Release date: 2009-06-16
Cao Huai Yuan Yuan, Anhui Food and Drug Administration, Anhui Province
Child fracture refers to the destruction of the integrity or continuity of a child's bone due to external forces. Children are in the stage of growth and development, and the anatomy, physiological function and biomechanical properties of the bones are constantly changing. Therefore, the surgical methods for the treatment of adult fractures and the internal fixation devices cannot be used for the treatment of fractures in children.
Children's fractures generally advocate conservative treatment such as manipulation, plaster or splint, but the surgical treatment should be considered if the opponent's method is unsuccessful. Because children have weak muscle strength and light weight, the stress on the fracture end is smaller than that in the adult, the fracture is healed quickly, and the shaping ability is strong. Therefore, the selection and use of the internal fixation implantable instrument should be especially careful when surgical reduction. The use of small damage, does not affect the growth of the epiphysis, simple and strong internal fixation.
Major problems in use
According to the product technical report, safety risk analysis report, clinical laboratory data, etc., the parts of the steel plate are mostly used in the specification and model, such as the "foot-and-bone LC-DCP plate" and " Upper limb 1/3 tubular bone plate" and so on. However, the author found in some medical institutions that in the children's fracture surgery, the application range of the steel plate is not reviewed, and the phenomenon of using the steel plate to change the position of the steel plate is extremely common. It is mainly used in the operation of the femoral shaft fracture in children. The upper limb tibia LC-DCP plate is used. , lower extremity tibia LC-DCP plate, upper limb ulna and ulna LC-DCP plate, etc., humeral fracture surgery using "tibia LC-DCP plate, ulna (tibia) LC-DCP plate, upper limb 1/3 tube-shaped bone Plate, etc., the operation of the humeral shaft fracture is performed using the "upper limb ulna and ulna LC-DCP bone plate".
Inappropriate product selection The anatomical and physiological characteristics of the child's bones determine that the use of the implantable device must be based on the principle of not damaging the epiphysis, and can not affect the rehabilitation of the fracture and the growth and development of the bone. However, in the actual treatment, the incident of child disability caused by the improper use of the implanted device sometimes occurs. The simple adult shrinkage often increases the damage of the fracture of the child, magnifies the treatment, and causes lifelong regret for the child. . For example, the use of cannulated nails, intramedullary nails, interlocking intramedullary nails and other intramedullary internal fixation through the bone end, severely damaged the epiphysis of the bone end, affecting bone growth, the growth and development of the bone end of the joint site, resulting in articular surface Unevenness, malformation, and even the dislocation of the left and right legs (arms) cause extremely serious adverse consequences for children's growth and physical and mental health.
Incomplete use records Establish a complete usage record file and manage it together with medical records, return visit records, etc., to enable effective quality tracking and traceability of the use of implantable devices for children. However, the current use tracking records of implantable devices in medical institutions are not uniform and irregular. Most of the information on the patient's age is not recorded. The information such as implantable device names, specifications and models are inaccurate, not rigorous, and are separated from the medical records. Daily supervision and future quality tracking tracebacks cause inconvenience.
Discussion on supervision countermeasures
Strengthen training and assessment, and strictly review the quality audit procedures of the links. The medical institutions are mainly medical quality management personnel and orthopedic clinicians. Implantable devices involve many disciplines, and the products and specifications are classified. However, medical institutions currently lack medical equipment or biomedical engineering professionals. The quality management personnel are mostly pharmacy, medicine or nursing, and the grassroots units do not even have such Professional. Clinicians generally pay attention to treatment, and they do not know enough about the use of implantable devices for children. They have not paid enough attention to the safety and effectiveness of their use. Therefore, the armed personnel must strengthen the related professional knowledge and legal knowledge of pediatric anatomy and physiology, pediatric orthopedics, implantable devices, etc., and establish the quality and risk awareness of the use of implantable devices for children's orthopedics. Training and assessment. Clinicians should fully consider the anatomy and physiology and growth and development characteristics of children's bones for selective application, and should not be blindly simplified and adultized. Quality management personnel should give full play to the quality management function and strictly conduct quality audits on children's orthopedic implantable devices according to their duties. The hospital should establish and improve the use and management system for children's high-risk implantable devices (including implantable devices brought by external experts), and strictly enforce them, strengthen pre-existing supervision and prevention, and make the quality of instruments used in a safe and controllable state. .
Establishing children's orthopedic implantable device use records The anatomical and physiological characteristics of children's fractures determine that the use records of children's orthopedic implantable devices should be different from those of adults. It is recommended that medical institutions use uniform, standardized and separate establishment of children's orthopedic implantable devices. Record the file. While real, comprehensive and accurate recording of general information on the use of implantable devices, it is necessary to increase the patient's age, clinical diagnosis, application reasons, safety risk assessment, discharge rehabilitation, etc., and manage them together with medical records and return visit records. This can not only better quality audit of children's orthopedic implantable devices, but also facilitate quality traceability management and use effect evaluation.
