An infusion set is a sterile device consisting mainly of tubing whose function is to convey, conduct, or deliver an intravenous (IV) fluid from a plastic or bottle container into a patient’s vein. The IV fluid container is hung well above and over the patient because the set operates by way of gravitational fluid administration. One end is equipped with a pointed structure (spike), which is used to prick the medical fluid container, and the other end is where the needle is attached. The needle is inserted into the vein of the patient.
The Information In The Packing
A disposable infusion set is an injectable device. Whatever is injected into it, it will immediately reach the patient’s blood, and it could cause immediate reactions if the set is not of good quality and does not possess requirements for safety. As such, they could cause harm to the patient faster and more life-threatening than drugs that are taken orally. Thus, the following information needs to be on the packaging same as required by the World Health Organization for pharmaceutical products:
(1) expiration date,
(2) manufacturing date,
(3) storage conditions and handling precautions,
(4) directions for use, and
(5) the name and address of the manufacturer.
As currently practiced in the industry, both the production and expiration dates are written in the packaging material of a disposable infusion set. Sometimes, the shelf life is not written. Thus, shelf life is derived by taking the length of time between the expiration and production dates, whc.
From a technical point of view, however, any product that has passed its shelf life might still be safe to be used, but its quality is no longer guaranteed. The shelf life is greatly influenced by storage conditions, such as exposure to heat and moisture. Therefore, in the manufacturing process, the requirements for proper storage of any product must be determined and established. These should be discussed well and incorporated in the product literature and brochure.
The expiration date of a product indicates the date after which the quality and safety of the product can no longer be guaranteed.
Thus, the shelf life takes care only of the quality of the product, whereas the expiration date takes care of the product’s quality and safety.
Shelf Life Of The Disposable Infusion Set
There are no medical and technical journals right now that define and establish the shelf-life of infusion sets. The right way to find out each product’s respective shelf-life is to consult each product’s literature and brochures.
Five Years
Our infusion sets are produced according to MDR standards and with a five years shelf life. Currently, the production and expiration dates are written on the package, either in the primary packaging or on the outer carton. There is also a label used to represent the date of manufacture. Besides they can also be found in the Certificate of Analysis by the manufacturer.
How To Determine Whether Infusion Set Is In Good Condition?
A disposable infusion set is still in good condition and has not yet expired if it is still within the shelf-life period as defined in the preceding. However, there are still other properties of the product which need to be considered:
Condition of the primary package:
· The primary packaging is not damaged: no folds, no small holes, or cracks;
· The primary packaging seal is in good condition, with no packaging tear or rents;
· Primary packaging leakage: The outer package’s oxygen permeability must meet the requirement because it directly affects the product’s shelf life period. It should meet the standard.
Physical properties:
· The appearance of the product is smooth, clean, and not tarnished with oil and other stains;
· The specifications of every component of the product met the requirements.
Biological properties:
· It is still sterile and pyrogen-free;
· Germ toxicity met the requirements;
· Hemolysis test met the requirements;
· Acute toxicity test met the requirements;
· Skin irritations and sensitizations were not observed.
Chemical properties:
· The pH requirement is met;
· Metal ions met the requirements;
· Evaporating dregs met the requirements;
· Ultraviolet ray absorption complied with the requirements;
· Dregs of epoxy ethane met the requirements.
Some of these critical factors are so difficult to evaluate based on external observations. Thus, the manufacturers need to submit the report(s) affirming that the preceding product requirements were met.
What Other Precautionary Measures Need To Be Observed In The Use Of Disposable Infusion Set?
The disposable infusion set is an example of an injection device used to administer intravenous or subcutaneous medications. In one study by Ling-ling Zhu et al. of the Second Affiliated Hospital of Zhejiang University, School of Medicine, Zhejiang University, People’s Republic of China, it was found about one-half of all harmful medication errors took place during the drug administration. Among those errors, about two-thirds involved injection devices. Therefore, injection device management is pivotal to the safe administration of medications.
The authors mentioned the following as some of the sources of errors: (1) improper selection of needle diameter, the material of infusion sets, pore size of the in-line filter, and (2) leakage of the intravenous fluid around the syringe needle. Therefore, the needle diameter needed for a specific indication must be specified in the product brochure and literature. At the same time, the competence of the male Luer-lock must be ensured.
