International consortium kicks off multicountry study on device traceability

International consortium kicks off multicountry study on device traceability

by John R. Fischer, Senior Reporter | July 03, 2018
Health IT Revenue Management

Other evaluations include Johnson and Johnson’s suggestion of a bar code reference sheet for nurses to scan; stickers that come with implant trays but often lack a full UDI and are prone to fading or getting lost; and sterile packaged items which are more expensive, may not be used in a case, and lose their UDI once opened.
“The study looks at all current and suggested ways of UDI compliance and aims to come up with a blend of suggestions for those in the U.S. and EU to comply with the upcoming UDI mandates in a safe and comprehensive way for maximum adoption,” said Donnelly. “We want a reasonable way that doesn't suggest any blockades or hurdles to those in the industry, including manufacturers, hospitals and public sector.”

The study is made up of 40 hospitals and 7 countries who seek to aid in collecting and providing international medical device data to programs such as the FDA’s National Evaluation System for Health Technology and the European Union’s Medical Device Regulation initiative, in order to ensure improved patient outcomes and reduce healthcare costs.

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Top UDI stakeholders overseeing the assessment include GS1 Ireland, American Hospital Association's AHRMM, Association of Peri-operative Registered Nurses (AORN), and various U.S. and European government agencies.

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