Lorena Petrella1, Paulo Fernandes2, Mário Santos1, Miguel Caixinha1,3, Sandrina Nunes4, Carlos Pinto2,5, Miguel Morgado6, Jaime Santos1, Fernando Perdigão2,5, Marco Gomes5. 1. Department of Electrical and Computer Engineering, Center for Mechanical Engineering, Materials, and Processes, Universidade de Coimbra, Coimbra, Portugal. 2. Department of Electrical and Computer Engineering, Universidade de Coimbra, Coimbra, Portugal. 3. Department of Physics, Universidade de Beira Interior, Covilhã, Portugal. 4. Association for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal. 5. Instituto de Telecomunicações-Coimbra, Coimbra, Portugal. 6. Coimbra Institute for Biomedical Imaging and Translational Research, Department of Physics, Universidade de Coimbra, Coimbra, Portugal.
Abstract
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/cm2 ) 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/cm2 , 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.
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/cm2 ) 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/cm2 , 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.
Authors: Lorena Petrella; Sandrina Nunes; Fernando Perdigão; Marco Gomes; Mário Santos; Carlos Pinto; Miguel Morgado; António Travassos; Jaime Santos; Miguel Caixinha Journal: Pilot Feasibility Stud Date: 2022-09-29