Federal law requires hospitals to report any serious injury which was potentially caused by a medical device to the manufacturer of that device within 10 days the injury occurred. Hospitals are also required to notify both the manufacturer and the Food and Drug Administration (FDA) of any deaths that may have resulted from a medical device injury. Once a manufacturer receives information of an injury or death of one of their devices, they are also required to file a report with the FDA.
However, the FDA recently announced that 12 hospitals in the United States failed to file reports of deaths and/or injuries in a prompt manner. Some of the medical devices cited in the FDA’s announcement included EKGs and in vitro tests, imaging machines, implants for joint and organ replacements, infusions pumps, robotics, and ventilators.
The agency examined data from 17 different hospitals and medical centers across the country. Six of those facilities failed to properly report patient fatalities and injuries which were linked to medical devices within the 10-day requirement. Five other facilities failed to report serious injuries in a timely manner. Several of these facilities are considered world-renowned hospitals, including Massachusetts General Hospital in Boston, New York-Presbyterian Hospital, Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center.
Also discussed in the FDA’s announcement was information regarding a Senate investigation earlier this year citing the failure of many hospitals across the country that contributed to superbug outbreaks from contaminated duodenoscopes. Mistakes by the makers of these devices were also cited in the Congressional report. More than 350 patients have been exposed to contaminated duodenoscopes.
If you have been injured by a defective medical device, or have lost a loved one due to a medical device injury, contact a skilled Virginia medical malpractice attorney to find out what legal recourse you may have against the medical facility and/or the device manufacturer for your pain and loss. It is important to note that under Virginia law, there is a time limit to filing a medical malpractice suit so it is critical to contact an attorney right away.