On February 7, 2007, FDA issued a press release announcing that Custom Ultrasonics, Inc., had signed a consent decree of permanent injunction in which the company agreed to stop manufacturing and distributing all devices, including its endoscope washers/disinfectors. The affected products include the System 83 Plus Washer/Disinfector, the System 83 Plus MiniFlex Washer/Disinfector, and all accessories. This regulatory action was taken because the company failed to comply with FDA regulations that help ensure that medical devices are safe and effective.
Today’s Notification is intended to further inform hospitals and other user facilities about FDA’s action, and to provide recommendations for facilities currently using the affected products. (Products already in use are not being recalled.)
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. A copy of the FDA Warning Letter to the company can be found at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2005/ucm075455.htm.
Public Health Significance of the Company’s Failure to Comply
When a device is designed and manufactured without adequate QS regulation controls, the safety and effectiveness of the device cannot be ensured. In this case, the result could be an increased risk of the transmission of pathogenic agents from patient to patient.
To date, there have been no reports of patient infections attributed directly to these devices. However, because follow-up of hospital-acquired infections is difficult, coupled with the company’s failure to establish an adverse reporting system and to report problems to FDA, infections may have occurred and been unreported.
Recommendations for Healthcare Facilities
FDA is recommending that facilities currently using Custom Ultrasonics endoscope washer/disinfectors discontinue their use if alternative automated endoscope reprocessors (AERs) are immediately available and it is feasible to make the switch. Before doing so, be sure that the facility’s endoscopes are compatible with the alternative AERs by referring to labeling, and that staff are trained in using the alternative device. Verify that the alternative AERs are properly maintained and operating correctly according to the labeling. Contact the manufacturer if necessary for further instructions, channel connectors, other critical accessories, and servicing recommendations.
If, after looking at the feasibility of switching to an alternative AER, a facility decides to continue using Custom Ultrasonics washer/disinfectors, it should 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.
FDA does not recommend manual reprocessing as an alternative to using functional AERs. We believe the risks inherent in manual reprocessing outweigh the benefits.
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.
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 email@example.com or by phone at 1-800-638-2041 or 301-796-7100
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Daniel G. Schultz, MD
Center for Devices and Radiological Health
Food and Drug Administration