Identification and Market Removal of Risky Medical Devices

JAMA Internal Medicine – Sept 28, 2020 – By Madris Tomes, Device Events Founder & CEO

Reporting of adverse events to the US Food and Drug Administration (FDA) has long been the primary mechanism of identifying safety issues with medical devices—ranging from nasal swabs to cardiac defibrillators to in vitro diagnostic test kits. Each day, approximately 3500 adverse event reports are collected in the agency’s Manufacturer and User Facility Device Experience (MAUDE) database. As anyone who has tried to use it will attest, the database provides a difficult-to-use interface to search these reports.

Read Full Article: JAMA 9-28-2020 Identification and Market Removal of RIsky Devices

FDA update adverse-event database

MASS DEVICE – Sept 21, 2020 – By Nancy Crotti 

In a long-promised move, the FDA today announced that it has added several updates to its database of injuries and deaths reportedly related to medical devices.

The agency said it now includes new adverse-event summaries, the number of events and exemption number fields in its eMDR, eSubmitter and Manufacturer and User Facility Device Experience Database (MAUDE).

The FDA also recently added a data field called “patient problem code,” an outcome code assigned to an adverse event. This has been available in drug reports but the device division redacted them from public view in the past, according to patient safety advocate Madris Tomes (CEO of Device Events and former FDA public health analyst).

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REPORT: IMPLANTED SPINAL CORD STIMULATORS FOR PAIN RELIEF

Public Citizen – June 10, 2020 – Michael A. Carome, M.D. – IMPLANTED SPINAL CORD STIMULATORS FOR PAIN RELIEF – Illustrating the FDA’s Dangerously Lax Oversight of High-Risk Implantable Medical Device

Executive Summary

For years, numerous commentators and patient safety advocates, including Public Citizen, have criticized the Food and Drug Administration’s (FDA’s) dangerously lax regulatory oversight of medical devices. The goals of this report, which was prompted by concerns about the safety of implanted spinal cord stimulators for pain relief that were raised in a 2018 Associated Press investigation by Weiss and Mohr,1 were to better understand the history of the FDA’s regulatory oversight of these devices, identify the deficiencies in this oversight that endangered patients, and recommend necessary changes to address those deficiencies.

In other countries, people have been heading down different paths when it comes to pain relief options. For example, CBD oil from https://blessedcbd.co.uk has become popular as an option for those suffering from spinal, and other, injuries in the UK. Blessed CBD and other providers of these products have their work cut out in the US, however, where manual devices hold a larger market share.

Still, with the status quo as it is, it is very much worthwhile for us to investigate these devices, to see if they are able to provide the pain relief that they are touted to accomplish. If they do work, then the “lax” oversight is justified. If they do not, then there may be a push towards alternative options opening onto mass markets.

Madris Tomes, Device Events Founder & CEO, was a contributor to the report providing adverse events metrics.

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‘They killed her’: Why are breast implants still putting millions of women at risk?

May 18, 2020 – FORTUNE – ARTICLE BY MARIA ASPAN – Allergan’s “medical aesthetics” products helped persuade AbbVie to buy the company. But what if the devices driving profit are also endangering women’s health?

“The breast implants that are on the market right now all have issues,” says Madris Tomes, a former FDA manager who tracks reported medical device failures at her Device Events firm. “I wouldn’t recommend them to anyone that I care about.”

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Signals Newsletter – Apr 2020 – Spinal Stabilization and Fusion Systems

DEVICE NAME:
PRODUCT CODE – DESCRIPTION
KWP                      – Appliance, Fixation, Spinal Interlaminal
KWQ                      – Appliance, Fixation, Spinal Intervertebral Boday
MNH                      – Orthosis, Spondylolisthesis Spinal Fixation
MNI                        – Orthosis, Spinal Pedicle Fixation
KNB                       – Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
OSH                       – Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

REPORTING PERIOD: JANUARY 2010 – MARCH 2020

ADVERSE EVENTS RECEIVED BY THE FDA FROM:

TOTAL……………………..34,500
INJURY……………………20,099
MALFUNCTION………….13,983
DEATH………………………..131
OTHER……………………….287

View Signals Newsletter – April 2020 – Spinal Stabilization and Fusion Systems

The U.S. needs more ventilators. Why can’t it make them in time?

March 25, 2020 – FORTUNE – ARTICLE BY MARIA ASPAN AND NAOMI XU ELEGANT – More hands are rapidly coming on deck to make ventilators for American coronavirus victims. There still might not be enough.

Madris Tomes, Device Events Founder & CEO and other experts warn “that the FDA’s restrictions on medical-grade materials, devices and processes exist for good reason…a rushed and potentially dysfunctional breathing machine can be worse than useless.”

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Leading the Call for Reform of Medical Device Safety Surveillance

December 20, 2019 – JAMA Internal Medicine – Article
Authors: James W. Salazar, MD, MAS1; Rita F. Redberg, MD, MSc1,2
An ideal surveillance system for medical device safety would comprehensively collect data on adverse events across the life span of a device. Preferably, the system would be integrated into electronic health records to allow seamless identification, tracking, and real-time reporting of device-associated adverse events. Moreover, it would parse adverse events to detect substantial safety signals and underperforming devices. Such a system would also allow implementation of corrective actions in a swift and commensurate manner.

Acknowledgements: We thank Madris Tomes, MBA, chief executive officer of Device Events, for her information on the history of unique identifiers and data on the number of adverse events entered in the US Food and Drug Administrations Manufacturer and User Facility Device Experience database. She was not compensated for is contribution.


Research Letter – Miscategorization of Deaths in the US Food and Drug Administration Adverse Events Database

October 7, 2019 – JAMA Internal Medical – Research Letter 

Authors: Lily Meier; Elizabeth Y. Wang, BA; Madris Tomes, MBA; Rita F. Redberg, MD, MSc

As the US Food and Drug Administration (FDA) moves to hasten approval of medical devices, data from postmarketing studies and registries are increasingly relied on to inform decision-making. With less time for premarketing clinical studies, postmarketing data are the principal way adverse events and risks become apparent. Even for high-risk implanted devices, premarketing trials are usually small and have short-term follow-up.1 The process of reporting adverse events is cumbersome, and reporting rates are low.2

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