A review of the Manufacturer and User Facility Device Experience database highlights the most common adverse event associated with medical devices.
A review of the Manufacturer and User Facility Device Experience (MAUDE) database highlights the most common adverse event associated with medical devices.
Adam Wulkan, M.D., a fellow at Massachusetts General Hospital in Boston who spoke at the American Society for Laser Medicine and Surgery annual conference last month in Dallas, presented findings from an analysis he conducted on adverse events associated with cosmetic medical devices.
The analysis is based on a review of MAUDE records from Jan. 1, 2014 to Oct. 1, 2017 for adverse events associated with seven noninvasive body contouring devices: cryolipolysis, 1060 nm diode hyperthermic laser lipolysis, high intensity focused ultrasound, 1440-nm pulsed laser, high frequency ultrasound, vacuum-assisted subcision and radiofrequency.
“Overall, these are all relatively safe devices when used properly. It is a highly competitive market for device manufactures, filled with devices that are revolutionizing the field of noninvasive body contouring,” he said.
Even though it is the most prominent database of its kind in the U.S., few physicians, manufacturers and patients use it, which may explain why so few adverse events have been recorded on MAUDE.
The analysis was associated with a number of limitations, including the tendency of adverse events reported by patients to be vague. While patient participation can be insightful, it’s not necessarily informative since many patients treat MAUDE like an online product review website, instead of a mechanism by which to report adverse events directly to the U.S. Food and Drug Administration, which manages MAUDE. More physician users would be beneficial, Dr. Wulkan said.
“Physician education about the existence of this database hopefully will initiate further interest in contributing to that growth. The more information manufacturers and clinicians have about these devices and their safety, the higher quality of care we can provide to our patients,” he said.
While not statistically significant, the findings were insightful. “It is critical to correlate the number of adverse events with the popularity of the device. One should anticipate that the more a device is used in practice, the greater the number of adverse events that may occur,” Dr. Wulk said.
Adverse events by treatment type
1060 NM DIODE HYPERTHERMIC LASER LIPOLYSIS
HIGH INTENSITY FOCUSED ULTRASOUND (HIFU)
1440-NM PULSED LASER
HIGH FREQUENCY ULTRASOUND