Toxicological Risk Assessment
In the toxicological risk assessment of a medical device, the information on the materials of construction, processing materials, process contaminants, extraction and leachable test data shall be gathered. The gathered information and test reports shall be screened for potentially hazardous substances. The exposure level of these substances to the patients shall be estimated based on the device's nature and duration of body contact. The risk posed by these potentially hazardous substances shall be evaluated.
The final device's characterization shall be performed as per the ISO 10993-18 and through extractable and leachable studies. The information obtained shall be subjected to extensive scientific evaluation of any toxicological data related to compounds in the public databases. If there is no or limited toxicity data available, the toxicity of a compound can be predicted based on the chemical structure or data available for structurally related compounds. The toxicological literature shall be reviewed for the no-observable-adverse-effect level (NOAEL) and the lowest-observable effect level (LOAEL). At this stage, the main focus is on identifying substances that may pose health hazards and their toxicity levels.
The nature of the hazard shall be characterized in terms of the types of toxic effects reported and the dose and route at which these toxic effects are observed. Based on the device's route and duration of exposure, the tolerable intake (TI) shall be calculated for the hazardous substances using modifying factor approach. The patient may get exposed to the same substance from the other medical device sources. Therefore, the Tolerable Exposure (TE) level shall be determined from the tolerable intake considering body mass and utilization factors. Technically and economically, the feasibility of meeting tolerable exposure to leachable substances in the medical device shall be evaluated. If it is feasible to meet the tolerable exposure, the allowable limit is considered same as tolerable exposure. If it is not possible to meet the tolerable exposure, a benefits evaluation shall be performed and the rationale for considering the benefit shall be documented.
Toxicological risk assessment is an integral part of the risk evaluation process of medical devices. Toxicological risk assessment helps to reduce the number of in vivo biological tests performed for medical devices. We have experienced toxicologists who can perform a detailed toxicological risk assessment for your devices.