White Paper: Test & Measurement
Get the Inside Story on Implantable Medical Devices
SPONSORED BY: ![]()
Get expert insights from Eurofins Medical Device Testing! Discover biocompatibility expertise with Eurofins’ experts as they answer key questions on implantable devices. Ensure rapid turnaround times with the highest level of service and advanced technologies. Don't miss this technical interview – essential for staying ahead in medical device testing.
Don't have an account?
Overview
The white paper discusses the critical importance of biocompatibility testing for implantable medical devices, emphasizing the need for a comprehensive biological evaluation plan that goes beyond the basic guidelines provided in Annex A of ISO 10993-1. Experts Geoffrey Moodie and Andrew Blakinger from Eurofins Medical Device Testing highlight that regulatory agencies require manufacturers to thoroughly understand and mitigate all risks associated with their products.
The paper outlines several key points regarding biocompatibility testing. First, it addresses the potential issues that can arise even when raw materials pass initial biocompatibility tests. Changes during processing, such as degradation from heat or sterilization, can alter the materials and affect their safety. Additionally, residues from manufacturing processes may introduce new risks, necessitating testing on the final product rather than just the raw materials.
The experts also discuss the implications of making changes to a product after testing has been completed. Such changes must be evaluated for potential additional risks, particularly if they involve components that come into contact with patients. In some cases, further testing may be required to ensure continued safety.
When faced with concerns from toxicological assessments, the paper suggests alternatives such as conducting simulated use extractables studies or kinetic analyses to better understand material release rates. These approaches can help in making a safety case for the device.
Overall, the white paper underscores the necessity of a thorough understanding of the materials and processes involved in medical device manufacturing. It advocates for a proactive approach to biocompatibility testing, ensuring that manufacturers are equipped to address any potential risks throughout the product's lifecycle, from development to end-of-life. This comprehensive strategy is essential for ensuring the safety and efficacy of implantable medical devices.