FDA Recalls Machine That Cleans Endoscopes
In the wake of CRE outbreaks in Los Angeles and Seattle comes yet another strike to the industry. Federal officials are recalling close to 2,800 machines made by a Pennsylvania manufacturer that are designed to clean endoscopes. Scopes that are near impossible to get clean have been pinpointed as the cause of outbreaks at a number of major hospitals around the country and are responsible for several patient deaths.
In 2012, a deadly pattern developed at hospitals in Seattle, Pittsburgh, Chicago and Los Angeles. The primary culprit in the outbreaks is the duoendoscope, a flexible, lighted tube that threads through the throat to the top of the duodenum. The scopes are used annually in more than 500,000 surgeries, primarily the endoscopic retrograde cholangiopancreatography procedure. The outbreaks involved the deadly superbug CRE that kills up to 40 percent of those infected.
In 2013, the Centers for Disease Control and Prevention notified the FDA of a potential risk of multidrug-resistant bacterial infections due to the improper cleaning of these scopes. The facilities involved in the outbreaks confirmed that they used the System 83 Plus disinfecting unit made by Custom Ultrasonics.
On Friday, November 13, 2015, the FDA announced they were recalling devices made by Custom Ultrasonics which are intended to kill bacteria and microorganisms on flexible, reusable endoscopes like the duoendoscope. William Maisel, MD, MPH, the deputy director for medical devices with the FDA, states that the agency recall is due to this company’s history of violations.
In 2007, the regulatory agency took action against this company. The settlement bars them for making or distributing machines despite the fact that Custom Ultrasonics did not admit to any wrongdoing. The court-ordered terms allow the company to continue to the service equipment.
An April inspection of the company found continued problems with their process. Custom Ultrasonics was unable to provide the agency with sufficient proof that their technology adequately washed and disinfected endoscopes. Hospitals and medical facilities that use machines from this company are ordered to find alternative ways to clean their endoscopes.
This recent action against Custom Ultrasonics is estimated to cost them between $30,000 to $50,000 dollars for each machine. The ban will remain in effect until the FDA deems that the machines fall within standards and that Custom Ultrasonics has fixed their ongoing problems.
In addition to the recall, the FDA is working with three major manufacturers of duoendoscopes to develop new disinfection procedures, ones that will ensure the scopes are safe to use.