Category: Standards



FDA Takes Stance on Duodenoscopes

Specifically, because of challenges with cleaning these devices for reprocessing and persistent high levels of contamination, the agency is recommending moving away from using duodenoscopes with fixed endcaps.



The Great Wait: Will the FDA Increase Service Regulations or Not?

Since March 2015, the FDA has been collecting information and receiving factual and anecdotal comments concerning whether there is a public health and safety issue that warrants increased regulation and oversight of medical device companies and individuals. This issue culminated in October’s two-day workshop of presentations to the FDA, which biomedical expert Patrick Lynch details in the latest installment of The LynchPin.

Servicing Legislation


Make Your Voice Heard  

As the voice of the HTM sector since 1996, 24x7 Magazine always stays up to date on the latest happenings in the industry. And suffice it to say that a lot has happened recently. In this installment of Up Front, chief editor Keri Forsythe-Stephens discusses what's going on and why it's critical to speak up.



CSPi Launches Medical Device Cybersecurity Solution

Cybersecurity provider CSPi and Seceon have linked up to develop a product to address one of the biggest security challenges related to the Internet of Things (IoT): where endpoint detection and response applications and other bolt-on security services cannot be deployed on IoT devices.