My name is Caitlin Kennedy, and I am a senior fellow at the National Research Center for Women & Families. I am reading this statement on behalf of myself and our President, Dr. Diana Zuckerman.
Our nonprofit research center does not accept funding from pharmaceutical or device companies, so we have no conflicts of interest. We scrutinize research to determine which medical treatments are safe and effective for adults and children. Our perspective is as scientists who are devoted to improving public health and from our president’s affiliation with the Center for Bioethics at the University of Pennsylvania.
Today’s goal is to decide whether nonthermal shortwave diathermy devices can be down-graded from a Class III to Class II. We agree with FDA scientists that the devices are not life-sustaining or life-saving, which is usually required for Class III.
But more importantly, we agree with FDA scientists and officials that in order to change the classification from Class III to Class II, FDA must have sufficient information to establish special controls that can provide reasonable assurance of the safety and effectiveness when using the device properly.
Does the FDA have that information? The answer is clearly no, because there is no evidence that these devices are safe and effective when used properly. There is very scant research on the safety and effectiveness of these devices, period.
These devices are used to treat postoperative pain and edema in the superficial soft tissue. It is crucial that the benefits outweigh the potential risks.
There are 6 valid randomized controlled trials. There was no evidence for the devices’ effectiveness for postoperative edema. There was also no commonly used or validated measure of postoperative edema.
Two pain studies found no benefits and 1 study found questionable results.
Three studies reported benefits, but these studies did not adequately describe their pre-specified primary endpoints, analysis methods, or adjustments for multiple analyses.
Also, these 3 studies examined pain following breast surgery only.
Given these shortcomings, no conclusions can be drawn about whether these devices are effective.
Are they safe? None of the 6 studies systematically measured and recorded adverse events.
This means that the safety of the devices also has not been established. Although there are only a small number of adverse event reports to the MAUDE database, we agree with the FDA conclusion that these adverse events are likely being under-reported, and that is consistent with most medical devices.
The FDA explains that a device can be Class II only if “General and special controls are sufficient to provide reasonable assurance of its safety and effectiveness.” Those critieria are not met. There is insufficient evidence of these devices’ safety OR effectiveness, despite these products being sold for more than 30 years.
The FDA’s own summary on this topic stated, “…The limited safety data do suggest that even low power SWD devices may cause injury if not used properly. The available studies are not adequate to establish a reasonable assurance of safety of SWD for the cleared indications.”
In summary: General and special controls cannot compensate for a lack of safety and effectiveness evidence.
Instead of doing the necessary studies, the companies that make these devices have used their resources to pressure the FDA to downclassify these devices. This could harm patients, because there are other treatments that are proven safe and effective.
That is why downgrading to Class II is NOT justified.
Last year, the FDA recommended keeping these devices as Class III. They were pressured to change their minds as so often happens, but you can see that the scientists have strong concerns about changing to Class II.
By requiring a Premarket Approval (PMA), companies that want to sell these products will finally be required to prove that their products are safe and effective. It’s about time.
Patients and their physicians deserve evidence that these devices are safe and effective. Please urge the FDA to keep these devices as Class III devices.