Effects and Satisfaction of Medical Device Safety Information Reporting System Using Electronic Medical Record / 대한의료정보학회지

OBJECTIVES: This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. METHODS: Medical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods. RESULTS: Sixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude, potential benefits, and positive benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction, but relatively low for time-consuming and decision-making. CONCLUSIONS: We were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management.

The Prevalence of Osteoporosis or Degenerative Osteoarthritis of Knee in Female Patients with Lumbar Spinal Stenosis Over 50 Years

OBJECTIVE: To evaluate the prevalence of osteoporosis and degenerative knee osteoarthritis (OA) in female patients over 50 years, who were surgically indicated for lumbar spinal stenosis (LSS). METHODS: The study subjects were 76 female patients who underwent spinal surgery for LSS between January and December 2006. Radiographs of thoracolumbar spine, hip and knee were taken. Osteoporotic profiles including lumbar and hip bone mineral density (BMD) measurements and proper treatment of osteoporosis were investigated. RESULTS: The mean age was 65.1 (50~86) years old. Seven-teen patients (22.4%) and nine-teen patients (25.0%) had spine and hip BMD below a T score of -2.5. Thirty-two patients (48.0%) and four patients (5.2%) had knee and hip OA of K-L grade III and IV each. Old thoracolumbar osteoporotic compression fractures were confirmed in 6 patients (7.8%). Forty-eight percent (48.0%) of enrolled patients had hypovitaminosis D. According to osteoporosis guidelines from the Korean Society of Bone Metabolism, 31 patients (40.7%) qualified to be candidates of intensive osteoporosis treatments. CONCLUSION: The prevalence of osteoporosis and knee OA in LSS patients was 25.0% and 42.1%. Based on checking up BMD and knee OA in female patient with LSS, proper treatments of osteoporosis and degenerative knee OA should be considered.

Ubiquitous-Severance Hospital Project: Implementation and Results / 대한의료정보학회지

OBJECTIVES: The purpose of this study was to review an implementation of u-Severance information system with focus on electronic hospital records (EHR) and to suggest future improvements. METHODS: Clinical Data Repository (CDR) of u-Severance involved implementing electronic medical records (EMR) as the basis of EHR and the management of individual health records. EHR were implemented with service enhancements extending to the clinical decision support system (CDSS) and expanding the knowledge base for research with a repository for clinical data and medical care information. RESULTS: The EMR system of Yonsei University Health Systems (YUHS) consists of HP integrity superdome servers using MS SQL as a database management system and MS Windows as its operating system. CONCLUSIONS: YUHS is a high-performing medical institution with regards to efficient management and customer satisfaction; however, after 5 years of implementation of u-Severance system, several limitations with regards to expandability and security have been identified.

20-Year-Follow up of Treatment Using Spine Osteotomy and Halo-pelvic Traction for Tuberculous Kyphosis: A Case Report

A 23-year-old male whose medical history included tuberculous spondylitis presented with a kyphotic deformity and incomplete paraplegia of twenty days duration. Preoperative radiographs demonstrated a T12-L4 kyphotic Cobb's angle of 100degrees with a complete block showing on the lumbar myelogram at L4-5. The patient underwent anterior osteotomy and release. After the operation, a halo-pelvic apparatus was fit onto the patient, and distraction was begun. After distraction for 2 months, posterior osteotomy and release was performed for final correction, and distraction was maintained for another three weeks. Finally, the kyphotic deformity was corrected to a Cobb's angle of 62degrees from T12 to L4. Supplementary anterior fusion was done, and the apparatus was removed after consolidation of the fusion mass.

Efficacy and Safety of the Electrospun Nanofibrous Adhesion Barrier for Laparoscopic Surgery in a Rabbit Model

PURPOSE: Most recently developed anti-adhesive membranes are not suitable for laparoscopic surgery due to weak mechanical properties or adhesive characteristics. To overcome these problems, we prepared electrospun bioabsorbable nanofibrous poly (lactic-co-glycolic acid)-based membranes as an adhesion barrier. We evaluated the efficacy and safety of this material for laparoscopic surgery in a rabbit model. METHODS: A standardized laparoscopic surgical trauma was made on the rabbit's uterine horn and adjacent abdominal wall to induce adhesion formation. The injured uterus was covered by a nanofibrous barrier or it was left untreated (the negative control group) (each group: n=14). To evaluate acute toxicity of this material, blood sampling was made 3 and 7 days after laparoscopic surgery to check liver and renal function. Three weeks after laparoscopy, a second look laparoscopy was performed and the adhesions were scored according to Blauer's scoring system. Tissue between abdominal wall and uterus was obtained to examine microscopically. Liver, kidney and uterus were harvested to examine chronic toxicity. RESULTS: 36.4% of the nanofiber treatment group and 70% of the untreated control group showed severe adhesions (grade>3) after laparoscopic surgery but failed to get a statistical significance (P=0.198). Acute and chronic toxicity induced by this material were not noted in the blood and tissue exam. CONCLUSION: This study showed that nanofiber barrier seems to be a novel resorbable biomaterial for the reduction of postoperative adhesions. Easy placement and handling of this material make these membranes potentially successful candidates for laparoscopic surgery. But further study is needed to get a statistical significance.

