Rapid Endotoxin Testing for Medical Devices

What is Bacterial Endotoxin?

Bacterial endotoxins are the lipopolysaccharides (LPS) bound to the bacterial cell wall and released when bacteria rupture or disintegrate. They are made up of three main parts: The O antigen, the core oligosaccharide, and the Lipid-A molecule. Contamination of endotoxin in bloodstream causes multiple negative biological effects, such as inflammatory response, invasion of the immune system, sepsis shock, adult respiratory distress syndrome, etc.

Endotoxin Limit in Medical Devices

According to FDA guidance, "Pyrogen and Endotoxins Testing: Questions and Answers", the endotoxins limit for a medical device is dependent on the intended use of the device and what the device contacts. For products in contact with the cardiovascular and lymphatic system, the limit is 0.5 EU/mL or 20 EU/device. For products in contact with cerebrospinal fluid, the limit is 0.06 EU/mL or 2.15 EU/device. For devices in contact with the intraocular environment, a low endotoxins limit is recommended.

Endotoxin Testing for Medical Devices

Measuring endotoxin in different medical device materials is critical for assessing a product's safety and mitigating risk. As the endotoxin regulatory scrutiny for medical devices is seeing a rise around national and international approval procedures, endotoxin testing becomes more important for medical device products, especially for injectable and implantable products. Currently, the mainly used method for endotoxin or LPS detection and quantification is Limulus Amebocyte Lysate (LAL) assay. In addition, photometric methods and mass spectrometry (MS)-based techniques are also applied in some detections.

STEMart offers Rapid Endotoxin Testing services for quick and quantitative endotoxin analysis to make prompt, confident decisions about the safety of your medical devices. Our testing methods include an array of endotoxin testing instruments, FDA-licensed reagents, and software, as well as our proprietary cartridge technology. These rapid testing methods allow you to improve sample management, decrease testing time and accelerate product production.

If you have additional questions about Rapid Endotoxin Testing for Medical Devices or would like to find out more about our medical device services, please feel free to contact us.