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O FDA alerta em transdutores do Ultrasound

por Barbara Kram, Editor | June 19, 2006

The importance of cleaning
For any reprocessing method to be effective, the reusable device must be thoroughly cleaned before it is subjected to the sterilization process. Brushes should be used, when required, to effectively clean the transducer assemblies, especially the lumens. Failure to brush needle guide lumens has resulted in improper reprocessing, and may have been associated with the transmission of patient infections. We have received reports of visible residue in the biopsy needle-guide channels of some patient-ready reusable transducer assemblies.

If your transducer assembly kits are not supplied with brushes, ask the manufacturer for all relevant specifications for the appropriate brush and a source(s) for purchase of these brushes.
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It is also essential to use appropriate detergents for cleaning and enzymatic cleaners for removing proteins from the transducer assemblies. Refer to the manufacturer's instructions for information on compatible detergents and cleaners.

Recommendations
In order to avoid reprocessing problems, it is critical that you follow the manufacturers' instructions for reprocessing these transducer assemblies. The operators manuals/user guides for these transducers should give detailed instructions for cleaning and sterilization for each specific brand and model of device, and specify the equipment and supplies needed to correctly reprocess the assemblies. These reprocessing instructions have been validated by the manufacturer. Sterilization processes that are recommended by the transducer manufacturer should be used. Steam sterilization or liquid chemical high level disinfection is to be used as recommended by the transducer assembly manufacturer. If there is anything in the manufacturer's instructions that is not clear, contact the manufacturer for clarity. Make no assumptions.

Remember, you can not achieve sterilization or high-level disinfection unless the assembly is cleaned first.

When cleaning and sterilizing re-usable ultrasound transducers, be sure to:

* Disassemble the transducer assembly parts for cleaning.
* Use a clean and properly-sized brush for each lumen of the device that is being cleaned.
* Thoroughly clean all surfaces of reusable components.
* Brush and thoroughly rinse the channels through which the biopsy needles pass and any areas where the needle guide passes through the transducer to loosen materials inside the lumens, and check to be sure that no visible soil remains.