The Association of Trial Lawyers of America (ATLA) is urging the Food and Drug Administration (FDA) to adopt stricter standards for tracking medical devices.
The U.S. Food and Drug Administration recently released a proposal for improving detection and reporting of problems once pacemakers, implantable cardiac defibrillators, and thousands of other medical devices are on the market and being used by patients.
These new standards may make it easier to determine whether devices are malfunctioning and may save many lives. In the past two years, many heart devices have been recalled because they were not functioning properly. If this sort of tracking had been in place, many people would not have had defective implants in the first place, because the FDA could have identified the trend of malfunctioning much sooner.