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Iowa Nursing Home Resident Suffocated Due to Grab Bar Entrapment

Med-Net Compliance

An Iowa nursing home was cited for placing its residents in immediate jeopardy after a resident became wedged between a bed and a grab bar and suffocated. Specifically, the facility failed to immediately report the event that resulted in the death of the resident. The facility submitted the incident report to the SSA 16.5

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Ensuring Safety and Quality in America’s Nursing Homes

CMS.gov

Ensuring Safety and Quality in America’s Nursing Homes. Nursing facilities. This duty is especially important when it comes to the care provided for some of the most vulnerable in our society, Americans residing in nursing homes. CMS’ approach to oversight of nursing homes is constantly evolving.

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FDA Guidance Provides Relief for MDR Reporting During a Pandemic

Exeed Regulatory Compliance

A new FDA guidance provides much-needed relief during a pandemic. FDA has just revised its relatively less known 2012 guidance entitled “Post-market Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic” to clarify that the guidance is applicable to any pandemic, not just an influenza pandemic.

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SQA Regulatory Surveillance Summary | Monthly Update 2022 – June

SQA

Ma rketing authorization holders (MAHs) can now register their Industry Single Point of Contact (i-SPOC) who will inform EMA about the supply and availability of critical medicines identified in the context of a ‘public health emergency’ or a ‘major event’. United States Food and Drug Administration (FDA) – Regulations and Guidances.

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Bonus Features – July 30, 2023 – Amazon gets into the generative AI game, HIMSS plans to sell off the annual trade show, and more

Healthcare IT Today

The deal only appears to involve the trade show – next slated for March 11-15, 2024 in Orlando – and makes no mention of smaller HIMSS events (in-person or online) or the Healthcare IT News or MobiHealthNews publications that HIMSS Media owns. UltraSight was granted FDA clearance for its AI-powered ultrasound guidance technology.

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SQA Regulatory Surveillance Summary | Monthly Update 2022 – Spring

SQA

United States Food and Drug Administration (FDA) – Regulations and Guidances. The FDA proposes to do so primarily by incorporating by reference the 2016 edition of the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485.

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A guide to connected health device and remote patient monitoring vendors

Healthcare IT News - Telehealth

Biovitals’ AI-based treatment algorithms then enable software-based therapeutic interventions that signal to clinicians what they should do next to intervene, in order to prevent critical events that would otherwise lead to hospitalizations or visits to the emergency department. iRhythm Technologies.

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