February 8, 2017 – Medical Device Epidemiology Network – Madris Tomes has been selected to Lead the Scope & Strategy Team of the Augmented Unique Device Identifier (AUDI) working group. There are a total of four working groups whose mission is to provide the framework for best practices in expanding the UDI-associated device system to manage clinically significant attributes not currently found in the GUDID.
January 20, 2017 – Central Penn Business Journal – The federal government fields some 70,000 reports a month on problems with medical devices, with implications ranging from minor to deadly. Patients, lawyers, doctors and others trying get a picture of possible problems with artificial knees, syringes and other devices don’t have the time to sift through all those reports. Madris Tomes of York County is trying to make sure they won’t have to.
York, PA – “A good number of attorneys have reported transvaginal mesh adverse events to the FDA on behalf of their clients/patients, but over 23,000 reports are from physicians,” says Madris Tomes, founder of Device Events and former FDA Program Manager. “Physicians are not great at reporting— this is a HUGE number.”
York, PA USA — 3 January 2017 – Device Events, LLC announced today the commercial launch and availability of their cloud-based medical device recall and adverse event search, reporting, and analysis service.
Device Events LLC, founded by Ms. Madris Tomes in 2015, provides a cloud-based software service that extracts, consolidates and provides easy access to clear and comprehensive information on the millions of medical device adverse event reports (MDRs) filed with the FDA.
(CNN) Many rules regulate the way pharmaceutical companies tell you, doctors and insurance companies about their products.
Or was it the fear of lawsuits that curtailed use of the laparoscopic surgical devices?
Qmed recently looked to Device Events for thoughts on JAMA study on morcellators. Here’s a link to the recent article.
Learn about how potentially mis-classified adverse events could be understating the risk of medical devices.
CMS’ pushback on integrating UDI into claims payment systems may now be a thing of the past. Learn how early compliance and understanding the intent of the UDI rule will help smooth the way for UDI in EHRs and in Claims.
The PDF link below can be viewed in your browser and is downloadable.
WASHINGTON, D.C. — Congressman Mike Fitzpatrick (PA-8) sent the following letter to the Food and Drug Administration Tuesday regarding dramatic changes in the reporting of adverse events caused by the medical device Essure:
Updated 10:01 AM ET, Tue March 1, 2016
(CNN)The U.S. Food and Drug Administration said it will require a new “black box warning” label for Essure, an implantable permanent contraceptive device. A black box warning in the labeling of products is “designed to call attention to serious or life-threatening risks,” according to the FDA website.
Monday’s announcement comes after more than 5,000 women filed grievances with the FDA between November 2002 and May 2015, complaining of unintended pregnancies, miscarriages, stillbirths and severe pain and bleeding after an Essure implantation.
Click here to read more: http://www.cnn.com/2016/02/29/health/fda-essure-birth-control-device/index.html