News

Home / News / Causes of bacterial and pyrogen reactions in clinical transfusion

Causes of bacterial and pyrogen reactions in clinical transfusion

Posted by Admin | 06 Mar

Infusion is increasingly used in clinical practice. Generally, fasting patients need to infuse 2000~3000 ml of glucose solution every day. Other patients such as diarrhea, burns, shock, and high fever also need more. It has been reported over the years that in spring and autumn, when the room temperature is high, sporadic and individual patients often have transfusion pyrogen reactions, and even inject the infusion with mold colonies into patients, which is very dangerous. The infusion is prepared under strict conditions and can be supplied to the pharmacy for clinical use only after passing the quality appraisal, sterility, pyrogen, and other tests. But why does pyrogen reaction often occur?

1. It is a hidden danger left in the production process

① Slight cracks in packaging materials such as infusion bottles: due to the long production process and storage and transportation process of infusion, most of the packaging materials are glass bottles and plastic bags. Although the products are sterilized, some bottles can often collide during cleaning and transportation, causing tiny cracks, which are not easy to be noticed. Some cracks are like clamshells, some are thin dots, and some are like stripes. You need to rotate the infusion bottle from different angles under the inspection lamp to see clearly. In the process of storage, this kind of infusion is easy to be contaminated once the air enters from the crack.

 

It is worth noting that some cracks are covered by labels, which are more difficult to find. In addition, some cracks are at the bottle mouth, which is often covered by aluminum caps, which are more difficult to find. Therefore, it is necessary to check carefully before use. Special attention should be paid to the melting and sealing of plastic bag products. When checking, you can apply slight pressure by hand to see if there is air leakage.

② Leakage of polyester lining film and rubber stopper: Due to the poor quality of rubber stopper at present, it is easy to pollute the liquid medicine, so the rubber stopper groove for infusion needs to be lined with polyester film to improve the clarity quality of infusion.

 

During production, due to the excessive speed or negligence of the subpackage, the polyester film was not aligned but skewed when the lining was filled, or the rubber plug was pressed improperly, resulting in polyester fern pleats and uneven folds, so it could not be evenly wrapped on the rubber plug, resulting in air leakage.

 

③ The sealing of the aluminum cap is loose: because the sealing machine often uses mechanical parts that are easy to loosen, sometimes the sealing is not tight, and the cracked bottle mouth leaks.

 

④  Individual infusion bottles are not clean: the amount of work required for the cleaning of infusion bottles is large, and there is mechanical cleaning or manual cleaning. It is necessary to ensure that each bottle is clean and meets the requirements.

 

⑤ Strictly prevent missing disinfection of individual products: In batch production, it is necessary to strictly prevent missing disinfection of individual products and mixing them into finished products. Some units have had a few missing infusion bottles without disinfection, resulting in mildew and deterioration.

 

2. It is a problem caused during loading, unloading, and storage.

① During the storage process of infusion, the seal is loose due to the stacking of finished products. Some storage tanks are low, and the infusion bottle is higher than the height of the box. The whole box is directly pressed on the aluminum cap, which can make the rubber plug aluminum cap lose.

 

② In the process of loading, unloading, and transportation, the bottles are not handled with care, which may damage the bottles and cause tiny cracks.

 

3. Problems related to an infusion set and infusion catheter

Infusion needs to be delivered into the body through an infusion catheter. There are currently two types of infusion devices:

 

① Indirect infusion. The device includes a glass bottle and infusion catheter, including a rubber tube, Murphy dropper, glass pipe, needle, and plastic thin tube. It is reported that if this method is not operated strictly, it can also cause pollution. If a small amount of liquid is not discarded at the beginning, or the infusion bottle mouth is placed on the mouth of the barrel to pour the liquid, or the barrel mouth is opened for a long time, it is easy to cause foreign matters to be mixed in the infusion. For example, when the infusion in a bucket of a certain unit is about to be finished, it is found that there is a pout on the liquid level. An ant was found in another bucket.

 

② Direct infusion. The device is that the original infusion bottle is directly installed on the infusion catheter.

 

Because the treatment of infusion device and infusion catheter does not meet the requirements, reactions caused by pyrogen are also common. It is reported that a hospital immediately rechecked the same batch of infusion in stock when the patient had an infusion reaction, and no pyrogen was detected. However, 16 batches of samples passing the test of the infusion catheter were pyrogen positive. The reason for the pyrogen positive of this batch of infusion tubes was due to the long-term disrepair of the high-pressure disinfection pot (vertical) and the improper use of the residual water sprayed from the bottom of the pot to pollute the infusion set.

 

It can be seen from this that the infusion catheter is also the main way of pyrogen pollution. Once used, if the catheter is not washed in time, it will adhere to the infusion (or blood) and become a good nutrient for microorganisms. If the temperature is appropriate, it is easy to breed rapidly. Although the catheter is sterilized under high pressure, it can not destroy the pyrogen, so a slight lax washing treatment can cause reactions. Therefore, it must be handled in strict accordance with the operating procedures, and pyrogen inspection can be carried out if necessary.

\

Contact Us

*We respect your confidentiality and all information are protected.