Sri Mandava

FDA Issues Warning To Duodenscope Manufacturers

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, […]

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Disappointed With The ROI From Your EHR Investment? You’re Not Alone

Yet another study has been published showing the disappointing return on investment that hospitals are experiencing with their electronic health record (EHR) implementations. The new study, published in the Journal of the American Medical Association (JAMA), showed that the costs of administering billing and insurance-related functions may actually have increased following EHR roll-outs. This is

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The Key To Figuring Out Your Cost Per Case

Historically, the cost of a surgical procedure has been a difficult equation to solve. As the US healthcare system moves more and more toward a value-based system, hospitals require now more than ever an accurate understanding of their procedure costs. These accurate procedure costs then need to be compared to outcomes in order to perform

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Pentax Issues Recall of Some of Its Duodenoscopes

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

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

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

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

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

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First Olympus Trial Gets A New Day In Court

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

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The “Post-EHR” Era Will Require Hospitals To Get More Value Out Of Their EHR Data

Hospitals are just scratching the surface of the value that they can derive from the data in their Electronic Health Records (EHRs). Simultaneously, they are facing a growing threat to their EHR data – physicians and other clinicians are increasingly vocal about their frustration with the time they are spending documenting encounters in EHRs instead

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How To Create A Digital Audit Trail For Your Tissue

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

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How To Create An All-Electronic Audit Trail For Your Scopes

Flexible endoscopes present a unique challenge for hospitals to track and manage – these expensive medical instruments must be quickly re-processed after usage in order to provide the required instrumentation for the next procedure, yet they must undergo rigorous, time-consuming reprocessing after every use to ensure the highest levels of patient safety. Due to different

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