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There's A Pediatric Air-Tube Shortage Because A Sterilization Facility Was Shut Down

Executive Summary

After an Illinois sterilization facility was shut down earlier this year, the US FDA says it has resulted in a temporary shortage of Bivona emergency breathing devices for children. The agency is working with the manufacturer, Smiths Medical, to figure out a solution quickly, but won’t have new inventory on the market for at least another week.

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The US medtech regulatory landscape in 2019 was capped at both ends by news of an ambitious rewrite of risk management standard ISO 14971, which was finalized in December. The international standard – used by most manufacturers that make and distribute medical devices within the United States – instructs device makers on how to best put together a risk management program. Other news of interest to readers last year included a rewrite of the US FDA’s Quality System Regulation (QSR) to harmonize it with ISO 13485, expanded Medicare coverage, troubles with ethylene oxide (EtO) used to sterilize devices – and much more. Here are 2019’s 10 most popular US regulation and policy stories from Medtech Insight.

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