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Cytotoxicity Failure Program

Cytotoxicity Failure Program

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.
 
Customer Benefits

· 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.


Applicable Standards

  • ANSI/AAMI/ISO 10993-5
  • USP <87>
  • ANSI/AAMI/ISO 10993-12

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test TAT (days) Request Quote
CTX110 Cytotoxicity: MEM elution, 48 hr inc., triplicate L929, 24 hr ext (non-implant) 10 Add
CTX112 Cytotoxicity: MEM elution, 72 hr inc., triplicate L929, 72 hr ext (implant/permanent) 14 Add
CTX115 Cytotoxicity: MEM elution, 72 hr incub., triplicate L929, 24 hr ext 13 Add
CTX125 Cytotoxicity: MEM elution, L929, titration method, 4 dose levels 10 Add
CTX110 - Cytotoxicity: MEM elution, 48 hr inc., triplicate L929, 24 hr ext (non-implant)
TAT: 10 days
CTX112 - Cytotoxicity: MEM elution, 72 hr inc., triplicate L929, 72 hr ext (implant/permanent)
TAT: 14 days
CTX115 - Cytotoxicity: MEM elution, 72 hr incub., triplicate L929, 24 hr ext
TAT: 13 days
CTX125 - Cytotoxicity: MEM elution, L929, titration method, 4 dose levels
TAT: 10 days

Sample Specifications

CTX110: 1 complete device, each device must be 120 cm2 or 4 grams
CTX112: Sample Amount: ? 120 cm² or 4 grams. Turn Around Time is 14 days from sample receipt.
CTX115: 1 complete device, each device must be 120 cm2 or 4 grams
CTX125: 1 complete device, each device must be 120 cm2 or 4 grams

Study Outline

The cytotoxicity test is a highly sensitive toxicity assay which is designed to determine if there are cytotoxic leachable substances or surface contaminants present in medical devices or raw materials. It is required testing for most medical devices and is used frequently as a routine screening test for raw materials and cleaning validations.
 
Occasionally, a device or material will exhibit a level of cytotoxic reactivity that is higher than what is allowed by the ANSl/AAMl/ISO 10993-5 standard and will result in a failed test. Although your product may have failed a cytotoxicity test, it does not necessarily mean that your device or material is unsafe for clinical use. It simply means that you are obligated to identify the source of the failure and assess any toxicological risks.
 
There are several possible causes for a failure, and Nelson Labs provides services to help you assess the failure and any toxicological risks.
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