Right now, if something goes wrong with a medical device like a hip replacement system, diagnostic tool, or surgical device, patients, doctors, hospitals and medical centers are supposed to report it through the FDA’s adverse event reporting system.
Critics have reported that this system is inefficient and may prevent the FDA from timely identifying a safety problem. In many cases, devices that were injuring patients remained in use anyway because the FDA was too slow to respond and protect the public.
Now, a new study suggests that the outdated system for tracking adverse event reports needs to be updated. The New England Journal of Medicine recently published a study that found that active surveillance of medical devices identified potential safety problems more quickly than the current system of voluntary adverse event reporting.
Active Surveillance Reveals Significant Risks with the Mynx Vascular-Closure Device
The researchers embarked on the study because of concerns about the current voluntary reporting system. Under the current system, regulators must rely on the voluntary reporting of adverse events, which has shown to be less than optimal. Researchers wanted to find out if active surveillance would have better results.
Using an integrated clinical-data surveillance system, the scientists compared the safety of a Mynx vascular-closure device, compared to an alternative vascular-closure devices. These devices are used to seal off small punctures or holes made in an artery after an angiogram. The FDA approved the Mynx for sealing off femoral arterial access sites.
Researchers were looking for complications that resulted from using the device, including bleeding problems, swelling, and other complications requiring treatment and/or repeat procedures.
Notably, there have been reports linking the Mynx device to a higher rate of bleeding problems than other similar vascular-closure devices. The researchers analyzed data from over 73,000 patients who had received Mynx devices between January 1, 2011 and September 30, 2013. They found that the Mynx was associated with a significantly greater risk of complications than other comparable devices. It was also linked with a greater risk of access-site bleeding and blood transfusion.
Automated Web System Detects Safety Problems Faster
The researchers used an active surveillance system, one that used an automated web-based system called the DELTA (Data Extraction and Longitudinal Trend Analysis) to analyze the data. This system links open-source database management with statistical analysis tools, and is designed to find potential safety signals in various clinical settings. This study found that this active surveillance system was more efficient at detecting problems than the current voluntary system.
According to the researchers, the active surveillance of a clinical registry “rapidly identified potential safety signals among recipients of an implantable vascular-closure device, with initial alerts occurring within the first 12 months of monitoring.”
“The takeaway is we were able to detect a safety signal fairly quickly,” said researcher Michael Matheny. “When it comes to post-market safety surveillance for medical devices, you have to be really timely in your safety alerting for it to matter. In our world, nine months is quick enough that if you could get the signal to the FDA, they could act on it.” He also noted that the DELTA system is freely available as open-source software, and can be adapted to survey medical devices and drugs.