FDA Proposes Early Warning System for Potential Device Safety Issues

The U.S. Food and Drug Administration (FDA) has issued draft guidance that outlines a system that would alert the public to possible safety issues with medical devices before the agency has investigated whether a serious risk actually exists.
 
The FDA currently issues press release, recalls, and safety communications to alert the public to concerns that arise after a device has entered the market. Historically, the agency has waited to release information about adverse events until it has investigated these issues and determined what to do about them.
 
However, after a year in which some patient advocates have raised questions about why patients were not informed earlier about issues potentially linked to medical devices, such as laparoscopic power morcellators, permanent birth control inserts, and mesh implants used to prevent female incontinence, the agency now “believe[s] there also 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,” according to a notice published in the Federal Register.
 
“Timely communication about emerging signals is intended to provide healthcare providers, patients, and consumers with access to the most current information concerning the potential benefits and risks of marketed devices, so that they can make informed treatment choices based on all available information,” the FDA said in the notice. “Such communication may also reduce or limit the number of patients exposed to the potential risk while the issue is being further evaluated.”
 
According to the draft guidance, the FDA will consider a number of factors when determining whether an issue should be identified as an emerging signal, such as:

• The seriousness of the adverse event(s)
• The likelihood of occurrence
• The strength of the evidence showing a causal relationship between using the device and the adverse event
• How broadly the device is used
• Whether the device is still manufactured and distributed
• Whether the issue disproportionately affects vulnerable patients, such as  children, pregnant women, the elderly, cancer patients, or people who are home or unmonitored
• The potential for preventing, identifying, monitoring, or mitigating the risk
• Whether other treatments or therapies are available
• How long it might take for the FDA to complete its assessment and develop recommendations