Review of regulatory management on standards and specifications for veterinary medical devices in Korea

Well-established standards and specifications for medical devices not only provide clarity and consistency in licensing processes but also secure device safety and effectiveness. This study reviewed regulatory standards and specifications for veterinary medical devices in Korea based on data obtained through analyses of those medical devices. General standards for electromechanical, electromagnetic, and biological safety and individual standards for 76 electric and 70 general medical device products have been established by the Korean Ministry of Food and Drug Safety. However, the first standards and specifications for veterinary medical devices were established in March 2000 for two products (disposable needle and syringe). Similar to the large number of standards for medical devices, there have been general standards for safety and individual standards for 72 veterinary medical devices (27 electric medical devices, 12 non-electric medical devices, 10 medical supplies, and 23 other types) established since 2014. These new standards considered, among other aspects, the devices' applications, usage characteristics, and industrial environment. To date, the establishment of standards and specifications for veterinary medical devices remains limited. This study suggests that improvements should be made to the regulation of general and individual standards associated with various veterinary medical instruments, supplies, and in vitro diagnostic medical reagents.

Work-Related Musculoskeletal Disorders among Spine Surgeons / 대한정형외과학회잡지

PURPOSE: To investigate the prevalence and risk factors of musculoskeletal disorder (MSD) among spine surgeons. MATERIALS AND METHODS: A modified version of discomfort survey was sent via e-mail to surgeons that belong to the Korean Society of Spine Surgery. The survey questionnaires were composed of demographics, factors relating to spine surgery, and MSD. We investigated the common sites of occurrence of MSD and its risk factors. RESULTS: The survey was sent to a total of 420 subjects; of which, 80 subjects (19.0%) responded. About 78.8% of the respondents had MSD for the past year. The common sites of occurrence included the neck (52.5%), back (46.3%), and shoulder (18.8%). The prevalence of pain in the elbow joint/forearm was higher in the group performing a higher frequency of spine surgeries (p=0.033). Moreover, the prevalence of pain in the wrist/hand (p=0.008) and in the back (p=0.042) was higher in those with greater frequency of major surgeries (>10 case/year) as compared with those with lower frequency of major surgeries. CONCLUSION: As shown, about 78.8% of spine surgeons experienced MSD for the past one year. Its prevalence was higher as compared with the general population. Thus, more attention should be paid to the prevention of MSD among spine surgeons.

Can Alarming Improve Compliance with Weekly Bisphosphonate in Patients with Osteoporosis?

BACKGROUND: Although bisphosphonate is effective for the prevention and treatment of osteoporosis, poor medication compliance is a key-limiting factor. We determined whether alarm clock could improve compliance with weekly bisphosphonate in patients with osteoporosis, by comparing with age- and gender-matched control group. METHODS: Fifty patients with osteoporosis were recruited and participated in alarm clock group. Patients were asked to take orally weekly risedronate for 1 year, and received alarm clock to inform the time of taking oral bisphosphonate weekly. Using the propensity score matching with age and gender, 50 patients were identified from patients with osteoporosis medication. We compared the compliance with bisphosphonate using medication possession ratio (MPR) between two groups. RESULTS: Although there was no significant difference of baseline characteristics between both groups, the mean MPR (0.80±0.33) of alarm clock group was higher than that (0.56±0.34) of control group (P<0.001). CONCLUSIONS: Alarming could improve the compliance with weekly oral bisphosphonate in patients with osteoporosis.

Revision Arthroplasty Using a MUTARS® Prosthesis in Comminuted Periprosthetic Fracture of the Distal Femur

Periprosthetic fractures after total knee arthroplasty (TKA) are gradually increasing, reflecting extended lifespan, osteoporosis, and the increasing proportion of the elderly during the past decade. Supracondylar periprosthetic femoral fracture is a potential complication after TKA. Generally, open reduction and internal fixation are the conventional option for periprosthetic fracture after TKA. However, the presence of severe comminution with component loosening can cause failure of internal fixation. Although the current concept for periprosthetic fracture is open reduction and internal fixation, we introduce an unusual case of revision arthroplasty using a MUTARS® prosthesis for a comminuted periprosthetic fracture in the distal femur after TKA, with technical tips.

