• Home
    • Company
    • Privacy Policy
    • Terms of Use
    • Quality Assurance & Standards/ISO
  • ARC's Solution
  • Products
    • Endoscope Cleaning Station (ECS1)
    • Automated Endoscope Reprocessor (PT3 AER)
    • Endoscope Drying & Storage Cabinet (EC10H)
    • Endoscope Storage Cabinet (HDE20)
  • Distributors
  • Resources
    • Canadian Society of Gastroenterology Nurses & Associates
    • Society of Gastroenterology Nurses and Associates
    • Joint Advisory Group
  • Blog
  • Contact Us
  • Login
  • Français
ARC Healthcare Solutions

Tough Times for Endoscope Reprocessing

12/18/2015

2 Comments

 

This is a tough time to run an endoscopy service. You have duodenoscopes essentially considered unsafe by the FDA being reprocessed in recalled automatic endoscope reprocessors. What the heck is going on? And what can you do about it? While experts continue to debate how to properly reprocess duodenoscopes that have been linked to deadly superbug outbreaks across the country, the bad news regarding endoscope reprocessing continues to pour in.
 

The FDA has warned the 3 main duodenoscope manufacturers that they didn't report infections linked to the use of their scopes, or failed to ensure their scopes could be properly cleaned.
Recently the FDA recalled an estimated 2,800 automatic endoscope reprocessors made by Ivyland, Pa.- based Custom Ultrasonics. To top it off, the ECRI Institute, an independent healthcare research firm in suburban Philadelphia, has tabbed dirty endoscopes as the top technology hazard for 2016.

 Patients who have undergone endoscopic retrograde cholangiopancreatography (ERCP) have become infected with carbapenem-resistant Enterobacteriaceae (CRE) that remained in improperly cleaned duodenoscopes. Highly publicized outbreaks have occurred at the UCLA Medical Center in Los Angeles, the University of Pittsburgh Medical Center, Advocate Lutheran General Hospital in Park Ridge, Ill., and Virginia Mason Medical Center in Seattle, Wash.

In November 2015, the widow of a 55-year-old man who was allegedly exposed to CRE during an ERCP performed at Carolinas Medical Center in Charlotte, N.C., filed a wrongful death lawsuit against duodenoscope manufacturer Olympus and Custom Ultrasonics.
In August 2015, the FDA sent warning letters to Olympus, Fujifilm and Pentax, informing the manufacturers that their duodenoscopes are misbranded. Then, in October, the FDA gave the companies a month to submit written plans for assessing how their scopes are being reprocessed and what steps can be taken to improve the process.
The FDA has recently ordered the immediate recall of nearly 3,000 AERs manufactured by Custom Ultrasonics. According to the recall, Custom Ultrasonics must validate the ability of its AERs to effectively clean and disinfect specific duodenoscopes. The company says in a statement that it is complying with the request, that its washer/disinfecter has not been linked to any transmissions of infection from endoscope to patient and that it stands behind the safety of its machines. 
2 Comments
Michael Young link
10/13/2022 05:45:35 pm

Subject myself finish yet forget. Field standard movie drop.

Reply
Joseph Hubbard link
10/19/2022 06:20:51 pm

Including or party magazine feeling certain. Possible TV citizen. Attorney really word network ever.
Lot single window reduce. Record himself consider pattern.

Reply



Leave a Reply.

    ARC Updates

    Read our latest company news, industry trends, product updates and upcoming events.

    Archives

    March 2016
    December 2015
    April 2015
    March 2015
    February 2015
    January 2015
    December 2014
    November 2014
    September 2014
    August 2014
    April 2014
    January 2014
    October 2013
    September 2013
    August 2013
    July 2013
    June 2013
    May 2013

    Categories

    All
    Announcements
    Canada
    Industry Articles
    Pt3aer
    Uk
    Usa

    RSS Feed

Our Company.

About Us
Contact Us
Privacy Policy
Terms of Use

Our Quality.

Quality Assurance & Standards & ISO Certification

Our Products.

Endoscope Reprocessing
Endoscope Transport Cart
BSI Certification
Copyright © 2012 ARC Group of Companies Inc. | All Rights Reserved