PLYMOUTH MEETING, PA—“An analysis by the nation’s largest patient safety organization shows that up to 70 percent of KN95 masks it tested do not meet U.S. standards for effectiveness, raising...
Earlier this year the U.S. Food and Drug Administration (FDA) was made aware of the potential to misinterpret colored hydrogen peroxide indicator strips used to validate vapor sterilization of medical...
FDA Safety Communication Regarding the Importance of Following Duodenoscope Reprocessing Instructions (IFUs) The FDA’s latest Safety Communication on duodenoscopes traces its history back to 2013 when the FDA first learned...
Pathogenesis of a Deep-Organ Surgical Site Infection (SSI) from a Contaminated Laparoscopic Instrument According to the Centers for Disease Control and Prevention (CDC), over 30,000 patients die every year in...
An Update On The Problems Caused By Non-Validated Endoscopes The ongoing problem of patient harm caused by endoscopes whose cleaning IFUs have not been validated continues to make the news....
FDA Seeks to Reduce Risk of Surgical Fires, Patient Injuries Surgical instruments and numerous medical devices are a chief ignition source for fires in the operating room. These instruments and...
Nearly Three-Quarters Of Commonly Used Medical Scopes Tainted By Bacteria! Data from three major hospitals documented the fact that seventy-one percent (71%) of their reusable medical scopes deemed ready for...
FDA Alert: Risk of cross-contamination from 24-hour multi-patient use endoscope connectors to healthcare facilities performing gastrointestinal endoscopy procedures (April 18, 2018) The FDA is alerting healthcare providers and facilities about the...
Breaking News: FDA Issues Warning Letters To Duodenoscope Manufacturers The U.S. Food and Drug Administration issued warning letters last week (March 9, 2018) to all three duodenoscope manufacturers for failing...
FDA, CDC and ASM are Providing Recommendations for Healthcare Facilities That Choose to Implement Duodenoscope Surveillance and Culturing Webinar March 22, 2018 from 1-2:30 PM (Eastern Time) The U.S. Food...
