Unknowns Are Unacceptable™ In Medical Devices That Come Into Contact With The Human Body

Preclinical Device Safety Testing is Essential

The International Organization for Standardization (ISO) offers guidance for many industries, including those developing medical devices that come into direct or indirect contact with the human body. The recently released ISO 10993 Part 1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” further emphasizes complete chemical characterization for identifying all of the chemical constituents in products. The standard has affected the way many device manufacturers are approaching their FDA submissions as well as the European Unions Medical Device Regulation, otherwise known as MDR. 

Risk-Assessment Approach Best Practices

ISO standards also serve as the basis for toxicological risk assessments of final finished devices. ISO 10993-17:2002 establishment of allowable limits for leachable standards outlines this risk-assessment approach. Risk assessments provide an analysis of risk that adverse health effects could result from exposure to chemicals and elements in devices during intended clinical use.

Important features of risk assessments are to:

  • Identify potential chemical/elemental hazards (typically generated from extractables/leachables testing)
  • Determine exposure (from understanding devices' intended use)

The chemistry data, with complete chemical characterization, and the test article’s indication of use, duration of contact and target population are necessary to conduct an effective risk assessment. Furthermore, risk assessments should be used to guide which biological tests are required to mitigate the identified risks.

ISO 10993-1 updates call for a Biological Evaluation which is a weight of evidence argument utilizing all of the data collected as part of your chemical characterization, toxicological risk assessment and biocompatibility testing.  The emphasis is on the data that you use to support safety.

Without Data it is Impossible to Accurately Assess Patient Risk

Download our whitepaper “Unknowns Are Unacceptable in Medical Devices That Come into Contact With The Human Body.” Gain understanding from our experts as they explain the often misunderstood consequences of chemical characterization that include data sets with compounds that have not been identified, or “unknowns”.  Under these circumstances, toxicologists have no recourse but to assume those chemicals are extreme hazards (mutagenic, carcinogenic) and it only takes a very small amount, 1.5 µg/device, to have a negative impact on your risk assessment and biological evaluation.

Learn more by downloading our whitepaper today!