Disinfection
Figure 2: Snapshot of European guidelines on semi-critical medical device disinfection, including ultrasound probes. care.18
The study followed almost one million
patient journeys retrospectively through linked national patient datasets between 2010 and 2016. Following the study, the Scottish government mandated high-level disinfection for semi- critical probes, including endocavitary probes.10 This infection risk is not confined to endocavitary
probes. Surface probes are unique in that they are used in medical procedures that span all three categories under the Spaulding classification system (critical, semi-critical and non-critical) depending on the type of tissue that the probe contacts during use. Consistently applying the Spaulding classification to each use of a surface probe is essential to prevent outbreaks. In 2021, an intraoperative probe was the source of an outbreak in patients undergoing hepatic surgeries.19
Inadequate reprocessing of
the probe was identified as one of the contributing factors. Another study found that ultrasound was associated with an increased risk of bloodstream infections when guiding central line insertions at the femoral and jugular sites.20 To break the chain of infection transmission,
every patient must be assumed to be infectious. Standardisation of disinfection processes and workflows is key to ensure compliance with Spaulding and protect patients from being exposed to infection risk.
Automation enables standardised POC disinfection Probe disinfection at point of care should be successful every time to reproducibly protect
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the next patient from infection transmission. Reproducibility depends on meeting the clinical parameters required to achieve the disinfectant’s validated label efficacy claims on all surfaces of a probe. These parameters include contact time, mechanical effect (e.g. pressure applied when wiping), temperature, chemical concentration or dosage, depending on the methods used.
Manual disinfection methods, such as wiping, are prone to human error. Automated reprocessing eliminates the variables inherent in manual methods and establishes traceable, reproducible processes. Automated processes are also validated to achieve their expected performance outcomes consistently every time. In Germany, the Robert Koch Institut (RKI) has reported that they were unable to identify any standards or guidelines that demonstrated the validation of manual wipes as a final disinfection step for semi-critical devices.21,22
RKI identified
that sufficient mechanical force and application of disinfectant to all surfaces and geometries of a device could not be guaranteed with wipes. German guidelines have recommended
automation for the reprocessing of reusable semi-critical devices, including ultrasound probes, since 2012. Health authorities across Europe, including those in Germany, Belgium, Wales, Netherlands and Ireland, all recommend automation as a preferred solution for the reprocessing of reusable semi-critical devices like ultrasound probes.7,23-26
of infection preventionists, 91% of respondents said they preferred to use automated processes for probe reprocessing.27
The importance of traceability A key consideration for point of care reprocessing is the keeping of essential documentation, including records of medical device reprocessing and patient procedures. The linking of reprocessing cycle records to a patient record is known as traceability. Guidelines in the UK and Ireland require medical devices classified as semi-critical and critical to have full traceability to the patient.7,10,11 The minimum dataset for a procedure record
includes patient identifier, medical record number, procedure type, and operator for the procedure.7
For reprocessing, the minimum
dataset required by guidelines includes transducer and serial number, cleaning and disinfection product serial numbers, date and time of disinfection, and operator.7 Because of its portability and use at point of
care, ultrasound presents unique challenges for traceability. It is essential to have traceability documentation for decision making about device recalls or patient notifications in outbreak settings. In an outbreak of Serratia marcescens attributed to an ultrasound probe used in a digestive surgery ward, 8 out of 9 patients who came into contact with the contaminated probe were infected.19
Traceability records were In a US national survey instrumental in identifying previously missed
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