Revision Arthroplasty Using a MUTARS® Prosthesis in Comminuted Periprosthetic Fracture of the Distal Femur

Periprosthetic fractures after total knee arthroplasty (TKA) are gradually increasing, reflecting extended lifespan, osteoporosis, and the increasing proportion of the elderly during the past decade. Supracondylar periprosthetic femoral fracture is a potential complication after TKA. Generally, open reduction and internal fixation are the conventional option for periprosthetic fracture after TKA. However, the presence of severe comminution with component loosening can cause failure of internal fixation. Although the current concept for periprosthetic fracture is open reduction and internal fixation, we introduce an unusual case of revision arthroplasty using a MUTARS® prosthesis for a comminuted periprosthetic fracture in the distal femur after TKA, with technical tips.

Performance assessment and improvement plan of the regulatory management system of veterinary medical devices in Korea / 대한수의학회지

In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.

Radiation safety management for diagnostic radiation generators and employees in animal hospitals in Korea / 대한수의학회지

A nationwide survey on radiation safety management in Korean animal hospitals was conducted. By 2013, 53 radiation generators were registered as veterinary medical devices (41 X-ray generators and 12 computed tomography scanners). Additionally there were six approved laboratories for radiation equipment and protection facility, and five approved laboratories for radiation exposure of employees, respectively. By March 2013, 2,030 out of 3,829 animal hospitals operated radiation-generating devices. Among these devices, 389 (19.2%) out of 2,030 were not labeled with the model name and 746 (36.7%) were not labeled with production dates. Thus, most veterinary X-ray generators were outdated (42.6%) and needed replacements. When periodic inspections of 2,018 animal hospitals were performed after revision of the Veterinarians Act in 2011, the hospitals were found to be equipped with appropriate radiation generators and protection facilities. Among 2,545 employees exposed to radiation at the hospitals, 93.9% were veterinarians, 4.3% were animal nurse technicians, and 18% held other positions. Among 169 employees supervised by administrators, none of those had a weekly maximum operating load that exceeded 10 mA.min. This study suggests that the radiation safety management system of animal hospitals was general good.

Radiation safety management for diagnostic radiation generators and employees in animal hospitals in Korea / 대한수의학회지

A nationwide survey on radiation safety management in Korean animal hospitals was conducted. By 2013, 53 radiation generators were registered as veterinary medical devices (41 X-ray generators and 12 computed tomography scanners). Additionally there were six approved laboratories for radiation equipment and protection facility, and five approved laboratories for radiation exposure of employees, respectively. By March 2013, 2,030 out of 3,829 animal hospitals operated radiation-generating devices. Among these devices, 389 (19.2%) out of 2,030 were not labeled with the model name and 746 (36.7%) were not labeled with production dates. Thus, most veterinary X-ray generators were outdated (42.6%) and needed replacements. When periodic inspections of 2,018 animal hospitals were performed after revision of the Veterinarians Act in 2011, the hospitals were found to be equipped with appropriate radiation generators and protection facilities. Among 2,545 employees exposed to radiation at the hospitals, 93.9% were veterinarians, 4.3% were animal nurse technicians, and 18% held other positions. Among 169 employees supervised by administrators, none of those had a weekly maximum operating load that exceeded 10 mA.min. This study suggests that the radiation safety management system of animal hospitals was general good.

The Effect of Early Percutaneous Vertebroplasty in Occult Osteoporotic Vertebral Fracture

OBJECTIVE: Recently, the definition of occult osteoporotic vertebral fracture has been established, and its clinical significance has come to our interest. We report the effect of early percutaneous vertebroplasty in occult osteoporotic vertebral fracture. METHODS: From January 2006 to January 2008, we performed percutaneous vertebroplasty for 50 levels in 47 patients. 21 levels (21 patients) of them were classified into occult osteoporotic vertebral fracture group, 29 levels (26 patients) were categorized into control group (not occult osteoporotic vertebral fracture) by the Pham T..s criteria. We obtained VAS score and measured the compression ratio at first hospital day and 1 day, 1 month, 3 months after procedure. RESULTS: There are noticeable improvements in VAS score. The mean VAS score at admission was 6.44 in occult group and 6.15 in control group, which changed 2.23 in occult group and 2.68 in control group after procedure. The compression rate was 1.008, 1.018, 1.016 in occult group and 0.862, 0.891, 0.881 in control group at admission and 1 month, 3 months after procedure. The conservative effect for vertebral height was higher than control group (p=0.011). CONCLUSION: Percutaneous vertebroplasty in occult osteoporotic compression fracture provided significant pain relief and conservative effect for vertebral height. It is probable that it can lower the rate of secondary adjacent vertebral compression fracture.

