Superbug Outbreak Blamed on Unapproved Medical Devices

March 6, 2015, 3:45PM. By Gordon Gibb

Washington, DCIn a telling statement as to the effectiveness of medical device oversight and adherence (or lack thereof) to long-held guidelines and approval tenets, the manufacturer of a product used in duodenoscopy managed to vend its device to the medical community for more than three years before anyone realized the device did not carry proper clearance by the US Food and Drug Administration (FDA). The resulting CRE Superbug Outbreak at UCLA Ronald Reagan Medical Center (RRMC) made seven patients seriously ill. Two died.

Health advocates are openly wondering how a medical device manufacturer could have assumed that a device could be sold and deployed in the health care field without approvals. Critics also wonder how the FDA somehow missed noticing the presence of the unapproved device for a period that lasted longer than three years.

According to a CNN report (3/5/15), the medical device manufacturer Olympus introduced the TJF-Q180V duodenoscope - for use in endoscopic procedures - in 2010. The device was used, presumably without incident, until reports began to surface at RRMC of patients contracting the so-called CRE Superbug. The latter is specifically described in medical terms as carbapenem-resistant Enterobacteriaceae, a potentially deadly infection. At RRMC, seven patients became infected and two had died before the hospital began to suspect the device. It was thus determined that the device was not properly approved by the FDA in the first place.

Dr. Steven Nissen, the chief of cardiovascular medicine at the Cleveland Clinic and a noted cardiologist often consulted for his views on the state of the medical and pharmaceutical drug industry by media and government, is appalled. “Can you imagine a prescription drug getting out on the market that didn’t go through the approval process? Devices need to be regulated more vigorously. This is really disturbing.”

In addition to the infections at RRMC, four patients at Cedars-Sinai Medical Center in Los Angeles came down with the CRE Superbug in a suspected association with infected duodenoscopes during procedures that occurred between August 2014 and January of this year. An additional 64 patients known to have undergone routine endoscopy with those particular duodenoscopes have been contacted. Back at RRMC, CNN reports that the center contacted 179 additional patients who underwent endoscopy procedures using the particular Olympus duodenoscope between October of last year and January of this year, offering those patients home tests to screen for bacteria.

It is not known how far back such checks are happening. However, pundits expect that to be thorough, all patients who underwent endoscopy procedures with the problematic duodenoscope at all facilities since the product appeared on the market in 2010 would have to be checked, along with their health records.

The legal community is expecting lawsuits. Regardless of the reasons behind the Olympus position that in its view it didn’t think it needed approval - and the reasons why the problematic duodenoscopes flew under the FDA’s radar for more than three years - the fact remains that all medical devices require some sort of approval status.

A brand-new device with a new and unique design requires an in-depth clinical trial. Improvements to an existing device are allowed to take advantage of a fast-track approvals process designed to get the device to market faster. However, most if not all devices that come into contact with human anatomy require some form of approval through the FDA.

Ironically, once the FDA became aware of the device in either late 2013 or early 2014, the agency mandated Olympus to properly submit the device for approval. CNN reports that the application is still pending.

It is not known if the FDA has required that the devices be removed from service until those approvals, if successful, come in. It is also not known if the FDA intends to officially cite Olympus, through fines or otherwise, for bringing the device to market without permission, resulting in carbapenem-resistant Enterobacteriaceae.

A spokesperson for the FDA told CNN that more than a half-million endoscopy procedures are performed in the US every year, “and the risk of bacterial transmission is actually really very, very low,” said Karen Riley, deputy director of strategy for the FDA’s Office of External Affairs.

That said, a perfect storm exists when an infected device transfers bacteria from one individual to another. In an age of antibiotic-resistant superbugs like the carbapenem-resistant Enterobacteriaceae, the combination can be deadly.

As for anyone, for whom the headline CRE Superbug Outbreak at UCLA Ronald Reagan Medical Center hits too close to home, legal action would not be far from the horizon.