As more and more advancements are made within the medical field, technology continues to improve. While many of these newer tools provide doctors and healthcare professionals with much needed support and enhanced skills, some can result in more harm than good when they are not properly tested.
That is what many believe has happened in a recent case involving an Olympus duodenoscope that is used to check out ducts in the gastrointestinal system. The company started selling the TJF-Q180V model back in 2010. This new model had several slight altercations to its design that were intended to help minimize risk for contamination. However, the new device caused contamination for several patients at Ronal Reagan UCLA Medical Center in Los Angeles. Furthermore, Olympus did not seek approval from the Food and Drug Administration for the changes they made to their scope. Now, several years later, the FDA finally took notice.
Though they never asked for clearance, Olympus put their updated duodenoscope on the market back in 2010. Many believe that this is an indication that the FDA needs to increase their policies and regulate medical devices more rigorously. However, Olympus claims that they believe the changes made to their device did not warrant requesting permission from the FDA. Still, the FDA states that a manufacturer must always seek clearance for a new model if it will include any changes that could affect the safety of the medical device.
OUTBREAK AT UCLA STIRS ATTENTION & CONCERN
The potential hazards with this unapproved device are not just hypothetical, but proven. As of now, seven hospital patients at the Ronal Reagan UCLA Medical Center have been infected with the deadly superbug CRE (carbapenem-resistant Enterobacteriacea). The infections are assumed to have taken place between October of 2014 and January of 2015. Sadly, two of those infected patients died.
According to reports, all of the patients caught to the superbug after undergoing routine endoscopic treatments. UCLA hospital officials state that they suspect that two of the medical scopes used still carried the deadly bacteria-despite the fact that the proper disinfection guidelines were followed.
There were roughly 179 other patients who underwent similar endoscopic procedures with some type of scope between the same time frame. In response, the hospital has offered home tests to screen for the bacteria. In addition, four patients at Cedars-Sinai Medical Center in Los Angeles have been infected with the superbug following the use of a contaminated duodenoscope, causing growing concerns amongst both medical professionals and manufacturers like Olympus.
OLYMPUS’ CHANGES FAILED TO MAKE DEVICE SAFER
Though the company states that they made changes with the hopes of making the medical scope more impervious to carrying infectious bacteria, it appears that their efforts were not successful. Despite the fact that they sealed up certain parts of the device called the elevator channel in their new model to make it safer, they never sought approval from the FDA. Just last year, Olympus finally agreed to seek permission to sell the scope at the FDA’s request. The application for the new model is still pending, as the FDA assess the modifications in light of the recent superbug outbreaks.
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