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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 Receives Renewal as ASC Accreditation Agency in California

HFAP, a health care accreditation program founded in 1945, was recently renewed as an approved accreditation agency for ambulatory surgery centers (ASC) in California. HFAP already has deeming authority for ASCs from the Centers for Medicare and Medicaid (CMS), allowing HFAP to conduct accreditation surveys and assess compliance with the Medicare Conditions for Coverage for ASCs.

The Medical Board of California awarded the approval after HFAP met all of the application requirements including accreditation standards and payment of renewal fees. The approval is valid through December 31, 2019.

“At HFAP, we pride ourselves on our customer-centered approach to accreditation that provides health care organizations with a relevant and comprehensive survey, as well as ongoing support and interaction with our team throughout the accreditation cycle,” said Meg Gravesmill, CEO of HFAP. “All organizations have ready access to resources and education to ensure continuing opportunities for learning, growth and advancement before, during and in between surveys.”

HFAP also holds deeming authority for clinical laboratories and acute care and critical access hospitals. In addition, HFAP’s new joint arthroplasty certification (launching in June) will join lithotripsy services, and wound care, as specialty recognition relevant to ambulatory facilities.

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

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