A Brief Introduction to Medical Device Biocompatibility

The phrase “First, do no harm” embodies the idea—with threads scattered back through the history of medicine—that when it comes to patient care, safety comes first. It is in defense of this idea that governments have founded regulatory bodies to protect public health in medical matters. Protecting patient safety by ensuring that new medical devices do no harm is also a calling applicable to manufacturers. Unintended harm inflicted by a medical device can originate from a variety of routes. Consider an implant immediately after implantation: If it is not clean and sterile, it can cause a life-threatening fever or infection. On a longer time scale, there are a variety of adverse effects that can happen, ranging from irritation of local tissues to cancer possibly arising from material issues. Demonstration of biocompatibility is meant to screen for possible adverse reactions a patient may have to medical devices and therefore ensure that first, the device does no harm. Biocompatibility of medical devices is a complex and evolving subject, the backbone of which is an international standard (actually a suite of documents), ISO 10993. The first chapter, ISO 10993-1, provides an overview of biocompatibility and the suggested approach for risk mitigation from the perspective of materials and processing. The remaining chapters dive deep into topics touching on risk mitigation, from sample preparation to animal studies and how to perform a toxicological risk assessment. FDA gen...
Source: MDDI - Category: Medical Devices Authors: Tags: BIOMEDevice Boston Testing Materials Source Type: news