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# Murray Introduces Duodenoscope Bill
- URL: https://www.fdaweb.com/murray-introduces-duodenoscope-bill/
- Published: 2016-02-04T12:00:00.000Z
- Updated: 2026-09-15T02:33:34.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134685

> Sen. **Patty Murray** (D-WA) has introduced the [Preventing Superbugs and Protecting Patients Act](http://www.murray.senate.gov/public/%5Fcache/files/886bc78a-b7c8-4ce7-976c-c8ad29a6cc01/20160201-s-preventing-superbugs-and-protecting-patients-act-one-pager.pdf?ref=fdaweb.com) to give FDA additional tools to review and ensure the safety of medical devices and contaminated duodenoscopes that were linked to life-threatening antibiotic-resistant infections. Murray says an investigation she led showed that manufacturers of the scopes knew that the devices could not be reliably cleaned and could pose a threat to patients’ lives.  
>  
> The bill would:  
> give FDA clear authority to refuse or deny a 510(k) submission based on whether the manufacturer can provide satisfactory data showing that the device can be reliably decontaminated between uses; and require FDA to prioritize updates to its guidance to clarify when manufacturers are required to seek agency clearance to market modified devices.  
>  
> “As my investigation made clear, there is much more we need to do to make sure that the medical devices patients rely on are safe and effective,” Murray says. “This legislation would give FDA some additional tools to review and ensure the safety of medical devices like duodenoscopes. There are additional steps we absolutely need to take as well, and I’m committed to continued work to improve our medical device monitoring system and protect patients and families in Washington state and across the country.”