Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

‘No Plans’ To Change Duodenoscope Cleaning Guide, But Cooperating With FDA, Pentax Says

This article was originally published in The Gray Sheet

Executive Summary

While Olympus has already updated its cleaning protocol in response to outbreak of bacterial infections and FDA recommendations, another duodenoscope maker, Pentax, says it has no specific plans to change instructions or designs for its devices. An FDA panel met May 14-15 to discuss duodenoscope safety and make recommendations.

You may also be interested in...



FDA Advisors Call For New Cleaning Methods, Sterilization For Duodenoscopes

Current reprocessing methods for duodenoscopes provide no reasonable assurance of safety and effectiveness, and manual cleaning steps need improvement, an FDA panel said. Most panelists called for upgrading manual cleaning, followed by lengthy sterilization of the products until they can be redesigned.

Olympus Releases Duodenoscope Cleaning Rules With New Brush On The Way

Olympus and FDA sent new reprocessing instruction notices to users of the company’s duodenoscopes requiring use of a small bristle brush and additional flushing rounds. The scopes were involved in bacterial contamination incidents in California, Illinois and other states in recent years.

FDA Lays Down Strict Disinfection Guidance In Wake Of Scope Incidents

The agency sped up release of a final guidance on reprocessing reusable devices, including a strict set of protocols for endoscope cleaning, disinfection data, and design guidelines, following reports of serious bacterial infections linked to duodenoscopes.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT033912

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel