HHS could make permanent pandemic-related exemptions for some devices

Medical Design & Outsourcing – January 19, 2021 – By Nancy Crotti

HHS has used the Trump administration’s waning days to propose permanently exempting certain medical devices — including infusion pump controllers and fetal monitors — from the FDA 510(k) clearance process.

In a notice published Jan. 15, 2021, in the Federal Register, the agency also listed seven types of patient examination gloves that it has decided to immediately stop reviewing for 510(k) clearance.

The agency also proposed permanently exempting 84 Class II devices from the clearance review process, including home ventilators, cardiopulmonary bypass pressure gauges, fetal cardiac monitors, long-term extracorporeal support systems, certain imaging software, ethylene oxide sterilizers and aerators, and certain masks (including N95 respirators), gloves and gowns.

The agency said it based its decisions on a review of adverse events reported to its MAUDE database about the types of devices between 2010 and 2020. The devices recommended for permanent exemption accounted for 46 deaths reported to MAUDE, including 16 related to facility-use apnea monitors.

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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.

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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.

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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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