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Group Calls for Updated FDA Reporting System

A recent report shows the number of recalled medical devices continuing to increase. In response, many watchdog and consumer protection groups are aiming to make stricter requirements for medical devices.

A “cadre of insurers and other healthcare stakeholders” is urging the U.S. Food and Drug Administration (FDA) to “establish more registries to monitor and report performance” of medical devices being used in the U.S. market, according to MassDevice.com.

This cadre is requesting that the medtech registries be updated to enable more detailed information-gathering on devices that have been cleared or approved. Hence, this would help to ensure that complications resulting from the use or implementation of a faulty device would be recorded as soon as possible. This could help alleviate scenarios in which faulty medical devices are used, even after the first reports of failure.

Insurance companies are a significant portion of the cadre and are calling for a boosted reporting system. Insurance companies lose a significant portion of profit every year to implementation of defective medical devices. The Pew medical device director told MassDevice.com that with the current reporting system it often takes too long, and at the expense of patient safety, for medical professionals to discover that a medical device is faulty.

This is not the first time that a group of industry professionals has requested that the FDA overhaul its regulatory branch. In 2011, according to ConsumerReports.org, a panel from the Institute of Medicine made this recommendation, alleging that the current FDA system “fails to ensure patient safety before and after products go on the market.” ConsumerReports.org also noted how tens of millions of Americans have defective medical devices implanted in their bodies, and “that most of them assume that someone, somewhere, tested the devices for safety and effectiveness.”

If you or someone you know has experienced negative side effects or danger because of a faulty medical device, you may be eligible for compensation. Contact an Arlington Heights defective medical device attorney for a consultation today.

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