FDA Flirts with the Learning Curve

In FDA’s recent announcement on robotic surgery for various cancers, the agency raised the little-discussed issue of surgeon skill and the role of experience in building that skill. In general, we would expect that reasonably talented surgeons would get better as they performed more procedures, even though they might start off a little bit rough. This improvement would be expected to be reflected in better outcomes and fewer complications. We might also expect that the improvement would plateau after some number of procedures, with that plateau preferably being at a decent level of performance. What has only been rarely studied is how many procedures of a particular kind must be done before a surgeon reaches an acceptable level of proficiency. Also little studied is how much variation there is among surgeons. There are the related questions of outcomes for early patients and what kinds of disclosures should occur. In addressing the robotic-surgery-for-cancer question, FDA recommended that patients ask surgeons about their training, experience, and patient outcomes with robotically assisted surgical device procedures; how many robotically assisted surgical procedures like the patient's a surgeon has performed; and possible complications and how often they occur. The latter question has two parts, one being complication rates across all surge...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news