infection prevention
By Diane Cullen , RN , MSN , MBA , CIC
Reprocessing Ultrasound Transducers
The Joint Commission receives many inquiries from healthcare organizations asking how to reprocess medical devices , and more specifically , about the requirements for reprocessing ultrasound transducers . Examples of questions received include : What level of reprocessing is required ? What do I do if the manufacturer ’ s instructions indicate a level of reprocessing that does not match my use of the transducer ? What ultrasound transducer reprocessing practices are surveyors looking for ?
The Joint Commission has recently published an article which addresses reprocessing practices for ultrasound transducers ( published in the July 2021 issue of Joint Commission
Perspectives .) The article describes some common survey observations regarding ultrasound transducers as well as related standard and element for performance ( EP ) scoring locations . To develop procedures for reprocessing transducers and to remain compliant with The Joint Commission Standards , organizations are encouraged to follow The Infection Prevention Hierarchy . The Hierarchy is a systematic approach which , when followed , will ensure an organization has considered local , state , and federal regulations ( which may require organizations to follow specific evidence-based guidance ), Centers for Medicare and Medicaid Services ( CMS ) Conditions of Participation , and abides by ( or resolves conflicts with ) the manufacturer ’ s instructions for use ( IFU ) for any specific product .
Because ultrasound transducers are medical devices , they are regulated by the Food and Drug Administration ( FDA ). The FDA has published a guidance document specific for
diagnostic ultrasound devices which refers to another guidance document :
Reprocessing Medical Devices in Health Care Settings : Validation Methods and Labeling . This document uses the Spaulding Classification System to guide device manufacturers when developing reprocessing instructions for medical devices based on the intended use of the device . For example , ultrasound transducers ( transducers ) may be used on intact skin , mucous membranes or within sterile body cavities or tissues during procedures . Each of these intended uses would result in a different requirement for reprocessing , based on Spaulding criteria :
●If a transducer is used in a sterile body cavity or sterile tissues , it is considered a critical device and requires sterilization .
●If a transducer is used on non-intact skin or mucous membranes , such as a vaginal , rectal or oral , it is a semi-critical device and should undergo high-level disinfection .
●If a transducer is only used on intact skin , it is considered non-critical and , regardless of whether it is contaminated with blood , the minimum requirement is low level or intermediate level disinfection .
● If the transducer manufacturer reprocessing instructions indicate that an instrument should be high-level disinfected if used to assist with percutaneous procedures or if contaminated with blood , the organization must follow the manufacturer instructions for use unless they have evidence to negate that instruction from the manufacturer .
A transducer sheath ( probe cover ), considered a medical device by the FDA , must be approved for use as a barrier . Transducer sheaths cannot be interchanged with items that have not been approved for barrier use ( e . g ., transparent IV dressings ) and are intended to be used during procedures to protect the transducer from body fluids . Sheaths are applied to surface transducers , endocavity transducers or transducer probes used in surgical procedures . There has been debate whether the use of a transducer sheath on any transducer would negate the need to perform the minimum level of disinfection specified in the reprocessing instructions , as required by the manufacturer . The FDA has stated that use of a transducer sheath does not affect 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 .
The Joint Commission expects all organizations to comply with instructions provided by the manufacturer based on intended use of the device . However , there are times that the device manufacturer ’ s instructions might not conform to rules about intended use ( Spaulding Classification System ) or may not provide enough information for the end user to determine the correct method for reprocessing . If these situations occur , then contact the manufacturer . If there is a question or possible conflict with the instructions provided , then it is the healthcare organizations responsibility to refrain from using the device until the manufacturer is contacted and differences are reconciled . It is also important to remember that if alternative instructions are provided to a staff member during conversation with the manufacturer , he or she should obtain those instructions in writing and present them at the time of survey .
In addition , if the manufacturer requires a specific product , The Joint Commission surveyor will look for that product at a healthcare organization or expect an organization to have contacted and resolved any issue related to compatibility of products used . If the manufacturer requires a certain time or temperature for reprocessing , The Joint Commission will expect a healthcare organization to establish a means and process to measure both . Healthcare organizations could be cited for :
●Failing to produce the IFUs of medical equipment and devices reprocessed at the organization ,
●Failing to follow the steps of cleaning and reprocessing described in the IFU ( if no steps have been taken to resolve deviation )
●Failing to use the products indicated in IFU ( unless compatibility of alternative products has been confirmed )
●Failing to provide adequate personal protective equipment to staff ( per IFU and hazard assessment ) to complete the reprocessing and
●Failing to provide training or assessment of competence for staff who perform those procedures .
The Joint Commission understands that instrument handling and processing can be complex and are available to help . We encourage healthcare staff to contact an infection preventionist at The Joint Commission with any questions at
Ask SIG .
Diane Cullen , RN , MSN , MBA , CIC , is assistant director of the Standards Interpretation Group for The Joint Commission .