The first quarter of 2018 included 343 medical device recalls by the US Food and Drug Administration (FDA). This was the highest for a first calendar quarter of any year on record and was up 126% from 2017. Experts point to the proliferation of software on medical devices as a primary driver for the record […]
Medical Device Recalls Reach Historic Highs In 2018 Read More »
The American Society for Gastrointestinal Endoscopy recently released guidelines for infection control during GI endoscopy and related procedures. The guidelines come at a time when reports of endoscope-related infections are becoming more prevalent in the media. While the overall incidences of such infections are rarely reported, there is a strong possibility of underreporting of adverse
ASGE Releases New Infection Control Guidelines For Endoscopy Read More »
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 »
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 »
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 »
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 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 »
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 »
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 »
Tissue and related specimens present a unique tracking challenge for hospitals and surgery centers – these often expensive and occasionally one-of-a-kind items are required to be closely monitored during the hospital’s handling of each unit. The US Food & Drug Administration (FDA), state Departments of Health and hospital accreditation bodies, such as The Joint Commission
How To Create A Digital Audit Trail For Your Tissue Read More »