By Diane M. Cullen, MSN, MBA, RN, CIC
As an infection preventionist (IP) working in the Standards Interpretation Group of the Joint Commission, an important function of my job is to answer infection prevention-related questions from health care organizations. As one might imagine, some of these questions can be very specific, especially when they refer to cleaning and reprocessing medical equipment.
While answering these questions, my colleagues and I often begin our responses with the caveat, “The Joint Commission Standards are not written to that level of detail … ” If we were to stop there, our response may not seem very helpful, but we continue by referring to a concept called the “Infection Prevention Hierarchy” (Hierarchy) as the key to helping organizations find the solutions they seek.
The “Infection Prevention Hierarchy” was originally published in the April 2019 issue of Joint Commission Perspectives (tinyurl.com/ykjdckrr). Following the rules of the Infection Prevention Hierarchy helps ensure that health care organizations comply with 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 abide by all manufacturer’s instructions for use (IFU) for any specific product. If those sources fail to provide the guidance needed, a health care organization may then choose to follow a specific evidence-based guideline (EBG) or consensus documents.
The Joint Commission receives numerous questions from health care organizations every week inquiring about requirements for reprocessing medical equipment. This stands to reason since there are so many medical devices and types of cleaning equipment and supplies, each with its own specific instructions for use. Some instructions offer very complex and precise requirements while others are more general and lack sufficient direction. The Food and Drug Administration (FDA) regulates labeling requirements for medical devices and requires that manufacturers provide information on intended use, directions for the consumer on how to use a device safely and how to properly clean and reprocess it. The FDA uses the Spaulding Classification System to guide device manufacturers to develop reprocessing instructions for medical devices based on intended use.
So, how does a health care organization develop its policies, procedures and practices for instrument reprocessing with so many instructions to navigate? By exploring ultrasound transducers as an example, we can take a closer look. Many organizations struggle with understanding how to reprocess ultrasound transducers and seek help to ensure they comply with The Joint Commission Standards.
The Joint Commission suggests the following:
Surface Ultrasound Transducers
Surface ultrasound transducers (transducers) are used for both diagnostic and therapeutic purposes and are found in various departments, locations and types of health care settings. Transducers are used on intact skin, mucous membranes and within sterile body cavities during surgical 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, 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 may be sterile or unsterile, latex or latex-free and are available in a variety of shapes and sizes. Sheaths are applied to surface transducers, endocavity transducers or transducer probes used in surgical procedures. There is confusion in the industry as to 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 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.
The Joint Commission expects all organizations to comply with the instructions provided by the manufacturer based on intended use of the device. If the manufacturer requires a specific product, we will look for that product at your health care organization during survey. If the manufacturer requires a certain time or temperature for reprocessing, The Joint Commission will expect your organization to establish a means and process to measure both.
Health care organizations will be cited for: not having IFU available, not following the steps of cleaning and reprocessing described in IFU, not having on-hand the products indicated in IFU, not providing adequate personal protective equipment to staff (per IFU) to complete the cleaning and for failing to provide training or assessment of competence for staff who perform those procedures.
Ensuring that health care organizations are reprocessing medical devices will be easier if leadership takes all requirements into consideration. Sometimes manufacturer instructions might not conform to rules about intended use nor provide enough information. It is very important for health care organizations to understand how a device will be used, what reprocessing should be required as a result of the intended use and that the manufacturer instructions will meet the level of disinfection required for each item’s use. If it does not – it is time to contact the manufacturer. If the instructions for reprocessing do meet the level of reprocessing based on intended use, health care organizations should ensure they are following all the manufacturer’s instructions for reprocessing. If there is a question or possible conflict with the instructions provided, then, it is the health care organization’s responsibility to refrain from using the device until the manufacturer is contacted and differences are reconciled.
The Joint Commission understands that instrument handling and processing can be complex, and we encourage you to contact Diane Cullen at email@example.com with any questions.
Diane M. Cullen, MSN, MBA, RN, CIC, is associate director of the Joint Commission’s Standards Interpretation Group.