Technological advances help to improve our lives, often by increasing efficiency and reducing mishaps. The medical field, similar to NASA, has pioneered and test piloted numerous cutting-edge devices. As with most advancements, there are a typically a few issues that arise that can potentially throw a wrench into the works. Unfortunately, hospitals, patients, and regulators may not be getting enough information on new devices to determine if they’re worth using. Information is critical for leveraging these technologies and ensuring the safety of patients being treated with these technologies.
One of these devices, the da Vinci Surgical System, has been in use since 2000 and employs some of the latest technology available at the time it was developed. A surgeon utilizing this device is fully in control of this system, which translates his or her movements into smaller and more precise micro-movements of tiny instruments inside a patient’s body. These micro-movements allow for improved procedure outcomes and less postoperative downtime for patients; however, the opposite has occurred for some individuals.
The FDA received over 245 adverse event reports related to the da Vinci Surgical System between January 2000 and August 2012, and many others have not yet been submitted. Originally approved by the FDA in 2000, it was used in an estimated 350,000+ procedures in the past year, and there are roughly 2000 of the devices available in the US in many health care centers. But problems caused by devices such as the da Vinci System are often reported late or not at all.
A study published in the Journal for Healthcare Quality in 2013 found that of the 245 adverse event reports received, 71 were deaths and 174 were nonfatal injuries due to use of the device. One nonfatal incident involved patient Erin Izumi. She underwent robotically assisted surgery to treat endometriosis. The operation was performed at St. Joseph Medical Center in Tacama, WA, and dragged on for nearly 11 hours. Ten days after undergoing this operation, Ms. Izumi was rushed to an emergency room, where doctors discovered that her colon and rectum had been torn during the operation. She underwent a series of procedures to repair the damage over the span of 5 weeks, including a temporary colostomy.
The FDA is responsible for assessing products based on device-related complications. If there is a malfunction, hospitals are required to report incidents to the manufacturers of the devices and they in turn report to the FDA. One of the study’s authors, Dr. Martin A. Makary, stated that while the future for robotic surgery is promising, there is a gray area when it comes to assessing the difference between doctor and device error. Benefits from the use of the device may be inconsistent. Robotic surgery has shown advantages when it comes to head and neck surgery; however, there is not necessarily a stark difference between conventional laparoscopic and robotic-assisted surgery when used for gall bladder removal.
The number of adverse events being reported with connection to the da Vinci System, while important, is not significantly high. Given the span of time and number of procedures that have been performed since its inception, the number being reported isn’t necessarily the issue, but the number of events that are not being reported is. A free flow of information is necessary to improve methods, procedures, and most importantly, safety.
By offering surgeons better tools to tackle the tasks at hand, less time is spent under the knife, and the incidence of potential mistakes is minimized. The advancements made in the last decade have been forward thinking, in both design and function. Robotics and other technologies have a great potential for use in many different areas of health care. We now have mechanical aortic valves, better prosthetic options, contact lenses to detect glucose levels, and more. As with almost anything new, there is a learning curve, and with time, improvements are made and technologies evolve. Therefore, the unfettered distribution of information during the development and during the use of new devices is necessary for their improvement and for increased patient safety.
- da Vinci Surgery website. http://www.davincisurgery.com/.
- Kaiser Health News, Evans M. Mishaps and deaths caused by surgical robots going underreported to FDA. PBS Website. November 1, 2013. http://www.pbs.org/newshour/rundown/mishaps-and-deaths-caused-by-surgical-robots-going-underreported-to-fda/.
- Lowes R. Complications of robotic surgery underreported, study says. Medscape website. September 5, 2013. http://www.medscape.com/viewarticle/810490.
- Rabin C R. New concerns on robotic surgeries. New York Times website. September 9, 2013. http://well.blogs.nytimes.com/2013/09/09/new-concerns-on-robotic-surgeries/?_php=true&_type=blogs&_r=0.