The Food and Drug Administration (FDA) has ordered a recall of Custom Ultrasonics’ System 83 Plus automated endoscope reprocessors (AER), accusing the company of violating federal regulations. An April 2015 inspection of Custom Ultrasonics’ Ivyland, Pennsylvania facility revealed the company’s failure to validate its System 83 Plus AER’s ability to disinfect endoscopes, the recall notes.
Automated endoscope reprocessors are Class II medical devices used to clean and sterilize endoscopes between procedures. Endoscopes are long, flexible medical devices with a light at the end user in minimally invasive procedures to look inside patients’ bodies.
The endoscope’s flexible design can make it very difficult to clean. Residual bodily fluids may leave behind bacteria in the channels of the endoscope if not properly reprocessed. If endoscopes are not adequately sterilized after use, patients may be put at risk of contracting severe, possibly life-threatening infections.
Patients undergoing routine medical procedures like endoscopic retrograde cholangiopancreatography (ERCP) can be exposed to antibiotic-resistant bacteria known as carbapenem-resistant Enterobacteriaceae (CRE).
CRE is the same type of drug-resistant bacteria linked to the deadly “superbug” outbreak at UCLA Medical Center and Virginia Mason Hospital in Seattle, Washington. Both cases involved improperly reprocessed Olympic Medical Q180V endoscopes.
The FDA recall affects approximately 2,800 Custom Ultrasonics AERs in the U.S. Custom Ultrasonics has seven days to provide the FDA with a recall proposal. The FDA recall affects the following Custom Ultrasonics AERs:
Custom Ultrasonics has a long regulatory history with the FDA. In 2007, the FDA slapped the AER maker with a Consent Decree of Permanent Injunction (Consent Decree), barring Custom Ultrasonics from distributing medical devices.
After being allowed to resume operations by the FDA in 2007, Custom Ultrasonics was again hit with injunctions to cease production in 2012 and 2013. The 83 Plus AER system was the only medical device Custom Ultrasonics had been allowed to produce, up until now.
If you or a loved one contracted a serious infection after undergoing an endoscopic procedure, it may be because the endoscope was not properly sterilized prior to use. The product liability attorneys of The Cochran Firm, D.C. have a team of in-house registered nurses and investigators ready to help you get answers. Contact one of our attorneys for your free legal consultation.