* Thoroughly examine all surfaces that have been cleaned and visually inspect the ENTIRE device to make sure it is clean.
* Steam-sterilize all heat-stable, reusable components after each use. If using automatic reprocessing equipment, be sure to utilize the proper connections to the transducer assemblies.
* Use a liquid chemical high-level disinfectant ONLY for heat-sensitive components that cannot withstand steam sterilization. Be sure to flush any lumens or channels with the disinfectant to ensure that the disinfectant reaches all areas inside the lumens.
* Always use sterile water for rinsing or removing residual germicides from devices which have been processed using liquid chemical germicides. Do not rinse reprocessed devices with tap water, which may recontaminate the device.
* Thoroughly dry the device after rinsing with sterile water.

* Do not reuse or reprocess items labeled for single-use (e.g., single-use biopsy needles), which have not been validated for reprocessing.
* After sterilization, appropriately package and store the device or component to ensure that sterility is not compromised prior to reuse.

If you find that the manufacturer's reprocessing instructions seem to be inadequate, please inform the manufacturer and MedWatch about those inadequacies.

Reporting 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 an ultrasound transducer assembly, you should follow the reporting procedure established by your facility.

We also encourage you to report adverse events related to ultrasound transducers used for biopsy procedures that do not meet the requirements for mandatory reporting. You can report these directly to the device manufacturer. You can also report to MedWatch, the FDA's voluntary reporting program. You may submit reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787; or online at http://www.fda.gov/medwatch/report.htm.
Getting More Information

If you have questions about this notification, please contact the Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, Fax at 240-276-3356, or by e-mail at phann@cdrh.fda.gov. You may also leave a voice mail message at 240-276-3357 and we will return your call as soon as possible.

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