“We have validated high level disinfection of silicone components with Glutaraldehyde chemical sterilant/disinfection solutions. In researching standards or recommendations for safe GLUT residuals in these devices we have found very little information available. OSHA and NIOSH have published or recommended some limited information on worker “exposure” to GLUT in the hospital and the work place. These include values in ppm that are sampled or pulled from the immediate atmosphere and recommendations related to direct contact, which can result in skin irritation issues. Does NELSON have defined tests for measuring patient or worker exposure to devices that have residuals of GLUT?”

I would actually take a slightly different approach and have the component tested at a biotesting company, such as NAMSA. In the past I have run evaluations using test method C0020 USP Physicochemical tests, which is a leachables and extractables test in water. This would pick up and identify the value in ppm of residual on the substrate. They do offer a test, C0046 Glutaraldehyde Analysis in Aqueous samples, which can be collected by rinsing the part in water, capturing the water, and sending it in for analysis. I expect that this C0046 test method has defined limits of what is allowable for patient contact, but a call into NAMSA would define the test further.

Safety biotesting, chemical safety, GLUT, Glutaraldehyde