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

Area of Science:

• Biomedical Engineering
• Analytical Chemistry
• Microbiology

Background:

• Lipopolysaccharide (LPS) is a critical endotoxin in Gram-negative bacteria, essential for medical device safety evaluations.
• Traditional detection methods face challenges with medical device matrices, automation, and regulatory compliance.
• Accurate LPS detection is vital for patient safety and regulatory adherence in the medical device industry.

Purpose of the Study:

• To review novel LPS biosensing technologies tailored for medical device quality control.
• To assess technologies based on regulatory requirements, matrix interference, and automation potential.
• To provide a roadmap for next-generation, compliant endotoxin detection platforms.

Main Methods:

• Systematic review of LPS-targeted biosensing technologies.
• Analysis based on a three-layer technical framework: biological recognition, interface engineering, system integration.
• Comparative assessment of TLR4 biomimetic sensing, genetically engineered elements, EIS, and microfluidics.

Main Results:

• Microfluidics integration is key for automated, miniaturized, and compliant detection systems.
• Each technology (TLR4 biomimetic sensing, genetically engineered elements, EIS, microfluidics) presents unique advantages and limitations for medical device applications.
• Device-specific matrix interferences and regulatory landscapes are critical considerations.

Conclusions:

• Novel biosensing technologies, particularly microfluidics, offer promising solutions for rapid, automated endotoxin detection in medical devices.
• Addressing matrix interferences and regulatory compliance is essential for industrialization.
• This review provides a foundation for developing advanced, pharmacopeial-compliant endotoxin detection platforms to enhance medical device safety.