Quality Control for Medical Devices: A Review of Detection Technologies, Regulatory Standards and Matrix Interference...

Lipopolysaccharide (LPS), as the core active component of endotoxins from Gram-negative bacteria, serves as a mandatory quality control indicator in the biological safety evaluation of blood- and body fluid-contacting medical devices. Its rapid and accurate detection is of paramount importance for ensuring clinical patient safety and meeting global regulatory compliance requirements. Traditional endotoxin detection methods have inherent limitations, including poor anti-interference capability against medical device-specific matrices, limited automation capacity, and narrow regulatory applicability, which hinder their utility in meeting the practical demands of the modern medical device industry for high-throughput online quality control and on-site rapid screening. This review focuses on medical device-specific regulatory requirements, characteristics of extract matrices, and full-process quality control scenarios, and systematically summarizes the research progress in novel LPS-targeted biosensing detection technologies. By constructing a three-layer technical framework (biological recognition, interface engineering, and system integration), we provide a comparative assessment of four mainstream technologies-TLR4 biomimetic sensing, genetically engineered elements, EIS, and microfluidics-based on their matrix compatibility, automation potential, and regulatory compliance. It deeply analyzes the core role of microfluidic integration technology in driving the upgrading of detection systems towards automation, miniaturization and compliance, and objectively evaluates the applicability and limitations of various technologies in medical device scenarios. Unlike general reviews on LPS detection, this work specifically addresses endotoxin testing within the medical device quality control context. We systematically examine device-specific matrix interferences and regulatory landscapes, synthesizing cutting-edge research with critical analysis of industrialization bottlenecks. This review provides a theoretical foundation and technical roadmap for developing next-generation, pharmacopeial-compliant rapid automated endotoxin detection platforms-accelerating the advancement of medical device safety standards.