Custom Ultrasonics resumes manufacturing

The Food and Drug Administration (FDA) is permitting Custom Ultrasonics to resume manufacturing the System 83 Plus Washer/Disinfector and all accessories.

The FDA previously had recommended that facilities stop using Custom Ultrasonics endoscope washer/disinfectors if alternative automated endoscope reprocessors (AERs) were immediately available and it was feasible to make the switch. The affected products included the System 83 Plus Washer/Disinfector, the System 83 Plus MiniFlex Washer/Disinfector, and all accessories.

The action followed what the FDA said were the company's deficiencies in failing to comply with FDA's Quality System 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 FDA said the company lacked adequate procedures to report problems with these devices and failed to report problems it knew about to the agency. There were no reports of patient infections attributed directly to these devices.

If you suspended use of your Custom Ultra-sonics endoscope washer/disinfector, have the company's service department perform the start-up maintenance procedures and verify the devices' safety and effectiveness. Contact the company at (215) 364-1477, and they will provide this service at no cost. This step will ensure there isn't a high level of bacterial contamination inside the devices while they were sitting idle, as well as ensuring the devices are operating within specifications. If you continued using the Custom Ultrasonics devices, have them serviced to ensure they are operating within specifications and that they can properly clean and disinfect endoscopes.

Always use the company's prescribed cleaning and disinfection procedures when using these devices. They can be downloaded at www.customultrasonics.com. For a copy of the FDA notice, go to www.fda.gov.