Is Metabolic Syndrome One of the Risk Factors for Gallbladder Polyps Found by Ultrasonography during Health Screening?

BACKGROUND/AIMS: We conducted this study to identify the risk factors for finding gallbladder polyps (GBP) in Korean subjects during health screening, and to determine the nature of the association between the presence of metabolic syndrome (MS) and the development of GBP. METHODS: A total of 1,523 subjects were enrolled, comprising 264 with GBP (81 women and 183 men) and 1,259 controls (696 women and 563 men with normal GB). Body mass index (BMI), waist circumference (WC), blood pressure (BP), insulin, fasting blood sugar (FBS), lipids, liver enzymes, hepatitis B antigens (HBs Ag), and hepatitis C antibodies (HCV Ab) were measured. MS was considered to be present when three or more of the NCEP-ATPIII (National Cholesterol Education Program-Adult Treatment Panel III) criteria were satisfied. Insulin resistance was calculated by homeostasis model assessment of insulin resistance (HOMA-IR). Independent risk factors were analyzed by logistic regression analysis. RESULTS: Univariate analysis revealed that the risk factors for GBP were age, sex, WC, smoking history, BP, BMI, FBS, serum lipids, HOMA-IR score, and MS. Multivariate logistic regression analysis revealed that the risk factors for GBP were presence of MS (Odds Ratio (OR)=2.35, 95%Confidence Interval (CI)=1.53-3.60), being male (OR=2.34, 95%CI=1.72-3.18), HOMA-IR score>2.5 (OR=1.64, 95%CI=1.19-2.26), and higher WC (OR=1.4, 95%CI=1.05-1.88). MS was present in 20.8% and 5.9% of GBP patients and controls, respectively, and was the highest risk factor for GBP. CONCLUSIONS: MS, male, insulin resistance, and abdominal obesity are probably risk factors for GBP, with MS appearing to be strongly associated with GBP in Koreans.

Seroprevalence of Helicobacter pylori in health check-up subjects / 대한내과학회지

BACKGROUND: H. pylori-associated gastrointestinal diseases have been widely recognized. The aim of this study was to investigate the seropositivity of H. pylori in health check-up subjects and to find out the relating factors. METHODS: From November 2004 through June 2005, total 7,676 health check-up subjects (age > or =20) responded to the self administered questionnaires. The prevalence of H. pylori was assessed by measuring anti-H. pylori IgG antibodies. RESULTS: The overall seropositivity was 56.7% in 7,676 and 1,137 (14.8%) has been found to have history of H. pylori eradication therapy. The seropositivity rate of H. pylori was 61.3% (2,653) in 4,328 subjects without history of H. pylori eradication and current gastrointestinal symptoms. Seroprevalence of H. pylori was significantly lower in 20~29 years old, female, high income and subjects from Seoul respectively. CONCLUSIONS: The seropositivity of H. pylori in 2004~2005 is found to be 61.3% in subjects without history of H. pylori eradication and current gastrointestinal symptoms. This seems to be lower than 66.9%, the seroprevalence rate in asymptomatic Korean population in the age of > or =16 years in 1998. This decrease might be caused by improvement of socioeconomic status.

