F.D.A. Deal Would Relax Rules on Reporting Medical Device Problems

July 11, 2017 – WASHINGTON — Makers of cardiac defibrillators, insulin pumps, breast implants and other medical devices might be able to delay reporting dangerous malfunctions to the Food and Drug Administration under an agreement heading for a vote in Congress.

Device makers will still have to quickly report any injuries or deaths related to their products. They would have more time, though, to file reports on devices that may not be working properly, and have the potential for injury.

The deal is part of a pact between the F.D.A. and the $148 billion device industry. Renegotiated every five years, the agreement includes the fees that device makers must pay for the agency to review their products. It is scheduled for a vote in the House of Representatives on Wednesday.

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“There are approximately 65,000 new adverse events every month, and you don’t have enough analysts to review those reports,” said Madris Tomes, who worked on such reports at the agency from 2010 to 2014. “They read them typically in order of importance, starting with deaths and injuries and malfunctions. When they come in the next day, they once again start with new deaths and injuries and malfunctions.”

Women harmed by sterilization coils push FDA to act

June 6, 2017 – Philadelphia Inquirer – The ranks of women harmed by Essure sterilization coils continue to grow, while the U.S. Food and Drug Administration’s efforts to inform them of the risks are not working, a 37,000-member advocacy group declared Tuesday.

Administrators of the six-year-old Facebook group Essure Problems said that in the first quarter of this year, the FDA received about 2,000 reports of women who underwent operations — usually hysterectomies — to remove coils that were causing complications such as pain and bleeding.

More than 9,000 removals have been reported since 2009, in addition to miscarriages, fetal deaths, and other problems, according to an analysis of the FDA’s “adverse events” reporting system. It was conducted by Madris Tomes, a former FDA manager who is the founding CEO of Device Events, based in York, Pa.

Madris Tomes to Lead “Scope and Strategy AUDI Working Group”

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.

Tracking trouble – Entrepreneur develops software to keep tabs on medical devices.

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.

Transvaginal Mesh Deaths Reported as Injuries?

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.”

Device Events LLC Launches Medical Device Adverse Event Reporting Service

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 Reports – FDA spotlights unapproved use of drugs, medical devices // Madris Tomes – Speaks at FDA Public Hearings

(CNN) Many rules regulate the way pharmaceutical companies tell you, doctors and insurance companies about their products.

Drug and medical device makers, insurance companies, lawyers and patients packed a room for two full days of public hearings at the Food and Drug Administration’s campus in Silver Spring, Maryland, this week to debate those rules.

FDA Spoke and Power Morcellator Use Dropped

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.

Qmed Article on Morcellators

Device Events featured on CNBC Power Lunch

Learn about how potentially mis-classified adverse events could be understating the risk of medical devices.

Increased oversight of medical devices needed?

Maetrics UDI White Paper

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.

https://www.deviceevents.com/wp-content/uploads/2016/06/Maetrics-UDI-White-Paper.pdf