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Senator: Northwestern University Withheld Documents in Medical Device Probe


Posted in Regulatory and Compliance by Jamie Hartford on April 1, 2014

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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At the same time the lease

At the same time the lease is the next level of sales method is used, or the practice of job applicants in a cover letters to the owners of the company has been in some of the parts education should be experienced.

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So what's your point in bringing up an 8 year old case? What do you expect to happen here? Seems to me that all should invest time in seeking warranty on implants vs. trying to play Watergate on old file loss. Implant warranty and driving toward quality control for UDI are topics you may want to practice investigative reporting skills on.