FDA PublicHealth Notification:

Reprocessing of ReusableUltrasound Transducer

Assemblies Used for BiopsyProcedures

j FDA

This is to alert you to the importance of properlycleaning and sterilizing reusable ultrasoundbiopsy transducer assembles (i.e., transducer

device and associated accessories) and to provide recom-mendations for doing so. If these devices are not cor-rectly reprocessed between patients, residual materialfrom a previous patient may contaminate the biopsyneedle and needle guide when the system is reused forbiopsies. This could lead to patient infections.

On April 3, 2006, the Department of Veterans Af-fairs (VA), Veterans Health Administration issued aPatient Safety Alert related to a particular company’sultrasound transducer assemblies. During patientsafety rounds, the lumen of a needle guide of an ultra-sound transducer assembly was found to be soiled. Thealert provided recommendations on reprocessing thatbrand of transrectal ultrasound transducer, which iswidely used throughout the VA. FDA is issuing thisnotification as a supplement to the VA alert becausewe believe inadequate reprocessing procedures may bea problem for all invasive ultrasound transducerassemblies.

BACKGROUND

Health care professionals use ultrasound transducer as-semblies to view body structures and obtain biopsysamples under ultrasonic guidance. To facilitate biopsy,these devices may have a needle guide attached thatdirects the insertion of a biopsy needle. The procedure

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often involves placing the transducer in a body cavitywhere contact with blood, other body fluids, or fecesis likely. During this procedure, the transducer assem-bly should be covered with a sterile barrier sheath. Itis important to follow the manufacturer’s labelingwith regard to the use of sterile covers for eachparticular device to reduce the risk of patient infection.

Insertion of the biopsy needle is often repeatedthrough the guide. Since a biopsy needle contacts theneedle guide before it penetrates sterile tissue for bi-opsy, the needle and needle guide should be reprocessedas critical devices.1 The biopsy needle and its containingguide must always be sterilized. This should apply evenif a sterile barrier sheath is used on the transducerassemblies during a biopsy procedure, as the sheath iscompromised by the penetration of the needle.

THE IMPORTANCE OF CLEANING

For any reprocessingmethod to be effective, the reusabledevice must be thoroughly cleaned before it is subjectedto the sterilization process. Brushes should be used,when required, to effectively clean the transducer

1Critical devices require sterilization between patients unless they cannotwithstand the rigors of sterilization. In these cases only, high-leveldisinfection can suffice for the parts that cannot be sterilized. Definitionsfor critical device, semicritical device, high-level disinfection, andsterilization are available at: ANSI/AAMI ST58:2005, ChemicalSterilization and High-Level Disinfection in Health Care Facilities(http://www.aami.org).

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FDA Public Health Notification FDAJOURNAL OF RADIOLOGY NURSING

assemblies, especially the lumens. Failure to brush nee-dle-guide lumens has resulted in improper reprocessing,and may have been associated with the transmission ofpatient infections. Reports have been received of visibleresidue in the biopsy needle-guide channels of some pa-tient-ready reusable transducer assemblies.

If the transducer assembly kits are not supplied withbrushes, ask the manufacturer for all relevantspecifications for the appropriate brush and a source(s)for purchase of these brushes.

It is also essential to use appropriate detergents forcleaning and enzymatic cleaners for removing proteinsfrom the transducer assemblies. Refer to the manufac-turer’s instructions for information on compatibledetergents and cleaners.

RECOMMENDATIONS

To avoid reprocessing problems, it is critical that themanufacturers’ instructions for reprocessing thesetransducer assemblies are followed. The operators’manuals/user guides for these transducers should givedetailed instructions for cleaning and sterilization foreach specific brand and model of device and specifythe equipment and supplies needed to correctly repro-cess the assemblies. These reprocessing instructionshave been validated by the manufacturer. Sterilizationprocesses that are recommended by the transducermanufacturer should be used. Steam sterilization or liq-uid chemical high-level disinfection is to be used as rec-ommended by the transducer assembly manufacturer.If there is anything in the manufacturer’s instructionsthat is not clear, contact the manufacturer for clarity.Make no assumptions.

Remember, sterilization or high-level disinfection cannotbe achieved unless the assembly is cleaned first

When cleaning and sterilizing reusable ultrasoundtransducers, be sure to

j Disassemble the transducer assembly parts forcleaning.

j Use a clean and properly sized brush for eachlumen of the device that is being cleaned.

j Thoroughly clean all surfaces of reusablecomponents.

j Brush and thoroughly rinse the channels throughwhich the biopsy needles pass and any areaswhere the needle guide passes through the trans-ducer to loosen materials inside the lumens andcheck to be sure that no visible soil remains.

j Thoroughly examine all surfaces that have beencleaned and visually inspect the entire device tomake sure it is clean.

j Steam-sterilize all heat-stable, reusable componentsafter each use. If using automatic reprocessing

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equipment, be sure to use the proper connectionsto the transducer assemblies.

j Use a liquid chemical high-level disinfectant onlyfor heat-sensitive components that cannot with-stand steam sterilization. Be sure to flush any lu-mens or channels with the disinfectant to ensurethat the disinfectant reaches all areas inside thelumens.

j Always use sterile water for rinsing or removingresidual germicides from devices which havebeen processed using liquid chemical germicides.Do not rinse reprocessed devices with tap water,which may recontaminate the device.

j Thoroughly dry the device after rinsing with ster-ile water.

j Do not reuse or reprocess items labeled for sin-gle-use (e.g., single-use biopsy needles), whichhave not been validated for reprocessing.

j After sterilization, appropriately package andstore the device or component to ensure that ste-rility is not compromised before reuse.

j If you find that the manufacturer’s reprocessinginstructions seem to be inadequate, please informthe manufacturer and MedWatch about thoseinadequacies.

REPORTING TO FDA

FDA requires hospitals and other user facilities toreport deaths and serious injuries associated with theuse of medical devices. If there is suspicion that a re-portable adverse event was related to the use of anultrasound transducer assembly, follow the reportingprocedure established by the facility.

Report adverse events related to ultrasound trans-ducers used for biopsy procedures that do not meetthe requirements for mandatory reporting. Reportthese directly to the device manufacturer. Also reportto MedWatch, the FDA’s voluntary reportingprogram. Submit reports to MedWatch by phone at1-800-FDA-1088; by fax at 1-800-FDA-0178; by mailto MedWatch, Food and Drug Administration, 5600Fishers Lane, Rockville, MD 20852-9787; or online athttp://www.fda.gov/medwatch/report.htm.

GETTING MORE INFORMATION

If you have questions about this notification, pleasecontact the Office of Surveillance and Biometrics(HFZ-510), 1350 Piccard Drive, Rockville, Maryland,20850, Voicemail 240-276-3357, Fax at 240-276-3356,or by e-mail at phann@cdrh.fda.gov.

FDA medical device Public Health Notifications areavailable on the Internet at http://www.fda.gov/cdrh/safety.html.

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