Medical device active surveillance of spontaneous reports: A literature review of signal detection methods.

Pharmacoepidemiology and Drug Safety
Gary ChungAndrew Yoo

Abstract

The collection and analysis of real-world data for the active monitoring of medical device performance and safety has become increasingly important. Spontaneous reports, such as those in the Food & Drug Administration's (FDA's) Manufacturer and User Facility Device Experience (MAUDE), provide early warning of potential issues with marketed devices. This review synthesizes the current literature on medical device surveillance signal detection and provides a framework for application of methods to active surveillance of spontaneous reports. Ovid MEDLINE, Ovid Embase, Scopus, and PubMed databases were systematically searched up to January 2019. Additionally, five methods articles from pharmacovigilance were added that had potential applications to medical devices. Among 105 articles included, the most common source of data (84%) was registries; median time between data collection and publication was 8 years. Surgical procedure outcome signal detection articles comprised 83% while 14% were on device outcome signal detection. The most common family of methods cited (70%) was Sequential Probability Ratio. Application of any signal detection algorithm requires careful consideration of influential factors, data limitations, and algorit...Continue Reading

References

May 11, 1996·BMJ : British Medical Journal·N Black
Apr 6, 2000·The Annals of Thoracic Surgery·A D Bernstein, V Parsonnet
Apr 1, 2003·Statistical Methods in Medical Research·O A GriggD J Spiegelhalter
Aug 23, 2003·Biostatistics·S H SteinerT Treasure
Dec 2, 2004·The Journal of Thoracic and Cardiovascular Surgery·Chris A RogersGianni D Angelini
Jan 15, 2005·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Cédric BousquetMarie-Christine Jaulent
Dec 17, 2005·Journal of the American Medical Informatics Association : JAMIA·Michael E MathenyFrederic S Resnic
May 25, 2006·The Journal of Bone and Joint Surgery. British Volume·S L HardoonJ H P van der Meulen
May 31, 2007·Statistics in Medicine·Sarah L HardoonJan H P van der Meulen
Jun 1, 2007·Clinical Pharmacology and Therapeutics·J S AlmenoffN Yuen
Jun 30, 2007·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Robert G HauserWilliam T Katsiyiannis
Jul 6, 2007·ANZ Journal of Surgery·Cheng-Hon YapDavid A Watters
Nov 19, 2008·Medical Decision Making : an International Journal of the Society for Medical Decision Making·Michael E MathenyFrederic S Resnic
Jan 10, 2009·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Elena Lopez-GonzalezAdolfo Figueiras
Feb 28, 2009·Statistics in Medicine·Landon H SegoWilliam H Woodall
Jan 15, 2010·Annual Review of Public Health·Robert D GibbonsJ John Mann
Aug 19, 2010·Biomedical Instrumentation & Technology·Terrie L Reed, Diana Kaufman-Rivi
Nov 11, 2010·JAMA : the Journal of the American Medical Association·Frederic S ResnicMichael E Matheny
Jan 5, 2011·European Journal of Surgical Oncology : the Journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology·G S CollinsP McCulloch
Mar 2, 2011·Contemporary Clinical Trials·Venkatesan D VidiFrederic S Resnic
Apr 23, 2011·Surgical Endoscopy·Hajime KayanoNobuhiko Tanigawa
Jul 26, 2011·Statistics in Medicine·Edit GombayStefan H Steiner
Oct 5, 2011·Statistics in Medicine·L Zeng, S Zhou
Dec 16, 2011·BMC Medical Informatics and Decision Making·Michael E MathenyFrederic S Resnic
Dec 23, 2011·International Journal for Quality in Health Care : Journal of the International Society for Quality in Health Care·Mark A Jones, Stefan H Steiner
Jan 25, 2012·Pharmacoepidemiology and Drug Safety·Melissa A RobbJanet Woodcock
Jan 25, 2012·Pharmacoepidemiology and Drug Safety·Jeremy A Rassen, Sebastian Schneeweiss
Jan 1, 2013·Burns : Journal of the International Society for Burn Injuries·G RobertsP Dziewulski
Mar 13, 2013·Journal of Interventional Cardiac Electrophysiology : an International Journal of Arrhythmias and Pacing·Kathleen Blake
Jul 13, 2013·Pharmacoepidemiology and Drug Safety·Becky A BriesacherJerry H Gurwitz
Apr 24, 2014·Statistical Methods in Medical Research·Giuseppe RossiMarco Marchi
Apr 24, 2015·Pharmacoepidemiology and Drug Safety·Zhiheng XuGerry Gray
Jun 4, 2015·Statistics in Medicine·Xiang Zhang, William H Woodall
Dec 9, 2016·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Josep PaneIrene Rebollo
Dec 17, 2016·International Journal of Radiation Oncology, Biology, Physics·Michael J ConnorJona A Hattangadi-Gluth
Jan 4, 2017·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Carrie E PierceNabarun Dasgupta
May 4, 2017·International Journal of Radiation Oncology, Biology, Physics·Michael J ConnorJona A Hattangadi-Gluth
May 2, 2018·Therapeutic Innovation & Regulatory Science·Rima IzemYueqin Zhao

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

Conference Proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society
Jih-Horn Stanley ChenWei-Shiang Lee
Therapeutic Innovation & Regulatory Science
Lan HuangRam C Tiwari
The Annals of Pharmacotherapy
Manfred Hauben
© 2021 Meta ULC. All rights reserved