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Safety Assessment of an A‐Scan Ultrasonic System for Ophthalmic Use
Author(s) -
Petrella Lorena,
Fernandes Paulo,
Santos Mário,
Caixinha Miguel,
Nunes Sandrina,
Pinto Carlos,
Morgado Miguel,
Santos Jaime,
Perdigão Fernando,
Gomes Marco
Publication year - 2020
Publication title -
journal of ultrasound in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.574
H-Index - 91
eISSN - 1550-9613
pISSN - 0278-4297
DOI - 10.1002/jum.15323
Subject(s) - medicine , standardization , ultrasonic sensor , patient safety , food and drug administration , medical physics , mechanical index , ultrasound , biomedical engineering , risk analysis (engineering) , radiology , computer science , health care , microbubbles , economics , economic growth , operating system
Objectives This study describes the safety assessment of an A‐scan ultrasonic system for ophthalmic use. The system is an investigational medical device for automatic cataract detection and classification. Methods The risk management was based on the International Organization for Standardization (ISO) standard DIN EN ISO 14971:2009‐10 and International Electrotechnical Commission (IEC) standard IEC 60601‐2‐37. The calibration of the ultrasonic field was conducted according to the standards IEC 62127‐1:2007 and IEC 62359:2010. The uncertainty on measurements was delineated in agreement with the guide JCGM 100:2008. Results After risk management, all risks were qualitatively classified as acceptable. The mechanical index (0.08 ± 0.05), soft tissue thermal index (0.08 ± 0.08) and spatial‐peak temporal‐average intensity (0.56 ± 0.59 mW/cm 2 ) were under the maximum index values indicated by the US Food and Drug Administration guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (0.23, 1, and 17 mW/cm 2 , respectively). Conclusions This study presents a practical approach for the safety assessment of A‐scan ultrasonic systems for ophthalmic use. The safety evaluation of a medical device is mandatory before its use in clinical practice. However, the safety monitoring throughout its life cycle should also be considered, since many device components may deteriorate over time and use.