By Diane Cullen MSN, RN, MBA, CIC, Associate Director, Standards Interpretation Group
Ultrasound transducers (transducers) are used for both diagnostic and therapeutic purposes and may be found in various departments, locations and types of health care settings. The Food and Drug Administration (FDA) regulates the labeling requirements for medical devices such as ultrasound transducers based on their clinical applications and the potential for cross-contamination. The FDA uses the Spaulding Classification system to guide the appropriate reprocessing of medical devices which are classified and reprocessed based on intended use.
- Non-critical devices—come in contact with intact skin only and require low- or intermediate-level disinfection
- Semi-critical devices—come in contact with mucosal surfaces and non-intact skin and require, at minimum, high-level disinfection
- Critical devices—used in sterile body cavities and require sterilization
The use of surface ultrasound transducers for percutaneous procedures (IV, CL insertion, blocks, steroid injection, etc.) has become very common in health care. In general, surface transducers are intended to be used on intact skin to locate a vessel, nerve, joint space, etc. and would thus be considered non-critical devices requiring low- or intermediate-level disinfection.
There are instances in which these transducers may become contaminated with blood or body fluids, and if they do, an intermediate-level disinfectant (effective against bloodborne pathogens) is recommended for cleaning the transducer, according to the FDA. However, some manufacturers have provided instructions for reprocessing surface transducers that have become contaminated with blood/body fluid, specifying high-level disinfection instructions for reprocessing. The wide variation in instructions from manufacturers and guidance that has been put out by various experts has resulted in confusion for manufacturers, customers and surveyors as to how The Joint Commission will survey compliance when transducers are used for percutaneous procedures.
Questions Surrounding Transducer Sheaths
Additionally, the use of a transducer sheath has raised more questions. A transducer sheath (probe cover) is considered a medical device by the FDA that must be approved for use as a barrier. Sheaths may be sterile or unsterile, latex or latex-free, and may come in many shapes and sizes. These devices cannot be interchanged with items that have not been approved for this purpose (e.g., transparent IV dressings) and are intended to be used during procedures to protect the transducer from body fluids.
Sheaths may be applied to surface transducers, endocavity transducers or transducer probes used in surgical procedures. There is some confusion in the industry as to whether the use of a transducer sheath on any transducer would negate the need to perform the minimum reprocessing instructions, as required by the manufacturer. The FDA has stated that the use of a transducer sheath does NOT change the Spaulding Classification of the transducer (as these sheaths may leak or tear) and therefore would not change the minimum level of reprocessing required for the transducer based on clinical use, unless otherwise indicated by the manufacturer. Your organization must follow the transducer’s manufacturer’s instructions for use (IFUs) for reprocessing the equipment.
Organizations will be scored for the following situations, if out of compliance at the time of survey:
- Not following the minimum reprocessing instructions for an ultrasound transducer probe. The minimum reprocessing surveyors would expect is based on intended clinical use of the device.
o A transducer which contacts sterile tissues, or a device inserted into sterile tissue during a procedure.
o Cleaning followed by sterilization, as per IFUs.
o A transducer which contacts mucous membranes or non-intact skin during procedure.
o Cleaning followed by high-level disinfection, as per IFUs.
o If transducer IFUs state a LOWER level of cleaning is indicated (e.g. intermediate-level disinfection) and if a validated sheath is used, then this will not be scored.
o A transducer which contacts only intact skin.
o Cleaning followed by low- or intermediate-level disinfection, as per IFUs and level of contamination.
- Using a non-sterile sheath when a sterile sheath was indicated, per IFUs.
It can be difficult to navigate which type of cleaning and level of reprocessing is required for medical equipment and devices. For this reason, it is essential that all health care organizations understand and comply with the manufacturer’s validated written instructions for cleaning and reprocessing. If there appears to be a mismatch between intended use and what is on the instructions provided by the manufacturer, you must contact the manufacturer to reconcile those concerns and ensure you are doing effective reprocessing to protect your patients. If there is a question or possible conflict with the instructions provided, it is the organization’s responsibility not to use the device until the manufacturer is contacted and differences are reconciled.
For more information, please review The Joint Commission’s FAQ: Manufacturer’s Instructions for Use - Expectations Regarding Access to IFUs for Medical Instruments and Devices. Further discussion is also provided in the July issue of Joint Commission Perspectives.
Diane Cullen, MSN, RN, MBA, CIC, is Associate Director, Standards Interpretation Group. Prior to this position, Cullen worked as an Infection Preventionist at numerous Chicagoland hospitals including Northwestern Memorial, RML Specialty Hospital, Advocate South Suburban Hospital and more in ascending roles for infection prevention leadership.