BROWSE TOPICS HOME Healthcare-Associated Infections

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2016 Preventing Device-Related Healthcare-Associated Infections (pdf)

Feb 18, 2020

FDA Issues Final Guidance on 510(k) Submissions for Peripheral Vascular Atherectomy Devices

Jan 28, 2020

FDA Reclassifies Certain Medical Image Analyzers

Jan 15, 2020

AAMI Risk Management Standard, TIR Recognized by FDA

Jan 13, 2020

FDA Exempts Some Devices from Premarket Notification

Jan 8, 2020

First Fully Disposable Duodenoscope Receives FDA Clearance

Dec 17, 2019

Stephen Hahn Confirmed as FDA Commissioner

Dec 17, 2019

FDA Final Rule Requires Medical Device Submissions in Electronic Format

Nov 26, 2019

CDRH Pilot, Innovation Challenges Address Ethylene Oxide Hurdles

Nov 19, 2019

FDA Guidance Describes Process for Requesting Review of Denied Export Certificates

Oct 25, 2019

CDRH Quality Pilot Expands to Include Noncompliant Manufacturers

Oct 15, 2019

FDA Outlines 2020 Guidance Priorities

Oct 1, 2019

FDA Encourages Patient Engagement in Medical Device Development

Sep 25, 2019

FDA Draft Guidance Outlines Proposed Details of ASCA Pilot

Sep 25, 2019

FDA Proposes Safer Technologies Program for Medical Devices

Sep 24, 2019

FDA Makes Progress on Safety and Performance Based Pathway

Sep 17, 2019

FDA Issues Four Guidance Documents with Aim to Modernize 510(k) Program

Sep 12, 2019

FDA Guidance Details Criteria for Assessing De Novo Requests

Sep 9, 2019

Safety Concerns Prompt FDA to Recommend Transition to ‘Innovative’ Duodenoscopes

Aug 10, 2018

Medical Technology and Healthcare-Associated Infections Forum

May 20, 2018

Checklists for Preventing Healthcare-Associated Infections

Apr 20, 2018

FDA Warns of Endoscope Connector Contamination Risk

Oct 18, 2017

Sterilization Professionals Address Field’s Top Challenges during Standards Week

Sep 13, 2017

Strong Evidence for Sterilization of Endoscopes Presented at Stakeholder Meeting

Mar 22, 2017

Study Shows Endoscope Processing Practices Often Insufficient

Mar 6, 2017

Study Suggests Hospital Floors Are ‘Reservoir’ for Pathogens, with Devices Playing Transmission Role

Jan 31, 2017

The Danger Within: Confronting the Challenge of HAIs (pdf)

Jan 5, 2017

Experts Weigh In on Combating HAIs with Device Design

Dec 27, 2016

2016_HAI_Report_Appendix_C (pdf)

Dec 27, 2016

2016_HAI_Report_Appendix_B (pdf)

Dec 27, 2016

2016_HAI_Report_Appendix_A (pdf)

Jul 28, 2016

Combating the Complex Challenge of Healthcare-Associated Infections (pdf)