The Scope Of The Problem

The U.S. Food and Drug Administration is charged with ensuring the safety and effectiveness of medical devices in the United States.  The FDA regulates more than 1,700 types of devices, 500,000 medical device models, and 23,000 manufacturers.  The FDA relies almost exclusively on industry device testing and passive device surveillance reporting to assess the safety and reliability of the medical devices it regulates.  In addition, the agency receives significant funding from the medical device industry to bolster its staff and expedite the review process for new device applications.  Other research organizations that are often hired to run clinical trials or analyze data also receive the majority of their funding from industry. 

Medical devices are becoming increasingly complex and play an important role in the treatment of many patients.  In fact, more than 4% of the U.S. population has an implanted medical device and some form of device is used for almost every patient encounter.  The total global medical device industry is approximately $130 billion dollars with almost half the global production and consumption occurring in the United States alone. 

Unfortunately, FDA approval of a medical device does not always ensure the devices' safety and reliability and, in fact, more than 500,000 medical device malfunctions have been reported to the FDA since 2000.  Numerous cases of faulty medical devices exist.  For example, more than 60 product recalls involving hundreds of implantable pacemaker and defibrillator models affecting more than 1 million patients have been issued since 1990.

MDSI works to improve the safety and reliability of medical devices for patients.