ISO17025:2017 accredited testing is essential to ensure validation of ultrasound transducer repair results
G. Wayne Moore, B.Sc., MBA, FASE
08/11/2020
Laboratory accreditation is highly regarded both nationally and internationally as a reliable indicator of technical competence. Most ultrasound manufacturers routinely specify ISO/IEC 17025:2017 accreditation for suppliers of testing and calibration services. This accredited testing also applies to validating the materials and processes used in transducer repair activities.
ISO/IEC 17025—the World Standard
ISO/IEC 17025:2017 accreditation is the single most important standard for calibration and testing laboratories around the world. ISO/IEC 17025 accredited laboratories have demonstrated that they are technically proficient and able to produce precise and accurate test and calibration data. This is a voluntary, third party-reviewed process that ensures a laboratory’s quality management system is thoroughly evaluated on a regular basis to guarantee continued technical competence and compliance with ISO/IEC 17025.
Accreditation
Laboratory accreditation bodies use the ISO/IEC 17025 standard specifically to assess factors relevant to a laboratory’s ability to produce precise, accurate test and calibration data; including:
- Traceability of measurements and calibrations to national standards
- Technical competence of staff
- Maintenance of test equipment
- Quality assurance of test and calibration data
- Validity and appropriateness of test methods
- Appropriate handling and transportation of test items
- Quality of testing environment and sampling
To ensure continued compliance, accredited laboratories are regularly re-assessed to check that they are maintaining their standard of technical expertise. These laboratories are also required to participate in regular proficiency testing programs as an ongoing demonstration of their competence.
A matter of patient safety and regulatory compliance
For the safe and effectual repair of ultrasound transducers (probes) ISO/IEC 17025 compliance is essential to determine if the materials, parts, and processes used have restored the transducer to substantial performance and safety equivalence to the manufacturers (OEM) specifications. Acertara’s accredited acoustic testing laboratory performs FDA Guidance1 compliance for OEMs on a worldwide basis; testing that the OEMs use in their FDA 510(k) submissions to gain market clearance to sell their products. We use these same rigorous testing procedures to validate and document in our quality system, materials (e.g., for the probe lens)2 and parts (e.g., acoustic stacks) that are used in the repair process to demonstrate objective evidence that substantial equivalence has been achieved. Acertara then incorporates those materials and parts into our ISO13485:2016 certified probe repair processes.
A partner you can trust
Acertara is the only probe repair facility in the world that has both an accredited ISO/IEC 17025:2017 acoustic testing laboratory and certified ISO 13485:2016 probe repair facility. Additionally, Acertara has developed the most sophisticated probe testing devices available such as ATLAS™ to diagnose failures in probes – crystal-by-crystal; including some of the most technologically advanced probes on the market such as the Philips X5-1 and X7-2t. This type of testing is the accepted best method for testing probes.3 Post-repair testing and evaluation is also performed/documented to validate a successful repair. Accreditation, certification, advanced probe testing, and highly trained probe repair technicians all working together to provide our valued clinical customers with the assurance that the repairs are performed correctly, economically, complying with international standards and FDA Guidance. For more than twenty years our team has proven time and again – that we are your trusted partner in providing for the safety of patients.
To download your own PDF copy of this white paper: Accreditation White Paper_GWM 2020
References:
¹Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, Guidance for Industry and FDA Staff, United States Food and Drug Administration June 27, 2019.
²Ensuring Clinical Efficacy and Patient Safety with Repaired Ultrasound Probes, Bigelow T., Moore GW., Zagzebski J., Journal of Ultrasound in Medicine, 2018; 37:315-328
³Routine Quality Assurance for Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine (AIUM) Page 3, 2008
About the Author
A 40-year veteran of the diagnostic ultrasound market Wayne has held senior level positions with several major medical equipment manufacturers, including Honeywell Medical Systems and Siemens Medical Solutions. Over his career, Wayne has been directly involved in the development and commercialization of more than 20 technologically intensive ultrasound systems. He is widely published in diagnostic ultrasound literature, a sought-after speaker at medical imaging conferences, has served as an expert witness in multiple ultrasound litigations and is co-Author on more than 25 US and International ultrasound related patents. Wayne is the 2020 Ultrasound Chair for the MITA (Medical Imaging and Technology Alliance) Ultrasound Section and is a co-Chair on the Output Standards Committee of the AIUM (American Institute of Ultrasound in Medicine). Wayne obtained his MBA from the University of Denver – Daniels College of Business.
He was elected as a Fellow of the American Society of Echocardiography (FASE) in 2009.