White PaperMedical
Documenting Device Changes in Biological Risk Assessments
SPONSORED BY: ![]()
Biological risk assessments help assess potential risks to patients that could result from device changes. ISO 10993-1 offers guidance on documenting device changes. One common change is that of a new material in a device. In this whitepaper the author, Katrina Hurst, PhD, a biocompatibility expert at Nelson Labs, presents a scenario of a material change to fictitious device from a fictitious manufacturer to guide readers through the process of completing a biological risk assessment.
Don't have an account?
Overview
The whitepaper titled "Documenting Device Changes in Biological Risk Assessments – Part One" by Nelson Laboratories outlines a structured approach to assessing the biological risks associated with changes in medical devices. It emphasizes the critical importance of conducting thorough risk assessments to ensure patient safety when modifications are made to device components, materials, or manufacturing processes.
The document details a five-step risk assessment strategy. Step 1 involves providing a comprehensive backstory and description of the device, which is essential for context. Step 2 focuses on gathering all relevant information about the current device and the proposed changes, including biocompatibility testing data and clinical studies. Step 3 requires a detailed comparison of the existing and new device variants, addressing how the changes may impact biocompatibility and patient safety.
Step 4 is a critical analysis of the known and potential impacts of the changes on the device and patient risk. This step encourages a proactive approach, anticipating regulatory questions and justifying the need (or lack thereof) for additional testing based on the nature of the changes and patient contact. Finally, Step 5 involves summarizing the findings and drawing conclusions, which may indicate whether further testing is necessary.
The whitepaper also provides practical examples, such as a case study involving a material change in a valve component, illustrating how to assess risks and determine if additional testing is warranted. It highlights that while some changes may not introduce new risks, others could significantly impact patient safety, necessitating a careful and thorough evaluation.
Overall, this whitepaper serves as a valuable resource for manufacturers and regulatory professionals, guiding them through the complexities of documenting device changes and ensuring compliance with safety standards. It sets the stage for further discussions in subsequent parts of the series.