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Activ Surgical Announces FDA Clearance for ActivSight Intraoperative Imaging Module

Activ Surgical announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ActivSight Intraoperative Imaging Module for enhanced surgical visualization.

Metrex Surface Disinfectant Portfolio Secures EPA Approval

The U.S. Environmental Protection Agency (EPA) has approved all eight surface disinfectant products made by an infection prevention leader, Metrex, as effective against SARS-CoV-2, the novel coronavirus that causes COVID-19.

Olympus Supports Safety Actions Regarding Surgical Smoke

Olympus has announced its support of The Joint Commission’s recommended safety actions for managing the hazards of exposure to surgical smoke for health care staff in operating rooms.

Exofin Fusion Redesign Receives FDA Approval

Chemence Medical, a leader in medical cyanoacrylate devices and products, announced the U.S. Federal Drug Administration’s (FDA) 510(k) approval of the company’s redesigned exofin fusion skin closure system.

Trump Administration Engages Hospitals in Unprecedented Data Sharing

The Centers for Medicare & Medicaid Services (CMS) sent a letter to the nation’s hospitals on behalf of Vice President Pence requesting they report data in connection with their efforts to fight the 2019 Novel Coronavirus (COVID-19). Specifically, the Trump Administration is requesting that hospitals report COVID-19 testing data to the U.S. Department of Health and Human Services (HHS), in addition to daily reporting regarding bed capacity and supplies to the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) COVID-19 Patient Impact and Hospital Capacity Module. CMS, the federal agency with oversight of America’s Medicare-participating health care providers – including hospitals – is helping the Trump Administration obtain this critical information to help identify supply and bed capacity needs, as well as enhance COVID-19 surveillance efforts. Hospitals will report data without personal identifying information to ensure patient privacy.

“The nation’s nearly 4,700 hospitals have access to testing data that’s updated daily. This data will help us better support hospitals to address their supply and capacity needs, as well as strengthen our surveillance efforts across the country,” said CMS Administrator Seema Verma. “America’s hospitals are demonstrating incredible resilience in this unprecedented situation and we look forward to partnering further with them going forward.”

The White House Coronavirus Task Force is already collecting data from public health labs and private laboratory companies, but does not have data from hospital labs that conduct laboratory testing in their hospital. This hospital data is needed at the federal level to support the Federal Emergency Management Agency (FEMA) and CDC in their efforts to support states and localities in addressing and responding to the virus.

Academic, University and Hospital “in-house” labs are performing thousands of COVID-19 tests each day, but unlike private laboratories, the full results are not shared with government agencies working to track and analyze the virus. By sharing this critical data, hospitals can help Federal and state government mitigate the effects of COVID-19 and direct needed resources from Federal Emergency Management Agency (FEMA) and the U.S. Government during this unprecedented crisis.

In Vice President Pence’s letter to America’s hospitals, he asks all hospitals to report data on COVID-19 testing performed in their “in-house” laboratories, which are hospitals’ onsite laboratories. To monitor the rapid emergence of COVID-19 and the impact on the healthcare system, the White House Coronavirus Task Force is requesting hospitals to report testing data to HHS each day and to the CDC’s NHSN. This new data request by the Trump Administration will help monitor the spread of severe COVID-19 illness and death as well as the impact to our nation’s hospitals. Because private and commercial laboratories already report, this letter is not applicable to them.

This action, and earlier CMS actions in response to COVID-19, are part of the ongoing White House Coronavirus Task Force efforts. To keep up with the important work the Task Force is doing in response to COVID-19, visit www.coronavirus.gov. For a complete and updated list of CMS actions, and other information specific to CMS, please visit the Current Emergencies Website.

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