Analysis of Regulatory Measures for the Rupture of the Anaesthetic Tube

In view of the above reasons, targeted measures to reduce the fracture rate, through various policy measures to reduce the rate of adverse incidents of catheter fracture, strengthen production quality control and registered technical data filing management, after-market supervision are effective interventions. Such as the development of a development-enabled catheter to facilitate the determination of the location of fractured parts in the body, improve material and product design, the cutting edge to increase the grinding process;

1. Strict production quality control.

The risk of epidural anaesthetic catheters is higher, belongs to Class III medical devices, which is approved by the State Drug Administration for pre-market audit and approval, and the current latest version of the standard YY0321.1 has increased the method of anti-bending test of the catheter compared to the 2009 version. Registration declaration on the process and stability verification data requirements are high, need to extrude and welding process, needle tip (no bending hooks, burrs, protrusions during the pull-back process), pipe cutting-edge molding process, various models of molding process, cutting-edge fracture force setting and tube fracture force verification, product quality stability to be fully verified. Foreign reports on the replacement of the development-oriented positioning of the special treatment of PVC raw materials after the Portex catheter rupture did not occur again.

2. Strengthen the supervision of the specification label.

The regulation and management of the specification may be regarded as an effective channel, and the notes, warnings and prompt contents shall be included in the 11instruction manual of the Regulations on the Administration of Medical Device Stoccops and Labels of the State Food and Drug Administration (No. 6). It is recommended that the product specify in the instructionmanual "to carry out epidural external tubes, must be operated by professionally trained medical personnel", medical personnel should carefully read the warning information in the instructions before using the epidural catheter, and in strict accordance with clinical procedures. Improper handling may lead to the occurrence of adverse events/complications such as catheter breakage, which in turn cause secondary damage to patients (e.g. foreign bodies remain in the body, infection, nerve damage, etc.), "Before using epidural catheters should be routinely checked for broken packaging and whether the catheter is complete, check whether the catheter is smooth, etc." "If the catheter is complete", "once found that the epidural catheter pull difficulties, should be in accordance with the relevant clinical practice, not to drag or quickly pull the catheter", "if there is an epidural catheter rupture and may leave the patient in the body, it is recommended that the hospital determine the appropriate follow-up treatment plan, so that the patient's injury or impact to a minimum." The measures for the common causes of fracture, the treatment method after the break occurred, and the method to avoid the increase of injury can help to improve the safety of their use, and the symptoms and countermeasures after the catheter break can be explained to reduce the risk of the rupture of the epidural catheter.

3. Strengthen education and legal supervision.

As anaesthetic catheterization is more common in surgery, the study and practice of doctor's practice should be strengthened, and attention should be paid to the improvement of the perinatal process of puncture needles in production enterprises and the supervision of various types of fault adverse events and recalls. It is recommended that enterprises improve product design, such as increasing catheter strength, body marking, improving materials, modifying instructions, and strengthening product use training, while the regulatory authorities improve the revision of pre-market standards and the soundness of technical information, and do a good job of targeted supervision and inspection after the market to reduce the risk of the catheter rupture.

Therefore, only to give sufficient attention and attention to the phenomenon of epidural anaesthetic catheter fracture, improve the corresponding regulations and supervision system, strengthen education and publicity, can effectively reduce the risk of the product fracture, reduce the casualty rate caused by the break.