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few months ago, I read a press release about the 510(k) U.S. Food and Drug Administration’s (FDA’s) clearance of a new device to treat a very common ENT disorder. The current gold standard treatment for the disorder is a short surgical procedure that has a low-risk profile but does require general anesthesia. The release stated that the current surgical treatment requires two weeks or more off of work for about 40% of patients. This number may not have stood out to readers outside of otolaryngology, but it raised my suspicion. When I looked at the referenced article, it was from an ENT journal that was published almost 25 years ago. I just could not resist reading the article to find out if this was the real published statistic.
You most likely already know where this story is going, but—SURPRISE—this was not the accurate statistic for return to work for the referenced procedure. In fact, 75% of patients returned to work in two weeks or less, and 25% returned to work in one week or less. The referenced study was a post-op survey mailed to patients, of whom only 40 completed the survey, so it’s difficult to truly know the typical return to work worldwide after this procedure. I did a little more research, and this same article was cited similarly for many articles about this device. Now, this device may be the best new thing to happen in our field in decades, but, just like when reviewing a manuscript in which the conclusions are overstated at least, I started to become suspicious.
What does 510(k) FDA clearance mean? It sounds fancy. It sounds like the FDA has thoroughly reviewed the clinical effectiveness and safety data and the new device has proven to be effective in the treatment of the specific disorder; however, it’s important to understand that 510(k) clearance does not require the independent demonstration of safety and effectiveness that is required for premarket approval. The 510(k) review standard is comparative, meant to determine if a new device is substantially equivalent to a device that is already on the market (a predicate device). This pathway aims to reduce the cost and time required for FDA approval of low-risk devices.
What this means for providers is that we must do our own due diligence when we introduce a new device to our patients. We need to understand the risk-benefit profile compared to our current gold standard. To do this, we have to be able to see the outcome data of the new device compared to our current treatment. Additionally, we need to understand the correct patient selection for the new technique. For some ENT devices, I have seen that instead of selecting a beachhead market and calculating the total addressable market, the company seems to target all people with a particular symptom instead of the patients the device is most likely to treat effectively. Cost is another important consideration. Does the new device reduce cost with the same outcome or increase cost but with an improved outcome? If not, then it’s not a viable new device. No one better understands the care and treatment of head and neck disorders than our community. Therefore, we play a vital role in how new devices are introduced to our patients.
—Robin