Medical Device Link .

One of the greatest challenges in medical device chemical characterization is performing adequate assessment of biological or toxicological risks from extractables that can compromise patient safety. EN/ISO 10993-17 has clearly stated that risk assessments are a part of material biocompatibility and that they are necessary for the assurance of biological safety. Toxicological hazard of the chemical constituents of the materials from which a medical device is made should be considered in biological safety. Therefore, the first step for a biological safety assessment is to characterize the chemicals of the materials. Toxicological hazards can be identified by understanding the toxicity of materials or extracted chemicals. A systematic analysis of biological risks can be found in the general principles set out in clause 3 of ISO 10993-1. Do not be tempted to use the matrix in ISO 10993-1 as a checklist to perform a standard set of tests. Instead, use the principles to develop an appropriate scientific evaluation program based on the specifics of the device. The results of all tests should be interpreted in the context of the overall risk assessment to determine whether a specific outcome indicates acceptable risk. Such a collaborative approach emphasizes the need for an overall scientifically valid risk assessment. The manufacturer, the analytical chemists, and the toxicological risk assessor must have input and each must be a significant contributor to the assessment process. A common question asked is: Does assessment of the risk that may be posed by a particular material or combination of materials require chemical characterization? This article addresses chemical characterization and defines the role of toxicological risk assessment for medical devices. Risk assessment has only recently been integrated into international standards and endorsed as an integral part of chemical characterization and biocompatibility studies for medical devices. The suitability of a medical device for a