• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts
    • MPR: Breakthrough Products Series
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
    • DeviceTalks
  • Coronavirus: Live updates
Home » JAMA editorial slams FDA over adverse-event reporting

JAMA editorial slams FDA over adverse-event reporting

January 9, 2020 By Nancy Crotti

This article has been updated with comments from the FDA.

A recent JAMA Internal Medicine editorial takes another swipe at the FDA for delays in improving its medical device adverse-event reporting.

Journal editor Dr. Rita Redberg and Dr. James Salazar, both of Department of Medicine, University of California, San Francisco, note several instances in which information was withheld from the public or not reported in full detail.

The editorial also highlights two studies published in the Dec. 20, 2019 issue, one about nationwide experience in Iceland of adverse events related to St. Jude Medical’s Riata defibrillator lead, and the other about “the high burden of serious adverse events (including death)” with Medtronic’s InSync III model 8042 heart failure pacemaker.

The InSync II article notes the length of time the FDA took from the first notice of device failure (19 months) to a recall of the device, and the FDA’s decision to classify the recall as Class II, which denotes a low probability of serious adverse events.

“This long unexplained delay before the recall and the inappropriate recall classification raise concerns about patient harms that could have been prevented by speedier and stronger regulatory actions,” Redberg and Salazar wrote. “When there is a device safety signal or recall, it is appalling that the United States, unlike Iceland, lacks even a rudimentary means to track medical devices.”

The FDA has been working on developing a unique device identifier (UDI) for each medical device since 2007. The agency began requiring UDIs in 2014 for high-risk (Class III) devices and in 2016 for Class II devices. the labeling requirement went into effect in 2014 for class III (high-risk) devices and in 2016 for class II devices. The requirement for class I (low to moderate risk) devices is set to take effect September 24, 2020. A guidance published in November 2018 gave medtech manufacturers  until Sept. 24, 2022 before they must comply with direct-mark requirements for these devices.

“The integration of UDIs into electronic health records, which is necessary for the identifier to be useful, is highly reliant on the vendors accommodating the FDA’s recommendations,” the authors said. “In addition, devices may have multiple UDIs, which has created challenges that medical centers are addressing.”

The agency has also been working on a National Evaluation System for Health Technology (NEST) for several years, including a funding boost in 2018. Meanwhile, media outlets including Kaiser Health News, the International Consortium of Investigative Journalists and Netflix have published scathing reports about the effects of medical device-related injuries and deaths and the FDA’s adverse-event reporting system.

“Progress on medical device safety will not be possible in the United States unless the FDA makes data collection and data transparency priorities and takes prompt and commensurate regulatory actions when safety issues are identified,” the JAMA editorial authors said. “There is no question that the current medical device surveillance system, which is based on the voluntary reporting of adverse events, requires substantial improvement to prevent avoidable serious illnesses and deaths. Patients deserve a robust medical device surveillance system that invariably puts patient safety first.”

In an email to MassDevice, the FDA said it does not generally comment on specific studies, “but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health. The FDA is reviewing the findings of the paper.”

“The FDA takes seriously its responsibility to monitor device safety and performance, take action when needed, and help ensure patients and providers have the information they need to make informed healthcare decisions,” the agency added. “In our April 2018 Medical Device Safety Action Plan we described several of the key actions we had taken in the past and steps we planned to take in the future. Since then we have been implementing the plan and have continued to enhance postmarket surveillance capabilities generally through several efforts, including enforcement of adverse event reporting requirements, improved summary reporting with public transparency, reorganization to share expertise and responsibility across pre- and postmarket activities, and support for the establishment of a National Evaluation System for health Technology (NEST) led by the Medical Device Innovation Consortium (MDIC).

“We are also in the process of a digital transformation to build a modern platform that will allow us to make more information readily available and easier to access analyze by the public. FDA remains committed to these ongoing improvements to enhance device safety.”

Filed Under: Cardiovascular, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance Tagged With: FDA, JAMA Internal Medicine, Medtronic, stjudemedical, Unique Device Identifier (UDI)

In case you missed it

  • Butterfly Network names new CEO before going public via merger
  • Authorities investigating death of California recipient of COVID-19 vaccine
  • FDA clears Aerobiotix system to clean air inside hospitals
  • Inogen names new CEO
  • FDA clears Theranica device for adolescent migraines
  • J&J touts results of robotic bronchoscopy trial
  • AdvaMed wants input on Biden pandemic DPA use
  • How continuous glucose monitors have transformed the diabetes landscape
  • Silk Road Medical issues voluntary recall of Enroute transcarotid stent system
  • Zimmer Biomet names chief transformation officer
  • MedTech 100 roundup: Another peak for the industry
  • 6 questions about facial swelling and COVID-19 vaccines answered
  • DTW Podcast Ep. 42 – How the pandemic has accelerated, slowed medtech innovation
  • The top 5 MassDevice stories of the week — January 22, 2021
  • Intuitive Surgical stock down despite Street-beating Q4
  • FDA says to limit mask decontamination to 4 cycles
  • 5 innovations to make duodenoscopes more single-use — and save lives

