By Anna E. Mazzucco, Ph.D.
February 21, 2014
My name is Dr. Anna Mazzucco, and I thank you for the opportunity to speak today on behalf of the NationalResearchCenter for Women and Families. After completing my Ph.D. in at Harvard Medical School, I conducted research at the National Institutes of Health. Those are the perspectives I bring today.
Our nonprofit organization conducts research, analyzes data from the research literature, compares the risks and benefits of medical products, and also explains the evidence so that it is understandable to patients and providers. Our president is on the Board of Directors of the Alliance for a Stronger FDA, which is a nonprofit dedicated to increasing the resources that the FDA needs to do its job. Our organization does not accept funding from medical device companies, and therefore I have no conflicts of interest.
Class III devices are defined by “potential unreasonable risk of illness or injury”. Based on that definition and the information that was provided to the committee and the public for this meeting, we are convinced, as FDA was for 2 decades, that iontophoresis devices are Class III devices that should be reviewed under the more rigorous PMA process.
The MAUDE reporting system lists 83 serious adverse events for these devices, including 33 second degree and 12 third degree burns. The severity of 35 of these burns were not specified.
Obviously, 83 reports isn’t that impressive, but we all know that this is the tip of the iceberg since reporting by physicians and patients is voluntary and very rare.
Perhaps more important, the MAUDE database only includes data for 49 of the 63 existing devices. This could mean that some of these devices are much safer than others. Patients and physicians deserve to know if their chances of burns are much lower with some of these devices compared to others. MAUDE reports can’t answer that question. The only way to know is to require clinical trials. Patients deserve to know that these devices have been carefully tested in studies, rather than being informally tested on the patients who buy them.
Changing the classification from class III to class II means 3 things:
- Companies making new models of iontophoresis devices will never have to demonstrate safety or effectiveness of their devices. They will only have to show that their devices are substantially equivalent to other devices already on the market – and they can get clearance by proving that their device is substantially equivalent to a device that has caused serious burns in other patients. In fact, a new device could be cleared if it is substantially equivalent to the worst iontophoresis device currently on the market.
Without PMA safety data, we will never have comparative safety research to determine which of these devices are most likely to burn patients. By notrequiring proof that the new device is itself safe and effective, we could be asking patients to take unnecessary risk.
2. As a Class II device, these manufacturers would NOT be subject to inspections BEFORE the devices go on the market. This is an important difference, because inspections help make sure that the devices are being made as the manufacturer claims. In 2005, improperly installed electrodes caused a second degree burn and resulted in a recall of one of these devices. The malfunction reports in the FDA summary caused electrical shocks and burns. 29% were attributed to the device itself, and most of the rest did not specify the cause of the malfunction. While we would hope that most companies would manufacture these devices very carefully, human error can be expected in some manufacturing facilities. Without pre-market inspections, serious problems will not be determined until after patients have been harmed due to defective electrodes or circuits.
3. As a 510k device, even the most dangerous device can’t have approval rescinded. It can only be subject to recall. This is another safeguard that would be lost if these devices are down-classified to Class II.
Special controls can require safety studies. However, special controls cannot provide the other 2 important safeguards I mentioned, namely pre-market inspections and withdrawn approval.
I would not want to have to rely on a high-risk product that was not specifically tested for safety and effectiveness, and inspected to make sure it was made correctly. Retaining Class III status is the best way to protect patients from preventable burns from these devices.