FDA Grand Rounds

 

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The FDA Grand Rounds is an educational presentation that is webcast monthly to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute educational presentation is followed by questions from the audience. You can also view the presentation under Past Grand Rounds following the live webcast. #FDAGrandRounds.

The next FDA Grand Rounds is scheduled for January 9, 2020.

Quality Control: Stopping infections before they happen through safer endoscope reprocessing

Thursday, January 9, 2020
12:00 p.m. - 1:00 p.m. EST
WO Building 2, Room 2047 (or via webcast)

About the Presentation:

Every year there are over 75 million endoscopic procedures in the US that allow healthcare providers to perform hundreds of essential procedures, ranging from colonoscopies to treatment of pancreatic cancer. FDA facilitates patient access to the world’s best endoscopic technologies and ensures that endoscopes can be safely used. An ongoing challenge related to endoscope use has been antibiotic-resistant bacterial infection outbreaks. Research has shown that biofilm can build up inside endoscopes over time, making current cleaning and disinfection procedures (called "reprocessing") less effective. To address this problem, the FDA has proactively taken measures with several warnings to manufacturers and healthcare facilities.

The FDA required manufacturers to study endoscopes being used in the clinic, and the results showed that about 2-5% of endoscopes do in fact have bacterial contamination. Recently, the Biofilms Research Group in the Center for Devices and Radiological Health’s Office of Science and Engineering Laboratories has developed tools that can tell hospitals how clean an endoscope is after reprocessing.  These tools can detect and quantify miniscule amounts of contamination, much lower than anything currently commercially available. The tools are quick and inexpensive for hospitals to use. We call this approach FDA QC-ER, or "FDA Quicker" for short, because the device helps hospitals maintain the quality (quality control) of their endoscope reprocessing.

In this talk, we will introduce FDA QC-ER and review results from testing in three hospitals and what we learned about factors contribute to scope cleanliness. Quality control of endoscope reprocessing can help hospitals to prevent future infection outbreaks.

Past Grand Rounds

2019

• Vet-LIRN – How FDA’s Network of Veterinary Diagnostic Laboratories advance animal food safety and public health by conducting outbreak investigations and monitoring resistance in animal pathogens
• Technical and Logistical Considerations for Examining FDA-Regulated Products at International Mail Facilities using Handheld and Field-Portable Analytical Devices

• Why FDA authorized the marketing of the IQOS heated tobacco product as “appropriate for the protection of the public health”

• Overview of FDA's Perinatal Health Center of Excellence: Development and Validation of Predictive Systems

• Cyclospora Cayetanensis: The Crossroads Between Scientific Advances and Knowledge Gaps 

• Gaining Insight into the Patient’s Experience by Harnessing the Power of Social Listening and FDA Archival Data 

• Uncertainty is the only certainty there is: Potential approaches for making public health decisions

• The VICTRE trial: an in-silico replica of a clinical trial for evaluating digital breast tomosynthesis as a replacement for full-field digital mammography

2018

• Jerky Pet Treats and illness in dogs:  a collaborative approach to investigating a mysterious outbreak
• Decomposition of Seafood Products by Mass Spectrometry with Sensory-Driven Predictive Modeling
• The Science to Inform a Tobacco Product Standard for the Level of Nicotine in Combusted Cigarettes
• Bisphenol A: Toxicology and Pharmacokenetic Data to Inform Ongoing Safety Assessments
• How Simulation Can Transform Regulatory Pathways
• FDA's Predictive Toxicology Roadmap: Implications and Opportunities for Stakeholders
• Are Stem Cells Ready for Prime Time? A Look at FDA Research Advances in Regenerative Medicine
• Ethnicity- and Gender-Related Differences in Alzheimer's Disease

2017

• Assessing the Safety and Effectiveness of New and Emerging Therapeutic Ultrasound Technologies
• Developing a Mechanistic Model-Based Approach to Assess Cardiac Safety of New Drugs
• Genome Trakr: How a Large Network of Sequencing Laboratories is Transforming Food Safety and Public Health
• Serious and Actionable Risks, Plus Disclosure: investigating an Alternative Approach for Presenting Risk Information in Prescription Drug TV Ads
• Vaccine adjuvants: New ways to evaluate their safety and effectiveness
• Developing Regulatory Methods for Characterizing Nanomaterials in FDA-Regulated Products

2016

• The Host Response to Whooping Cough Infection and Vaccination [Archived]
• Antibiotic resistance surveillance in the age of genomics: New answers to old questions [Archived]
• FDA Research into 3D Printing of its Regulated Products [Archived]
• Rapid Screening of Dietary Supplements for Undeclared Ingredients [Archived]
• Metabolomics and Proteomics Biomarkers: Discovery and Validation in Toxicity Studies [Archived]

Resources For You

• FDA's Predictive Toxicology Roadmap
• Don't Miss the CDC Public Health Grand Rounds