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Update: July 16, 2007
Original publication date: February 27, 2007
This is to update you on new information regarding the Custom Ultrasonics endoscope washer/disinfector, and to provide recommendations for facilities either using these products or planning to use those that have been taken out of service.
On January 25, 2007, FDA entered into a Consent Decree to Custom Ultrasonics, Inc., because the firm failed to comply with FDA regulations that help ensure that medical devices are safe and effective. As part of the Decree, the company agreed to stop manufacturing and distributing all devices it manufactures, including the System 83 Plus Washer/Disinfector, the System 83 Plus MiniFlex Washer/Disinfector, and all accessories.
On May 8, 2007, the FDA issued a letter to Custom Ultrasonics stating that the firm has now complied with the requirements of the Consent Decree and is permitted to resume manufacturing the System 83 Plus Washer/Disinfector and all accessories. FDA's most recent inspection of the firm completed on March 29, 2007, found its manufacturing operation to be in compliance with FDA's Quality System regulation. The firm has also been found to be in substantial compliance with the Medical Device Reporting (MDR) regulation.
Recommendations for Healthcare Facilities
For facilities that suspended use of their Custom Ultrasonics endoscope washer/disinfectors:
- Prior to returning the devices to service, have the firm’s service department perform the start up maintenance procedures and verify the safety and effectiveness of devices. Facilities should contact the firm’s service department at (215) 364-1477 about performing these procedures. The firm will provide this service at no cost. It is important to do this prior to putting the device back into service to assure that there is not a high level of bacterial contamination that developed inside the device while it was sitting idle, as well as assuring that the device is operating within specifications.
For facilities that continued using their Custom Ultrasonics endoscope washer/disinfectors:
- Have these devices serviced by the firm to assure that they are operating within specifications and that they properly clean and disinfect endoscopes.
For all users:
- Follow the firm’s prescribed cleaning and disinfection procedures when using these devices. The most current version of these procedures can be accessed and downloaded from the Custom Ultrasonics website.
- Report any concerns or questions about how the device is functioning to Custom Ultrasonics immediately.
Reporting Adverse Events to FDA
FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of a Custom Ultrasonics endoscope washer/disinfector, you should follow the reporting procedure established by your facility.
We also encourage you to report adverse events related to Custom Ultrasonics endoscope washer/disinfectors that do not meet the requirements for mandatory reporting. You can report these directly to the device manufacturer or to MedWatch, the FDA’s voluntary adverse event reporting program. This can be done online, by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mailing FDA form 3500 to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or faxing to 1-800-FDA-0178.
Getting More Information
Custom Ultrasonics can be contacted at 215-364-1477.
FDA Medical Device Public Health Notifications are available on the Internet. You can also be notified through email each time a new Public Health Notification is added to our web page. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39.
Daniel G. Schultz, MD
Center for Devices and Radiological Health
Food and Drug Administration
If you have questions about this Notification, please contact FDA's Division of of Small Manufacturers, International and Consumer Assistance (DSMICA) by e-mail at firstname.lastname@example.org or by phone at 1-800-638-2041 or 301-796-7100