1. Anyfusion cylinder pump was
selected for FDA STeP because it completely overcame the problems of existing drug
infusion pumps with significant safety and efficacy issues. The existing
products were inappropriate for drug infusion pumps. Therefore, the FDA set up
a separate division of the Injection Device Team to specially manage and
continuously recommend the development of alternative products. In addition,
the FDA compared the drug library pump with Anyfusion in the STeP, which
improved the safety and effectiveness of the existing pump. However, although
the drug library program was built into the existing pump to improve the safety
and effectiveness, the original technology of the existing pump did not
guarantee the safety and effectiveness, so the FDA compared it with Anyfusion.
2. Closed system transfer
devices (CSTDs) worth 20,000 won each are used to offset the negative pressure
and prevent leakage and exposure risk in the dispensing of toxic anti-cancer
drugs and contamination risk injectable drugs, as the negative pressure makes
it impossible to accurately extract quantitatively from vials and bottles under
vacuum to human syringes. CSTDs are only used to extract the drug and transfer
it to the dispensing container, not to inject it. As of 2019, the market was
worth more than 5 trillion won per year in 28 developed countries. By 2023, it
is expected to reach $7 trillion. The
Anyfusion ACPi system is a complete shutdown device (CSTD) from dispensing to
infusion, making CSTDs for dispensing only meaningless.
Regarding 1 and 2, 1) Anyfusion cylinder pump for
drug injection and Anyfusion ACPi suytem, an integrated system for dispensing
and injecting anti-cancer (injection) drugs, are manufactured and sold in
Italy, where the owner couple is a doctor and manufactures and sells PCA pumps
in the field of drug injection, and exclusive contracts are being finalised
with Spain (Eastern Catalonia, Western Andalusia) and Saudi Arabia, which are
partners for more than 15 years as G company and EZ Regular with Anyfusion
competitiveness. 2) Anyfusion ACPi system, an
anti-cancer (injection) drug dispensing system, has received an explosive
response from around the world, and explosive sales are expected once
certification is completed. 3) The adjustment of screening
benefits to nursing benefits will be decided soon. 4) Anyfusion cylinder pump was
lunching at Eulji University Hospital.
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