RSS From Medical Design & Outsourcing

  • Freudenberg Medical expands U.S. molding operations
    Freudenberg Medical announced that it has expanded injection molding operations at its Baldwin Park, Calif., operation, which is focused on thermoplastics. Freudenberg Medical Baldwin Park has added six injection molding machines including three new Arburg molding machines, a work cell for two-shot molding and a Wittmann Battenfeld micro-molding machine with in-process visual inspection capability. The… […]
  • Cretex Companies names new CEO
    Cretex Companies has announced the retirement of CEO Lynn Schuler effective January 31, 2021. Schuler will be succeeded as CEO by company president and COO Jeff Wollerman. Schuler has been with Cretex Companies for 36 years and held numerous leadership positions, including six years as a business unit president and two years as CFO. Schuler… […]
  • How continuous glucose monitors have transformed the diabetes landscape
    Continuous glucose monitors (CGMs) are among the most potent diabetes management tools to emerge in recent decades. FDA approved the first professional CGM in 1999, and the technology has evolved swiftly since then. Current models beam data via Bluetooth to smartphones (plus the Apple Watch) and the cloud, enabling patients to explore their blood glucose… […]
  • FDA clears Theranica device for adolescent migraines
    Theranica announced today that the FDA has granted expanded clearance for the use of its Nerivio acute migraine treatment device by people 12 years and older. The use of the device in the treatment of adolescents is supported by a study recently published in Headache. According to the study, 28 of 39 (71%) of the… […]
  • Alleviant Medical wins FDA breakthrough device designation for transcath heart failure treatment
    Alleviant Medical (Austin, Texas) has received FDA breakthrough device designation for its no-implant, interatrial shunt technology for treating certain types of chronic heart failure. Founded in 2017, Alleviant’s minimally invasive transcatheter tech decompresses the left atrium without a permanent cardiac implant or open-heart surgery. Alleviant developed the teach to treat people who have heart failure […]
  • AdvaMed wants input on Biden pandemic DPA use
    AdvaMed reacted to President Joe Biden’s plan to use the Defense Production Act (DPA) to tackle the pandemic with some cautionary words. In a letter responding to Biden’s 200-page COVID-19 plan, the medtech trade group asked for collaboration and urged the president to consider the industry’s experience with DPA orders issued by former President Trump.… […]
  • January 2021 Issue: The Leadership in Medical Technology Issue
    9 lessons in crisis management from Stryker CEO Kevin Lobo These 10 stories mattered the most for medtech in 2020 How ResMed is advancing sleep and respiratory care How Dexcom CEO Kevin Sayer is leading the company forward Black engineers group works to promote diversity in medtech, equity in healthcare Taking the guesswork out of… […]
  • Olympus recalls thousands of endo devices due to packaging defect
    Olympus is recalling approximately 26,000 disposable EndoTherapy devices because of a packaging defect that could compromise their sterility. The announcement affects113 models distributed in the U.S.since early 2019, with different numbers of SKUs available in different regions worldwide. The company is asking customers to quarantine the devices until they can be shipped back to Olympus.… […]
  • FDA says to limit mask decontamination to 4 cycles
    Soon after healthcare workers began warning of personal protective equipment (PPE) shortages, companies and other organizations started claiming their decontamination systems could reprocess used filtering facepiece respirators (FFRs) such as N95s up to 20 times. The FDA began issuing emergency use authorizations (EUAs) for FFR decontamination systems with a range of allowable cycles and major… […]
  • 5 innovations to make duodenoscopes more single-use — and save lives
    Duodenoscopes are important medical devices that are used for endoscopic retrograde cholangiopancreatography (ERCP) procedures. However, the devices have had serious problems in the past. Luckily, several medical device companies have stepped in to solve the problems. Duodenoscopes are flexible, lighted tubes threaded through the mouth, throat and stomach into the top of the small intestine.… […]
  • Plastic Molding Manufacturing adds 5 molding machines
    Plastic Molding Manufacturing (Hudson, Mass.) announced that it has added five new injection molding and two coordinate measuring machines in upgrades to its manufacturing and quality operations. The $1 million-plus investment will enable the custom molding company to distribute the pair of 214-ton machines, two 259-ton machines, and a 101-ton machine throughout its manufacturing network,… […]

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Tweets by @MassDevice
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion

MASSDEVICE

Subscribe to MassDevice
Advertise with us
About
Contact us

Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2021 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS