Healthcare DIVE October 10, 2019
Medical devices used outside of acute care settings, such as point-of-care ultrasound, and those whose rapid development has outpaced safety assessments, namely robots, are among the top health technology hazards that nonprofit ECRI Institute has identified in a new report.
Leading the organization’s list, however, are accidents associated with a decades-old technology, surgical staplers. Problems associated with staplers have led FDA to propose reclassifying the devices from Class I to Class II, a higher-risk category that would allow the agency to establish special controls and labeling requirements for the devices.
An advisory panel for the agency endorsed the proposal in May, and Medtronic and the Society of American Gastrointestinal and Endoscopic Surgeons both have voiced support for formal reclassification.
ECRI...
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