Balancing Disinfection and Manufacturer Recommendations in Ultrasound Technologies

Introduction

As the use of ultrasound technology continues to expand across various medical disciplines—from radiology and cardiology to point-of-care applications—ensuring appropriate and effective disinfection practices has become increasingly critical. While ultrasound is celebrated for its nonionizing radiation and ability to image sensitive tissues safely, it also presents a significant risk of cross-contamination if not properly disinfected. Understanding and adhering to manufacturer recommendations for reprocessing ultrasound devices is essential to mitigate this risk, yet the complexity of these guidelines often leads to challenges in implementation.

The Importance of Proper Reprocessing

Regardless of whether an ultrasound device is used in a high-end radiology department or as a handheld tool in an emergency setting, the importance of proper reprocessing cannot be overstated. Ultrasound professionals are generally well-versed in the cleaning and disinfection of the equipment they use. However, as ultrasound technology becomes more prevalent in diverse clinical settings, new users may not fully recognize the importance of proper reprocessing, particularly with transducers (probes) that come into contact with mucosal surfaces or are used in sterile body cavities.

Dr. Earle Spaulding's Classification System

Dr. Earle Spaulding's classification system, which categorizes reusable medical devices based on the risk of infection, provides a foundational guideline for determining the appropriate level of disinfection. For ultrasound probes:

• Non-critical devices (e.g., those that contact only intact skin) generally require low-level disinfection (LLD).
• Semi-critical devices (e.g., probes that contact mucous membranes) require high-level disinfection (HLD).
• Critical devices (e.g., probes used in sterile body cavities) demand sterilization.

While these guidelines are well-established, the practical application of these recommendations can vary based on the specific ultrasound device and its use case.

Challenges in Following Manufacturer Recommendations

Vendors of ultrasound equipment must validate reprocessing products and processes as part of the FDA 510(k) clearance requirements. However, following these recommendations can be challenging, particularly in facilities that utilize ultrasound equipment from multiple vendors. Each manufacturer may recommend different cleaning and disinfection products, creating a complex environment for healthcare providers.

For example, a probe used for an abdominal ultrasound may only require cleaning with a vendor-approved disinfectant wipe, whereas a probe used for an endovaginal ultrasound requires a more intensive cleaning and HLD process. It’s important to note that while HLD is often used as a substitute for sterilization, it may not be sufficient for all semi-critical devices, and facilities must carefully evaluate their practices against both vendor recommendations and regulatory guidelines.

Conflicting Guidelines and Recommendations

One of the significant challenges in ultrasound reprocessing is the inconsistency between guidelines from different sources. For instance, the 2021 Intersocietal Position Statement on the disinfection of ultrasound transducers used in percutaneous procedures suggests that probes covered by a sterile sheath only require LLD between uses. However, this recommendation contrasts with other guidelines that classify these probes as semi-critical devices, necessitating HLD.
When faced with such conflicting information, healthcare providers must collaborate closely with their facility’s infection prevention specialists to develop a protocol that:

• Ensures effective disinfection to the required level (LLD, HLD, or sterilization).
• Aligns with vendor recommendations, particularly when using equipment from multiple manufacturers.
• Minimizes workflow disruptions while maintaining compliance with infection control standards.

In cases where a disinfectant is not listed in the device’s Instructions for Use (IFU), providers should consult the manufacturer to confirm whether the product can be safely used. Any deviations from vendor guidelines should be documented with a clear rationale in the facility’s infection prevention and control policy.

Comprehensive Reprocessing: Beyond the Transducer

While the transducer is a primary focus of ultrasound reprocessing, other components of the ultrasound system, such as the scanner itself, keyboards, and gel bottles, must also be appropriately disinfected. These elements can harbor contaminants that pose a risk of infection to patients and caregivers. As ultrasound use continues to grow, ensuring a comprehensive approach to reprocessing is essential to maintaining the safety and effectiveness of this valuable imaging modality.

Conclusion

The safe use of ultrasound technology hinges on proper reprocessing practices that are informed by both manufacturer recommendations and regulatory guidelines. By understanding the complexities of these recommendations and working closely with infection prevention specialists, healthcare providers can develop effective protocols that safeguard patient health while ensuring the longevity and reliability of their ultrasound equipment.

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