Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

More Medical Scopes Infect Patients

January 13, 2016 By Associated Press

At least 250 people, mostly in the U.S., were sickened with potentially deadly infections linked to contaminated medical scopes in the past three years, according to a new Senate committee report released Wednesday.

The number of infections, including those that sickened dozens at Seattle’s Virginia Mason Medical Center, is far higher than federal investigators previously estimated.

The report from the Senate Committee on Health, Education, Labor and Pensions was commissioned Sen. Patty Murray, D-Washington, the committee’s ranking member, following a yearlong staff investigation into outbreaks of antibiotic-resistant infections linked to the medical devices.

Between 2012 and spring 2015, at least 25 incidents of antibiotic-resistant infections linked to specialized duodenoscopes sickened at least 250 people worldwide — nearly double the 142 infections identified since 2010 by the federal Food and Drug Administration, The Seattle Times reported.

The new figures include the outbreak at Seattle’s Virginia Mason Medical Center, where 18 died between 2012 and 2014 after being infected with multidrug-resistant infections spread by scopes that could not be properly cleaned, even after following manufacturers’ directions.

“Patients should be able to trust that the devices they need for treatment are safe and effective,” Murray said in a statement. “Unfortunately, this investigation makes clear that current policies for monitoring medical-device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented.”

The report recommends a number of legislative and regulatory changes. It urges Congress to adopt unique identifiers to better track medical devices, and it calls on the FDA to quickly evaluate scope design and implement a recall to fix or modify the tools.

“We appreciate the report from Senator Murray and will carefully consider its recommendations, many of which FDA is already taking steps to address,” FDA spokeswoman Deborah Kotz wrote in an email.

The report also found that at least 16 U.S. hospitals traced antibiotic-resistant infections directly to the devices, called duodenoscopes, but that the hospitals generally did not raise alarms about these infections with federal regulators.

The report found that by early 2013, Olympus, the manufacturer of 85 percent of the duodenoscopes used in the United States, knew that the scopes could harbor dangerous bacteria but didn’t warn U.S. hospitals until early 2015.

Olympus spokesman Mark Miller told the Times on Tuesday that it would be premature to comment without seeing the full report.

The devices are snaked down the throat and into the gut, where they’re used to diagnose and treat problems, including cancers and blockages in bile and pancreatic ducts. Tests by Virginia Mason and others found the closed channel at the end of the scopes retains bacteria, even after rigorous cleaning, and can spread germs among patients.

Gale Robinette, a Virginia Mason spokesman, told the Times that hospital officials were eager to read the report. “We will evaluate any guidance the report offers as an opportunity to further improve our processes. Patient safety and quality care are the highest priorities at Virginia Mason,” he said in an email.

Related Articles Read More >

Avail Medsystems
How Avail Medsystems seeks to create a connected OR experience
Engineer inspecting artificial hip joint parts in quality control department in orthopaedic factory
Deburring and finishing for beautiful, functional medical devices
FDA logo
FDA seeking innovations to move beyond heater-cooler device problems
Logos of Creo Medical and Intuitive
Creo Medical inks collaboration agreement with Intuitive

DeviceTalks Weekly.

July 1, 2022
Boston Scientific CEO Mike Mahoney on building a corporate culture that drives high growth results
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

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.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. 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 LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech