White Paper Category: Biocompatibility

One of the most important safety tests for blood-contacting medical devices is hemocompatibility. Hemocompatibility ensures that a device does not cause red blood cell destruction through hemolysis, cause clotting that could lead to the formation of a thrombus, activate platelets, activate the complement system, or bind platelets, and leukocytes.

In the current climate in the United States and around the world, there are a significant number of companies who previously made commercial goods who are now joining the call to produce masks, ventilators and other medical devices in short supply. This article will focus on the current US environment.

By definition, a wound is an injury to a living tissue, but most commonly skin.  These wounds can be ulcerative, caused by a burn, or be full thickness due to some sort of induced mechanical trauma.  There are certainly internal wounds caused by surgery or other traumatic events but the devices used to treat these […]

ISO 10993-1 was revised in August of 2018 and included a big expansion on the risk based development and safety evaluation of medical devices.  There were not a lot of big changes, but there were a few including an expansion of evaluation requirements in Table A.1 in Annex A, noting reusable devices need to be […]

ISO 10993-1 was revised in August of 2018 and greatly expands upon the concepts of bringing risk management into medical device development and manufacturing. Most ISO 10993 documents related to individual evaluation topics revise pretty regularly, however the main governing document, ISO 10993-1, updates a little less frequently and was last revised in 2009.

This white paper examines the interpretation of the ISO 10993 guidelines for sub-acute, sub-chronic, and chronic systemic toxicity testing of medical devices. It suggests study designs from the pharmaceutical industry that are compliant with ISO 10993 and could result in better quality test conditions, more accurate data, and overall acceptance.

Biocompatibility testing is an essential part of receiving regulatory approval for medical devices. While the testing itself is important, the correct preparation of samples used for testing is equally as important. Below you will learn about the many requirements and factors that must be considered when preparing samples for accurate biocompatibility testing.

This white paper proposes a test method that addresses FDA expectations, practical considerations, and inherent limitations of the canine thrombogenicity test. It discusses the history of the test, considerations when initiating the test, standard methodology, and evaluation criteria.

Contemporary regulations surrounding natural products have grown in scope and complexity, as both regulatory agencies and consumers demand assurances that ‘natural’ medical products in the market are safe. With these considerations in mind, honey-derived or honey-containing medical products should receive the full battery of biocompatibility evaluations to ensure patient safety.