The FDA is no longer requiring Custom Ultrasonics to recall its Automated Endoscope Reprocessors, despite two previous orders to facilitate the recall, according to a Kaiser Health News report.
Here are seven key notes:
1. In November 2015, the FDA ordered Custom Ultrasonics to recall all of its 2,800 Automated Endoscope Reprocessors in use in healthcare facilities around the country. The FDA ordered the recall due to "the firm's continued violations of federal law and a consent decree entered with the company in 2007."
2. The FDA reiterated its November 2015 order in February of this year. The agency urged organizations using Custom Ultrasonics' Automated Endoscope Reprocessors to transition to alternative methods to reprocess flexible endoscopes.
3. The FDA has now retreated from its orders saying that Custom Ultrasonics' signature product, the System 83 Plus machine, can remain in the market while regulatory issues are addressed.
4. FDA regulators and the company have stated while its AERs cannot be used to disinfect duodenoscopes, they can be used to wash other endoscopes.
5. Improperly disinfected duodenoscopes have been linked to a number of superbug outbreaks in hospitals around the country last year, including Thomas Jefferson University Hospital in Philadelphia and Massachusetts General in Boston.
6. The February order noted the FDA found Custom Ultrasonics' submitted recall strategy inadequate. The company made no more subsequent proposals to recall its AERs.
7. An FDA spokeswoman declined to discuss any new information that Custom Ultrasonics provided.