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Writer's pictureJL Tox Consulting

How Toxicological Risk Assessments Work

Professional toxicological risk assessments are a cornerstone of ensuring the safety of medical devices. At JL Tox Consulting, we specialize in providing comprehensive toxicological evaluations to help medical device manufacturers navigate the complex regulatory landscape. Our expertise ensures that devices are safe for patient use while complying with stringent international standards.


toxicological risk assessments

The Principle of Toxicological Risk Assessments

The foundational principle of toxicology can be traced back to Paracelsus, a Swiss physician and alchemist of the German Renaissance, who famously stated, "All things are poison, and nothing is without poison; only the dose makes a thing not a poison." This adage is often condensed to "The dose makes the poison," which underscores that the toxicity of a substance is dependent on its dosage.


Our toxicological risk assessments build upon this principle by evaluating the potential health risks associated with exposure to various chemicals found in medical devices.


Importance of ISO 10993-17

One of the key standards guiding our toxicological risk assessments is ISO 10993-17, which outlines procedures for determining acceptable limits for leachable substances within medical devices. These substances can migrate from the device into the body and potentially cause adverse effects. Regulatory agencies globally mandate a thorough toxicological risk assessment to ensure that any leachables are within safe limits.


Steps in Conducting a Toxicological Risk Assessment


1. Chemical Characterization

Before a toxicological risk assessment begins, the first step involves identifying and quantifying the chemicals present in the medical device. This process, known as chemical characterization, assesses both the raw materials used in manufacturing and any by-products that may be formed during device production. Accurate chemical characterization is crucial for identifying potential hazards.


2. Hazard Identification

The next step involves reviewing the scientific literature and databases to identify the toxicological profiles of the identified chemicals. During this process, we may consider factors such as carcinogenicity, mutagenicity, reproductive toxicity, and other health effects.


3. Dose-Response Assessment

We then examine the relationship between the chemical dose and the severity of the toxic effect. This assessment helps establish threshold levels below which no adverse effects are expected. It also aids in understanding the potency of the chemical and its potential impact on human health.


4. Exposure Assessment

This process estimates the extent of exposure to identified chemicals. It takes into account the device's intended use, the duration of contact, and the likelihood of chemicals being released. During this step, we assess various exposure scenarios to create a comprehensive risk profile.


5. Risk Characterization

The last phase involves seamlessly integrating all previously gathered data. This phase assesses if the identified risks fall within the acceptable limits set by regulatory guidelines. If the risks exceed acceptable levels, we propose mitigation strategies accordingly.


Where to Find Toxicological Risk Assessments

Toxicological risk assessments are integral to the industry, helping manufacturers ensure medical device safety and compliance. At JL Tox Consulting, we leverage our expertise to provide thorough and accurate evaluations, assisting clients in navigating the complexities of regulatory requirements. Through our detailed processes and specialized services, we help make medical devices safer for patient use. Contact us today at info@JLTox.com to learn more.


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