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: March 7, 2024
Subject: FDA Issues Class I Recall of VOCSN Patient Breathing Package
Source: FDA
On March 7, 2024, the FDA issued a Class I recall, the most serious type of recall, for Ventec Life Systems’ VOCSN Patient Breathing Package. The recall is due to a manufacturing issue which causes the bonded spiral wrap to detach before or during ventilation. The patient breathing package may be used in various healthcare settings, e.g., patient homes, hospitals, and during patient transports to and from different areas of a medical facility.
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: March 11, 2024
Subject: ECRI Releases Top 10 Patient Safety Concerns for 2024
Source: ECRI
On March 11, 2024, ECRI released a special report of their top 10 patient safety concerns for 2024.
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: March 21, 2024
Subject: FDA Issues Class I Recall of Abiomed Impella Left Sided Blood Pumps
Source: FDA
On March 21, 2024, the FDA issued a Class I recall, the most serious type of recall, for Abiomed Impella Left Sided Blood Pumps due to perforation risks that may lead to injury or death.
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: March 21, 2024
Subject: FDA Issues Class I Recall of Vyaire Medical AirLife Manual Resuscitators
Source: FDA
On March 21, 2024, the FDA issued a Class I recall, the most serious type of recall, for Vyaire Medical AirLife Manual Resuscitators due to a manufacturing defect that may lead to injury or death.
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: March 26, 2024
Subject: FDA Issues Class I Recall of Certain Saline and Sterile Water Products
Source: FDA
On March 25, 2024, the FDA issued a Class I recall, the most serious type of recall of certain Medline Kits and Trays distributed from November 1, 2021, to November 10, 2023. The recall is due to sterility concerns of kits containing 0.9% sodium chloride irrigation USP and sterile water for irrigation USP manufactured by Nurse Assist, LLC, which may lead to injury or death.
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: March 29, 2024
Subject: CDC Issues Health Alert for Increase in Meningococcal Disease
Source: CDC
On March 28, 2024, the Centers for Disease Control and Prevention (CDC) issued a Health Alert Network (HAN) advisory of an increase in invasive meningococcal disease, mainly attributable to Neisseria meningitidis serogroup Y in the U.S. Further information may be obtained at https://emergency.cdc.gov/han/2024/han00505.asp
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.