Hardware Podcasts

Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?

Global Medical Device Podcast · 7 Nov 2019 · 25m · Episode 2

What this episode covers

Moderator Bill Loss hosts Mike Drues of Vascular Sciences, Jon Speer of Greenlight Guru, and Jason McKibbin to discuss whether design controls could have prevented the superbug outbreak linked to improperly reprocessed duodenoscopes. The panel argues that manufacturers must adopt 'design for reprocessability' by considering the hospital reprocessing environment during the design phase, rather than ignoring unintended reuse. They contend that existing FDA regulations and ISO 14971 risk management standards are sufficient if followed rigorously, emphasizing that better communication between OEMs and hospitals is the critical missing link.

Most relevant to

established companies

Topics

Mentioned

Companies
Vascular Sciences, Greenlight Guru, Medicis, Medline Industry, UCLA Ronald Reagan Medical Center, FDA, Health Canada
Products
Duodenoscope
Also
ISO 14971

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