According to a Senate report released on January 13th, serious infections have been linked to a medical device known as “closed-channel duodenoscopes”—long tubes fitted with cameras used to examine the small intestine—because of how difficult these devices are to clean. These devices have now been linked to hundreds of antibiotic-resistant infections worldwide over the last three years.
Who Is At Fault?
Legislators are now looking for answers from manufacturers, who are supposed to report any and all potential complications which could have led to serious injury or death to the Food and Drug Administration (FDA) within 30 days of learning of them. However, the FDA appears to only have been informed of about half of these incidents. Specifically, it appears that the manufacturer knew of their potential to transmit bacteria as early as 2013 but did not inform the FDA until less than a year ago.
Yet, can all the blame be placed on the manufacturer? According to some Senators, some of the hospitals were delayed in notifying patients about the dangers associated with the device, and the FDA also did not act quickly enough once it caught wind of the negative reports. Hospitals are required to notify the manufacturer if/when a serious illness develops and the FDA in cases where a patient died. According to the report, many hospitals traced infections to the devices but they did not raise alarms with federal regulators.
Regardless of this report, however, the FDA still has not evaluated the devices or implemented a recall, meaning that they are still out there being used on some patients. The report has also called for these types of devices to be included in insurance claims so that manufacturers can more easily link particular outcomes to particular devices and the establishment of a national medical device evaluation system so that potential dangers can be identified beforehand and not simply after they’ve taken place and been reported.
When medical devices hurt people and a variety of parties—including the manufacturers, doctors, and hospitals—act negligently in addressing the issue, lawsuits can be filed against each of the parties for their contribution to any complications, injuries, and/or death. Some of these bacterial infections can be life-threatening and bring about additional surgeries and even permanent disabilities. Many of these devices are also lacking in warnings and/or instructions, and sometimes aren’t even properly tested before being placed on the market.
If you or a loved one has suffered after being misinformed (or not informed at all) about the dangers associated with a medical device, surgery, or other medical procedure, you can count on the attorneys at Dana & Dana to aggressively fight for your rights. Contact us for a free consultation today so that we can get started evaluating your case.