In January 2016, the FDA announced its plans to take a more aggressive approach to informing the public on medical device safety risks, specifically the speed in which information is prepared to be released.
Current Medical Device Risk Warning Methods
Presently, the FDA creates benefit-risk documents for all medical devices after clearance that are distributed to anyone who may come in contact with the device, including consumers, patients and medical professionals. When these devices spend time on the market, often times new information is discovered which can significantly change these benefit-risk documents. While the FDA certainly investigates these emerging post market medical device signals, their new approach looks to more quickly communicate important changes.
New Medical Device Risk Warning Methods
The FDA's new communication format looks to have staff members reviewing important medical device updates within 30 days of receiving them. Once they have determined whether or not there is cause for concern, the FDA will provide updates so the public can stay well-informed instead of relying on potentially inaccurate benefit-risk documents.
The FDA emphasizes that these updates will include inconclusive, emerging signals, to ensure consumers know about potential risks ahead of time, hopefully enabling patients and medical professionals to choose alternatives until the FDA has time to fully investigate.
Why the FDA is Changing Their Strategy
The FDA wants to make sure that those affected by medical devices are the first to know when new information is discovered or being analyzed. As stated in the FDA's public notice:
"We believe there is a need to notify the public about emerging signals that the Agency is monitoring or analyzing, even when the information has not been fully analyzed, validated, or confirmed, and for which the Agency does not yet have specific recommendations."
Because information about medical devices can change rapidly after market exposure, it was determined that keeping consumers informed, even on unofficial information, is beneficial in case potential issues become real issues.
What This Means for Consumers
As a consumer, you're going to have access to more emerging medical device information. It's important that you recognize that these “signals” may not be conclusive or entirely accurate, but rather preliminary information about unproven risks being investigated. The FDA offers a Medical Devices Database that allows users to access a large quantity of important information regarding different types of medical device risks. Be sure to discuss with your doctor any information you discover, or any actions your doctor suggests based on this information.
If you're concerned that you've been a victim of personal injury involving a medical device risk, we're here to help. Call Lipkin & Apter at our Chicago office at (312) 624-9342 or contact a personal injury attorney.