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A Study on Development of Guideline on Writing Technical Document for Electrical Medical Devices: Dental X-ray Equipment (치과용엑스선장치의 기술문서 작성을 위한 가이드라인 개발 연구)

  • Lee, Seung-Youl;Kim, Jae-Ryang;Lee, Jun-Ho;Park, Chang-Won
    • Journal of radiological science and technology
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    • v.39 no.4
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    • pp.651-660
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    • 2016
  • Due to recent population aging, the number of check-up for senior citizens has increased steadily. According to this trend, the market size of dental X-ray equipment and the number of approval and review for these devices have simultaneously increased. The technical document of medical device is required for approval and review for medical device, and medical device companies needs to have work comprehension and expertise, as the document needs to include the overall contents such as performances, test criteria, etc.. Yet, since most of domestic manufacturers or importers of medical devices are small businesses, it is difficult for them to recruit professional manpower for approval of medical devices, and submission of inaccurate technical documents has increased. These problems lead to delay of the approval process and to difficulties in quick entering into the market. Especially, the Ministry of Food and Drug safety (MFDS) standards of a dental extra-oral X-ray equipment, a dental intra-oral X-ray equipment, an arm-type computed tomography, and a portable X-ray system have been recently enacted or not. this guideline of dental X-ray equipment adjusting revised standards was developed to help relative companies and reviewers. For this study, first, the methods to write technical document have been reviewed with revised international and domestic regulations and system. Second, the domestic and foreign market status of each item has been surveyed and analyzed. Third, the contents of technical documents already approved by MFDS have been analyzed to select the correct example, test items, criteria, and methods. Finally, the guideline has been developed based on international and domestic regulation, through close review of a consultative body composed of academic, industrial, research institute and government experts.

The Analysis of Predictive Factors for the Identification of Patients Who Could Benefit from Respiratory-Gated Radiotherapy in Non-Small Cell Lung Cancer (비소세포성 폐암에서 호흡동기방사선치료 적용 환자군의 선택을 위한 예측인자들의 분석)

  • Jang, Seong-Soon;Park, Ji-Chan
    • Radiation Oncology Journal
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    • v.27 no.4
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    • pp.228-239
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    • 2009
  • Purpose: 4DCT scans performed for radiotherapy were retrospectively analyzed to assess the possible benefits of respiratory gating in non-small cell lung cancer (NSCLC) and established the predictive factors for identifying patients who could benefit from this approach. Materials and Methods: Three treatment planning was performed for 15 patients with stage I~III NSCLC using different planning target volumes (PTVs) as follows: 1) PTVroutine, derived from the addition of conventional uniform margins to gross tumor volume (GTV) of a single bin, 2) PTVall phases (patient-specific PTV), derived from the composite GTV of all 6 bins of the 4DCT, and 3) PTVgating, derived from the composite GTV of 3 consecutive bins at end-exhalation. Results: The reductions in PTV were 43.2% and 9.5%, respectively, for the PTVall phases vs. PTVroutine and PTVgating vs. PTVall phases. Compared to PTVroutine, the use of PTVall phases and PTVgating reduced the mean lung dose (MLD) by 18.1% and 21.6%, and $V_{20}$ by 18.2% and 22.0%, respectively. Significant correlations were seen between certain predictive factors selected from the tumor mobility and volume analysis, such as the 3D mobility vector, the reduction in 3D mobility and PTV with gating, and the ratio of GTV overlap between 2 extreme bins and additional reductions in both MLD and $V_{20}$ with gating. Conclusion: The additional benefits with gating compared to the use of patient-specific PTV were modest; however, there were distinct correlations and differences according to the predictive factors. Therefore, these predictive factors might be useful for identifying patients who could benefit from respiratory-gated radiotherapy.

Influence of Delayed Gastric Emptying in Radiotherapy after a Subtotal Gastrectomy (위부분절제술 후 방사선치료에서 음식물 배출지연에 따른 영향)

