Wednesday, April 08, 2015

A Potential Safety Blind Spot

A new article on the Jama Network addresses the issue of credentialing doctors in the use of robotic surgery.  It's worth reading.  Here's the lede: 

This Viewpoint reviews an important legal ruling on robotic surgery that highlights potential safety concerns in hospital credentialing and privileging with regard to new technologies.

Innovative procedures and technologies are regularly introduced into clinical practice. Although the US Food and Drug Administration (FDA) exercises strict regulatory control over new drugs, it exerts minimal oversight for new devices and no oversight for new surgical techniques. When technology such as the da Vinci robot enters the field of surgery, it is less clear who is responsible for ensuring its safe introduction. 

And the authors make this point: 

In recent years, controversey has arisen when manufacturers go beyond their traditional role (i.e., to reasonably design and manufacture a device) and participate in training and credentialing physicians to use their company's product. 

And how much more so when the company also pays for the equipment and training?

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