Author: Haley Lentz, Senior Sales Manager, Life Sciences
Several years ago, our team met with a medical device manufacturer to review the safety and quality profile for one of their devices. During the review, the individual noticed a device problem they had not reviewed in the past. They asked to examine the supporting adverse event report related to this specific device problem. We filtered through the list of adverse event reports by device problem to uncover the associated adverse event report and the individual exclaimed, “I had no idea that existed! Now I know what I am spending my weekend on.”
This type of occurrence is not unusual. While most device manufacturers have a solid understanding of the adverse event reports fielded through their quality management system, they are often unaware of those voluntarily reported to the FDA.
Health professionals, patients and consumers may submit an adverse event, quality issue, error or failure directly to the FDA. Voluntary submissions may be reported through an online form on FDA’s MedWatch site. Medical device manufacturers may never receive a report of these incidents. Manufacturers interested in reviewing voluntary adverse event reports must navigate FDA MAUDE, perform a search of all device products, manually read and review each adverse event report and then compare to internal quality management systems to discern whether or not the adverse event was reviewed.
To complicate matters further, MAUDE is not a standardized database. This means health professionals, patients and consumers may submit the voluntary adverse event report using a naming nomenclature that does not exactly match how the manufacturer identifies the device. Identifying information such as device model number, catalog number, lot number, serial number, expiration date, UDI and even manufacturer name are optional fields on the MedWatch Voluntary Report. This reporting structure means a manufacturer will need to search the MAUDE database for any product names that may be used to classify the adverse event report. The results may be varied and incomplete.
Fortunately, there is a better way for medical device manufacturers to control and monitor voluntary adverse event reports. Reed Tech Navigator™ for Medical Devices standardizes medical device data to facilitate easier quality and risk management and can provide proactive alerts of new voluntary adverse events. Navigator enables setting a watchlist for a specific product or group of products. As new events are reported, including Voluntary Adverse Events, Device Problems and Recalls, Navigator flags the event in an Alerts Inbox. With this automation, subscribers to Navigator can quickly understand safety and quality profiles among their own and competitor’s devices.
For more information on Reed Tech Navigator for Medical Devices, contact Haley Lentz at email@example.com.