Regulatory Compliance

Olympus Continues To Set Aside Reserves For Expected Scope-Related Lawsuits

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

As the United States Department of Justice continues to examine Olympus’ role in infections related to the use of its duodenoscopes, the company is setting aside millions of dollars in reserves to cover expected losses from related lawsuits. As the leader in duodenoscope and endoscope sales in the US, Olympus expects to bear a majority […]

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Improper Ultrasound Probe Disinfection Leads To Class Action Lawsuit

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

A hospital in Western Pennsylvania has recently been hit with a class action lawsuit from patients who underwent ultrasound procedures at the hospital. UPMC Jameson, a hospital in the UPMC Health System, had recently reached out to more than 200 patients who underwent ultrasound procedures at the hospital from October 2017 to October 2018. Attorney

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Study Reveals Bronchoscopes Ready For Use On Patients Are Still Dirty

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

Several recent studies have shown that despite best efforts to follow manufacturer reprocessing guidelines, bronchoscopes deemed ready for patient use are still contaminated at a high rate. Some of the most recent research highlighting the difficulties of disinfecting bronchoscopes was published by Cori Ofstead, MSPH. In a recent presentation at the annual meeting of the

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How Patients Are Being Coached To Question Their Hospital’s Scope Cleaning Practices

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

With the numerous reports coming out lately about the difficulty in cleaning endoscopes and ensuring complete disinfection, the mainstream media has started to coach patients on how to select a hospital that’s right for their scope-related procedures. With the concern for scope safety increasing every day, facilities must now prepare to answer tough questions about

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UDI One Step Closer To Reality

Big Data, Cath Lab, Clinical Documentation, Hospital Finance, Hospital IT, Hospital Management, Operating Rooms, Operational Efficiency, Patient Safety, Radiology, Regulatory Compliance, Revenue Cycle, Supply Chain, The Business of Surgery, Tissue Management /

The United States Food & Drug Administration (FDA) and its European equivalents are currently conducting a real-world pilot aimed at bringing unique device identifiers (UDIs) one step closer to reality. UDIs have been a long-term dream for many in healthcare, who view the ability to track and trace medical devices using unique item-level codes as

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Caught In The Act: Can You Stop Dirty Scopes From Being Stored With Your Clean Scopes?

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

Does this scenario sound familiar to you? Your hospital has a great set of processes and protocols in place when it comes to reprocessing your flexible endoscopes. You even have a great system for logging clean scopes in and out of your scope storage areas. You believe that your staff are properly trained, re-certified and

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Study Shows Bronchoscopes Still Dirty After Reprocessing

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

A new study has shown that flexible bronchoscopes that were reprocessed according to institutional standards at several US hospitals were still found to be dirty in a majority of the cases. The study was presented at the 2018 Association for Professionals in Infection Control (APIC) Conference. The study on bronchoscopes now joins other recent studies

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The 4 Steps Of An Endoscope Risk Assessment

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

Flexible endoscopes continue to make headlines due to the risk of infection stemming from their use on patients. Many hospitals find themselves in the unenviable position of determining how they can perform critical endoscope-based procedures while minimizing the risk of infection. There is ample evidence showing that endoscopes can spread life-threatening illnesses when not properly

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Infection Rates From Colonoscopies Greatly Exceed Prior Estimates

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

A recent study conducted by Johns Hopkins reveals that colonoscopies performed at ambulatory surgery centers lead to post-procedure infection rates that greatly surpass previous estimates. The study, sponsored by the US Department of Health and Human Services and the Agency for Healthcare Research and Quality, studied the results of colonoscopies and upper-GI endoscopies (EGDs) performed

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Medical Device Recalls Reach Historic Highs In 2018

Cath Lab, Clinical Documentation, Hospital Management, Infection Control, Operating Rooms, Operational Efficiency, Patient Safety, Radiology, Regulatory Compliance, Supply Chain, The Business of Surgery /

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

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