Alert on Custom Ultrasonics Endoscope Washers and Disinfectors
FDA Patient Safety News: Show #62, April 2007
FDA is notifying healthcare professionals that Custom Ultrasonics has agreed to stop making and distributing all of its endoscopic washer/disinfectors because of the company's failure to comply with FDA manufacturing regulations.
When a company does not comply with these regulations, the safety and effectiveness of the product cannot be assured. In this case, the result could be an increase in the risk of transmitting pathogenic agents from patient to patient.
The affected products are the System 83 Plus and the System 83 Plus Mini-flex, and all accessories. Products already in use are not being recalled. There have been no reports to date of patient infections attributed directly to these devices. But because follow-up of hospital-acquired infections is difficult, and because the company has failed to report problems to FDA, infections may have occurred and been unreported.
FDA is recommending that facilities stop using Custom Ultrasonics endoscope washer/disinfectors if alternative automated endoscope reprocessors are immediately available, and if it is feasible to make the switch. Before doing so, be sure that your endoscopes are compatible with the alternative reprocessors, and that the staff is trained in using the alternative device. Verify that the alternative devices are properly maintained and operating correctly according to the labeling.
If, after looking at the feasibility of switching to an alternative reprocesser, you decide to continue using Custom Ultrasonics washer/disinfectors, be sure that these devices have been adequately maintained and that the most current instructions are being followed. Report any concerns or questions to Custom Ultrasonics immediately.
FDA does not recommend manual reprocessing as an alternative to using automated reprocessors, because the risks inherent in manual reprocessing outweigh the benefits.
Additional Information:
FDA MedWatch Safety Alert. Custom Ultrasonics System 83 Plus Washer/Disinfector System 83 Plus Mini-flex Washer/Disinfector. February 7, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#System83