There Is No Such Thing as Zero Risk

At yesterday's FDA Centennial celebration in Philadelphia, Robert O'Holla, vice president of regulatory affairs for medical devices and diagnostic products at Johnson & Johnson, said something during his presentation that sums up my problem with much mainstream media coverage of the device industry:"The Internet has taken over, and the public knows more. The press feeds its thirst for knowledge. But it has also planted the seeds of mistrust. It has fostered the public's expectation of zero risk, which makes things impossible for regulators and industry.

May 17, 2006

1 Min Read
There Is No Such Thing as Zero Risk

How can we get risk equation discussions to a level that the public can understand?"There is no such thing as a risk-free medical device. Medical procedures by definition carry some level of risk. Yet somehow, the press has equated "safe and effective" with "zero risk." While of course that should be aspired to, it's impossible to achieve. The press, and through them the public, needs to be educated that "safe and effective" means "based on available information, risk is mitigated." Until then, too much coverage of the device industry will be based on uninformed hysteria.

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