China
Africa
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Labeling, label, and language: A truly global matter
Published in Jack Wong, Raymond K. Y. Tong, Handbook of Medical Device Regulatory Affairs in Asia, 2018
Evangeline D. Loh, Jaap L. Laufer
One of the key elements of labeling in the near future will be the use of a UDI, a unique device identifier. While the idea itself makes eminent sense, it must be feared that in absence of a well-defined electronic structure allowing for the proper handling and management of the huge quantity of data influx, the objective of the electronic tracing of individual products from the manufacturer to the user will stay an illusion for many years to come. To this end, the Global Harmonization Task Force (GHTF) has issued guidance on UDI [1] (UDI System, September 16, 2011) which implores countries to consider the GHTF guidance in promulgating regulations on UDI. It would appear the USA FDA will be the first in line to publish a draft rule (expected in the fall of 2011) [2]. The FDA has published this draft UDI as a proposed rule (Federal Register, Vol. 77, No. 132, 10 July 2012). https://www.gpo.gov/fdsys/pkg/FR-2012-07-10/html/2012-16621.htm; however, the EU, with their revision of the medical devices directives, will similarly seem to require UDI [3]. The draft Medical Device Regulation introduces the use of UDI. https://www.gpo.gov/fdsys/pkg/FR-2012-07-10/html/2012-16621.htm.
Role of real-world digital data for orthopedic implant automated surveillance: a systematic review
Published in Expert Review of Medical Devices, 2021
Thibault Dhalluin, Sara Fakhiri, Guillaume Bouzillé, Julien Herbert, Philippe Rosset, Marc Cuggia, Leslie Grammatico-Guillon
To the best of our knowledge, our study is the most exhaustive literature review on the initiatives using real-world digital health data to monitor joint replacement surgery. The targeted nature of this literature review makes it possible to assess the use of real-world digital data for a specific use cases and to evaluate the state of the art and perspectives. We showed that real-world digital data offer many opportunities for improvement in the automation of monitoring in orthopedics. The contribution of real-world data, especially through natural language processing, is needed for automated and more robust health surveillance. The use of a UDI in the EHR and the integration of device databases will help to better identify the various orthopedic devices.
Preparing healthcare, academic institutions, and notified bodies for their involvement in the innovation of medical devices under the new European regulation
Published in Expert Review of Medical Devices, 2022
Francesco Garzotto, Rosanna Irene Comoretto, Lorenzo Dorigo, Dario Gregori, Alessandro Zotti, Gaudenzio Meneghesso, Gino Gerosa, Mauro Bonin
To facilitate collaborations with other countries, a central unit managed at a regional or national level by the health-care system will coordinate with the local MDU. The implementation of the EUDAMED and the UDI further support the creation of partnerships between different countries [42]. The implementation of an MDU requires an initial financial investment with a foreseeable quick payback. Our preliminary pilot experience of such an organization has gone beyond its intended objectives and expectations, being able to provide in vitro testing [49], clinical protocols, MD risk analysis during the COVID-19 pandemic [50,51] and providing solutions aimed at preventing infectious disease and cross-contamination in intensive care units [52].