Surgeries involving malfunctioning robots have led to the death of more than a hundred patients in the past 14 years, according to an analysis of health records from the U.S. Food and Drug Administration (USFDA).
In a study featured in the servers of arXiv, a team of researchers from the Rush University Medical Center, the University of Illinois and the Massachusetts Institute of Technology (MIT) examined data of robotic surgeries collected from the records of the USFDA, known as the Manufacturer and User Facility Device Experience (MAUDE).
They discovered that surgical procedures that featured a robotic surgeon resulted in the death of 144 patients, from 2000 to 2013. While some types of robotic surgeries are considered to be riskier compared to others, procedures that involved the patients' head, neck or chest (cardiothoracic) are shown to be nearly 10 times riskier than other forms of surgical operations.
The findings also showed that between 2007 and 2013, the number of robotic surgeries in the United States has significantly increased, with patients undergoing over 1.7 million surgical procedures that featured robot surgeons. Many of these recorded surgeries were conducted in urology and gynecology.
Rush researcher Jai Raman and his colleagues noted that these operations were carried out even without a comprehensive study on the safety of prospective patients and the reliability of robot surgeons.
In their analysis of MAUDE records, the researchers found adverse events during robotic surgeries that they arranged into five different categories.
These categories involved surgery equipment sparking in the middle of the procedure, which led to the burning of 193 patients from 2000 to 2013, and instances where pieces of broken or burning equipment falling on the body of the patient, which happened 100 times and even resulted in the death of one individual.
Another category the researchers discovered the uncontrolled movement of surgical instruments, which led to the injuring of 52 individuals and the death of two patients.
Errors in the system, such as the sudden loss of the video feed during procedures, led to nearly 800 of the adverse events found by Raman and his colleagues.
Despite containing reports of the 144 patient deaths during robotic surgeries, the MAUDE database had the detailed accounts of only a small fraction of the procedure. More than 60 percent of the incidents cited, however, involved malfunctioning devices, while the rest of the cases were caused by errors on the part of the operator and other risks inherent to surgical procedures.
The fact that some types of surgical procedures are riskier compared to others is being viewed as a cause for concern for patients.
Raman said that the high number of patient death or injury for head, neck and chest surgeries could potentially be explained by the increasing complexity of the procedures, the infrequent use of robotic instruments and the inadequacy of experience in using robotic devices for such operations.
The results of the multi-organizational study are published in the servers of arXiv.
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