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FDA Taking Another Look At Safety of Robotic Medical Tools

There is always a critical balancing act that must be performed with so many technological advances in the medical field. On the one hand, there is a desire to get these new products and procedures in place as soon as possible so as to help as many medical patients as possible. We lose people each and every day who might have been saved by earlier use of advances or specialized tools. Of course, on the flip side, just as these tech tools can save lives, they can also take them away. Medical care is an incredibly delicate process, and any errors, imperfections, or slip ups can literally be the difference of life and death.

This inherent tension is why federal regulators have created various layers of oversight and a formalized approval process for most medical advances–from new devices to drugs. This ensures that medical patients do not unknowingly suffer the consequences of being an unwanted guinea pig for something that doesn’t yet have all the kinks worked out. As those who have followed various mass recalls and medical malpractice cases in the medical field appreciate, even when the approval process is followed, serious harm can still result. One need look no further than the thousands of medical patients suffering as a result of defective DePuy hip implants to understand what can happen when defective products are on the market.

Robotic Surgical Tool Injuries
In that same spirit of ensuring medical patients are not unnecessarily exposed to increased risks, reports this week suggest that the U.S. Food and Drug Administration is taking another look at the safety of the armed robotic tool used in surgeries known as “da Vinci.” The extremely complex machine is often said to “wow” physicians, and more and more are deciding to utilize it. Reports suggest that over 400,000 surgeries were performed last year alone with da Vinci.

But now that the initial outburst of support has waned, many are raising red flags about bugs that still need to be worked out. These patient safety advocates point out that there have already been several cases where patients may have died as a result of errors with the equipment. For example, in one case the robotic tool apparently would not let go of one patient’s tissue that it had grasped during the operation. In another case a patient was hit hard directly in the face by one of the tool’s robotic arm.

In fact the FDA noted that they have seen a rise in reports about accidents using da Vinci–that includes at least five reports of deaths within the last year alone.

Illinois Medical Malpractice
A few of the patients who may have been harmed as a result of problems with da Vinci include Illinois residents. For example, in 2007 a Chicago resident died during a spleen surgery when the robot was in use. It is unclear from these reports whether or not that case resulted in any legal liability.

Of course, “some” reports of problems does not mean that da Vinci is an inherently dangerous product or even that changes need to be made to lower risks. However, it is important to remember two points. First, even if an incident is rare, those affected still may have the right to recover for their losses. Second, the only way to fully understand if there are systematic issues with any medical product is for open and complete reporting about those possible errors. That requires all involved parties, from patients to the device maker to be forthright about their concerns and documenting possible adverse events.

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