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Thoughts on the breakage of the supervision of Anesthesia Catheter

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Author : Joe Wong
Update time : 2020-07-28 15:42:57
Thoughts on the breakage of the supervision of Anesthesia Catheter 


With the vigorous development of our country's medical device manufacturing industry, anesthesia puncture kits have been fully localized. The wide application of epidural anesthesia technology and the subsequent adverse events of anesthesia catheter rupture are frequently reported. Epidural catheter rupture (ECR) refers to the application of anesthesia puncture kits for clinical epidural placement Broken the anesthesia catheter during the tube and extubation process. Broken catheters often cause hematoma, pain, local swelling and effusion, etc., and generally do not cause life-threatening. If there are no symptoms, they can be left untreated. If laparoscopy is not performed, the lumbar spine instability after ordinary operation or local irritation of the migrating catheter Injury can also bring medical disputes [1, 2]. This article analyzes and summarizes the causes and countermeasures of epidural anesthesia catheter rupture from the perspective of supervision.

1. Analysis of the causes of epidural anesthesia catheter rupture

1. Overview of the current situation of anesthesia catheter rupture

The epidural anesthesia catheter is used as a pipeline for the delivery of anesthetics and is used in conjunction with an epidural puncture needle. It is composed of a tube body, a guide head, and a catheter connector. Epidural analgesia is widely used in clinical departments, and rupture is mainly seen in painless delivery in obstetrics and gynecology. The incidence of ECR ​​at home and abroad is 0.06%~0.2%[3] and 0.0017%~0.04%[4]. The responsibility for ECR identification results is often the medical party. The earliest report of ECR ​​was seen in the 1970s abroad, and the earliest report in China was seen in 1984[5]. There were more than a dozen fractures reported in the literature in the past 30 years. According to statistics, there were a total of 255 adverse events of anesthesia catheters nationwide in 2018, involving Henan, Jiangsu, Zhejiang and Shandong provinces. Among them, the catheter was blocked in 73 cases, broken in 54 cases, and broken in 43 cases; 12 cases were broken before use, 3 cases were broken in vitro, 36 cases were broken in vivo (24 cases were not removed), and 3 cases were unclear. Among the 36 cases of internal rupture, 18 cases were caused by catheter insertion difficulties, blockage, unclear scale, poor position, bleeding pain, etc. when the catheter was indwelled before anesthesia. The rupture occurred when the catheter was pulled out and reinserted; 16 cases were in After the anesthesia, when the body is pulled out, the muscles are clamped, and the pipeline is broken, which makes it difficult to pull out and breaks.

2. Reasons and analysis of anesthesia catheter break

   Because the anesthesia catheter such as endotracheal tube, laryngeal mask airway are relatively slender, it is prone to migration, twisting, knotting and damage to the tube body during the application process, so the product material requirements are higher. The epidural puncture needle used in conjunction with it has a cutting edge and a sharp tip bevel. The operator is often a first-line resident or an intern. Due to lack of knowledge and experience, if it is not used in accordance with clinical operating standards, repeated catheter pulls will occur. Excessive force, or the patient's back is tight and pressured, and local developmental deformities are likely to cause catheter rupture [6]. In the adverse event monitoring data, there are reports mentioning that "the tip of the puncture needle was found to have a sharp curl after the catheter was broken." Investigations show that the inner edge of the tip of the domestic self-produced puncture needle is basically not treated.

2. Analysis of the supervision measures of the fracture

In response to the above reasons, targeted measures to reduce the fracture rate, various policy measures to reduce the incidence of adverse events of catheter fracture, strengthening of production quality control and registration of technical information filing management, post-marketing supervision are all effective interventions. Such as the development of a catheter with a visualization function to facilitate the determination of the position of the broken part in the body, improve the material and product design, and increase the polishing process for the cutting edge; the lack of guidance and warning information in the manual should be corrected.

1. Strict production quality control

   Epidural anesthesia catheters are relatively risky and belong to Class III medical devices. They are subject to pre-market review and approval by the State Food and Drug Administration. Currently, the latest version of the standard YY0321.1 adds a catheter bending resistance test method compared to the 2009 version. The registration application has high requirements for the process flow and stability verification materials. It requires the extrusion and welding process, the needle tip (no hooks, burrs, and protrusions will appear during the withdrawal process), the catheter tip molding process, and the molding process of various models. The tip breaking force setting, the pipe breaking force verification, and the product quality stability are fully verified. It has been reported abroad that the Portex catheter breakage did not occur again after switching to a specially processed PVC raw material that can be developed and positioned [7].

2. Strengthen the supervision of instructions and labels

The standardized management of the instructions can be regarded as an effective channel. According to the “Order of the State Food and Drug Administration” (No. 6), Article 11 of the “Regulations on the Administration of Medical Device Instructions and Labels”, the instructions must include relevant precautions, Warning and suggestive content [8]. It is recommended that the product clearly specify "Epidural catheter placement must be performed by professionally trained medical personnel" and "Medical personnel should carefully read the warning information in the manual before using the epidural catheter, and strictly follow the clinical operating procedures Implementation. Improper operation may lead to the occurrence of adverse events/complications such as catheter rupture, which in turn may cause secondary harm to the patient (such as foreign body retention in the body, infection, nerve damage, etc.)", "The use of epidural catheters should be routine before use Check the packaging for damage and the integrity of the catheter, check whether the catheter is unobstructed, etc.", "Clinical medical staff should check if the catheter is complete after the catheter is taken out", "Once the epidural catheter is found to be difficult to pull out, it should be carried out in accordance with relevant clinical operating specifications Operation, do not violently drag or pull the catheter quickly", "If the epidural catheter breaks and may be left in the patient's body, etc., it is recommended that the hospital determine an appropriate follow-up treatment plan to minimize the patient's injury or impact." Specifying the countermeasures against common causes of fracture, the treatment methods after the fracture, the methods to avoid aggravation of the injury, etc. help to improve its safety, the symptoms and countermeasures after the catheter fracture, and the reduction of the epidural catheter The risk of fracture.

3. Strengthen publicity, education and legal supervision

   Since anesthesia catheter placement is more common in surgery, doctors should be strengthened to learn and practice operating standards, and at the same time pay attention to the improvement of the processing technology of the inner edge of the puncture needle of the manufacturer and the supervision of various rupture and recall events. It is recommended that companies improve product design, such as increasing catheter strength, tube body marking, improving materials, modifying instructions, and strengthening product use training. At the same time, the regulatory authorities improve the revision of pre-marketing standards and the soundness of technical data, and conduct targeted supervision and inspection after listing To reduce the risk of the catheter breaking.

    Therefore, only by paying sufficient attention and attention to the phenomenon of epidural anesthesia catheter rupture, perfecting the corresponding laws and regulations, and strengthening education and publicity, can the risk of the product rupture and the injury rate caused by the rupture be effectively reduced.