As I noted last month, surgeon training is one of the issues that was debated in the various product liability lawsuits that were filed against Intuitive Surgical in recent years. This begs the question: How much training should a surgeon complete before being handed the keys to a surgical robot?
In one of the Intuitive trials, the surgeon—who had performed only two proctored surgeries before operating on the plaintiff—testified that he wasn’t informed by Intuitive that competency on the da Vinci surgical robot was reportedly obtained after 20 or more operations were complete.
This is consistent with the findings of a recent study published on February 9th in JAMA Otolaryngology-Head & Neck Surgery, entitled Assessment of Surgical Learning Curves in Transoral Robotic Surgery for Squamous Cell Carcinoma of the Oropharynx. Researchers in that study found that although the learning curve for transoral robotic surgery (“TORS”) is surgeon-specific, “[i]nflection points for most learning curves peak between 20 and 30 cases.”
Because they returned a defense verdict, the jury in the Intuitive trial does not appear to have been swayed by the physician’s testimony. Nevertheless, in order to minimize litigation risk and ensure an added level of patient safety, manufacturers should make all reasonable efforts to tailor their training programs so that they are consistent with the prevailing expert views on the level of practice required before basic competency is obtained on a particular system. Given the unique complexities associated with emerging technologies like surgical robots, as well as jury unpredictability, the importance of carefully ascertaining physician learning curves cannot be overstated.