Caution and Warning from Korea Institute for Healthcare Accreditation

Korea Institute for Healthcare Accreditation ( has issued a caution and warning due to a safety incident with a conventional infusion pump.

Superior general hospitals are evaluated annually by the Medical Center Evaluation and Accreditation Agency.  If a hospital fails to meet the evaluation criteria in the medical organization evaluation, its designation as a superior general hospital will be canceled. If the designation is revoked, the medical insurance rate for the highest grade is lowered, resulting in legislative disadvantages as well as other support projects. During the evaluation period, medical institutions put everything aside and focus on this work. During this period, they do not conduct demos because they may be criticized.

As shown in the attached document, the original technical limitations of the existing drug infusion pump are 1) checking the locking status of the fluid regulator due to a rapid infusion (free flow) medical accident when the door is opened while the pump fluid set locking device (clamp) is open, 2) periodic monitoring because real-time accuracy is not guaranteed, and 3) guidance on prohibiting non-medical staff manipulation due to a medical accident caused by a patient arbitrarily removing the pump fluid set and rapidly injecting or arbitrarily adjusting the infusion amount.  Evidence of the measures taken and the basis for implementation must be provided when evaluating medical institutions to receive an evaluation score. (Refer to the August 30, 2023 press release from the Korea Accreditation Agency for Healthcare Organization Evaluation and Certification ( on the issuance of the 4th Patient Safety Alert on August 30, 2023 - attached)

As a result of the KOIHR's issuance of a cautionary alert, senior general hospitals are required to record the contents of the cautionary alert in real time and leave data. It has already been institutionalized in the United States, and in the future, the work of users and officials of advanced general hospitals using medication infusion pumps has been aggravated.

Anyfusion cylinder pump has been selected as a STEP by the FDA by fundamentally solving medical accidents 1), 2), and 3) above with cylinder cartridge source technology. Since the FDA has certified the Anyfusion cylinder pump as a drug infusion pump that fundamentally solves these problems, the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, the Health Insurance Review and Evaluation Service, and the Medical Center Evaluation and Accreditation Service should issue a guideline stating that the Anyfusion cylinder pump does not have to fulfill the obligation to issue a caution or an alarm. That way, as the FDA has institutionalized with STeP and corresponding guidelines, medical errors can be reduced, overworked staff can be freed, and quality medical care can be provided.

Thank you.

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