A common failure source for medical devices is metal ions that can leach from metal implants, reusable instruments and single use polymers containing colorants. However, it is often difficult to determine if these failures are associated with the test article material or if they are caused by residual manufacturing solvents or cleaning fluids. In the past, if your product failed cytotoxicity testing you would need to send new samples for additional testing to determine the cause of the failure. We have recently added a new service to help our customers potentially save time and money when conducting these evaluations. If you request the Nelson Labs Cytotoxicity Failure Program (CTX702) when submitting your samples to the lab, we will store an aliquot of the extraction fluid from your cytotoxicity test until you receive your test results. In the case of a failing result, we will connect you with one of our subject matter experts who will help you develop a plan for investigation. Because we have retained a sample extract from your original cytotoxicity test, we can quickly test the retained fluid for metals using inductively coupled plasma – mass spectrometry (ICP-MS). If the test detects cytotoxic metals in the extract, we will then contact you with details regarding initiating a toxicological risk assessment. Our toxicologists can assess the metals and determine if the concentration would be sufficient to lead to any patient safety issues.
Preservation of the original sample extract will allow us to quickly conduct a failure investigation to help identify and eliminate any potential causes.
No need to provide additional samples, which could increase costs and delay testing.
Follow-up testing will not only identify if cytotoxic metals are present in the sample, but also provide a quantitative analysis of those metals.
If requested, the toxicological risk assessment will evaluate if the concentration of metals found would be sufficient to lead to any patient safety issues.
- ANSI/AAMI/ISO 10993-5.
- USP <87>.
- ANSI/AAMI/ISO 10993-12.