Establishing a registration management system for orthopedic implantable devices for children At present, the registration of domestic orthopaedic implantable devices is almost inconsistent with the application of a single child in the specification model and scope of application, resulting in confusion in the use of implantable instruments for children. Shrinking, improper use of parts, and even misuse, pose serious risks to the health of fractured children. The performance indicators of orthopedic implantable instruments mainly include material, model, type, number of holes, thickness, width, length, angle, etc. According to the anatomical and physiological characteristics of children's bones, they are analyzed from biology, biomechanics and materials. Orthopedic implantable devices should also be different from adults. Therefore, in order to ensure the safety and effectiveness of children with fractures, it is necessary to implement separate registration of children's orthopaedic implantable devices or to clarify the application of children in the scope of application.
Strengthening the supervision of the use of implantable devices for children At present, the regulations on the management of the use of medical devices issued by various provinces (cities) have clearly defined that medical institutions should track the use of medical devices implanted in the human body and establish a record of use records; The medical device that the employer asks for the doctor's own medical device should be inspected according to the general medical device purchase regulations; the user must not use the medical device that does not meet the quality standard or exceeds the applicable scope. The violation of the above provisions clearly clarifies the legal responsibility that must be borne, making the use of implantable devices more law-abiding. The author believes that strengthening the use of children's implantable devices should be the most important. For the use of implantable devices for children, the regulatory authorities must not only review the legality of the products themselves, but also strengthen the supervision and management of the medical devices in the medical institutions to ensure that the children's machinery is safe and effective.
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Commonly used implantable instruments for children with fractures
1. Kirschner wire: used to fix short fractures or avulsion fractures and other stress-fixed fractures, and is often used in the fixation of temporary fractures in orthopedic surgery. It is often used for internal fixation in the treatment of children with supracondylar fractures of the humerus, femoral neck (neck) fractures, and double forearm fractures. It is simple, economical, and reliable, and has little damage to the epiphysis.
2. Plate screw internal fixation: It is an effective method for treating bone fractures in children, especially for complex fractures, which is irreplaceable by other internal fixation methods. Although the wide range of exposure during the internal fixation of the plate screw, the tissue around the fracture end is damaged, it is necessary to re-surgery to take the plate and the skin remains scarred, but it does not damage the epiphysis, can reduce the fracture anatomy, fix the exact, and have relatively few complications. It has the advantages of good curative effect and is suitable for the fixation of various types of fractures, which is safe and effective compared with the overall treatment of children.
3. Screws: It is fixed by 3~4 screws, the bone and surrounding tissues are less damaged, the fractures are tightly combined, and the short-term gypsum external fixation is used to obtain early fracture healing and rapid recovery of limb function. effect. At present, the absorbable screw has great advantages in the use of suitable fractures. It not only avoids the re-injury of the second operation, but also has the advantages of small rejection reaction, and is a very good internal fixation method.
4. Intramedullary needles: Intramedullary nails have obvious advantages in the treatment of upper and middle fractures of the femur and multi-segmental fractures. It has the advantages of small damage, strong anti-angling ability, and easy nail removal after fracture healing. However, it has poor anti-rotation ability and is not suitable for the middle and lower femoral fractures. It is often used for internal fixation for the treatment of children's femoral shaft (middle and upper segment) fractures and double forearm fractures. Intramedullary needle fixation can damage the femoral neck isthmus sacral plate, leading to abnormal structure of the proximal femur in children's growth period, so it is necessary to be cautious when choosing. Elastic intramedullary nails can avoid some shortcomings, and it is a minimally invasive surgery for the treatment of long bone fractures in children. It has the characteristics of small trauma, simple operation, satisfactory fracture reduction, effective fixation, less complications, no involvement of osteophytes, and short hospital stay. The scar is small and the appearance is beautiful.
5. Plum blossom needle: Plum blossom needle internal fixation is simple, less interference to periosteum and soft tissue, and good postoperative fracture stability, but this surgery may damage the intramedullary branch of the femoral neck isthmus and femoral nourishment artery, resulting in femur near the growth period. The end structure is abnormal. Indications for plum-needle internal fixation are limited to stable fractures in the upper and middle third of the femur of children over 5 years of age.
6. Elastic intramedullary nail: It is an internationally advanced minimally invasive technique for the treatment of long bone fractures in children. Because it does not expose the fracture end, does not peel the periosteum, does not destroy the blood supply at the fracture end, and the fracture is well aligned. The BO principle of fracture treatment, and the fracture healing time is short, and it has sufficient stability for early activities. At the same time, the children have a short hospital stay and can return to school early, avoiding the educational and psychological barriers caused by long-term separation from school and social life, meeting the requirements of personalized and humanized treatment, and achieving good clinical treatment and society. effect. (China Medical News)
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