Patient Safety

FDA Issues Warning On Multi-Patient Endoscope Connectors

Infection Control, Joint Commission, Managing Endoscopes, Patient Safety, Regulatory Compliance /

The U.S. Food and Drug Administration (FDA) recently released a public alert that warned about the risk of cross-contamination from the use of certain endoscope connectors commonly seen in gastrointestinal endoscopy. The alert primarily points out the risks associated with the use of 24-hour multi-patient use endoscope connectors that are labeled for use with multiple […]

FDA Issues Warning On Multi-Patient Endoscope Connectors Read More »

Hospitals Still Struggle To Combat Infectious Bacteria In Their Scopes

Hospital Management, Infection Control, Joint Commission, Managing Endoscopes, Patient Safety /

Recent research has once again shined the spotlight on the struggle hospitals face to rid their reusable medical endoscopes of dangerous bacteria. In this particular study, published in the American Journal of Infection Control, 71% of “patient-ready” scopes at 3 major US hospitals tested positive for bacteria. The study found problems in various types of

Hospitals Still Struggle To Combat Infectious Bacteria In Their Scopes Read More »

Supply Stock-Outs Have An Outsized Effect On The Bottom Line

Cath Lab, Cost Reduction, Hospital Finance, Hospital Management, Operating Rooms, Operational Efficiency, Patient Safety, Radiology, The Business of Surgery /

A recent survey conducted by Cardinal Health showed that 40% of hospital staff have cancelled a case due to an out-of-stock supply, and 69% of staff have had to delay a case while a missing supply is being tracked down. Having spoken to hundreds of staff in operating rooms, cath labs and interventional radiology labs,

Supply Stock-Outs Have An Outsized Effect On The Bottom Line Read More »

Duodenoscope Surveillance Protocols Released By FDA and CDC

Infection Control, Managing Endoscopes, Patient Safety, Regulatory Compliance /

The U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and American Society for Microbiology (ASM), along with other endoscope culturing experts, recently announced the availability of voluntary, standardized protocols that were developed for duodenoscope surveillance sampling and culturing. As noted by the FDA: “Hospitals and health care facilities that utilize

Duodenoscope Surveillance Protocols Released By FDA and CDC Read More »

Accreditation Firms Like Joint Commission Receive Further Scrutiny From Congress

Hospital Management, Infection Control, Managing Endoscopes, Patient Safety, Regulatory Compliance /

Following the publication of a Wall Street Journal article last year, hospital accreditation organizations have received unwanted attention from the US Government. Members of the House Energy and Commerce Committee have requested additional information from the Centers for Medicare & Medicaid Services (CMS) and 4 major hospital accreditation organizations regarding their processes. Concerned with CMS’

Accreditation Firms Like Joint Commission Receive Further Scrutiny From Congress Read More »

FDA Issues Warning To Duodenscope Manufacturers

Infection Control, Managing Endoscopes, Patient Safety, Regulatory Compliance /

Last week, the U.S. Food and Drug Administration (FDA) sent a warning to all three major duodenoscope manufacturers. The warnings were sent due to the failure of Olympus, Pentax and Fujifilm to comply with postmarket surveillance study requirements set with them by the FDA in 2015. During the FDA’s investigation of duodenoscope-related infections in 2015,

FDA Issues Warning To Duodenscope Manufacturers Read More »

Pentax Issues Recall of Some of Its Duodenoscopes

Infection Control, Managing Endoscopes, Patient Safety, Regulatory Compliance /

Pentax Medical recently issued an urgent recall of one of its duodenoscope models.  Pentax is informing customers of its voluntary recall of all ED-3490TK duodenoscopes. As part of the recall, Pentax aims to replace the forceps elevator mechanism, O-ring seal and distal end cap. There will also be an update issued to the Operation Manual

Pentax Issues Recall of Some of Its Duodenoscopes Read More »

How To Set And Track Hang-Time Limits For Flexible Endoscopes

Hospital Management, Infection Control, Joint Commission, Managing Endoscopes, Operating Rooms, Operational Efficiency, Patient Safety, Regulatory Compliance /

Hang-time limits for flexible endoscopes have been a hot topic among GI, Infection Control and Sterile Processing professionals for the last several years. With no consensus emerging in hang-time limits (sometimes called an endoscope’s shelf life), hospitals are left to make this decision on their own. With different stakeholders within the hospital looking at different

How To Set And Track Hang-Time Limits For Flexible Endoscopes Read More »

Massachusetts-Based Hospital The Latest To Reveal Endoscope-Related Infection Risk

Hospital Management, Infection Control, Managing Endoscopes, Patient Safety /

Springfield, Massachusetts-based Baystate Medical Center is notifying nearly 50 patients that a recent colonoscope procedure may have exposed them to a life-threatening illness.  The news was reported by Masslive.com, and continues the trend of endoscope-related safety issues across the US. Noble Hospital, which was acquired by Baystate Health in 2015, was found to have had

Massachusetts-Based Hospital The Latest To Reveal Endoscope-Related Infection Risk Read More »

First Olympus Trial Gets A New Day In Court

Hospital Management, Infection Control, Managing Endoscopes, Patient Safety, Regulatory Compliance /

The first trial accusing Olympus Corp. of wrongdoing associated with contaminated duodenoscopes in US hospitals will be re-tried due to the discovery of new evidence that may aid the plaintiff’s case. The case examines the death of Richard Bigler, a 57 year-old patient who underwent a scope procedure while battling pancreatic cancer in 2013.  The

First Olympus Trial Gets A New Day In Court Read More »