Whitehouse Laboratories is excited to announce that it has accepted an invitation to participate on the medical device reprocessing panel discussion at MD&M East. The panel discussion, titled “The Gray Zone between Usability and Reprocessing” will be held on Tuesday, June 13th, at 10:50 AM. The panel discussion will address key issues related to FDA and Industry expectations as well as considerations in the design process when mitigating the risk of infection associated with reusable devices. Key participants include moderator Mary Beth Privitera, PhD, Principal at HFE/Research & HS-Design, Inc., principle speaker John Iannone, Director of Extractables/Leachables & Impurities at AMRI Global, and additional panelists Noah Gostout, Senior Global Product Manager at Boston Scientific, and Alpa Patel, Senior Scientist at Nelson Labs
Understanding this Grey Zone is driven by designing better devices and processes to combat Healthcare-associated infections (HAI)s. The issue of HAIs is a very serious matter—a recent Harvard Medical School study estimates they cost the U.S. nearly $10 billion a year. To exacerbate the issues, the bugs causing these infections are becoming increasingly difficult to treat, since the pipeline of new antibiotics (to replace the ones that are no longer effective) is drying up. We are now facing the consequences of our apathy,” says John Iannone, Director of Extractables/Leachables & Impurities at AMRI Global, “and it is now more critical than ever to develop new materials and processes that battle this epidemic while still proving safe to the patient and maintaining adequate usability.” Join us for this lively discussion that will touch on regulatory requirements and considerations with reprocessing, device design, material selection, qualification, patient safety and microbiological concerns.
Panel: The Gray Zone Between Usability and Reprocessing
Principal –HFE/Research, HS-Design, Inc.
Senior Scientist, Nelson LabsLocation: 1E07
Date: Tuesday, June 13
Time: 9:50am – 10:30am
Track: Medtech: User-Centered Design
Session Type: Conference (Paid)
Pass Type: Conference (Paid) – Get your pass now!
- What FDA does and does not say about validating reprocessing methods
- Understanding what usability tests should be conducted for reusable devices
- Mitigating the risk of infection associated with reusable devices and how that affects the design process