Cargando…

EU postmarket surveillance plans for medical devices

PURPOSE: Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive‐reactive postmarket surveillance (PMS) system. Various European Union (EU) national competent authorities have started to focus on strengthening the postmarket risk evalu...

Descripción completa

Detalles Bibliográficos
Autores principales:	Pane, Josep, Francisca, Reynold D.C., Verhamme, Katia M.C., Orozco, Marcia, Viroux, Hilde, Rebollo, Irene, Sturkenboom, Miriam C.J.M.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2019
Materias:	Review
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6771951/ https://www.ncbi.nlm.nih.gov/pubmed/31318470 http://dx.doi.org/10.1002/pds.4859

Ejemplares similares

Descriptive analysis of postmarket surveillance data for hip implants
por: Pane, Josep, et al.
Publicado: (2020)

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines
por: Pane, Josep, et al.
Publicado: (2016)

Challenges Associated with the Safety Signal Detection Process for Medical Devices
por: Pane, Josep, et al.
Publicado: (2021)

Postmarket Surveillance of Medical Devices: A Comparison of Strategies in the US, EU, Japan, and China
por: Kramer, Daniel B., et al.
Publicado: (2013)

Impact of different assumptions on estimates of childhood diseases obtained from health care data: A retrospective cohort study
por: Osokogu, Osemeke U., et al.
Publicado: (2018)

The Importance of Registries in the Postmarketing Surveillance of Surgical Meshes
por: Köckerling, Ferdinand, et al.
Publicado: (2018)

Postmarketing Surveillance of Pregnancy Outcomes With Dolutegravir Use
por: Crawford, Melissa, et al.
Publicado: (2020)

Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies
por: Sinaci, A. Anil, et al.
Publicado: (2015)

Improving the Postmarket Surveillance of Total Joint Arthroplasty Devices
por: Mahomed, Nizar N, et al.
Publicado: (2008)

Sleep-Walking with Zolpidem: Need for Continued Postmarketing Surveillance
por: Sharma, Ajitha, et al.
Publicado: (2015)

Current development in medical devices postmarket surveillance in Taiwan
por: Lan, Cheng-Wen, et al.
Publicado: (2014)

Pediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project
por: de Bie, Sandra, et al.
Publicado: (2015)

Postmarketing Surveillance Study of the Efficacy and Safety of Phentermine in Patients with Obesity
por: Kim, Hyun Ok, et al.
Publicado: (2013)

Development, Production, and Postmarketing Surveillance of Hepatitis A Vaccines in China
por: Cui, Fuqiang, et al.
Publicado: (2014)

Signal detection using change point analysis in postmarket surveillance(†)
por: Xu, Zhiheng, et al.
Publicado: (2015)

Safety analysis of Ziagen® (abacavir sulfate) in postmarketing surveillance in Japan†
por: Kurita, Tomoko, et al.
Publicado: (2014)

An Evaluation of “Drug Ineffective” Postmarketing Reports in Drug Safety Surveillance
por: Misu, Takashi, et al.
Publicado: (2018)

Safety of Brexanolone in Adults with Postpartum Depression: Postmarketing Surveillance Data
por: Garafola, Svetlana, et al.
Publicado: (2023)

Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis
por: Koike, Takao, et al.
Publicado: (2011)

Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance
por: Kramer, Daniel B., et al.
Publicado: (2012)

A Postmarket Surveillance Study on Electro-Neuro-Adaptive-Regulator Therapy
por: Bonello, Rod P., et al.
Publicado: (2014)

Postmarketing surveillance of the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis
por: Harigai, Masayoshi, et al.
Publicado: (2016)

Transvenous Implantable Cardioverter-Defibrillator Lead Reliability: Implications for Postmarket Surveillance
por: Kramer, Daniel B, et al.
Publicado: (2015)

Postmarket surveillance of 3D-printed implants for sacroiliac joint fusion
por: Cher, Daniel, et al.
Publicado: (2018)

Safety of Gliadel Implant for Malignant Glioma: Report of Postmarketing Surveillance in Japan
por: NISHIKAWA, Ryo, et al.
Publicado: (2021)

Harmonizing national growth references for multi-centre surveys, drug monitoring and international postmarketing surveillance
por: Hermanussen, M, et al.
Publicado: (2012)

Postmarketing surveillance of tocilizumab for rheumatoid arthritis in Japan: interim analysis of 3881 patients
por: Koike, Takao, et al.
Publicado: (2011)

Lasting treatment effects in a postmarketing surveillance study of prolonged-release melatonin
por: Hajak, Göran, et al.
Publicado: (2015)

Postmarketing Safety Surveillance and Reevaluation of Danhong Injection: Clinical Study of 30888 Cases
por: Li, Xue-Lin, et al.
Publicado: (2015)

Effectiveness of drug postmarketing all-case surveillance as a safety measure in Japan
por: Kondo, Hideyuki, et al.
Publicado: (2021)

Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance
por: Yuan, Jinyi, et al.
Publicado: (2022)

Evaluation of the quality and value of data sources for postmarket surveillance of the safety of cough and cold medications in children
por: Green, Jody L., et al.
Publicado: (2018)

Postmarketing safety surveillance data reveals protective effects of botulinum toxin injections against incident anxiety
por: Wollmer, M. Axel, et al.
Publicado: (2021)

Investigation assessing the publicly available evidence supporting postmarketing withdrawals, revocations and suspensions of marketing authorisations in the EU since 2012
por: Lane, Samantha, et al.
Publicado: (2018)

Governance of conflicts of interest in postmarketing surveillance research and the Canadian Drug Safety and Effectiveness Network
por: Ferris, Lorraine E, et al.
Publicado: (2010)

Safety and Effectiveness of Micafungin in Japanese Pediatric Patients: Results of a Postmarketing Surveillance Study
por: Kobayashi, Chie, et al.
Publicado: (2015)

Safety and Antihypertensive Effect of Selara® (Eplerenone): Results from a Postmarketing Surveillance in Japan
por: Takahashi, Shoko, et al.
Publicado: (2016)

Pharmacodynamic analysis of hypertension caused by lenvatinib using real‐world postmarketing surveillance data
por: Otani, Yuki, et al.
Publicado: (2021)

Postmarket surveillance of high-risk medical devices needs transparent, comprehensive and independent registries
por: Fraser, Alan G
Publicado: (2020)

Eight-Year Postmarket Safety Surveillance of Delayed Complications With a Flexible Lip Filler
por: Cohen, Joel L., et al.
Publicado: (2022)

Cannot write session to /tmp/vufind_sessions/sess_aq6mvfrltfo3vciu8d5diprnbo