The role of endoscopy, 24 hour ambulatory esophageal pH monitor and bernstein test for gastroesophageal reflux disease and its relationship with symptom / 대한내과학회지

BACKGROUND: The aim of this study is to evaluate the diagnostic usefulness of endoscopy, 24 hour esophageal pH monitor and Bernstein test for GERD and its relationship with GERD symptom in the presence or absence of reflux esophagitis (RE). METHODS: This study was performed for 168 patients with GERD. Clinical symptoms and the results of endoscopy, 24 hour esophageal pH monitor, esophageal manometry with Bernstein test were analyzed. RESULTS: 168 (42%) of 403 patients who complained symptoms suggestive of GERD were diagnosed as GERD (65% as RE, 35% as nonerosive reflux disease) using diagnostic tools for GERD. The most chief complaint symptoms were heartburn (18.5%), regurgitation (18.5%), noncardiac chest pain (10.7%), cough (10.7%), laryngeal symptoms (11.3%), non specific dyspepsia (24.4%) and others (6%). When comparison of symptoms depending on RE among GERD patients was performed, laryngeal symptoms were significantly more frequent in patients without RE (p=0.001), and dyspepsia in patients with RE (p<0.001), respectively. Regarding diagnostic efficacy of each test depending on symptom, patients with heartburn showed higher positive rate of Bernstein test (p=0.035) and patients with laryngeal symptoms showed higher positive rate of 24 hour esophageal pH monitor (p=0.015), respectively. In addition, there was no correlation among endoscopy, 24 hour esophageal pH monitor and Bernstein test in the diagnosis of GERD by Kappa index. CONCLUSIONS: Typical reflux symptoms of GERD such as heartburn and regurgitation were found in 37% of GERD patients in Korea, lower than in Western countries. The lack of correlation among the diagnostic tools for GERD suggests that these tools are complementary to each other for the diagnosis of GERD.

A Case of Adenocarcinoma in Ileocecal Valve Mimicking Inflammatory Bowel Disease / 대한소화기내시경학회지

Adenocarcinoma of the ileocecal valve is rare. It's clinical manifestations are non-specific such as intestinal intussusception, obstruction and right lower abdominal discomfort according to type of cancer. Particularly infiltrative type carcinoma of the ileocecal valve may be easily misdiagnosed as inflammatory bowel disease by radiological imagings and clinical symptoms. We experienced one case of adenocarcinoma of the ileocecal valve mimiking inflammatory bowel disease in radiological features. Colonoscopic findings also could not differentiate malignancy with chronic inflammatory condition. We report a case of adenocarcinoma of the ileocecal valve, which endoscopic findings mimic chronic inflammatory disease, with a review of literature.

Sonographic evaluation of new bone formation at the distraction site in ilizarov limb lengthening procedure / 대한정형외과학회잡지

No abstract available.

Anterior Interbody Fusion Using Kaneda Device in Unstable Thoracolumbar Spinal Lesions

Recently anterior spinal device in the treatment of the unstable thoraco-lumbar spine has been used. We have experienced 11 patients of the unstable thoraco-lumbar spine, which were composed of 8 patients with burst fracture and 3 patients with tuberculous spondylitis. The 11 patients with neurological deficit were treated with an one stage anterior operation consisting of anterior decompression through vertebrectomy, realignment with Kanedae device. No patient showed neurologic deterioration after surgery. The anterior spinal instrumentation with Kaneda device afford enough stability to enable early ambulation with good alignment and solid fusion.

Radiological evaluation of tuberculous spondylitis with computed tomography

Spinal tuberculosis is curable disease, and early diagnosis is mandatory for early treatment. We reviewedconventional radiographies and CT from Histopathologically confirmed 30 cases of spinal tuberculosis, and comparedthese findings with radiologic findings from 2 cases of pyogenic spondylitis and 4 cases of meastasis. The resultswere as follows: 1. The frequnet site of involvement were thoracolumbar juntion and low lumbar vertebrae, and themost frequent type is multisegmented subligamentous type (93.3%). 2. CT was not of great use in the diferentaldiagnosis of the tuberculosis. Dominant CT findings of tuberculous spondylitis were anterior vertebral bodydestruction, paravertebral soft-tissue mass and thick walled abscess formation occasionally containingcalcification and disc space narrowing, in the setting of an indolent or relatively benign course. 3. CT is thebest modality for imaging the extent and anatomy of the destructive process, the degree of canal encroachment, andthe change of adjacent vital structure. So CT was particularily useful in pre-operative planing of debridement andstabilization surgery. 4. The most common causes of neurologic manifestations in tuberculous spondylitis were thecompression of spinal cord by sequestrated bony fragments and disc material, granulation tissue or abscess in thespinal canal.