ve and evaporative heat transfers from the neonate. Therefore it is important to eliminate eddies around the neonate in the design of neonatal incubators.
Biocompatibility of materials
Biocompatibility testing is required for all parts of the device that have direct or indirect contact the patient and is performed to determine the potential toxicity that can result from contact of the component materials of the device with the patient's body. The materials used in the construction of the device should not, either directly or indirectly through the release of their material constituents, produce unreasonable risk of adverse local or systemic effects; be carcinogenic; or cause adverse reproductive and developmental effects.
The evaluation of any new device intended for human use requires data from systematic testing to ensure that the benefits provided by the final product will exceed any potential risks produced by device materials. Biocompatibility testing is indicated when a "new" or non-conventional material or chemical component is incorporated into a device and there is no known appropriate predicate use or for which the safety or effectiveness of the resulting formulation is in question. These materials or chemical components include plastics, metals, colorants, plasticizers, germicides, and chemical or other treatments of the device or device components.
Biocompatibility testing should be performed on the finished product, using test conditions simulating as closely as possible actual patient use. Materials and chemical components that have already been incorporated in legally marketed devices with similar conditions of use, or have a demonstrated history of safety and effectiveness may not require biocompatibility testing; however, the biocompatibility of these materials and chemical components should be fully discussed to support the lack of testing. (Refer to ISO-10993-1:1992, Part I "Biological Evaluation of Medical Devices, Evaluation and Testing", and the FDA-modified Matrix to identify the types of biocompatibility testing that should be considered in evaluating the safety-in-use of medical devices and materials.
The ISO Standard, Part 1, uses an approach to test selection that is very similar to the Tripartite Guidance. It also uses a tabular format (matrix) for laying out the test requirements based on the various factors discussed above. The matrix consists of two tables, "Initial Evaluation Tests for Consideration" and "Supplementary Evaluation Tests for Consideration."
It is important to the user that the labelling for the neonatal incubator and neonatal transport incubator bear clear, accurate, and complete information for use concerning any relevant indications for use, conditions and limitations of use, hazards, contraindications, and precautions in their use.
Compiled by: John Sandham IEng MIIE MIHEEM