The Gordian Knot of Glutaraldehyde-Treated Autologous Pericardium in Open Cardiac Surgery

Abstract

Glutaraldehyde is classified as a biocide-pesticide under the hazard class for toxic substance and control laws for the human health and environmental worldwide. The regulatory bodies restrict the intended use to disinfectant or laboratory application in hospital. The parenteral pathway in human is not considered and then not allowed, for the high-risk profile, so the constraints are an integral part of the Classification Labeling and Packaging for exposure of occupational health. Contextually, there are no preclinical-safety data as Risk Related Reference (DMEL probability of occurrence and severity of adverse effect (s)/event (s) in a given population under defined exposure conditions), or Chemical Safety Reports that justify any authorization for patient consumer uses. In the context of cardiac surgery, the biomechanical stability in treating the autologous pericardium with glutaraldehyde in solution, results as a hand-built biotech for a patient valve device. Theoretically, the surgeon is a manufacturer that uses a toxic chemical compound for the own product that does not comply to the law and regulations. Contrary to pharmaceutical definition for marketing authorized drugs, the off-label not allowed use of toxic chemical derived manufacture, expose the physicians to legal vulnerability of which it is inclusive the malpractice for thepatient's informed consent.