PODCAST: 10 Tips For Writing Effective IFUs For Medical Devices – And More
This article was originally published in The Silver Sheet
Executive Summary
Online-Only Content >>> In the wake of troubling patient infections and deaths due to improperly sterilized duodenoscopes, human factors experts Michael Wiklund and Jonathan Kendler of UL-Wiklund Research & Design provide tips on writing effective instructions for use in this "Silver Sheet" podcast.
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.
Commissioner Defends FDA On Duodenoscope, LDT Actions At Senate Hearing
In her last appearance before a Senate committee March 10, FDA Commissioner Margaret Hamburg presented a strong defense of FDA’s actions to address contaminated duodenoscopes, regulation of lab developed tests and other hot button issues raised by Senators, who also praised her leadership at FDA.
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.