The FDA originally issued the recall in November 2015, citing continued violations by Custom Ultrasonics that could put patients at increased infection risk. Namely, the FDA said Custom Ultrasonics could not “validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.” The agency reiterated the recall at the end of February.
But now, the FDA says the System 83 Plus Machine can stay on the market while Custom Ultrasonics addresses regulatory issues.
“Based on information provided by the company, the FDA has determined that the products may remain in the field,” the FDA said in a statement to Kaiser Health News, but an FDA spokeswoman did not reveal the new information.
Medical scopes have caused at least 350 infections in the U.S. between 2010 and 2015, according to the FDA.
A Senate investigation into the scope-related infections found 10 percent to 20 percent of AERs used in U.S. hospitals are made by Custom Ultrasonics, and that “it appears the defective machines played a significant role in allowing the [scopes] to remain contaminated between uses.”
However, the machines used to clean the scopes are only part of the problem when it comes to duodenoscopes and scope-related infections — the complicated design of the scope also make it extremely difficult to clean the devices.
More articles on scope-related infections:
FDA ups estimate of scope-related infections to 350
Olympus sought higher prices for their scopes after equipment linked to superbug outbreaks
Olympus asks hospitals to return Q180V duodenoscopes for redesign
