FDA: Stop using Custom Ultrasonics washer

The Food and Drug Administration (FDA) recommends that facilities stop using Custom Ultrasonics endoscope washer/disinfectors if alternative automated endoscope reprocessors (AERs) are immediately available and it is feasible to make the switch. The affected products include the System 83 Plus Washer/Disinfector, the System 83 Plus MiniFlex Washer/Disinfector, and all accessories.

The company's deficiencies in failing to comply with FDA's Quality System (QS) regulation included failure to establish an adequate quality assurance program for manufacturing these devices, inadequate procedures to prevent and correct problems, inadequate design control, and inadequate procedures to process and analyze complaints. In addition, the company lacked adequate procedures to report problems with these devices and failed to report problems it knew about to the FDA.

Before making a switch, look at the labeling to ensure that the facility's endoscopes are compatible with the alternative AERs and be certain that staff members are trained in using the alternative device. If, after looking at the feasibility of switching to an alternative AER, a facility decides to continue using the Custom Ultrasonics washer/disinfectors, be sure that these devices have been adequately maintained and that the most current instructions are being followed. Any concerns or questions about how the device is functioning should be reported to Custom Ultrasonics immediately [Phone: (215) 364-1477.]

There have been no reports of patient infections attributed directly to these devices. However, infections may have occurred and been unreported, the agency says.

The FDA does not recommend manual reprocessing as an alternative to using functional AERs. FDA officials believe the risks inherent in manual reprocessing outweigh the benefits. [Editor's note: For more information on the FDA action, go to www.fda.gov. If you have questions about this FDA Notification, contact the Office of Surveillance and Biometrics in Rockville, MD. Phone: (240) 276-3357. Fax: (240) 276-3356. E-mail: phann@drh.fda.gov.]