|Adam Saltman, MD PhD
Medical Officer, CDRH/Office of Compliance
MD (Cardiothoracic surgery)
Using Decision Analysis tools to advance regulatory science.
Proposed Research Project for FDA Fellow
FDA currently uses a qualitative, semi-formal process to arrive at recall classifications and corrective actions for defective medical devices, partly because there is a significant gap in regulatory science related to multi-decision analysis techniques. This project will use Decision Analysis tools (for example, Analytica by Lumina Decision Systems) to develop a comprehensive, quantitative “device recall process model” that will use objective, quantitative input data to help form recall classifications and strategies that protect the public health and minimize patient exposure to risk.
This Fellow will learn and employ these tools to:
1. Harness data from diverse sources;
2. Build a functional model with appropriate outputs (classification and strategy); and
3. Minimize the risk to public health while maximizing patient benefit.
The Fellow’s final product will be a flexible, adaptable, working Decision Analysis model that can be used to advance regulatory science and help regulators arrive at transparent, evidence-based medical device recall classifications and recall strategies.
Basic familiarity with statistics, simple mathematical models, and fundamental distributions.
Selected Recent Publications
1. Seiver A and Saltman AE, in Association for the Advancement of Medical Instrumentation. Postmarket Risk Management: A Framework For Incorporating Benefit-Risk Assessments Into Correction And Removal Decisions. Pages 5-16 and 41-61. Arlington, VA: AAMI, 2016. http://s3.amazonaws.com/rdcms-aami/files/production/public/FileDownloads/WhitePaper/Postmarket_Risk_Management_120816.pdf. Accessed 6 Jan. 2017.
2. Saltman AE. D-ribose-L-cysteine supplementation enhances wound healing in a rodent model. Am J Surg. 2015;210:153-8. doi: 10.1016/j.amjsurg.2014.11.014. Epub 2015 Mar 27
3. Fukuhara S, Saltman AE. Massive postpartum pneumomediastinum. Asian Cardiovascular and Thoracic Annals. 2013;21:372.
4. Saltman AE. Cardima Surgical Ablation System: a novel tool for cardiac ablation in the treatment of atrial fibrillation. Expert Rev Med Devices. 2009;6:231-236.
5. Saltman AE, Gillinov AM. Surgical approaches for atrial fibrillation. Cardiol Clin. 2009;27:179-88.