Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Bacterial Outbreaks Triggering Tougher FDA Reprocessing Standards

This article was originally published in The Gray Sheet

Executive Summary

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.

You may also be interested in...



FDA Clears Pentax’s Easier-To-Disinfect Duodenoscope

The US FDA cleared Pentax Medical’s new duodenoscope as the first in the US with a disposable elevator part that reduces the number of parts needed to be disinfected compared to earlier designs.

Olympus, Pentax Working On Responses To Sen. Murray Duodenoscope Contamination Concerns

Two duodenoscope manufacturers – Olympus and Pentax – this week joined Fujifilm in saying they are aware of Senate HELP Committee ranking member Patty Murray’s concerns about recently released duodenoscope contamination levels and are working to complete postmarket surveillance studies of their devices, as required by the US FDA.

Preventable Hospital Events Moving In Right Direction, CMS Says

The volume of hospital-acquired conditions, including some device-related infections, has dropped in the past five years, according to an interim report released by the Centers for Medicare & Medicaid Services.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

MT033694

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