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Let's Move Forward

Wed, 05/15/2013 - 10:13am
Mike Schmidt, Editor, Surgical Products

I often find it difficult to contain my excitement when I see, hear, or read about a new advancement in technology. After all, there’s something quite heartening and inspiring about an individual or a group developing an innovative product or service to solve a problem or satisfy a need.

The thought process behind most of these technological advancements is fairly obvious. Many serve to make a process less complex, more efficient, and more cost-effective. Perhaps that’s why I root so well for them to catch on and become relevant, even though I’m fully aware the path to prominence and widespread adoption can be a rocky and uncertain one.

According to a recent Associated Press article, Intuitive Surgical’s da Vinci robot was used in approximately 400,000 surgical procedures in the United States a year ago. However, a spike in adverse events has caused the U.S.  Food and Drug Administration to take a closer look at the technology and how it is being used in operating rooms across the country.

The investigation is not without merit. Medpage Today recently cited some troubling statistics in an informative piece about the FDA’s probe. The number of AERs for the da Vinci Surgical System filed with the FDA's Manufacturer and User Facility Experience (MAUDE) database increased 34 percent, going from 211 in 2011 to 282 in 2012. During that period, the number of procedures performed with the da Vinci system in the United States increased 26 percent, going from 292,000 to 367,000, according to a quarterly report that Intuitive Surgical filed earlier this month with the U.S. Securities and Exchange Commission (SEC).

I was quite discouraged to read these findings, given the immense promise of robotic surgery. Obvious potential benefits include more precise surgery, greater dexterity for the surgeon’s hands, improved outcomes, shorter hospital stays, among others. However, lingering doubt or unanswered questions related to patient safety cannot be overlooked. Now, it seems, they all but completely overshadow the potential benefits of employing the new technology.

It’s reasonable to expect critics of robotic surgery to cite the recent news about the FDA’s probe as evidence to support their indictment of the technology, and that’s fine.  Meanwhile, proponents of the technology and providers of robotic surgery accessories will defend the robot and extol its virtues as an innovative, efficient, and cost-effective means to conduct surgery. This is also an acceptable position to take.

My stance won’t involve defending or criticizing the surgical robot. I only hope that the FDA’s efforts investigate the technology will not slow or dissuade brilliant individuals and forward-thinking companies from developing more useful solutions for the operating room. I have no desire to see hospitals, surgeons, and OR staff members balk at these solutions in favor of re-embracing traditional or old-fashioned practices and attitudes. Progress is attained by looking and moving forward, not backward. Let’s keep this in mind as the surgical robot is investigated further by the government and tried in the court of public opinion.

 

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