The FDA has clarified its safety recommendations concerning Custom Ultrasonics’ system 83 plus automated endoscope reprocessors.
Here are five key notes:
1. Custom Ultrasonics’ system 83 plus automated endoscope reprocessors are used by healthcare facilities to wash and disinfect flexible endoscopes and scope accessories between uses.
2. In November 2015, the FDA ordered Custom Ultrasonics to recall its entire line of system 83 plus automated endoscope reprocessors from healthcare facilities. This past May, the FDA retreated from the recall order, allowing the product to remain on the market.
3. The FDA's ongoing investigation of the products found that use of the system 83 plus automated endoscope reprocessors for reprocessing duodenoscopes is associated with patient infections.
4. However, when investigating flexible endoscopes that are not duodenoscopes, FDA found no association between Custom Ultrasonics’ reprocessors and bacterial infections.
5. While the FDA maintains that healthcare providers should cease using the automated endoscope reprocessors for duodenoscopes, it is updating its prior safety communications to emphasize that the reprocessors can be used for other flexible endoscopes.