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New Usability Standard Aims To Help Firms Institute Human Factors Programs

This article was originally published in The Silver Sheet

Executive Summary

HUMAN FACTORS ENGINEERING IS GETTING A LEG UP with the upcoming release of an international standard that explains how medical device manufacturers can ensure their products are easy to use. Experts believe that better human factors engineering may lead to fewer device recalls and adverse events. Expected to be finalized this fall, IEC 62366 shows firms how risk management and usability work hand-in-hand, referring often to ISO 14971, the voluntary international standard on risk management. "IEC 62366 is an important accessory to ISO 14971, since management of risk associated with device use requires special techniques and processes that are not provided in ISO 14971," says CDRH Human Factors Engineer Pete Carstensen. Meanwhile, FDA has launched a new human factors workgroup that will look at a variety of postmarket issues, including how usability problems are reported by way of the MedSun adverse event reporting system...

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