Copy
View this email in your browser

Signals from Device Events
January 2021

Signals is a newsletter that highlights current medical device news and activity.


INTRODUCTION
The proliferation of medical devices and resulting adverse events have doubled over the past 5 years.  In 2016, the average monthly number of reported adverse events was 65,000.  In 2020, the average was 127,000 per month.  A 100% increase.  The reasons for this increase are the continued introduction of new devices and the improving transparency in reporting of adverse events driven by the FDA and patient advocacy groups.

This Signals Newsletter highlights the general trends in adverse events for all devices as reported to the FDA and captured in the FDA MAUDE database and provides insight into recent news worthy events.

ADVERSE EVENT ACTIVITY SPOTLIGHT
                   All Medical Devices 
 
NOTE: The following Adverse Event data was extracted from the FDA MAUDE database using Device Events, a cloud-based software service that extracts, consolidates and provides comprehensive reports and trends on the millions of medical device adverse event reports that have been submitted to the FDA. 
All Adverse Events, as of December 2020, in the FDA MAUDE Database.
 
ADVERSE EVENTS RECEIVED BY THE FDA
 
Acronyms: Medical Device Reports (MDR) and Alternative Summary Reports (ASR)
 

All Devices - All Adverse Event Type Trend -  (MDR's Only)

All Devices - Death Event Trend - (MDR's Only)


All Devices - Injury Event Trend - (MDR's Only)



All Devices - Malfunction Event Trend - (MDRs Only)
In The News
Medical Device Tracking - How It Is and How It Should Be

JAMA Network – December 16, 2020 -Madris Kinard, MBA; Lisa McGiffert, BA

Tracking Medical Devices With the US Food and Drug Administration’s Unique Device Identification System

In 2007, Congress mandated that medical device manufacturers create a unique identifying number for each of their products that was similar to a vehicle identification number on automobiles.1 Work to implement the law did not begin until in 2012, when Congress added a deadline. In 2013, the US Food and Drug Administration (FDA) adopted the final rule.2

Currently, device manufacturers must include a unique device identifier (UDI) on the label of all implantable and life-supporting/life-sustaining medical devices. By September 2022, the UDI will also be required for lower-risk, nonimplantable devices. The UDI is meant to be readable by people and also scannable; it contains up to 62 data elements, such as the company name, device name, and model number.3 This information is stored in the Access Global Unique Device Identification Database (AccessGUDID), a free, publicly available database maintained by the FDA.

Read More…


When Diabetes Devices Fail

Consumer Reports – December 8, 2020 – By Rachel Rabkin Peachman

Malfunctions or design flaws with continuous blood glucose monitors, insulin pumps, and other equipment can be devastating

Pamela, a 64-year-old from Arkansas, began using an insulin pump to manage her type 2 diabetes in 2013. She and her husband, Gary, were trained to use the pump, made by Medtronic, and according to a lawsuit later filed against the company, Gary often helped set up his wife’s device. (CR isn’t using their last name to protect their privacy.)

So it wasn’t unusual when one night in January 2016, Gary filled the pump’s reservoir with insulin and changed its infusion set, which connects the reservoir to the body via a thin plastic tube.

But Pamela and Gary didn’t know that the infusion set had a flaw that could cause the pump to deliver too much insulin—something that the lawsuit alleged happened to Pamela that night. While Gary was sleeping, Pamela’s blood sugar levels plummeted, and the next day he found her in a coma. Attempts to revive her failed; she died in a hospital a week later.

Read More…


Report: Implanted Spinal Cord Stimulators for Pain Relief – Illustrating the FDA’s Dangerously Lax Oversight of High-Risk Implantable Medical Devices

Public Citizen - June 10, 2020
 

In a report delivered to the Commissioner of the Food and Drug Administration (FDA) and key congressional committees, Public Citizen documented the FDA’s dangerously lax regulatory oversight of high-risk implanted spinal cord stimulators for pain relief, which has resulted in unnecessary harm to patients. The FDA’s regulatory oversight of implanted spinal cord stimulators for pain relief has had serious, wide-ranging deficiencies for several decades and is emblematic of what’s wrong with the agency’s oversight of medical devices.

Read More...

ABOUT DEVICE EVENTS
Device Events LLC is a Pennsylvania-based company that provides a cloud-based software service that extracts, consolidates and provides clear and comprehensive metrics and reports on the millions of complex medical device adverse event reports (MDRs) and recalls that have been filed with the FDA. · Our service helps all organizations associated with healthcare by providing them with clear, comprehensive and cost effective access to the most up to date information on problem medical devices. ·  We are committed to making information on problem devices easily accessible to our customers so they can improve health outcomes and patient safety while reducing risk for their organizations.  For more information visit our website at www.deviceevents.com
Copyright © 2021 Device Events, Inc, All rights reserved.


Want to change how you receive these emails?
You can update your preferences or unsubscribe from this list.

Email Marketing Powered by Mailchimp