Becker's Clinical Quality & Infection Control

34 Executive Briefing SPONSORED BY A dvancements 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." 1 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. 1 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. 1 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. 3 Patients who developed infections likely underwent ultrasound- guided 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. 2 CDC and FDA have also advised healthcare facilities review their facility probe reprocessing practices in response to the outbreak. 2,3 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. 4 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. 5,6 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. 7 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. 8 Data driven insight in ultrasound infection prevention: Frontline & facility standardization Fig 1. TJC surveyors observed ultrasound IP compliance gaps in 2020, including failure to clean or disinfect non-critical probes. 1

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