Patients in Louisiana who undergo surgical procedures assume their safety and well-being are top priority. However, in some cases patients have been gravely injured by surgical procedures, which can entail use of medical devices like duodenoscopes.
Bloomberg reports on links between certain types of duodenoscopes and dangerous infections that have spread to numerous patients. In 2012 up to 250 patients who underwent procedures using these duodenoscopes fell ill after being exposed to a so-called "super bug", and approximately 12 patients succumbed to their infections. Accordingly, many medical professionals have pointed to multiple issues in establishing the safety of medical devices, and have also implicated manufacturers for their failure to uphold patient safety.
For instance, Olympus (a manufacturer of duodenoscopes) was criticized for failing to alert the American medical community about certain design flaws that rendered the device difficult to sterilize (although the manufacturer did inform the medical community within Europe). There were also issues with the reporting of patient illness, with some hospitals neglecting the proper procedures when reporting potential issues. When reports were made, the U.S. Food and Drug Administration failed to recognize similarities between outbreaks, and therefore did not issue warnings regarding use of potentially problematic duodenoscopes.
According to the LA Times, patients are now taking legal action against Olympus for its failure to provide adequate warnings about any potential dangers. The family of one patient, who died after being exposed to antibiotic resistant bacteria, have recently filed a lawsuit alleging that Olympus intentionally withheld safety information in the interest of profits. Many other patients have followed suit, with some medical professionals claiming that the number of infections could become even greater as hospital injury reports are probed.