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Medical Device Surveillance Project

Optimizing Medical Device Post-Market Surveillance for Public Value

Dhruva SS, Parzynski CS, Gamble GM, Curtis JP, Desai NR, Yeh RW, Masoudi FA, Kuntz R, Li S, Shaw RE, Marinac‐Dabic D, Sedrakyan A, Normand SLT, Krumholz HM, Ross JS. Attribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data. JAHA. 2020; 9(4):e013606. doi: 10.1161/JAHA.119.013606

Bates J, Parzynski CS, Dhruva SS, Coppi A, Kuntz R, Li S, Marinac‐Dabic D, Masoudi FA, Shaw RE, Warner F, Krumholz HM, Ross JS. Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators. Pharmacoepidemiol Drug Saf. 2018;1–9.

Dhruva SS, Ross JS, Schulz WL, Krumholz HM. Fulfilling the Promise of Unique Device Identifiers. Ann Intern Med. 2018 August 169(3):183-185. doi: 10.7326/M18-0526

Ross JS, Bates J, Parzynski CS, Akar JG, Curtis JP, Desai NR, Freeman JV, Gamble GM, Kuntz R, Li SX, Marinac-Dabic D, Masoudi FA, Normand SLT, Ranasinghe I, Shaw RE, Krumholz HM. Can machine learning complement traditional medical device surveillance? A case-study of dual-chamber implantable cardioverter–defibrillators. Medical Devices. 2017 August (10):165-188. DOI: 10.2147/MDER.S138158

Samuel AM, Rathi VK, Grauer JN, Ross JS. How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval? Clin Orthop Relat Res. 2016; 474(4):1053-1068.

Phillips AT, Rathi VK, Ross JS. Publication of Clinical Studies Supporting FDA Premarket Approval for High-Risk Cardiovascular Devices Between 2011 and 2013: A Cross-sectional Study. JAMA. 2016; 176(4):551-552.

Rathi VK, Kesselheim AS, Ross JS. The US Food and Drug Administration 515 Program Initiative Addressing the Evidence Gap for Widely Used, High-Risk Cardiovascular Devices? JAMA Cardiol. Published online March 09, 2016. doi:10.1001/jamacardio.2016.0002.

Bikdeli B, Wang Y, Minges KE, Desai NR, Kim N, Desai MM, Spertus JA, Masoudi FA, Nallamothu BK, Goldhaber SZ, Krumholz HM. Vena Caval Filter Utilization and Outcomes in Pulmonary Embolism: Medicare Hospitalizations From 1999 to 2010. J Am Coll Cardiol. 2016; 67(9):1027-1035.

Ross JS, Kesselheim AS. FDA Policy and Cardiovascular Medicine. Circulation. 2015; 132(12):1136-1145.

Rathi VK, Ross JS, Samuel AM, Mehra S. Postmarket Modifications of High-Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration. Otolaryngol Head Neck Surg. 2015; 153(3):400-408.

Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011. JAMA. 2015; 314(6):604-612.

Ross JS, Blount KL, Ritchie JD, Hodshon B, Krumholz HM. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey. Medical Devices: Evidence and Research. 2015;8:241-249.

Lampropulos JF, Kim N, Wang Y, et al. Trends in left ventricular assist device use and outcomes among Medicare beneficiaries, 2004–2011. Open Heart. 2014; 1(1):e000109. doi:10.1136/openhrt-2014-000109.

Gupta A, Desai MM, Kim N, Bulsara KR, Wang Y, Krumholz HM. Trends in intracranial stenting among medicare beneficiaries in the United States, 2006-2010. J Am Heart Assoc. 2013; 2(2):e000084. doi: 10.1161/JAHA.113.000084.

FDA supports Yale/Medtronic medical device surveillance initiative
Yale News, January 9, 2013

FDA Think Tank Presentation

Dr. Harlan M. Krumholz FDA Think Tank on Surveillance Planning on June 1, 2016.