White Papers

Our distinguished scientific staff not only fully understand medical device and pharmaceutical product testing requirements; they help create them. Key Toxikon staff are contributors to the professional panels and organizations that define industry best practices and influence regulation and legislation.

The study directors, scientists, and technicians working on your testing programs regularly share their collective knowledge through white papers, case studies, and conference presentations. We’re pleased to share these educational resources with you; collaborating on education and best practices will lead to better products and, therefore, improved quality of life for patients worldwide.

Biocompatibility

  • Saving Time With Solvent Compatibility Testing

    When developing a preclinical testing plan for medical devices, selecting the correct extraction solvents can be confusing.
    Incompatibility between solvent and device may result in an extract that is unusable or harmful to the test system. A Solvent Compatibility Test can make the selection process easier, as well as avoid post-extraction changes that cause complications during testing, saving time, and resources.

  • Preclinical Biological Evaluation of Medical Devices Interacting with Blood

    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.

  • Biocompatibility of Medical and Surgical Masks

    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.

  • Do’s And Don’ts Of Wound Care Device Biocompatibility

    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 many times have hemostatic or anti-adhesion properties, which will be separately addressed in a separate forthcoming article.

  • FDA Recognition of ISO 10993-1: 2018

    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 evaluated at the end of their validated reprocessing life cycle and the introduction of transitory and non-contacting devices and their material components.

  • ISO 10993-1: 2018 In Review

    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.

  • Sub-Acute, Sub-Chronic, and Chronic Systemic Toxicity Testing of Medical Devices

    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.

  • Sample Preparation of Medical Devices for Biocompatibility Testing

    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.

  • Considerations for the Canine Thrombogenicity Test

    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.

  • Biocompatibility Evaluation Of Honey-Based Medical Devices

    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.

Extractables and Leachables

  • Saving Time With Solvent Compatibility Testing

    When developing a preclinical testing plan for medical devices, selecting the correct extraction solvents can be confusing.
    Incompatibility between solvent and device may result in an extract that is unusable or harmful to the test system. A Solvent Compatibility Test can make the selection process easier, as well as avoid post-extraction changes that cause complications during testing, saving time, and resources.

Microbiology

  • Super Spreaders: The Curious and Consequential Impact of Spreaders on Bioburden Testing

    Bioburden testing of medical devices or products determines the presence of the total number of viable microorganisms present on and/or within a device, which is expressed as Colony Forming Unit(s) (CFUs) per device. Accurate bioburden results are critical and used by medical device manufacturers to determine the microbiological load of devices, assess control over manufacturing and assembly processes, and define appropriate sterilization dose.

Ocular Studies