Wordstat is a highly rated advanced content analysis and text mining software with unmatched handling which comes along with analysis capabilities. Maude offers a localized database for passive postmarket surveillance of medical devices. The machine learning programs talend realtime bigdata platform. A primer to the structure, content and linkage of the fdas. Maude is a highperformance reflective language supporting equational and rewriting logic. The examples in the manual and in the book all about maude is also available here. Food and drug administrations maude database manufacturer and user facility device experience. Adverse clinical events reported during invisalign. Nov, 2019 all in all, maud is a very nice software solution for analyzing textures, as its packed with lots of useful tools and features. Maude database audit shows inaccurate representation of. The maude database houses medical device reports submitted to the fda by mandatory reporters 1 manufacturers, importers and device user facilities and voluntary reporters such as health care. The fdas maude database for medical device adverse event reporting after market introduction of a device. Reporting standards for adverse events after medical device.
That makes it a valuable resource for the medical community. Analysis of safetycritical computer failures in medical. Using fda reports to inform a classification for health. A secondary procedure performed to address problems that arise as a result of the index procedure. Events that occur from the procedure, irrespective of the device. Attempt analysis using text mining alone ignore device evaluate if general text mining provides any insights2. The download data files consist of voluntary reports since june 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since august 1996. Manufacturer and user facility device experience maude database. The maude database houses mdrs submitted to the fda by mandatory reporters1 manufacturers, importers and device user facilities and voluntary reporters such as health care professionals. For each event, the maude database contains a master record that is linked to freetext. Subjects and methods the maude database was searched for all reports on adverse events involving balloon sinuplasty devices from the 3 leading manufacturers. The maude database houses medical device reports submitted to the fda by mandatory reporters manufacturers, importers and device user facilities and. It a powerful software i am using it for years now to analyze complex xrd pattern.
Top 37 software for text analysis, text mining, text. Food and drug administration provides to monitor medical devices. Full text reporters occupation and source of adverse. This was a retrospective analysis of the manufacturer and user facility device experience maude database of the united states food and drug administration fda. Simply select your manager software from the list below and click on.
The maude database contains medical device problem and. As part of risk analysis, i was told that we can search for product codes. The maude system is an implementation of rewriting logic developed at sri international. Adverse events involving radiation oncology medical devices. Perform standard disproportionality analysis on structured data prr, ebgm, adj. Maude 8, a modeling language based on rewriting logic that has proved suitable for modeling and analyzing distributed systems. Health information technology hit has the potential to deliver great benefits but, if poorly designed or implemented, poses a risk to patient safety. Using algorithms and analysis, icij screened millions of records and found cases where. Maude data represents reports of adverse events involving medical devices. Sep 17, 2016 this a video tutorial on rietveld refinement easily and quickly. The maude database houses mdrs submitted to the fda by mandatory reporters1 manufacturers, importers and device user facilities and voluntary reporters such as health care professionals, patients and consumers. The download data files consist of voluntary reports.
Maude database and similar devices risk analysis, quality. Analysis of safetycritical computer failures in medical devices. An analysis of the fda maude database and the search for. Text mining the maude database linkedin slideshare. It can be searched by several variables including product problem, product class, event type, manufacturer, model number. Full maude is written in maude, and is thus platformindependent. Oct 21, 2018 the maude database can be used to search adverse events for different product codes. The november research group ngr announced on september 17, 20 that it had won an fda contract to have its pharmacovigilance report intake and managed output primo software system eventually replace the fdas manufacturer and user facility device experiences maude system. Methodology this section presents our methodology, including the analysis of adverse event reports on robotic surgical. Perform standard disproportionality analysis on structured data.
Rietveld refinement in 4 minute the simplest way to. Quick base is a webbased platform from which workgroups can easily create unlimited customizable applications to control data. It can be used to fit diffraction, fluorescence and reflectivity data using xray, neutron, tof or electrons. The entire maude database from jan 1, 1997 to dec 31, 2018, was downloaded from the fdas website 2 and uploaded to a postgresql server. Mauve is a system for constructing multiple genome alignments in the presence of largescale evolutionary events such as rearrangement and inversion. Manufacturer and user facility device experience database. Most were cases in which surgeons complained that the software registered incorrect locations for pedicle. To compare the overall agreement between maude and tvtderived event rates, we performed a regression analysis comparing all events for tavr compiled from the maude reports based on the nlp analysis to the results from the tvt database figure 2, a. Because of the importance of these observations, a repeat analysis of the entire maude database was undertaken to determine the reporting source and reporter occupation. The dictionaries of keywords for surgery typesspecialties and surgical instruments were constructed based on the online information available on the da vinci surgeries 32 and instruments catalog 33 from the manufacturer. The maude database houses medical device reports submitted to the fda by mandatory reporters 1 manufacturers, importers and device user facilities and voluntary reporters such as health care professionals, patients and consumers. It is similar in its general approach to joseph goguens obj3 implementation of equational logic, but based on rewriting logic rather than ordersorted equational logic, and with a heavy emphasis on powerful metaprogramming based on reflection. Comparison of adverse event and device problem rates for.
