Introduction to Currently Applied Device Pathology
| Autor: | Staci L. Jessen, Alan Glowczwski, Brad R. Weeks, Nicole A. Mehta, Breanna F. Brocklesby, Molly C. Friedemann, Cedric B. Robinson, Fatima H. Charara, Anne Marie Ginn-Hedman, Fred J. Clubb, Steven Jokerst, Courtney N. Kaulfus |
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| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
030204 cardiovascular system & hematology Toxicology Pathology and Forensic Medicine Food and drug administration 03 medical and health sciences 0302 clinical medicine Device Approval Pathology Animals Humans Medicine Medical physics Molecular Biology 030304 developmental biology 0303 health sciences Equipment Safety United States Food and Drug Administration business.industry Histological Techniques Cell Biology United States Equipment and Supplies Models Animal business Quality assurance PATH (variable) |
| Zdroj: | Toxicologic Pathology. 47:221-234 |
| ISSN: | 1533-1601 0192-6233 |
| Popis: | Pathologic evaluation is crucial to the study of medical devices and integral to the Food and Drug Administration and other regulatory entities’ assessment of device safety and efficacy. While pathologic analysis is tailored to the type of device, it generally involves at a minimum gross and microscopic evaluation of the medical device and associated tissues. Due to the complex nature of some implanted devices and specific questions posed by sponsors, pathologic evaluation inherently presents many challenges in accurately assessing medical device safety and efficacy. This laboratory’s experience in numerous collaborative projects involving veterinary pathologists, biomedical engineers, physicians, and other scientists has led to a set of interrelated assessments to determine pathologic end points as a means to address these challenges and achieve study outcomes. Thorough device evaluation is often accomplished by utilizing traditional paraffin histology, plastic embedding and microground sections, and advanced imaging modalities. Combining these advanced techniques provides an integrative, comprehensive approach to medical device pathology and enhances medical device safety and efficacy assessment. |
| Databáze: | OpenAIRE |
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