Pathology and Histopathology Evaluations of Biomaterials and Medical Devices

Schuh, JoAnn C. L.

doi:10.1007/978-3-030-35241-7_9

Cited by 2 publications

(2 citation statements)

References 208 publications

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“…23 Other fixatives may be needed if the study protocol also requires immunohistochemistry (IHC) or transmission electron microscopy (TEM) to answer specific questions related to the biological response. 23,24…”

Section: Considerations For Medical Device Implant Site Evaluationmentioning

confidence: 99%

“…Particularly for superficial implants (cutaneous, subcutaneous, and intramuscular), special sense organs, and mucosal tissues, species-specific lymphatic drainage patterns should be thoroughly investigated prior to finalizing the study protocol so that the most proximal draining lymph nodes or mucosa-associated lymphoid tissue will be examined. 23-28 Collection and examination of distant superficial or internal lymph nodes or other lymphoid tissues (spleen, thymus, or bone marrow) may also be relevant as controls or to evaluate systemic distribution of implanted materials. 29…”

Section: Considerations For Medical Device Implant Site Evaluationmentioning

confidence: 99%

See 1 more Smart Citation

Scientific and Regulatory Policy Committee Points to Consider for Medical Device Implant Site Evaluation in Nonclinical Studies

O'Brien

Schuh²,

Wancket

et al. 2022

Toxicol Pathol

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Nonclinical implantation studies are a common and often critical step for medical device safety assessment in the bench-to-market pathway. Nonclinical implanted medical devices or drug-device combination products require complex macroscopic and microscopic pathology evaluations due to the physical presence of the device itself and unique tissue responses to device materials. The Medical Device Implant Site Evaluation working group of the Society of Toxicologic Pathology’s (STP) Scientific and Regulatory Policy Committee (SRPC) was tasked with reviewing scientific, technical, and regulatory considerations for these studies. Implant site evaluations require highly specialized methods and analytical schemes that should be designed on a case-by-case basis to address specific study objectives. Existing STP best practice recommendations can serve as a framework when performing nonclinical studies under Good Laboratory Practices and help mitigate limitations in standards and guidances for implant evaluations (e.g., those from the International Organization for Standardization [ISO], ASTM International). This article integrates standards referenced by sponsors and regulatory bodies with practical pathology evaluation methods for implantable medical devices and combination products. The goal is to ensure the maximum accuracy and scientific relevance of pathology data acquired during a medical device or combination drug-device implantation study.

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Section: Considerations For Medical Device Implant Site Evaluationmentioning

confidence: 99%

Section: Considerations For Medical Device Implant Site Evaluationmentioning

confidence: 99%

Scientific and Regulatory Policy Committee Points to Consider for Medical Device Implant Site Evaluation in Nonclinical Studies

O'Brien

Schuh²,

Wancket

et al. 2022

Toxicol Pathol

Self Cite

View full text Add to dashboard Cite

show abstract

Toxicologic Pathology Forum*: Opinion on Assessing and Communicating Adversity for Implantable Medical Devices

Wancket,

Bolon,

Funk

et al. 2024

Toxicol Pathol

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Medical devices are a product class encompassing many materials and intended uses. While adversity determination is a key part of nonclinical safety assessments, relatively little has been published about the unique challenges encountered when determining adversity for implantable medical devices. The current paper uses the Society of Toxicologic Pathology (STP)’s “Scientific and Regulatory Policy Committee Recommended (‘Best’) Practices for Determining, Communicating, and Using Adverse Effect Data from Nonclinical Studies,” which were crafted for conventional bio/pharmaceutical products (small and large molecules, cell and gene therapies, etc), as a framework for making adversity decisions for medical devices. Some best principles are directly translatable to medical devices: (1) adversity indicates harm to the animal; (2) effects should be assessed on their merits without speculation regarding future or unmeasured implications; (3) adversity decisions apply only to the test species under the specific conditions of the nonclinical study; and (4) adversity decisions and supporting evidence should be clearly stated in reports. However, unique considerations also apply for evaluating implanted medical devices, including testing of multiple articles in the same animal and the unavoidable tissue trauma during device implantation. This opinion piece offers suggestions for applying previously published STP best practice recommendations for assigning adversity to implantable medical devices.

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Pathology and Histopathology Evaluations of Biomaterials and Medical Devices

Cited by 2 publications

References 208 publications

Scientific and Regulatory Policy Committee Points to Consider for Medical Device Implant Site Evaluation in Nonclinical Studies

Scientific and Regulatory Policy Committee Points to Consider for Medical Device Implant Site Evaluation in Nonclinical Studies

Toxicologic Pathology Forum*: Opinion on Assessing and Communicating Adversity for Implantable Medical Devices

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