UDI: 5 Opportunities You May Not Have Considered
It may only be three letters, but for some manufacturers, UDI is a four-letter word. There are others who see the regulation as an opportunity to better understand product performance, speed up regulatory approval and coverage decisions, and improve the cost of doing business with customers. For those not familiar with the acronym, an increasing number of regulatory bodies around the world, including the U.S. FDA and the European Commission, are requiring manufacturers to fulfill three primary requirements: 1) assign unique device identifiers (UDIs) to their products; 2) label those products with the UDIs in both human and machine (think bar code, RFID) readable formats; and 3) publish additional attributes about those products to regulatory databases. Compliance with those requirements is an ongoing effort (not a one-time project) that requires coordination across a wide variety of functions within a manufacturer organization, from regulatory affairs and printing to marketing and information technology. Data governance is also critical, especially as more countries and regions of the world begin to publish their own UDI regulations. China recently published its draft regulations, and UDI activity is underway in Saudi Arabia, Taiwan, South Korea, and Brazil, to name just a few. Despite efforts by regulators to harmonize their UDI regulations according to guidelines published by the International Medical Device Regulatory Forum, even minor differences in regulatory language an...
Authors: Khurram A, Abedi D, Abedi M PMID: 32497473 [PubMed - as supplied by publisher]
CONCLUSION: Use of VR facility tours as an alternative to in-person tours of affiliate training facilities during a residency interview day is a viable and innovative option that can save time and money and favorably impact the applicant's impression of the program. More research is necessary to assess whether VR tours can replace in-person tours at the main teaching site, however, while social distancing measures are in place, VR tours may become necessary for programs moving forward. ABBREVIATIONS: Med-Peds: Internal Medicine-Pediatrics; VR: Virtual Reality; AAMC: Association of American Medical Colleges; IRB: Instit...
Authors: Edigin E, Eseaton PO, Shaka H, Ojemolon PE, Asemota IR, Akuna E PMID: 32493181 [PubMed - in process]
Authors: Roberts V, Malone K, Moore P, Russell-Webster T, Caulfield R Abstract Our personal views about the challenges of continuing to deliver peer teaching during a pandemic. We are a group of 4th year medical students who are part of a student society which has delivered structured, highly formulaic peer-led teaching sessions for the past three years. During the COVID-19 pandemic, the reduced access to our normal clinical teaching highlighted the importance of peer-led teaching sessions. We wanted to continue with our peer-taught sessions but knew we would have to devise a new format to make our teaching accessi...
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