

Analytical Chemistry Chemical Characterization Extractables and Leachables Testing Inter–laboratory Study (ILS)Repeatability Reproducibility

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Main Results:

The central 90% range for repeatability and reproducibility relative standard deviations were (0.09, 0.22) and (0.30, 0.85), respectively.
Results indicate potential differences up to 240% between laboratories with 95% confidence.
Analytical method variability is a substantial contributor to overall variability.

Conclusions:

High variability in chemical testing of medical device extractables was observed.
Large reproducibility limits have significant implications for biocompatibility risk evaluation.
Variability impacts exposure dose estimation and chemical equivalence assessments.