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FDA, Cardinal Health Assess Scope of Potential Contamination Risk

Dr. Jeffrey E. Shuren MD, JD, Director - CDRH Offices: Office of the Center Director, released the following statement on Thursday (January 16, 2020): “On Jan. 11 and again on Jan. 15, 2020, medical device manufacturer Cardinal Health alerted its customers to...

U.S Health System Uses Medtronic Stealth Autoguide Cranial Robotic Guidance Platform

Phoenix Children’s Hospital is the first-ever health system in the U.S. to receive and deploy the newly FDA-cleared Medtronic Stealth Autoguide platform.

Cook Medical TriForce Peripheral Crossing Set Now Available

Cook Medical’s TriForce® Peripheral Crossing Set is now commercially available. As of January 2020, these products are available to physicians in the United States to support procedures to treat patients with vascular obstructions.

PENTAX Medical Launches IMAGINA Endoscopy System in U.S.

IMAGINA offers practitioners a modern user interface and unique endoscope design to provide excellent visualization, improve the operator experience and positively influence long-term patient care costs.

HFAP Ownership Change Receives Approval from CMS

Announcement Confirms Continuous Deeming Authority throughout Transition

HFAP, America’s original healthcare accreditation program founded in 1945, recently received approval from the Centers for Medicare and Medicaid Services (CMS) for a Change in Ownership (CHOW) after the Accreditation Association for Hospitals and Health Systems purchased HFAP from the American Osteopathic Association (AOA). This approval ensures AAHHS/HFAP retains its CMS deeming authority for the following accreditation programs: hospitals, critical access hospitals (CAHs) and ambulatory surgery centers (ASCs).

CMS will continue to recognize the accreditation of hospitals, CAHs and ASCs currently accredited under the AOA/HFAP program for the remainder of their terms of accreditation. In the future, all surveys with AAHHS/HFAP will be considered reaccreditation surveys for organizations previously accredited by AOA/HFAP.

“Our team strived to create a seamless, integrated transition to best serve the needs of our accredited organizations and other stakeholders,” said Meg Gravesmill, MBA and CEO of AAHHS. “Our accredited organizations will not be required to undergo an Initial Deemed Status Survey, nor will there be any change in the dates of their triennial surveys.”

The current term of accreditation program approval granted by CMS for AOA/HFAP will be fulfilled as AAHHS/HFAP, as published in the Federal Register:

“The HFAP program has provided deemed status surveys since the inception of CMS in 1965,” said Gravesmill. “The range of accreditation and certification products HFAP represents has grown substantially since coming under the management of AAHHS in 2015. We are excited to continue HFAP’s culture of outstanding customer service as we embrace the responsibilities of deeming authority under CMS.”

For more information on HFAP accreditation programs, please visit www.hfap.org.

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