Safety Assessment of an A-Scan Ultrasonic System for Ophthalmic Use.
A-scan
ophthalmology
risks
safety
ultrasound
Journal
Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine
ISSN: 1550-9613
Titre abrégé: J Ultrasound Med
Pays: England
ID NLM: 8211547
Informations de publication
Date de publication:
Nov 2020
Nov 2020
Historique:
received:
25
03
2020
revised:
10
04
2020
accepted:
13
04
2020
pubmed:
28
5
2020
medline:
15
5
2021
entrez:
28
5
2020
Statut:
ppublish
Résumé
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. 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. 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 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.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2143-2150Subventions
Organisme : Portuguese Foundation for Science and Technology
ID : POCI-01-0145-FEDER-028758
Organisme : Portuguese Foundation for Science and Technology
ID : UIDB/50008/2020
Informations de copyright
© 2020 by the American Institute of Ultrasound in Medicine.
Références
Henry Mundt G, Hughes WF. Ultrasonics in ocular diagnosis. Am J Ophthalmol 1956; 41:488-498.
Baum G, Greenwood I. The application of ultrasonic locating techniques to ophthalmology. AMA Arch Ophthalmol 1958; 60:263-279.
Pavlin C, Foster S (eds). Ultrasound Biomicroscopy of the Eye. 1st ed. New York, NY: Springer; 1995.
Bhardwaj V, Rajeshbhai GP. Axial length, anterior chamber depth: a study in different age groups and refractive errors. J Clin Diagn Res 2013; 7:2211-2212.
Coleman DJ, Carlin B. A new system for visual axis measurements in the human eye using ultrasound. Arch Ophthalmol 1967; 77:124-127.
Sunder Raj P, Ilango B, Watson A. Measurement of axial length in the calculation of intraocular lens power. Eye 1998; 12:227-229.
Huang CC, Ameri H, DeBoer C, et al. Evaluation of Lens hardness in cataract surgery using high-frequency ultrasonic parameters in vitro. Ultrasound Med Biol 2007; 33:1609-1616.
Paunksnis A, Kurapkiene S, Maciulis A, Kopustinskas A, Paunksniene M. Ultrasound quantitative evaluation of human eye cataract. Informatica 2007; 18:267-278.
Huang C, Chen R, Tsui P, Zhou Q, Humayun MS, Shung K. Measurements of attenuation coefficient for evaluating the hardness of a cataract lens by a high-frequency ultrasonic needle transducer. Phys Med Biol 2009; 54:5981-5994.
Tsui PH, Huang CC, Zhou Q, Shung KK. Cataract measurement by estimating the ultrasonic statistical parameter using an ultrasound needle transducer: an in vitro study. Physiol Meas 2011; 32:513-522.
Caixinha M, Santos M, Santos J. Automatic cataract hardness classification ex vivo by ultrasound techniques. Ultrasound Med Biol 2016; 42:989-998.
Caixinha M, Amaro J, Santos M, Perdigao F, Gomes M, Santos J. In-vivo automatic nuclear cataract detection and classification in an animal model by ultrasounds. IEEE Trans Biomed Eng 2016; 63:2326-2335.
Tabandeh H, Wilkins M, Thompson G, Nassiri D, Karim A. Hardness and ultrasonic characteristics of the human crystalline lens. J Cataract Refract Surg 2000; 26:838-841.
Huang CC, Zhou Q, Ameri H, et al. Determining the acoustic properties of the lens using a high-frequency ultrasonic needle transducer. Ultrasound Med Biol 2007; 33:1971-1977.
Santos J, Gomes M, Santos M, et al. Sistema ultrassónico de exame ocular para deteção precoce e classificação da catarata em tempo real. Instituto Nacional de Propriedade Industrial; April 18, 2019; Portugal.
Caixinha M, Jesus DA, Velte E, Santos MJ, Santos JB. Using ultrasound backscattering signals and Nakagami statistical distribution to assess regional cataract hardness. IEEE Trans Biomed Eng 2014; 61:2921-2929.
Petrella L, Gomes M, Perdigão F, et al. Eye scan ultrasound system for automatic cataract detection: from a preclinical to a clinical prototype. Medicon. Coimbra, Portugal: Springer; 2020:811-819.
International Organization for Standardization. DIN EN ISO 14971: 2007 Medical Devices-Application of Risk Management to Medical Devices. Geneva, Switzerland: International Organization for Standardization; 2007.
International Electrotechnical Commission. IEC 60601-2-37, Medical Electrical Equipment-Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment. Geneva, Switzerland: International Electrotechnical Commission; 2007.
International Electrotechnical Commission. IEC 62127-1, Ultrasonics-Hydrophones, Part 1: Measurement and Characterization of Medical Ultrasonic Fields up to 40 MHz. Geneva, Switzerland: International Electrotechnical Commission; 2007.
International Electrotechnical Commission. IEC 62359, Ultrasonics-Field Characterization: Test Methods for the Determination of Thermal and Mechanical Indices Related to Medical Diagnostic Ultrasonic Fields. Geneva, Switzerland: International Electrotechnical Commission; 2017.
Stuart Foster F, Pavlin CJ, Lockwood GR, et al. Principles and applications of ultrasound backscatter microscopy. IEEE Trans Ultrason Ferroelectr Freq Control 1993; 40:608-617.
Preston RC, Bacon DR, Smith RA. Calibration of medical ultrasonic equipment-procedures and accuracy assessment. IEEE Trans Ultrason Ferroelectr Freq Control 1988; 35:110-121.
International Organization for Standardization. JCGM 100:2008: Evaluation of Measurement Data-Guide to the Expression of Uncertainty in Measurement. Geneva, Switzerland: International Organization for Standardization; 2008.