Metabolic abnormalities and catheter-related infections are common complications of parenteral nutrition (PN). Particulate contamination is a catheter-related complication can occur when administering PN: mixing the electrolytes, trace elements, vitamins into the PN, or puncturing a rubber stopper at the PN formulation. In addition, the aggregation of the components of the PN solution by a drug incompatibility reaction could be related to particulate contamination. PN contaminated with precipitates, insoluble particles, and bacteria was reported as the cause of the death of a patient. The Food and Drug Administration recommended that the filters be used during PN administration. In-line filters can retain the bacteria and insoluble particles in PN solutions, and prevent their infusion into the patient. Therefore, in-line filters are recommended to prevent catheter-related complications that can occur during PN infusion. A 0.2µ filter for lipid-free PN and a 1.2µ filter for lipid-containing PN solutions can be used. On the other hand, when a filter is applied, the infusion rate can decrease and the economic burden will increase for patients requiring long-term PN. In addition, small particles, such as viruses, polymers, and proteins cannot be filtered out completely. In conclusion, in-line filers are recommended to prevent catheter-related complications that can occur during PN administration, but there are no international standardized guidelines. Therefore, standardized guidelines will be needed based on evidence accompanied by clinical trials. In addition, in-line filter applications should be considered in the clinical field depending on the patient’s condition.

Enteral nutrition (EN) formulas are foods that are used to improve the nutritional status of patients and these foods’ safety and quality must be ensured. Therefore, EN formulas in other countries are managed differently from that of general foods. We investigated the direction of development of the relevant laws regulations and guidelines pertaining to EN formulas and we compared these laws regulations and guidelines from different countries, including Korea. The United States and Europe manage EN formulas as foods, but they are managed differently compared to general foods because of separate laws or programs pertaining to EN foods. In addition, the use of the formulas does not necessarily require a prescription, but when used by prescription, then medical insurance covers them. In Japan, there are two types of EN formulas, food and drug, and there are differences for their management and insurance coverage. In the case of Korea, EN formulas are classified as food and drug, and different management and insurance are applied in each case, which inhibits their systematic management and industrial development. Integration of a management system and establishment of a legal foundation is necessary for the systematic management and development of EN formula in Korea.

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