The Efficacy and Safety of HA/CMC Anti-adhesion Barrier Solution with Varying Viscosities

PURPOSE: Guardix-sol(TM) is solution type of anti-adhesion barrier, and it is composed of a mixture of hyaluronate (HA) and carboxymethylcellulose (CMC). The anti-adhesive effect was proved through several clinical trials with using this material, but the most efficient viscosity for this solution has not been shown by the previous research. The objective of this study was to evaluate the efficacy and safety of HA/CMC mixture solutions, with varying viscosities, in a rat model. METHODS: Three different viscosities (low=LV, mid=MV and high=HV) of the HA/CMC mixture solutions were prepared to evaluate their potential as a tissue adhesion barrier. The viscosity was measured by a Brookfield viscometer. To evaluate the anti-adhesion effect, a cecal-abdominal wall abrasion model was adopted. The denuded cecum was coated by a HA/CMC mixture of different viscosity or it was left uncoated (the negative control group) and then the denuded cecum was apposed to the abdominal wall (each group: n=10). All the rats underwent a second celiotomy after 14 days to evaluate the extent of their abdominal adhesions and tissue reactions (inflammatory response, granulation tissue formation and toxicity in organs). RESULTS: The viscosities of the HA/CMC mixture solutions were 248.+/-24.4 cps in the LV, 1,353.8+/-4.4 cps in the MV and 3,556.7+/-38.8 cps in the HV. The grade of adhesion and the adhesion area were significantly lower in the all HA/CMC mixture solution groups compared to the control regardless of their viscosity. The inflammatory responses were not remarkable at the application site and the major solid organs did not show histological change in the experimental groups. CONCLUSION: The difference of viscosity of HA/CMC mixture solutions did not affect the efficacy of the adhesion barrier. All the HA/CMC mixture solutions with varying viscosities showed a low inflammatory response and non-toxicity.

The Efficacy and Safety of HA/CMC Anti-adhesion Barrier Solution with Varying Viscosities

PURPOSE: Guardix-sol(TM) is solution type of anti-adhesion barrier, and it is composed of a mixture of hyaluronate (HA) and carboxymethylcellulose (CMC). The anti-adhesive effect was proved through several clinical trials with using this material, but the most efficient viscosity for this solution has not been shown by the previous research. The objective of this study was to evaluate the efficacy and safety of HA/CMC mixture solutions, with varying viscosities, in a rat model. METHODS: Three different viscosities (low=LV, mid=MV and high=HV) of the HA/CMC mixture solutions were prepared to evaluate their potential as a tissue adhesion barrier. The viscosity was measured by a Brookfield viscometer. To evaluate the anti-adhesion effect, a cecal-abdominal wall abrasion model was adopted. The denuded cecum was coated by a HA/CMC mixture of different viscosity or it was left uncoated (the negative control group) and then the denuded cecum was apposed to the abdominal wall (each group: n=10). All the rats underwent a second celiotomy after 14 days to evaluate the extent of their abdominal adhesions and tissue reactions (inflammatory response, granulation tissue formation and toxicity in organs). RESULTS: The viscosities of the HA/CMC mixture solutions were 248.+/-24.4 cps in the LV, 1,353.8+/-4.4 cps in the MV and 3,556.7+/-38.8 cps in the HV. The grade of adhesion and the adhesion area were significantly lower in the all HA/CMC mixture solution groups compared to the control regardless of their viscosity. The inflammatory responses were not remarkable at the application site and the major solid organs did not show histological change in the experimental groups. CONCLUSION: The difference of viscosity of HA/CMC mixture solutions did not affect the efficacy of the adhesion barrier. All the HA/CMC mixture solutions with varying viscosities showed a low inflammatory response and non-toxicity.

