ReviewSensors (Basel, Switzerland)2026
Quality Control for Medical Devices: A Review of Detection Technologies, Regulatory Standards and Matrix Interference Solutions.
Review in Sensors (Basel, Switzerland), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
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.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.