From the Boston Globe:
Despite its plans to closely monitor deadly malfunctions and misuses of medical devices through a new computer reporting system, the Food and Drug Administration has frozen the project in place well short of its goal of connecting 500 hospitals.
The system, known as MedSun, allows doctors nationwide to directly report to the FDA problems with pacemakers, stents, and defibrillators. The FDA had aimed to connect 500 of the nation’s 5,000 eligible hospitals, but is stuck at 350 and won’t fund further expansion for the next several years.
That means more doctors are using an older system, through which they report problems to manufacturers, who then notify regulators. Some fear the process allows device makers to downplay bad news to the FDA.
The FDA estimates that problems with medical devices cause 300,000 deaths and injuries annually.