Infection Prevention

Customer Letter

PENTAX Medical Actively Engaged With the FDA To Further Mitigate Potential Cross-Contamination With Duodenoscopes  |  Download PDF


Product Information

ED-3490TK Video Duodenoscope  |  Visit Product Overview

 

Guideline for Reprocessing PENTAX Medical Endoscopes Prior to Return Shipment  |  Download PDF

Statement on Third-Party Repair of PENTAX Medical Flexible Endoscopes  |  Download PDF


Industry Links

Food and Drug Administration (FDA)
FDA Safety Communication  |  Visit Site


Society of Gastroenterology Nurses and Associates (SGNA)
SGNA Resources for Quality and Safety  |  Visit Site


Center for Disease Control and Prevention (CDC)
Patients Face More Lethal Infections from CRE  |  Visit Site


American Society for Gastrointestinal Endoscopy  (ASGE)
Multiple GI Society Statement - Gastroenterology Societies Discuss Patient Safety in Gastroenterology | Download PDF
FDA Issues Important Safety Communication: Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning  |  Visit Site

 

American Gastroenterological Association (AGA)
Continued Infection Risk with Duodenoscopes Used for ERCP is Unacceptable  |  Visit Site

 

Association for Professionals in Infection Control and Epidemiology (APIC)
Key points: Infections associated with duodenoscope procedures  |  Visit Site
APIC and SHEA statement on infections associated with duodenoscope procedures  |  Download PDF
ERCP procedures and duodenoscopes - Infection risks and considerations  |  Visit Site


Advancing Safety in Healthcare Technology (AAMI)
FDA Cites ‘Complex Design’ of Scope in Safety Advisory  |  Visit Site


References:
Petersen, B.T., J. Chennat, J. Cohen, P.B. Cotton, D. A. Greenwald, T.E. Kowalski, M.L. Krinsky, W.G. Park, I.M. Pike, J. Romagnuolo, and W.A. Rutala. June 2011. Multisociety guideline on reprocessing flexible GI endoscopes. Infect. Cont. Hospital. Epidemiol. 32(6):527-537.

If you have additional questions related to Infection Prevention and Control, please don't hesitate to email us at pamc.customersupport@pentaxmedical.com.