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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2019-11-07
- Length: 25m
- Episode: 2
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-should-design-controls-have-prevented-the-recent-reprocessing-tragedy-do-we-need
- Listen: https://podcast.greenlight.guru/episode/should-design-controls-have-prevented-the-recent-reprocessing-tragedy-do-we-need-new-regulation

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-should-design-controls-have-prevented-the-recent-reprocessing-tragedy-do-we-need#t=0) Introduction and Background on the Duodenoscope Tragedy
- [5:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-should-design-controls-have-prevented-the-recent-reprocessing-tragedy-do-we-need#t=324) Responsibility Shift: OEMs vs. Hospitals in Reprocessing
- [8:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-should-design-controls-have-prevented-the-recent-reprocessing-tragedy-do-we-need#t=531) The Case for Existing Regulations and 'Design for Reprocessability'
- [15:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-should-design-controls-have-prevented-the-recent-reprocessing-tragedy-do-we-need#t=903) Integrating Reprocessing into Design Controls and Risk Management
- [21:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-should-design-controls-have-prevented-the-recent-reprocessing-tragedy-do-we-need#t=1300) Final Thoughts on Communication and Prudent Engineering

## Topics

- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

established companies

## Mentioned

- Vascular Sciences (company)
- Greenlight Guru (company)
- Medicis (company)
- Medline Industry (company)
- UCLA Ronald Reagan Medical Center (company)
- FDA (company)
- Health Canada (company)
- Duodenoscope (product)
- ISO 14971 (other)

## Related episodes from other shows

- [S1E35 Harley-Davidson, Device Reprocessing, & Keeping a High Level Perspective | Tim Rempfer](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-09-04-s1e35-harley-davidson-device-reprocessing-keeping-a-high-level-perspective-tim-r) (Being an Engineer)
- [How Design-First Thinking Supercharges Manufacturing Performance with Clarity Design Founder Tom Lupfer](https://hardwarepodcasts.com/podcast/ems-c-level/2026-03-11-how-design-first-thinking-supercharges-manufacturing-performance-with-clarity-de) (EMS@C-LEVEL)
- [123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-14-123-uncovering-huge-quality-issues-inspection-readiness-in-2024-data-integrity-a) (Let's Combinate)
- [70 - Charlie Webb from Van Der Stahl Scientific](https://hardwarepodcasts.com/podcast/people-of-packaging/2021-08-19-70-charlie-webb-from-van-der-stahl-scientific) (People of Packaging)
- [071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-08-071-steel-industry-to-medtech-important-quality-systems-with-etienne-nichols) (Let's Combinate)

## Citing this page

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