scholarly journals Medical Devices Biological Safety Assessment: Towards Animal-free Testing

2019 ◽  
Vol 10 (1) ◽  
pp. 91
Author(s):  
Nadège Sachot ◽  
Augusto Vitale
Keyword(s):  
Medical Devices ◽  
Safety Assessment ◽  
Biological Safety

scholarly journals Biological Safety Assessment of Functional Activated Carbons Prepared from Three Agricultural Wastes

2014 ◽  
Vol 59 (2) ◽  
pp. 321-331
Author(s):  
Han Chien Lin ◽  
Li-Ying Tseng ◽  
Ying-Jang Lai ◽  
She-Ching Wu ◽  
Noboru Fujimoto
Keyword(s):  
Safety Assessment ◽  
Activated Carbons ◽  
Agricultural Wastes ◽  
Biological Safety

Safety assessment of residual amounts of disinfectants based on quaternary ammonium compounds on medical devices

2021 ◽  
pp. 36-39
Author(s):  
Andrey Lvovich Karaev ◽  
◽  
Marina Vasilevna Bidevkina ◽  
Margarita Vladimirovna Matrosenko ◽  
◽  
...  
Keyword(s):  
Medical Devices ◽  
Silicone Rubber ◽  
Quaternary Ammonium ◽  
Safety Assessment ◽  
Quaternary Ammonium Compounds ◽  
Image Analyzer ◽  
Toxicity Index ◽  
Test Items ◽  
Ammonium Compounds

Has been made an assessment of the toxicity of residual amounts of disinfectants after using them on products, made from various materials, with DS solutions based on QAC. The working solutions were used in concentrations from 0.3 to 7 % (by DV). The safety of the studied samples was assessed by the toxicity index "It" (in%) on an AT-05 Image Analyzer. Washing out of the residual amounts of DS in concentrations of 0.3–0.7 % (by DW) did not significantly affect the total time of disinfection treatment or pre-sterilization cleaning. At higher concentrations of solutions, there were differences in the time of washing test items and dishes for receiving safe amounts of DS. It is concluded that it is inexpedient to use solutions based on QAC in a concentration of more than 4.5 % (in terms of DV) for disinfection treatment and pre-sterilization cleaning of products made of natural and silicone rubber. Keywords: disinfectants, quaternary ammonium compounds, product washing, AT-05 image analyzer, to­xicity index.

scholarly journals Safety Assessment of Alumina and Aluminum Hydroxide as Used in Cosmetics

2016 ◽  
Vol 35 (3_suppl) ◽  
pp. 16S-33S ◽  
Author(s):  
Lillian C. Becker ◽  
Ivan Boyer ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Corrosion Inhibitor ◽  
Aluminum Hydroxide ◽  
Drug Administration ◽  
Medical Devices ◽  
Safety Assessment ◽  
Expert Panel ◽  
Safety Data ◽  
Over The Counter ◽  
Buffering Agent ◽  
Animal Safety

This is a safety assessment of alumina and aluminum hydroxide as used in cosmetics. Alumina functions as an abrasive, absorbent, anticaking agent, bulking agent, and opacifying agent. Aluminum hydroxide functions as a buffering agent, corrosion inhibitor, and pH adjuster. The Food and Drug Administration (FDA) evaluated the safe use of alumina in several medical devices and aluminum hydroxide in over-the-counter drugs, which included a review of human and animal safety data. The Cosmetic Ingredient Review (CIR) Expert Panel considered the FDA evaluations as part of the basis for determining the safety of these ingredients as used in cosmetics. Alumina used in cosmetics is essentially the same as that used in medical devices. This safety assessment does not include metallic or elemental aluminum as a cosmetic ingredient. The CIR Expert Panel concluded that alumina and aluminum hydroxide are safe in the present practices of use and concentration described in this safety assessment.

Pigs and Ferrets as Models in Toxicology and Biological Safety Assessment

2000 ◽  
Vol 19 (3) ◽  
pp. 149-168 ◽  
Author(s):  
Shayne C. Gad
Keyword(s):  
Animal Models ◽  
Drug Development ◽  
Safety Assessment ◽  
Key Factors ◽  
Biological Safety

Both the pig and the ferret are used as animal models in toxicology and drug development, with the pig having been subject to a significant increase in usage (particularly in Europe) over the last 5 years. These two species are quite different from primates and dogs, the “standard” nonrodent models. This article seeks to both survey the rationales for and extent of use of the pig and ferret, and to highlight consideration and key factors in their use in studies.

scholarly journals Using the monocyte activation test as a stand-alone release test for medical devices

ALTEX ◽  
2021 ◽  
pp. 151-156
Author(s):  
Jeffrey Brown
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Safety Assessment ◽  
National Institutes Of Health ◽  
Monocyte Activation ◽  
Device Development ◽  
Medical Device Manufacturers ◽  
Regulatory Evaluation ◽  
Limulus Amebocyte Lysate Test ◽  
The U.S

Monocyte activation tests (MAT) are widely available but rarely used in place of animal-based pyrogen tests for safety assessment of medical devices. To address this issue, the National Toxicology Program Interagency Center for the Eval­uation of Alternative Toxicological Methods and the PETA International Science Consortium Ltd. convened a workshop at the National Institutes of Health on September 18-19, 2018. Participants included representatives from MAT testing laboratories, medical device manufacturers, the U.S. Food and Drug Administration’s Center for Devices and Radio­logic Health (CDRH), the U.S. Pharmacopeia, the International Organization for Standardization, and experts in the development of MAT protocols. Discussions covered industry experiences with the MAT, remaining challenges, and how CDRH’s Medical Device Development Tools (MDDT) Program, which qualifies tools for use in evaluating medical devices to streamline device development and regulatory evaluation, could be a pathway to qualify the use of MAT in place of the rabbit pyrogen test and the limulus amebocyte lysate test for medical device testing. Workshop outcomes and fol­low-up activities are discussed.

Investigations on Tissue-Simulating Medium for MRI RF Safety Assessment for Patients With Active Implantable Medical Devices

2019 ◽  
Vol 61 (4) ◽  
pp. 1091-1097 ◽  
Author(s):  
Jingshen Liu ◽  
Jianfeng Zheng ◽  
Qi Zeng ◽  
Qingyan Wang ◽  
John Rondoni ◽  
...  
Keyword(s):  
Medical Devices ◽  
Safety Assessment ◽  
Implantable Medical Devices ◽  
Rf Safety
Sign in / Sign up

Export Citation Format

Share Document