The findings of a new report suggests that active surveillance of medical devices would help identify problems more efficiently than the current voluntary adverse event reporting system used in the United States.
A study recently conducted with funding by the FDA, compared the outcomes of a strategy of active surveillance of postmarketing data and usage of medical devices, specifically implantable vascular-closure devices, and compared that to the FDA Adverse Event Reporting System (FAERS).
Researchers sought to determine which was better at identifying safety signals and differences in how the devices performed in real-world settings, as compared to clinical trials. The findings were published on January 25 in the New England Journal of Medicine.
An active clinical data system, known as DELTA (Data Extraction and Longitudinal Trend Analysis), was used to monitor clinical registries and other sources to monitor the implantable vascular-closure device known as the Mynx, which places a gel on the surface of the artery to seal it.
Despite existing data and registries that suggest the Mynx is linked to a higher rate of bleeding problems and the need for repeat procedures, it’s use has been increasing, according to the researchers.
By analyzing active surveillance data on 73,124 patients who had received the Mynx from January 2011 to September 2013, researchers were able to determine that it was associated with a significantly greater risk of any vascular complication than alternative devices. They also found a significantly greater risk of access-site bleeding.
Using active surveillance instead of adverse event reports, the risks were discovered within the first 12 months of monitoring.
“Medical devices have revolutionized health care, but assurance of their postmarketing safety relies on voluntary reporting of adverse events,” researchers noted. “This system has resulted in incomplete ascertainment and an inability to evaluate the safety of medical devices in an active, prospective fashion.”
According to the study, the FDA has made a priority of the evaluation and implementation of a system that would continuously monitor large clinical data sources, instead of relying on voluntary reporting.
Concerns Over Reporting of Medical Device Adverse Events
In recent years, the FDA has faced criticism over its approval of medical devices before health risks are known, and its inability to quickly inform the public about emerging risks once they are discovered. However, the FDA is hindered by reporting of such incidents.
Adverse events are generally first reported by either a medical professional who witnesses a problem occurring with a patient, or by the patients themselves. Often, these are reported to the manufacturers, who then are legally obligated to pass along that information to the FDA in a timely manner. However, a number of recalls and medical device adverse events have revealed that manufacturers do not always meet their reporting requirements.
Additionally, reporting of adverse events is voluntary, and it is estimated that only about 10% of adverse events are actually reported to the FDA by consumers or medical providers.
Tags: Medical Devices