The U.S. Food and Drug Administration has asked the companies that manufacture the complex scopes tied to drug-resistant bacteria infections to prove their recommended cleaning methods work, according to a New York Times report.
Duodenoscopes, which are used during endoscopic retrograde cholangiopancreatography procedures so they are also known as ERCP scopes, have been pointed to as the cause of infections in patients at Ronald Reagan UCLA Medical Center in Los Angeles and at Virginia Mason Medical Center in Seattle.
The FDA previously released a safety warning about the scopes, telling hospitals and other organizations to follow the manufacturer's instructions for cleaning and reprocessing the instruments was the best way to avoid infection.
However, even when providers "appear to be doing everything right, there has been transmission" of bacteria, Arjun Srinivasan, MD, associate director for healthcare-associated infection prevention programs with the Centers for Disease Control and Prevention, told the Times.
Despite the infections, some of the manufacturers have come out and defended their cleaning methods as adequate. A spokesman for Pentax Medical told the Times that the company's protocols achieved "high level disinfection of duodenoscopes," and a spokeswoman from Fujifilm gave a similar sentiment of her company's standards.
Regardless, some hospitals have started using different techniques that go beyond the manufacturer's instructions for use. For instance, Virginia Mason now quarantines and tests its scopes for bacterial growth before the scopes can be used on patients again. UCLA now uses ethylene oxide gas to sterilize the instruments, according to the Times.
For tips from experts on how to safely reprocess ERCP scopes with the current instructions, click here.