Endoscopy tools, including power morcellators, have come under investigation by the Department of Justice (DoJ). This is after various complaints have been received that have shown a link between medical scopes and infections. The DoJ has issued four subpoenas in total but more similar stories continue to emerge.
“The widening problem is sure to ratchet up pressure on the Food and Drug Administration and scope makers to better address concerns about patient safety. Both regulators and the companies have been under fire for ignoring earlier warnings on the infection risk.”
Three subpoenas have been sent to device manufacturers and one to a Seattle hospital. Additionally, the FDA has sent out a number of warning letters on endoscopy devices. It is believed that the DoJ subpoenas went to the manufacturers, which are Pentax, Fujifilm and Olympus Corp.; and to Virginia Mason Medical Center. However, these details have not been officially confirmed. Except that both Virginia Mason and Olympus have publicly announced that they have received subpoenas.
It is possible that the investigation will eventually lead to criminal charges. It was launched after various duodenoscope hospital infections broke out, most notably the CRE (carbapenem-resistant enterobacteriaceae) infections at UCLA’s Ronald Reagan Medical Center in February of this year.
“The UCLA Health System notified 179 patients on Feb. 18 that they may have been exposed last fall to the carbapenem-resistant enterobacteriaceae (CRE) bacteria during an endoscopic procedure to diagnose and treat diseases of the liver, bile ducts and pancreas at Ronald Reagan UCLA Medical Center. A total of seven patients were infected; the infection was a contributing factor in the death of two patients.”
Besides the seven infections and two deaths, it was believed that at least another 200 individual patients were at risk of being infected with CRE. All these patients had been treated using duodenoscopes that the hospital purchased through a single manufacturer: Olympus Corp. Further research is being conducted into how and why these infections are happening.
It is believed that the infections may be caused by issues that exist within the ‘reprocessing’ instructions in the medical scope. This is basically the procedure that is used before a certain medical item is used on a different patient. Usually, in endoscopic retrograde cholangiopancreatography (ERCP) procedures, equipment is reused after having been thoroughly cleaned. There is now reason to believe that this cleaning is not effective.
In the subpoenas, it appears that the main focus is on the communication between the manufacturers of the device and the Virginia Mason hospital. The hospital’s attorneys have made statements to the media, in which they have highlighted that the probe of the subpoena centers around possible health care offenses. Meanwhile, Virginia Mason has teamed up with the surviving relatives of patients who died due to infections following medical scope procedure, as well as with patients who survived infections, and they have brought a lawsuits against Olympus Corp.
“Olympus failed to inform our organization about this safety risk associated with its product,” said Andrew Ross, the head of gastroenterology at Virginia Mason. “Their silence on this important issue was unethical, irresponsible and put patient lives at risk.”
Meanwhile, Olympus has filed their own counter lawsuit, targeting Virginia Mason in particular. In their lawsuit, they claim that the hospital did in fact not properly use or clean the devices, and that it is this negligence that caused the infection. They also claim that the hospital is making a targeted attack on the reputation of the Olympus Corp. by stating that the device would not clean properly if company instructions were followed.
Meanwhile, although Olympus claims that their name is being smeared by the Virginia Mason (and other) lawsuits, they have revised the cleaning instructions for their devices. The revision happened in March, after the FDA echoed the claims made by Virginia Mason, mainly that the endoscopy devices could not be safely cleaned if official instructions were followed.
“Olympus has issued new, validated manual reprocessing instructions for the TJF-Q180V duodenoscope to replace those provided in the original labeling. The FDA has reviewed these new reprocessing instructions and the validation data as part of its ongoing review of the 510(k), and recommends that any facilities that are using Olympus’ TJF-Q180V duodenoscope train staff on the new instructions and implement them as soon as possible.”
Recently, an advisory committee with the FDA found that manual cleaning continues to be very important and should always continue. However, they also made the recommendation to have duodenoscopes reclassified by the FDA to a critical medical device, instead of its current semi-critical status. In so doing, reprocessing will no longer be ‘high level disinfection’ but rather ‘full sterilization’.
Although these concerns are very real, it was also determined that ERCP procedures still have fantastic benefits that generally outweigh the risks of duodenoscope usage. This is why the FDA has been asked to create a best practices guide, so that medical professionals can properly follow manufacturers’ instructions, and so that better instructions are created overall.
Before the panel met, reviewers from the FDA released a report that showed the FDA was already aware of the fact that current cleaning instructions were inadequate. Additionally, it showed that there was a link between this and outbreaks of infections. However, no warning was issued until February.
Olympus is now facing a number of different lawsuits and it is important that consumers know who to turn to if they fear they been infected by a duodenoscopic procedure. The difficulty, however, is that there is no clarity on how these cases are going to go, since the manufacturers claim they are not at fault, and the FDA claims they are not at fault either. Some are now suggesting that lawsuits should be filed against the FDA, which is something the DoJ is also looking into.