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Senator: Northwestern University Withheld Documents in Medical Device Probe
Senator Charles Grassley says it appears Northwestern University and Northwestern Memorial Hospital failed to provide him with documents he requested in 2008 and 2009 as part of a probe into the Myxo-ETlogix 5100 Ring.
April 1, 2014
1 Min Read
By Jim Dickinson
Senator Charles Grassley (R-IA) says it appears that Northwestern University and Northwestern Memorial Hospital failed to provide him with documents he requested in 2008 and 2009 as part of a probe into allegations that the Myxo-ETlogix 5100 Ring had not been cleared for marketing by FDA before it was implanted in patients as part of an outcomes study.
In a March 4 letter to presidents of the two institutions, Grassley says he was informed by a former Northwestern Feinberg School of Medicine professor that documents falling within the scope of his 2008 letter were withheld without any notice that they were being withheld.
Grassley also says it appears that Dr. Patrick McCarthy made contradictory statements about the similarity of the Myxo Ring to preexisting devices. And, he says, it appears that the documents that were not submitted to him were either signed or submitted by McCarthy in 2006.
The letter asks for the following documents relating to IRB Project 1532-0054:
A protocol application signed by McCarthy.
An echo protocol written by McCarthy.
A waiver of consent form signed by McCarthy.
A 6/29/09 letter from the university institutional review board to McCarthy approving the project.
A HIPPA wavier of authorization form attached to the 6/29/06 cover letter.
Copies of any other documentation, form, report, email, or memo about the project, including a New Project Submission Form that is in the possession of the institutions.
Jim Dickinson is MD+DI's contributing editor.
[image courtesy of SCOTTCHAN/FREEDIGITALPHOTOS.NET]
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