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Home News

ISO Testing May Not Detect Wear in SACH Foot

by The O&P EDGE
July 25, 2023
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To introduce a study of wear patterns in prosthetic feet, the authors noted that International Organization for Standardization (ISO) 10328 standards, used to verify the safety of lower limb prosthetic devices, do not account for environmental or sociocultural factors associated with prosthetic use.

For example, the authors wrote, most locally manufactured prosthetic feet from low- and middle-income countries do not meet the ISO standards yet are safely used for years. An investigation of naturally worn prosthetic feet found that much of the wear occurred at the end of the keel, which, the researchers concluded, would not be detectable in ISO 10328 tests.

To conduct the study, the research team analyzed 66 replaced prosthetic feet from the Jaffna Jaipur Center of Disability and Rehabilitation in Sri Lanka. Delamination between the keel and rest of the foot could not be detected with ultrasound. Sole wear pattern was quantified by photographing the soles and dividing them into 200 rectangles and scoring the rectangle’s wear from 1 to 9 (no wear to extreme wear). Scores were averaged to create a contour map of prosthetic foot wear.

The analysis revealed that the highest levels of wear occurred at the heel, end of the keel, and the perimeter of the prosthetic foot. All regions of the prosthetic feet had significantly different wear scores. The authors found that locally manufactured SACH feet display high levels of wear in localized areas of the sole of, which can limit their lifespan.

The study, “The mechanical failure of locally manufactured prosthetic feet from the Jaffna Jaipur Centre for Disability Rehabilitation (JJCDR), Sri Lanka,” was published in Prosthetics and Orthotics International.

 

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