Healthcare Regulatory Alerts
CIHQ-ARS notifies its client organizations of any new or modified accreditation standard, or CMS COP for acute care hospitals. Alerts are also published when changes are made by CDC, OSHA, NIOSH, NFPA. Each alert summarizes the standard, regulation, recommendations, likely impact to members, and recommendations for compliance strategies. Whenever possible, alerts are limited to one-page in length so that they can be quickly read and disseminated.
New Regulatory Alert
Date: January 11 2024
Subject: FDA Issues Class I Recall of Phillips MRI Systems
Source: FDA
On December 20, 2023, the FDA issued a Class I recall, the most serious type of recall. Philips North America LLC is recalling the Panorama 1.0T HFO due to a risk of explosion during a quench procedure caused by excessive pressure buildup of helium gas.
Discussion & Recommendations:
CIHQ Accredited Hospitals, ARS Members and Healthcare Accreditation Certified Professions: To view the discussion & recommendations portion of the alert, log in to your facilities account. All alerts are archived in the library for future access and reference.
Not a CIHQ Accredited Facility, ARS Member or hold HACP certification?
» Visit CIHQ.org to learn more, and to apply.
New Regulatory Alert
Date: January 11 2024
Subject: FDA Issues Class I Recall of ResMed Ltd. CPAP Masks
Source: FDA
On January 11, 2024, the FDA issued a Class I recall, the most serious type of recall. ResMed Ltd. is recalling all their Continuous Positive Airway Pressure (CPAP) masks with magnets due to possible magnetic interference with certain medical devices.
Discussion & Recommendations:
CIHQ Accredited Hospitals, ARS Members and Healthcare Accreditation Certified Professions: To view the discussion & recommendations portion of the alert, log in to your facilities account. All alerts are archived in the library for future access and reference.
Not a CIHQ Accredited Facility, ARS Member or hold HACP certification?
» Visit CIHQ.org to learn more, and to apply.