It can be searched by several variables including product problem, product class, event type, manufacturer, model number, report number, brand name, and product code. It is similar in its general approach to joseph goguens obj3 implementation of equational logic, but based on rewriting. Assuming that the tvt registry is the gold standard for realworld applications of tavr, the. One question came up as i was doing some risk analysis for a particular product code. A threelayered approach to radiation therapy software recall analysis. Risk analysis session input probability, severity and detectability are metrics prescribed by iso 14971 and. Data extraction and analysis flow from the fda maude database.
What is the best software to use for xrd peaks identification. Dec 12, 2018 the maude database is a passive surveillance system of mdrs. A software framework for simulation of safety hazards in. Rietveld refinement in 4 minute the simplest way to refine. Sep 08, 2014 maude stands for the manufacturer and user facility device experience. Only mdrs reported within the past 10 years are included in the maude database. This a video tutorial on rietveld refinement easily and quickly.
Maude manufacturer and user facility device experience fda. Used by half of the fortune 100, quick base is the fastest, easiest and most flexible way for growing companies to create and manage data, regardless of. Maude database audit shows inaccurate representation of mesh. The maude database is a passive surveillance system of mdrs.
The dictionaries of keywords for surgery typesspecialties and surgical instruments were. The fda uses mdrs to monitor device performance, detect potential devicerelated safety issues and contribute to benefitrisk assessments of these products. However, most basic training programs focus on a single specialty. The fda makes medical device reports available to the public on the fdas public maude database. In the midst of the coronavirus pandemic and reduced travelnetworking, please remember our resources page offers the latest. Maude database for development due diligence starfish medical. High scores especially in the other classification4.
Rietveld combined analysis tool for the analysis of materials using diffraction, fluorescence, reflectivity\. Maude stands for the manufacturer and user facility device experience. Reporting standards for adverse events after medical. If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. You may contact the company sales manger stev to get a free copy. Maude, or manufacturer and user facility device experience, is an fda database that houses medical device reports mdrs submitted to the fda. To compare the overall agreement between maude and tvtderived event rates, we performed a regression analysis comparing all events for tavr compiled from the maude reports based on the.
We searched 899 768 reports of events submitted to maude from january 2008 to july 2010. Maude database published by the fda are inaccurate at a significant rate and should not be used in. Rietveld combined analysis tool for the analysis of materials using diffraction, fluorescence, reflectivity\\n. Manufacturer and user facility device experience database maude maude data represents reports of adverse events involving medical devices. A rietveld extended program to perform combined analyses. Materials analysis using diffraction, program for generalised rietveld analysis. However, a search of fdas manufacturer and user facility device experience maude database yields 22 reports of adverse events in 2018 and 2019 involving the brainlab spinal navigation system. Adverse clinical events reported during invisalign treatment. How machine learning algorithms helped flag medical device issues. Used by half of the fortune 100, quick base is the fastest, easiest and most flexible way for growing companies to create and manage data, regardless of location or industry. Rogers proceedings of the human factors and ergonomics society annual meeting 2012 56.
A github repository with examples programs that can be used to import the maude data. Our maude model includes main components of cassandra such as data partitioning strategies, consistency levels, and timestamp policies for ordering multiple versions of data the details. Multiple genome alignments provide a basis for research into comparative genomics and the study of genomewide evolutionary dynamics. The dictionaries of keywords for surgery typesspecialties and surgical instruments were constructed based on the online information. The maude database can be used to search adverse events for different product codes. Each year, the fda receives several hundred thousand medical device reports mdrs of suspected deviceassociated. Filed under material analysis texture analyzer diffraction analysis. Maude manufacturer and user facility device experience.