The Tale of a Medical Device

The Tale of a Medical Device

January 04, 2006

Senator Hillary Clinton traveled 6,000 miles to dramatize the need for faster medical device approvals.

Hard to believe, isn’t it? In fact, Sen. Clinton herself may not believe it, since she probably didn’t realize just what she was doing. Nor, for that matter, did most of the people who saw news accounts of the event.

Actually, it wasn’t really an event; but a photo-op, and the resulting shot was carried on the front page of The Washington Times on November 15. Its caption: “Senator Hillary Rodham Clinton…practiced cardiopulmonary resuscitation techniques while medical personnel looked on in Jerusalem.” 

This would have been the end of the story, except for one thing. In the Senator’s hand was a small blue device that, 11 years ago, became a symbol of the Republican campaign to reform the Food and Drug Administration (FDA). The device is a CardioPump, essentially a sophisticated suction cup that enables CPR to be administered more effectively.  

 

 

 

 

In 1994 Rep. Newt Gingrich learned of the CardioPump and its problems at FDA from CEI, and he began using it to illustrate the shortcomings of the agency’s approval process for new drugs and devices. The CardioPump did not pose new risks for people receiving CPR, but at the time FDA had halted testing of the device in the U.S. because unconscious heart attack victims had not “consented” to its use! Nonetheless, the CardioPump was being used in other countries because there was encouraging data on how it improved the abysmally low rate of CPR subjects who make it to the hospital.

Rep. Gingrich soon came under heated attacks from journalists, who claimed that the CardioPump was medically unproven and thus an example of Republican know-nothingness. Congress enacted its FDA modernization program, but the agency still refused to approve the device because, in its view, there wasn’t enough long-term data. At CEI, however, that didn’t stop us from putting the CardioPump to good use.

Years passed.  More studies supporting the device appeared in such eminent medical publications as the New England Journal of Medicine and Circulation. And then Sen. Clinton showed up for her photo-op in Jerusalem.

FDA, however, has still not approved the CardioPump. 

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