Toxicological Evaluation: A Cornerstone of Ensuring the Safety and Efficacy of Medical Devices

Toxicological evaluation (ISO 10993-17) is a cornerstone of ensuring the safety and efficacy of medical devices. At NABI, we specialize in providing comprehensive testing solutions in biocompatibility and chemistry, including robust toxicological evaluation protocols. In this blog post, we explore the intricacies of toxicological evaluation, its definitions, examples of usage, and the critical needs it fulfills in the medical device industry.

Defining Toxicological Evaluation

Toxicological evaluation encompasses the assessment of potential adverse effects of substances on living organisms. This evaluation involves studying the toxic properties of materials, chemicals, or compounds to determine their safety for human or environmental exposure.

Complete toxicological risk assessment of a medical device typically involves two crucial steps. In the first step, data is meticulously gathered using chromatographic methods in accordance with ISO 10993-18 standard. This step involves extracting materials from the device and analyzing them to identify any potential chemical compounds that could pose risks upon exposure.

In the subsequent step, all identified compounds from the extractable/leachable study undergo rigorous evaluation for potential hazards in accordance with ISO 10993-17 standard. This process entails an in-depth examination of toxicological data related to each compound. However, in cases where available toxicological data is insufficient, predictive modeling and specialized software are employed for compound toxicity prediction (In silico analysis).

Based on the type of compound, allowable exposure limits, and other relevant factors, each tested compound’s Margin of Safety (MOS) is derived. The Margin of Safety provides a crucial metric for assessing the safety of the compound in relation to its potential exposure levels, helping to inform risk management strategies and ensure patient safety.

Usage

1. Chemical Safety Assessment: Toxicological evaluation is employed to assess the safety of chemicals used in medical device manufacturing, including polymers, adhesives, coatings, and sterilization agents. By evaluating the toxicological profile of these chemicals, potential risks to human health can be identified and managed throughout the device’s lifecycle.

2. Material Biocompatibility: Medical device materials undergo rigorous toxicological evaluation to ensure their biocompatibility and safety for use within the human body. This includes assessing the potential for leachables, extractables, and degradation byproducts to cause adverse effects such as inflammation, cytotoxicity, genotoxicity, and carcinogenicity.

3. Risk Assessment: Toxicological evaluation is integral to conducting risk assessments for medical devices, considering factors such as exposure levels, duration, and route of administration. By identifying and quantifying potential hazards, manufacturers can implement appropriate risk mitigation strategies to safeguard patient health and well-being.

Needs for Toxicological Evaluation

1. Regulatory Compliance: Regulatory agencies worldwide, including the FDA and EMA, require comprehensive toxicological evaluation as part of the regulatory submission process for medical devices. Compliance with regulatory standards is essential for obtaining market approval and ensuring patient safety.

2. Risk Mitigation: Toxicological evaluation helps identify and mitigate potential risks associated with medical device materials and chemicals, reducing the likelihood of adverse effects on patients and healthcare professionals.

3. Product Development: Toxicological evaluation informs decision-making throughout the product development lifecycle, guiding the selection of materials, formulation of products, and implementation of manufacturing processes that prioritize safety and efficacy.

Summary and Conclusion

In conclusion, toxicological evaluation is a vital component of medical device testing, ensuring the safety and efficacy of devices for patient use. By assessing the potential risks associated with device materials and compounds, toxicological evaluation helps mitigate hazards, comply with regulatory requirements, and safeguard patient health. At NABI, we are committed to conducting thorough and reliable toxicological evaluation services, supporting the development and regulatory approval of safe and effective medical devices.