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

Lumened Device Designs Should Facilitate Reprocessing – FDA/AAMI Meeting

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers of reusable devices with lumens and difficult-to-reach channels should design them so that they can more easily be disassembled for cleaning and subsequently reassembled, according to participants at a recent medical device reprocessing summit.

You may also be interested in...



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.

Bacterial Outbreaks Triggering Tougher FDA Reprocessing Standards

Inadequate validation testing paired with highly-publicized bacterial outbreaks in Illinois and California involving use of contaminated duodenoscopes has led to stricter reprocessing standards for those devices. And FDA is likely moving towards tougher reprocessing requirements more broadly for reusable devices in an upcoming guidance.

AAMI To Address Reprocessing Concerns In “Technical Reports” Due In 2013

Reports are being developed with input from FDA and will cover endoscope reprocessing, standardized cleaning instructions and human factors for device reprocessing.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT030641

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