Radiographic Morphometry of Lumbar Intervertebral Disc Space in Normal Korean / 대한척추외과학회지

STUDY DESIGN: Radiographic measurement of the lumbar disc height OBJECTIVES: To measure the lumbar disc height on the radiographs in normal Koreans. SUMMARY OF LITERATURE REVIEW: Many reports show good results after many procedures, such as inter-vertebral body fusion using a cage or total disc replacement, which restores the adequate disc height. However, there are no references regarding the range of normal lumbar disc heights in Korean adults, which can be used as a standard for the implant size. MATERIALS AND METHODS: One hundred and thirty two subjects (age range 20 to 40 years), who had no previous history of low back pain and no significant findings on the physical examination, were enrolled in this study. The plain lateral lumbar spine radiograph was taken in the supine position. The intervertebral disc heights were measured at the anterior, middle and posterior portion of each lumbar disc. The average magnification rate was 115%, and the disc heights were corrected by the magnification rate in each segment. RESULTS: The lumbar disc height showed a cranio-caudal pattern in both the male and female groups. The L4-5 disc heights were highest at the anterior, middle and posterior portion in males. The L4-5 disc heights were highest at the middle and posterior portion in females. The L5-S1 disc height was highest at the anterior portion in females, but there was no significant difference between the L4-5 and L5-S1 disc height at the anterior portion. There was no significant difference in disc height between males and females except at the anterior portion of the L1-2 and L2-3 disc. There was no significant decrease in disc height in overweight people at all measured site in males and females except at the posterior portion of the L1-2 disc in males. CONCLUSION: This study is meaningful in that it provides a reference value for the lumbar disc height in Korean adults. The measured values might also be useful for manufacturing a Korean model of an artificial lumbar disc prosthesis or surgical instruments for lumbar interbody fusion.

Usefulness of Screening Ultrasound for Thyroid Gland

PURPOSE: The purpose of this study was to investigate the usefulness of the ultrasonography as a screening test for thyroid diseases. MATERIALS AND METHODS: For 7 months, thyroid ultrasonography (7.5 MHz linear array) was performed prospectively by radiologists on 1,316 subjects who do not have a history of the thyroid disease. We analyzed the morphological abnormalities of thyroid gland and these were classified as the nodulal, cystic and diffuse types in accordance with the gender and ages of the patients. We performed ultrasound-guided fine needle aspiration in 21 patients who had sonographic features that were suggestive of malignant thyroid nodules. Physical examination was performed for all subjects by clinicians before the thyroid ultrasonography, and we compared the detectability of thyroid lesions between ultrasonography and physical examination. RESULTS: Thyroidal abnormalities were detected in 94 (7.1%) of 1,316 subjects. Among the 94 patients, 72 (5.5%) showed as nodules, 18 (1.4%) showed as cysts and 4 (0.3%) showed as diffuse abnormalities. The result of the ultrasound-guided aspiration on 21 patient showed 4 malignant nodules, 16 benign nodules and 1 undetermined nodule. Physical examination detected abnormalities in only 12 patients (12.8%) of the 94 patients, which were showed as nodules, cysts and the diffuse type by ultrasonography. CONCLUSION: Thyroid disease of the general population was relatively common and the detection rate with performing physical examination for the thyroid nodule, cyst and the diffuse type was lower than that for ultrasonography. Thyroid ultrasonography is a useful screening modality for detecting thyroid diseases.

Designing Electronic Medical Record using Health Level 7 Development Framework / 대한의료정보학회지

OBJECTIVE: This is designing the part of Electronic Medical Record using HL7 Development Framework and Reference Information Model to realize the building medical standard data model for sharing medical record between heterogeneous hospital systems. METHODS: The process used development of HL7 specifications consists of the following seven activities: 1.Project initiation. 2.Requirements Documentation. 3.Specification Modeling. 4.Specification Documentation. 5.Specification Approval. 6. Specification Publication. 7.Implementation Profiling. Each activity is briefly described in the subsections that follow and described in detailed in the methodology chapters that follow this introduction.3. Result. The steps, after 4 step, needs to standardized the results. So we didn't followed that steps1). RESULTS: We got the diagrams at each steps of the HDF methodology: 1.A dynamic description. 2.A static description of the concepts involved in the business process. 3.A Use Case model which identifies the system involved in the actual HL7 data/information exchange1). CONCLUSION: It was confirmed that HL7 RIM could take in the domestic demands of medical records, and concrete methodology was applied in practice. It can be a good reference for the hospitals constructing new information system and for the enterprises developing medical information systems to apply the HL7 version 3 to their works.