scholarly journals Progress in Deep Geologic Disposal Safety Assessment in the U.S. since 2010.

2019 ◽  
Author(s):  
Paul Mariner ◽  
Laura A. Connolly ◽  
Leigh Cunningham ◽  
Bert Debusschere ◽  
David Dobson ◽  
...  
2019 ◽  
Author(s):  
Laura Painton Swiler ◽  
Jon C. Helton ◽  
Eduardo Basurto ◽  
Dusty Marie Brooks ◽  
Paul Mariner ◽  
...  

ALTEX ◽  
2021 ◽  
pp. 151-156
Author(s):  
Jeffrey Brown

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.


2018 ◽  
Author(s):  
Paul E. Mariner ◽  
Emily R. Stein ◽  
Leigh J. Cunningham ◽  
Jennifer M. Frederick ◽  
Glenn Edward Hammond ◽  
...  

1988 ◽  
Vol 32 (15) ◽  
pp. 885-888
Author(s):  
Robert J. Shively

Recently, the U.S. emergency medical services (EMS) industry has received a great deal of negative publicity concerning its safety record. It has been noted that the EMS industry has an accident rate that is five times that of the rest of the helicopter industry (Harvey and Jensen, 1987; Harvey, 1986. While it is true that during 1987 and early 1988 the safety record has improved, the industry cannot become complacent. The National Transportation and Safety Board recently conducted a study of the EMS industry and returned specific recommendations for the FAA and NASA. One of the critical factors in EMS missions is the pilot's decision accept or reject a mission. This can often be influenced by such factors as the urgency of the care required. This, along with other factors, may prompt a pilot to accept a mission of unacceptable risk. The present paper presents a computer- based decision aid, based upon earlier work by the Army and Coas Guard, to assist the pilot in objective assessment of the probable risk of an EMS mission. Data for validation of this technique will be collected at an EMS operator and from the EMS Safety Reporting Service.


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