SHEBOYGAN, Wisconsin, Jan. 6, 2020 /PRNewswire/ — Dr. Nalini Rajamannan — a specialist for patients with valvular heart disease in Most Sacred Heart of Jesus Cardiology, Sheboygan, WI — confirms today that patients finally may get answers about whether medical devices placed in their bodies are tested and safe, as the Food and Drug Administration begins to allow access to volumes of previously shielded data from consumers.
A recent investigation by Kaiser Health News has exposed a myriad of issues with the FDA’s reporting laws for “exempt” medical devices. The decades-long practice of “filing for exemption” allowed medical device makers to conceal millions of device reports from the general public, according to a series of articles by Christina Jewett of KHN.
As outlined in KHN, the exempt FDA Database means that there was no public access to these exempt devices making it difficult to learn what kind of adverse events may have occurred in US Citizens who received these medical devices. Dr. Nalini Rajamannan was in the operating room in 2006 when that heart device was being implanted in patients at Northwestern University as confirmed by the Project of Government Oversight. She now works as a specialist for patients with valvular heart disease at Most Sacred Heart of Jesus Cardiology, in Sheboygan, WI. In 2007, the device manufacturer confirmed the exempt status in a two-line email to the hospital.
Dr. Elisabeth Rosenthal, Award-Winning former New York Times Reporter and now editor of Kaiser Health News highlighted the issues as they relate to the American health care system in her interview on the CBS Morning Show, Dec. 31, 2019.
Dr. Rosenthal’s new book “An American Sickness” highlights the issues related to exempt medical devices in the chapter, “How to get into a Patient’s Heart? Follow the Money.” The chapter outlines the events summarized by eye-witness Dr. Nalini M. Rajamannan in the series “The Myxo Files a XXIV: A Tale of Three Rings” as published by Kindle Publishing on Amazon.com. The Myxo Files detail a doctor’s personal journey towards understanding the FDA exemption laws allowing a device manufacturer to self-certify the FDA approval for a heart valve device, prior to sales of the device on the US market to the FDA.
After 911, until 2019, Chairman Charles Grassley initiated several investigations of predicate devices and reporting during clinical trials on and off the battlefield to understand more of the FDA exemption and 510(k) process while on the Senate Finance Committee. These decade-long investigations by the Senate Finance and Senate Judiciary Committees are now more clear due to the lifting of the exempt reporting laws. In March 2009, the FDA Congressional office wrote to the Senate Finance Committee’s Chairman Grassley of the Finance Committee, classifying the device as not exempt from reporting the device to the FDA, and that the device manufacturer needs to submit a new approval application. (See Linked PDF of the FDA Congressional Letter.)
The FDA letter confirms “The Daily Northwestern’s” comprehensive article in 2019, regarding the FDA’s Congressional letter to Senator Grassley that there was no device approval at the time of the study and the University’s decision to stop the study after three months was correct.
Releasing the FDA’s Congressional letter today is now possible after the KHN news stories. The status of the device prior to 2009, and any information regarding adverse events related to this and other exempt devices prior to any FDA approvals, will provide important medical information to US Citizens.
The Senate Finance committee is involved in these investigations on behalf of Medicare and Medicaid because government dollars fund the use of medical devices in patients’ health. More importantly, the new changes to the FDA reporting laws as outlined by Kaiser Health News will help patients know more about medical devices implanted into their bodies.
Dr. Nalini Rajamannan is a heart valve expert in the field of cardiovascular medicine. She earned her undergraduate science pre-professional degree from the University of Notre Dame, her Medical Doctorate from Mayo Medical School and her post-graduate training in Internal Medicine and Cardiology at the Mayo Clinic and Research Fellowship on the NIH training Grant. She also worked at the Mayo Clinic as a staff consultant in Internal Medicine and an Associate Professor of Medicine at Northwestern University and the Lakeside and Westside VA. Currently, she practices consultative valvular medicine and Osteocardiology at Most Sacred Heart of Jesus Cardiology and Valvular Institute, WI.
Press Officer for Most Sacred Heart of Jesus Cardiology and Valvular Institute
Former NBC Bureau Chief Latin America
US Senate Finance Committee Investigation of Exempt Medical Devices
Senator Charles Grassley
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