Fujifilm recalls duodenscope model

AHA News Now

Fujifilm Medical Systems today voluntarily recalled its ED-530XT model duodenoscopes to replace certain parts in an effort to reduce potential risk associated with inadequate reprocessing of the device, which is used to visualize the upper digestive tract. The company plans to contact all customers by... read more

Topic: Quality and Patient Safety
Tags: patient safety, regulation

FDA to extend REMS requirements to immediate-release opioids

AHA News Now

The Food and Drug Administration intends to update its Risk Evaluation and Mitigation Strategy requirements for extended-release and long-acting opioid analgesics, and extend the same requirements to immediate-release opioid analgesic products, FDA Commissioner Scott Gottlieb, M.D., announced this week.... read more

Topic: Quality and Patient Safety
Tags: physicians, nurses, regulation, opioids

CMS releases 2018 outpatient PPS and physician payment proposed rules

AHA News

The AHA July 13 criticized proposed deep cuts to how much the Centers for Medicare & Medicaid Services reimburses hospitals for drugs acquired under the 340B Drug Pricing Program and proposes changes to site-neutral payment policies under Section 603 of the 2015 Bipartisan Budget Act. The provisions are... read more

Topics: Quality and Patient Safety, Advocacy and Public Policy
Tags: 340B, site neutral payment, Drug Pricing Program, Medicare, regulation

FDA alerts providers to defibrillator recall

AHA News Now

Phillips Healthcare has recalled a device used by health care providers to pace people with a slow heart beat or deliver lifesaving electrical shocks to people with sudden cardiac arrest, the Food and Drug Administration announced Friday. Electrical and battery connection issues with the HeartStart MRx... read more

Topic: Quality and Patient Safety
Tags: patient safety, regulation

FDA issues MRI safety recommendations for patients with implantable infusion pumps

AHA News Now

The Food and Drug Administration today alerted health care providers and patients to safety concerns with the use of implantable infusion pumps in the magnetic resonance imaging environment, citing reports of serious adverse events. Implantable infusion pumps are surgically implanted under the skin,... read more

Topic: Quality and Patient Safety
Tags: quality, physicians, safety, nurses, regulation

FDA alerts providers to cardiac device cybersecurity vulnerability, software patch

AHA News Now

St. Jude Medical is deploying a software update to a remote monitoring system used with its implantable pacemakers and defibrillator devices to reduce the risk of patient harm due to cybersecurity vulnerabilities, the Food and Drug Administration announced this week. The agency said health care providers... read more

Topic: Quality and Patient Safety
Tags: quality, physicians, safety, Cybersecurity, nurses, regulation

FDA: Automatic external defibrillator electrode recalled

AHA News Now

Leonhard Lang has recalled certain lots of an automatic external defibrillator electrode because the user may not be able to connect it to the defibrillator when a shock is needed due to a compatibility issue, the Food and Drug Administration announced Friday. A delay in delivering electrical therapy to... read more

Topic: Quality and Patient Safety
Tags: quality, patient safety, regulation

CDC advises hospitals to notify patients, clinicians of potential device-related infection risk

AHA News Now

The Centers for Disease Control and Prevention today warned health care providers and patients about the potential risk of infection from certain devices used during open heart surgery. Stöckert 3T heater-cooler devices, made by LivaNova PLC (formerly Sorin Group Deutschland GmbH), may have been... read more

Topic: Quality and Patient Safety
Tags: quality, patient safety, regulation

CMS opens registration for May 12 webinar on overall hospital star ratings methodology

AHA News Now

The Centers for Medicare & Medicaid Services today opened registration for a May 12 webinar on its overall hospital quality “star ratings” methodology. During the 90-minute webinar, which begins at 1 p.m. ET, presenters will explain the methodology used to generate the summary rating for individual... read more

Topic: Quality and Patient Safety
Tags: quality, rating systems, regulation

FDA: Providers should use revised Olympus duodenoscope reprocessing instructions

AHA News Now

Olympus Corporation of the Americas has issued revised manual reprocessing instructions for its TJF-160F and TJF-160VF duodenoscope models to replace those provided in the original device labeling, the Food and Drug Administration reports. Health care facilities using the duodenoscope models should train... read more

Topic: Quality and Patient Safety
Tags: patient safety, regulation

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