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: February 16, 2024
Subject: FDA Issues Class I Recall of Medfusion Model 4000 Syringe Pump
Source: FDA
On February 14, 2024, the FDA issued a Class I recall, the most serious type of recall. Smiths Medical ASD Inc. is recalling Medfusion model 4000 syringe pumps due to issues associated with software versions of the medical pump that may affect the alarm system, the pump, the control screen, and other parts of the pump.
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.
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