1. Esaote S.p.A.

2. Il gruppo di lavoro
Ramona De Luca – Ultrasound Probes,
Usability, Reprocessing and Accessories Leader
Daniele Fiesoli – Ultrasound
Probes Compliance Specialist
Simona Bellavia – Materials
Chemical Compatibility Specialist
Marianna Oliverio – Project
Management Specialist

3. Descrizione
In recent years, ultrasound imaging has seen a rapid expansion in a wide range of
clinical applications and procedures. This tool is frequently used by sonographers,
doctors, nurses, and other medical professionals in hospitals, outpatient
ambulatory settings and medical offices. This expansion and these diverse areas
of sonography emphasize the need for the development, validation and routine
management of proper infection prevention and control to protect patient and
clinician health, prolong the transducer life, ensure optimized imaging
capabilities.
“…The instructions provided above have been validated by the manufacturer of
the medical device as being capable of preparing a medical device for reuse. It
remains the responsibility of the processor to ensure that the processing, as
actually performed using equipment, materials and personnel in the processing
facility, achieves the desired result. This requires verification and/or validation and
routine monitoring of the process…” (ISO 17664-1:2021, ANNEX B)

4. Obiettivi e destinatari del lavoro
The aim of this abstract is to provide education and practices guidelines to meet
development, validation and routine management requirements to guarantee
proper infection prevention and control.
The responsibility assignment matrix for appropriate probe reprocessing,
includes healthcare facilities/personnel, medical device manufacturers and
manufacturers of cleaning/disinfection/sterilization agents and methods.
Therefore, this abstract is addressed to all the healthcare professionals involved
in the reprocessing management and execution, including sonographers,
paramedics, clinical engineers, finance/procurement officers.

5. Risultati
This abstract builds upon regulations, standards and technical guidelines and
provides a comprehensive set of recommendations that any healthcare
professional can use to answer probe reprocessing questions or to implement
such recommendations.
Example of IFU pictograms for the reprocessing of a non-critical ultrasound probe (References: ISO 17664-2:2021; ISO 20417:2021;
IEC 62366-1:2015+AMD1:2020)

6. Ramona De Luca, PhD
ramona.deluca@esaote.com
Ultrasound Probes, Usability, Reprocessing and Accessories
Leader