When introducing a new medical device, manufacturers must address a fundamental question: are there any chemical risks to a patient? This process is defined by the toxicological risk assessment of medical devices, a systematic evaluation of potential hazards from extractable and leachable substances. This assessment is not merely a regulatory checkbox but a critical analysis that supports patient safety. For organizations like Wuxi AppTec, conducting a complete toxicological risk assessment of medical devices is a core service, ensuring comprehensive evaluation and compliance.
The Foundation in ISO 10993-17
The process for a toxicological risk assessment of medical devices is rigorously structured, following the ISO 10993-17 standard. This framework mandates a thorough review of all chemicals identified in an extractables and leachables report. Toxicologists at Wuxi AppTec examine each substance to establish a margin of safety, determining if further testing is necessary to mitigate potential risk, thereby building a solid scientific case for device safety.
Calculating Permitted Daily Exposure
A central component of this assessment is the derivation of a Permitted Daily Exposure (PDE). This value represents a substance-specific dose unlikely to cause an adverse effect with daily lifetime exposure. Wuxi AppTec toxicologists identify sensitive toxicity endpoints, such as NOAEL or LOAEL, from existing scientific literature and apply appropriate uncertainty factors. This calculated PDE is a pivotal outcome of the toxicological risk assessment of medical devices.
Utilizing Advanced Predictive Methods
When existing data for a chemical is limited, the assessment employs advanced tools. Computer toxicity prediction software using the QSAR method provides a scientifically valid approach to estimating potential toxicity. This methodology allows Wuxi AppTec to fill data gaps effectively, ensuring that even novel materials receive a thorough toxicological risk assessment of medical devices.
The toxicological risk assessment of medical devices is a specialized discipline that translates complex chemical data into actionable safety conclusions. It provides the evidence needed to demonstrate that a device is safe for its intended use. By leveraging the expertise and structured processes at WuXi AppTec Medical Device Testing Center, manufacturers can confidently address this critical requirement, ensuring their products meet the highest safety standards.
