Data driven insight in ultrasound infection prevention: Frontline & facility standardization

Advancements in ultrasound imaging have enabled transformational digital visualization of the patient anatomy, driving a growing list of procedures across healthcare. The quality care provided by healthcare staff, the ultrasound technology they use and frontline infection prevention (IP) practices are together linked to patient outcomes. Yet recent reports from The Joint Commission (TJC) and Federal agencies are a constant reminder to review proper ultrasound IP practices. Nanosonics strives to create solutions that make IP compliance easier for staff both at the frontline and system level. 

TJC: compliance gaps in ultrasound IP 

The TJC reaffirmed this August that healthcare facilities must follow the minimum level of probe reprocessing based on intended use, dictated by the Spaulding classification adopted by the FDA.1 

"Healthcare organizations must determine intended use(s) based on how the surface ultrasound transducers and endocavity probes are used within their organization and resolve any discrepancies with the manufacturer."

The TJC infection control standard IC.02.02.01 requires that the hospital reduces the risk of infections associated with medical equipment, devices, and supplies; 22 percent of facilities were noncompliant with IC.02.02.01 EP1 and 46 percent with IC.02.02.01 EP2 in 2020.

Surveyors’ observed compliance gaps related to ultrasound included failure to clean or disinfect noncritical probes (Fig. 1), reprocessing of semi-critical and critical ultrasound probes inconsistent with intended use or manufacturer instructions for use (IFUs), and reliance on probe covers as replacements for these minimum reprocessing requirements.

Federal call to action 

A multistate gel-associated outbreak of Burkholderia cepacia has resulted in a call to action from the FDA and CDC on ultrasound gel use and probe reprocessing this August.2,3 The outbreak has included 66 patient infections in six states, including 60 bloodstream infections.

Patients who developed infections likely underwent ultrasoundguided transcutaneous procedures such as paracentesis and central intravenous catheter placements, according to the CDC.2 The CDC has advised single-use sterile ultrasound gel should be used in preparation for or during transcutaneous procedures, including avoiding nonsterile ultrasound gel for visualization prior to these procedures. CDC and FDA have also advised healthcare facilities review their facility probe reprocessing practices in response to the outbreak.

Educate and train 

Healthcare staff are at the heart of facilities and drive quality patient care every day, yet unintended human error in IP can be a reality. Staff completing probe reprocessing, traceability documentation or selecting and preparing the probe for use may not be IP experts. Quality control programs should include continuous monitoring and verification that staff involved in reprocessing adhere to facility policies and procedures. Education and training are also critical components to ensure ongoing policy compliance at the frontline, to empower staff and help manage risk.

Reproducible outcomes with automation

Probe disinfection should be successful every time to reproducibly protect the next patient from infection transmission risk. Reproducibility depends on meeting the critical parameters required to achieve the disinfectant’s validated label efficacy claims on all surfaces of a probe. Critical parameters are key variables impacting efficacy and can include contact time, temperature and chemical concentration or dosage depending on the methods used.

 Automation enables reproducibility in medical device reprocessing by minimizing human factors. Human factors are recognized to impact compliance and reproducibility in manual endoscope reprocessing in the literature and by regulators. In November 2020, The Robert Koch Institute (RKI), the German public health institute, published a statement determining that they were unable to identify any standard or guidelines that demonstrated the validation of wipes as a final disinfection step for semi-critical devices.RKI identified sufficient mechanical force and application of disinfectant to all surfaces and geometries of a device, could not be guaranteed with wipes. In a U.S. National survey of IPs, 91 percent of respondents preferred to use automated processes for probe reprocessing.

Standardized documentation through digitization 

Documentation is essential for communication and continuity of patient care through the healthcare system. Whether considering laboratory, pharmacy, imaging, communications or other hospital sub-systems, standardization of data collection and linkage to the patient is critical for meaningful interpretation and reporting. 

In medical device reprocessing, American National Standards recognize that digitization allows "better legibility, accuracy, traceability, security, and data integrity." Documentation is also evidence of a department or facility’s ultrasound IP quality control program. These qualities are essential for decision making about device recalls or patient notifications in outbreak settings. Digitization can streamline workflow and standardize data collection compared to paper-based record keeping, enabling accuracy and demonstrated compliance. 

Nanosonics AuditProTM: Data driven insight for frontline and facility

The new Nanosonics AuditPro provides facilities with the opportunity to improve and standardize ultrasound infection control compliance across all ultrasound procedures, supporting the management of organizational and facility risk and patient care. 

Nanosonics AuditPro comprises a mobile scanning device (MSD) for ultrasound users coupled with sophisticated software to manage compliance. The MSD uniquely sits with the ultrasound console at point of care enabling staff to incorporate infection control considerations as part of everyday practice. 

With built in education as part of the workflow, staff qualify every procedure against the Spaulding classification for probe disinfection requirements, standardizing the IP decision every time.

 "I like that [AuditPro includes] the Spaulding classification on the MSD, it educates the sonographer, makes them critically think. I really like that part of it."

 The software combines ultrasound patient procedures and probe disinfection information, and interrogates data captured through the clinical workflow to create noncompliance notifications and intuitive information rich dashboards. The standardized reporting can support data driven decision making at the system level about training needs, providing inputs into quality and risk management programs. The AuditPro software also combines HLD records from the Nanosonics trophon®2 device with ultrasound patient procedures and probe information, streamlining data searching capabilities.

"I like, most importantly, that you can pull your logs, and that you can connect your cycle with the patient, [AuditPro] gives us this capability."

trophon®2: leader in automated ultrasound probe HLD 

Nanosonics trophon® is the global standard of care in ultrasound probe HLD helping protect patients from the risk of cross contamination. The trophon family includes trophon® EPR and trophon®2 which share the same core technology of sonically activated hydrogen peroxide. trophon is bactericidal, fungicidal, virucidal and mycobactericidal. 

Every day, 88,000 patients are protected from cross contamination risk because the ultrasound probe used in their procedure has undergone HLD with trophon. Over 23,000 units are used across North America, in over 5,000 hospitals and clinics including all luminary hospitals. 

The trophon HLD process is standardized in every department. The critical parameters are automatically controlled and validated by the device, further verified with a chemical indicator each cycle. Nanosonics’ second generation device, trophon2, launched in 2018 and is enabled with AcuTrace® RFID technology to deliver digitized capture of the reprocessing record.

"The trophon device has been a wonderful addition to the ultrasound room as it’s reduced the time we need to reprocess equipment while giving us the peace of mind that our equipment will be properly disinfected and ready for each new patient." Tia Bowen, Clinic Manager, Physicians for Women: Melius, Schurr & Cardwell 

Together, trophon2 and AuditPro mitigate risk to patients and healthcare facilities, arming healthcare staff, IPs and risk and quality managers with tools to drive compliance. Discover how Nanosonics AuditPro can standardize your ultrasound IP practices, help you meet accreditation requirements and deliver best practice patient care across your organization.

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