Regulatory Compliance

FDA Releases Statement On Potential Dangers Of Duodenoscopes

Contrary to recent claims by Olympus regarding the safety of its duodenoscopes, the United States Food and Drug Administration (FDA) has put out a statement regarding the dangers of using duodenoscopes. Duodenoscopes have been in the spotlight over the past several years due to a large number of patient safety incidents reported around the world. […]

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How One Tissue Manager Passed Their Joint Commission Survey

A customer recently relayed on to us their experience going through a Joint Commission accreditation survey. The tissue manager in the operating rooms of this particular hospital utilizes Mobile Aspects’ iRISecure system to track their tissue. She uses iRISecure to ensure the quality of documentation for patient safety and regulatory compliance. The Joint Commission (“TJC”)

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Having Trouble Tracing Endoscopes To Patients? This Technology Can Help

With The Joint Commission (TJC) spending an increasing amount of time in Sterile Processing Departments, Perioperative Departments and Endoscopy Suites during site surveys, the focus on maintaining high quality endoscope-related documentation has become a focus for many hospitals. TJC surveys, though only occurring once every 3 years, have become a huge a point of emphasis

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Is The Joint Commission Too Conflicted?

Continued pressure on The Joint Commission (TJC) is calling into question whether or not the non-profit organization best known for its hospital accreditation services is too conflicted to provide high quality accreditation surveys. The Centers for Medicare and Medicaid Services (CMS) is weighing a decision to allow accreditation organizations that also have consulting arms to

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Tissue Documentation Lacking? This Technology Can Help

In the past few years, we have heard the stories about surprise inspections from The Joint Commission (TJC) from many of our customers. The tissue managers and operating room administrators have all agreed on two points: 1) TJC, state Departments of Health and the FDA have all been focused on the tissue management and documentation

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Olympus Pleads Guilty To Selling Misbranded Duodenoscopes

Olympus’ recent legal battles took a serious turn this week when the Japanese company pleaded guilty to distributing endoscopes carrying known infection risks. Olympus and one of its executives pleaded guilty in a New Jersey court to 4 counts – 3 counts for Olympus and 1 count for an executive – of wrongful distribution of

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Olympus Denies Link Between Its Scopes And Superbugs

In response to a recent research report by the International Consortium of Investigative Journalists (ICIJ), Olympus has claimed that there is no link between its endoscopes and for a series of over 200 superbug infections around the world. The constant legal battles that Olympus is facing have yet to find the Japanese company solely responsible

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Research Reveals Number Of Superbug Infections Tied To Olympus Endoscopes

A research report by the International Consortium of Investigative Journalists (ICIJ) has revealed that the number of superbug infections in patients following the use of an Olympus endoscope totaled over 190 between 2012 and 2015 in the United States and Europe. The number of deaths linked to patients infected with superbugs and the role superbugs

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Scope Documentation Lacking? This Technology Can Help

Over the last several years, endoscope-related outbreaks from around the US and the world have led to increased oversight of the endoscope high-level disinfection (HLD) process at many hospitals. Many hospitals are now finding themselves in a struggle to oversee the HLD process at their facilities without introducing too much oversight and intervention into the

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

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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