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Chris Nace
Chris Nace
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FDA warns: Inaccuracies with Surgical Computer Systems Could Result in Injury or Death

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For the second time in a little more than a month, the FDA warned of accuracy errors associated with stereotaxic navigation systems—a computer system that “guides” surgeons within the body in real-time by using 3D-like imaging—most often employed during brain or spinal surgery.

 

The first announcement in May covered the NavLock Tracker by Medtronic; the same medical device manufacturer that paid out millions over their controversial Infuse bone graft product. Similar in situation to the allegations that the Infuse product was used “off label,” Medtronic claims that the current issue is due to doctors using their NavLock Tracker in unapproved ways. Specifically, the FDA cautions using non-Medtronic tools with the NavLock system, an unsanctioned application that has resulted in at least 28 medical device reports (MDRs) to the FDA in addition to 11 serious injuries and two patient deaths.

 

Then in June, the FDA issued another warning that went beyond any one system or device manufacturer and advised surgeons of accuracy issues with all frameless stereotaxic systems. Within the warning, the FDA also states that the provided recommendations for avoiding adverse events could also apply to framed stereotaxic systems, a less commonly used device in most hospitals. The main difference between the systems is that a frame-based system utilizes a “frame” that is attached to the patient’s head to help with trajectory and distance calculations in relation to the surgeon’s tools. Frameless systems rely on the patient’s anatomy to serve as reference points or landmarks when representing “where” the surgeon is in the body during a procedure.

 

It is doubtful that anyone going into surgery wants to consider the possibility of a computer malfunction, but they do happen with some frequency. Most reporting from hospitals lump this type of event into a category I discussed in a recent blog called “medical errors”—a catch-all that has been getting some well-deserved attention lately due in part to a recent study by John Hopkins Medicine that says the number of deaths each year due to such errors could qualify the category as the third leading killer in the U.S. just after heart disease and cancer.

 

So what can you do to minimize your exposure to a medical error? Know that, as with any procedure that involves computer-assisted intervention, there is always a risk of either user error, hardware malfunction or software glitches. As a patient, it would be prudent to discuss with your doctor any future procedures that would involve computer-assisted technology and to research the devices that are to be used.