Publications by authors named "Naomi Fujita-Rohwerder"
Objective: To systematically assess the diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children under real-life conditions.
Design: Systematic review and meta-analysis.
Data Sources: MEDLINE, Embase, Cochrane Database for Systematic Reviews, INAHTA HTA database, preprint servers (via Europe PMC), ClinicalTrials.
Objective: To assess the methodological quality of pre-market clinical studies performed on medical devices (MDs), including in-vitro diagnostic (IVD) MDs, in Europe.
Design: Observational cross-sectional study.
Setting: A large German ethics committee.
ARTHROSCOPIC SURGERY FOR KNEE OSTEOARTHRITIS: IMPACT OF HEALTH TECHNOLOGY ASSESSMENT IN GERMANY.
Int J Technol Assess Health Care
January 2017
Objectives: This study aims to describe how a negative reimbursement decision-based on the health technology assessment (HTA) report of a nondrug intervention-affects healthcare providers in Germany.
Methods: Knee arthroscopy was chosen as an example, because as of April 2016 this procedure is no longer reimbursed for osteoarthritis, but is still covered for other indications, including meniscal lesions. The exclusion followed an HTA report prepared by the Institute for Quality and Efficiency in Health Care (IQWiG).
Background: The surgical community and the medical device industry enjoy a fruitful cooperation for the benefit of patients, but during the last years several high-risk products have led to problems and scandals, thus highlighting the need for reforms in European CE marking requirements. In October 2013, the European Parliament voted on a draft regulation on medical devices that intends to replace the current directives in 2014.
Purpose: This article offers guidance to surgeons on how to select and assess medical devices for clinical use.