November 16, 2015 — The FDA is forcing Custom Ultrasonics to recall thousands of endoscope cleaning machines because they might not work, which could lead to outbreaks of infection.
The recall was issued under terms of a consent decree entered with the company in 2007. The FDA issued a Safety Communication asking healthcare facilities to transition to other methods for endoscope sterilization as soon as possible.
About 2,800 Automated Endoscope Reprocessors (AERs) made by Custom Ultrasonics are still in use throughout the United States. The dishwasher-sized machines are used to sterilize endoscopes.
In 2012, the FDA asked Custom Ultrasonics to recall the AERs after the company failed to get clearance for significant software changes. After the company got clearance, the AERs remained on the market.
After an inspection in April 2015, the FDA noted “continued violations” that could result in an increased risk of infection transmission:
“Violations include the inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.”
Units affected by the recall include:
- System 83 Plus
- System 83 Plus 2
- System 83 Plus 9
The FDA has increased oversight of endoscope reprocessing methods after several hospitals reported deadly outbreaks of infection. In many cases, scopes remained contaminated even after hospitals followed the manufacturers’ instructions. The risk of disease-transmission is low, but the problem has become more serious as antibiotic-resistant “superbugs” become more common in healthcare facilities.