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- Ensuring Patient Safety of Medical Devices
Ensuring Patient Safety of Medical Devices: The Importance of Traditional Biocompatibility Testing
Historical Perspective of a Changing Regulatory Landscape
In recent years, the medical device industry has had a positive progression when proving the safety of a device. A shift towards considering the impact to the patient has enabled a more risk based approach to be adopted and implemented.
Medical devices were not always evaluated as rigorously as they are today. Medical device manufacturers once relied heavily on test data provided by suppliers. This eventually led to a lack of control and inspection of incoming material. From a regulatory perspective, the ISO 10993 guidelines require the assessment of device biocompatibility to be of the final finished device, as it would be presented to the patient. This requirement ensured the appropriate assessment of device safety as it considered any factors that would alter the resulting effect of the product during clinical use. Such factors include changes due to exposure to manufacturing chemicals and procedures, sterilization processes, various interactions, packaging affects, in-use degradation, and other related factors. As the importance of these factors was better understood, the practice of utilizing material and/or component biocompatibility test data from suppliers was recognized as inadequate to ensure proper assessment and protection for the actual use conditions of the medical device.