2023 International Academy of Toxicologic Pathology (IATP) Satellite Symposium: "Medical Device Safety Assessment: Pathology and Toxicology Perspective".

Medical devices represent a complex category of medicinal products with varying definitions depending on the regional jurisdiction of regulatory agencies. A common aspect of these definitions is that a medical device is intended to be used for specific medicinal purpose where the primary intended action of the device is not achieved through pharmacologic (or other chemical) means. While regional regulatory frameworks for medical devices are different than for pharmaceutical or biological products, medical device manufacturers are required to evaluate the safety and performance of these products in the context of their intended use.

Encapsulating therapeutic cells in RGD-modified agarose microcapsules.

Current cell-based strategies for repairing damaged tissue often show limited efficacy due to low cell retention at the site of injury. Encapsulation of cells within hydrogel microcapsules demonstrably increases cell retention but benefits can be limited due to premature cell escape from the hydrogel microcapsules and subsequent clearance from the targeted tissue. We propose a method of encapsulating cells in agarose microcapsules that have been modified to increase cell retention by providing cell attachment domains within the agarose hydrogel allowing cells to adhere to the microcapsules.

Updating the Standards of Professional Competence in the Field of Toxicology: The Second Generation of Best Practice.

The American Board of Toxicology (ABT), in consultation with ACT Credentialing & Career Services (ACT), performed a practice analysis study of general toxicology in 2020-21. This work follows up on an initial practice analysis commissioned by the ABT and conducted in 2014-2015, results of which were published in 2016. The purpose of the current, second-generation study was to update and validate the existing process-based delineation of practice of general toxicologists, including major domains of responsibility and tasks performed in practice.

Best practices in prenatal health promotion: Perceptions, experiences, and recommendations of Ottawa, Canada, prenatal key informants.

Background: Prenatal health promotion includes the provision of evidence-based information and practical skills to optimize maternal-fetal outcomes. Increasingly, prenatal education is delivered by both healthcare professionals and allied childbirth educators, in community- or hospital-based group classes, targeted outreach programs, and online modules.

Objectives: To better understand how prenatal health promotion relates to a diverse urban community, we assessed the perspectives of Ottawa, Canada prenatal key informants.

A case study: Re-evaluating the biological risk following a processing aid change on a marketed cardiovascular implant device.

Per ISO 10993-1:2018, a processing change to a medical device requires re-evaluation of biological risk. Here, we present the biological evaluation of a marketed cardiovascular implant following a detergent formulation change. This change was initially assessed through a qualitative toxicological risk assessment based on the fully disclosed detergent formulation and a limited panel of biological testing.