Assessing the safety of a medical device means looking beyond how it functions. Materials used in these devices can break down, leach harmful chemicals, or retain manufacturing residues, posing health risks even when the device performs as intended. A toxicological risk assessment identifies these hazards, ensuring patient safety and regulatory compliance.
Why Medical Devices Require Toxicological Risk Assessments
Modern medical devices contain a complex mix of polymers, metals, ceramics, coatings, and adhesives. Each of these materials carries the potential to introduce unintended risks. These risks don’t just stem from the raw materials. They come from chemical leachables, degradation byproducts, and manufacturing residues.
For example, metal implants can release nickel or cobalt ions over time. This could trigger allergic reactions or lead to systemic toxicity. Similarly, certain plastics used in IV tubing or catheters may contain plasticizers that leach into the bloodstream, disrupting hormone function. These risks can only be managed through a toxicological evaluation that determines safe exposure levels and identifies the need for material substitutions or process modifications.
Breaking Down the Toxicological Risk Assessment Process
A toxicological risk assessment follows a structured approach to ensure no potential hazard is overlooked. Each stage in the toxicological risk assessment builds upon the last to form a complete picture of the device’s safety.
1. Identifying Chemical Substances
The first step in the toxicological risk assessment is identifying the chemical substances present in the device and determining whether they might migrate into the body. This includes:
- Extractables and leachables testing: Analyzes what chemicals could be released under real-world conditions.
- Material characterization: Identifies the chemical makeup of polymers, metals, and coatings.
- Degradation studies: Assesses how the device breaks down over time and what byproducts may form.
Sophisticated analytical techniques such as Gas Chromatography-Mass Spectrometry (GC-MS) and High-Performance Liquid Chromatography (HPLC) help detect and quantify these substances.
2. Understanding Patient Exposure
Not all chemicals identified in a device pose a meaningful risk. The key factor is how much exposure a patient has to a given substance and for how long. Exposure assessment takes into account:
- Duration of contact: A wound dressing that remains on the skin for a few hours presents a different risk than a pacemaker, which remains in the body for years.
- Route of exposure: A substance that touches the skin may pose minimal risk. However, one that enters the bloodstream or nervous system requires far more scrutiny.
Regulatory guidelines, like those outlined in ISO 10993-17, help define acceptable exposure levels. They also determine the risks associated with different contact scenarios.
3. Evaluating Toxicological Hazards
Once the potential chemical exposures are known, the next step is determining whether they pose a biological risk. This is done through toxicology tests, including:
- Cytotoxicity testing (ISO 10993-5): Assesses whether the material damages human cells.
- Genotoxicity testing (ISO 10993-3): Evaluates the risk of DNA mutations.
- Systemic toxicity testing (ISO 10993-11): Identifies potential impacts on organs such as the liver, kidneys, and nervous system.
For each identified chemical, toxicologists compare exposure levels to established safety thresholds such as Permissible Daily Exposure (PDE) and Tolerable Intake (TI) values. If a substance exceeds these limits, corrective actions must be taken.
4. Managing and Mitigating Risks
When a potentially harmful chemical is identified, manufacturers must take steps to minimize patient exposure. Several strategies can be used:
- Switching to safer materials can eliminate the issue entirely, such as replacing phthalate-containing plastics with BPA-free alternatives in medical tubing.
- Applying protective coatings to implants and metal components can reduce the release of harmful ions.
- Refining manufacturing processes can lower residual contamination from solvents, sterilization agents, or catalysts.
In cases where risks cannot be completely eliminated, manufacturers may need to provide additional clinical justifications demonstrating the device’s benefits outweigh its risks.
Ensuring Compliance and Avoiding Regulatory Pitfalls With a Toxicological Risk Assessment
A toxicological risk assessment not only protects patients but plays a key role in regulatory approval. The findings of the toxicological risk assessment must be documented in a Biological Evaluation Report (BER) and submitted to agencies such as:
- The U.S. FDA: Requires toxicological data for 510(k) and PMA submissions.
- The European Union’s MDR: Mandates comprehensive safety evaluations for CE marking.
ISO 10993 standards also provide a globally recognized framework for biocompatibility testing. Failure to conduct a proper toxicological risk assessment can result in regulatory rejection, costly delays, or forced product recalls.
Why Skipping a Toxicological Risk Assessment is a Costly Mistake
Overlooking toxicological risks can result in consequences beyond regulatory non-compliance. Manufacturers who fail to conduct a thorough toxicological risk assessment may face:
- Lawsuits and financial penalties if a device is found to pose a toxicological hazard.
- Compromised patient safety due to unexpected reactions such as inflammation or toxicity.
- Market bans or recalls, leading to financial losses and reputational damage.
Rather than risking these outcomes, manufacturers should view toxicological risk assessments as an investment in patient safety and long-term success.
Building a Safer Future for Medical Devices
As medical technology advances, ensuring material safety remains essential. A comprehensive toxicological risk assessment allows manufacturers to bring products to market confidently while minimizing risks. With expertise in chemical analysis, exposure modeling, and toxicological evaluations, Jordi Labs supports manufacturers through extractables and leachables testing, chemical characterization, and regulatory compliance. Our data-driven approach helps companies meet the highest safety standards. Reach out to discover how we support medical device safety with our toxicology services.
