pyrogen testing
Laboratory testing to detect fever-causing bacterial endotoxins that may remain on reprocessed instruments despite sterilization.
Full Definition
Pyrogen testing is a critical quality assurance measure used to detect pyrogenic substances, primarily bacterial endotoxins, on medical devices and instruments. Unlike sterilization processes that kill microorganisms, pyrogen testing identifies heat-stable toxins that can cause fever and other adverse reactions in patients even after successful sterilization. Common methods include the Limulus Amebocyte Lysate (LAL) test and recombinant Factor C assays. This testing is particularly important for implantable devices and instruments used in sterile procedures where endotoxin contamination could cause serious patient complications.
Usage
Usage note: Distinct from sterility testing; pyrogens can remain active even after successful sterilization.
In Context
- "Pyrogen testing revealed elevated endotoxin levels on the reprocessed orthopedic implants despite successful sterilization." — Quality control report
- "The LAL assay used for pyrogen testing must be performed under strict environmental controls to prevent false positives." — Laboratory procedure