A cloud-based software service that searches, reports and analyzes medical device recalls and adverse events has been launched by Device Events LLC (York, Pa.)
“The FDA started accepting adverse event reports in late 1991, but the majority of the 5.8 million reports have been submitted in the last 15 years,” company founder and CEO Madris Tomes tells The Aesthetic Channel. “Prior to 2002, there were only about 350,000 adverse event reports total. In recent months, though, the FDA has received roughly 70,000 reports per month.”
Furthermore, the publicly available recall data shows 12,158 recalls. “However, I do not know if there are recalls that were not made public, but we provide access to anything made publicly available,” says Tomes, who previously worked for the FDA and CMS.
“With the growing number of adverse events reported to the FDA each month, it has become increasingly clear that a powerful search and analytics tool is vital in the marketplace,” Tomes says.
With the Device Events service, data can be filtered in many different ways. For instance, the user can search for breast implant reports on saline-filled or silicone breast prosthesis.
“Within that search result, you can also view all the reports submitted by physicians, or by the device company’s risk manager,” Tomes says. You can also search by model or brand name, as well as by limiting reports to certain keywords like lymphoma or seroma.
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Access for AEs
With more than 70,000 adverse event reports per month, “it is vital that they are made available to the public,” Tomes says. “The FDA simply does not have the staff needed to read every single report.”
Tomes notes that adverse event reports are often read in order of importance: death reports first, followed by injuries, then malfunctions.
“When a death report is misclassified as a malfunction or injury, it can take an inordinately long amount of time for the FDA to identify the true nature of the report,” Tomes says.
The service is used by hospitals and physicians to identify suspect devices and weigh less risky options. It is also employed by law firms to determine if a device company has a large numbers of deaths and injuries that may have been under-reported or if certain side effects are not on the device’s label.
The subscription-based tool costs the typical customer $30,000 annually to purchase five licenses (five users).
“The FDA takes 2 months to 2 years to take action on a pattern of adverse events,” Tomes says. “We make this data available immediately, so that physicians, patients and hospitals can make care decisions on their own, rather than waiting for the FDA to take action.”
Learn More about Device Events.