  • Kim, Dong-Hyun;Kim, Won-Taek;Lee, Mi-Ran;Ki, Yong-Gan;Nam, Ji-Ho;Park, Dal;Jeon, Ho-Sang;Jeon, Kye-Rok;Kim, Dong-Won
    • Radiation Oncology Journal
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    • v.27 no.4
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    • pp.194-200
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    • 2009
  • Purpose: This aim of this study was to evaluate changes in gastric volume and organ position as a result of delayed gastric emptying after a subtotal gastrectomy performed as part of the treatment of stomach cancer. Materials and Methods: The medical records of 32 patients who underwent concurrent chemoradiotherapy after a subtotal gastrectomy from March 2005 to December 2008 were reviewed. Of these, 5 patients that had more than 50 cc of residual gastric food detected at computed tomography (CT) simulation, were retrospectively enrolled in this study. Gastric volume and organ location was measured from CT images obtained before radiotherapy, twice weekly. In addition, authors evaluated the change of radiation dose distribution to planning the target volume and normal organ in a constant radiation therapy plan regardless of gastric volume variation. Results: A variation in the gastric volume was observed during the radiotherapy period (64.2~340.8 cc; mean, 188.2 cc). According to the change in gastric volume, the location of the left kidney was shifted up to 0.7 - 2.2 cm (mean, 1.2 cm) in the z-axis. Under-dose to planning target volume (V43, 79.5${\pm}$10.4%) and over-dose to left kidney (V20, 34.1${\pm}$12.1%; Mean dose, 23.5${\pm}$8.3 Gy) was expected, given that gastric volume change due to delayed gastric emptying wasn't taken into account. Conclusion: This study has shown that a great change in gastric volume and left kidney location may occur during the radiation therapy period following a subtotal gastrectomy, as a result of delayed gastric emptying. Detection of patients who experienced delayed gastric emptying and the application of gastric volume variation to radiation therapy planning will be very important.

Clinical Features of Infectious Ileocecitis in Children (소아 감염성 회장맹장염의 임상적 고찰)

  • Lee, Tae-Ho;Hong, Yoo-Rha;Yeon, Gyu-Min;Lee, Jun-Woo;Park, Jae-Hong
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.13 no.1
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    • pp.30-35
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    • 2010
  • Purpose: Infectious ileocecitis is an infection confined to the ileocecal area and one of the most common causes of pediatric abdominal pain. This study was performed to demonstrate the clinical features of infectious ileocecitis in children. Methods: The medical records and radiologic findings of 37 patients with ileocecitis diagnosed by ultrasonography and/or computed tomography, who were admitted to Pusan National University Hospital from January 2004 and July 2008, were reviewed retrospectively. Viral gastroenteritis and secondary ileocecitis were excluded. Results: The mean age of the patients was 4.8${\pm}$3.4 years. One-half of the patients were preschool children. The chief complaint was abdominal pain (75.7%), diarrhea (10.8%), and vomiting (8.1%). Accompanying symptoms were fever (56.8%), vomiting (21.6%), and diarrhea (16.2%). The mean duration of abdominal pain, fever, diarrhea, and vomiting was 3.8${\pm}$2.1, 3.0${\pm}$1.9, 3.4${\pm}$1.9, and 2.4${\pm}$2.3 days, respectively. The frequency of diarrhea and vomiting was 5.8${\pm}$2.2 and 4.0${\pm}$2.8 per day, respectively. Diagnosis was made by abdominal ultrasonography in 22 patients (59.5%), abdominal CT in 2 patients (5.4%), and both modalities in 13 patients (35.1%). Besides the radiologic finding of thickening of the bowel wall, mesenteric lymphadenitis (59.5%), ascites (5.4%), and both mesenteric lymphadenitis and ascites (16.2%) were revealed. The mean duration of illness was 7.5${\pm}$5.0 days. There were no specific laboratory findings, and culture studies with stool or blood were negative. All of the patients recovered completely without specific treatment. Conclusion: Infectious ileocecitis has acute appendicitis-mimicking symptoms, but is self-limited within a few days, thus unnecessary treatment and work-up is avoided. However, distinguishing infectious ileocecitis from appendicitis, inflammatory bowel disease, and mesenteric lymphadenitis is important.

Effect of Acupuncture on Regional Cerebral Blood Flow at Acupoints GV 20, GV. 26, LI. 4, ST. 36, SP. 6 Evaluated by Tc-99m ECD Brain SPECT (Tc-99m ECD 뇌혈류 SPECT를 이용한 백회, 인중, 합곡, 족삼리, 삼음교에서 체침의 뇌혈류에 대한 효과)

  • Song, Ho-Chun;Bom, Hee-Seung;Kang, Hwa-Jeong;Ahn, Soo-Gi;Kim, Seong-Min;Jeong, Hwan-Jeong;Kim, Ji-Yeul
    • The Korean Journal of Nuclear Medicine
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    • v.34 no.6
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    • pp.456-464
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    • 2000
  • Purpose: To evaluate the effect of acupuncture on regional cerebral blood flow (rCBF) at acupoints suggested by oriental medicine to be related to the treatment of cerebrovascular diseases. Materials and Methods: Rest/acupuncture-stimulation Tc-99m ECD brain SPECT using a same-dose subtraction method was performed on 54 normal volunteers (34 males, 20 females, age range from 18 to 62 years) using six paradigms: acupuncture at acupoints GV. 20, GV. 26, LI. 4, ST. 36 and SP. 6. In the control study, needle location was chosen on a non-meridian focus 1 cm posterior to the right fibular head. All images were spatially normalized, and the differences between rest and acupuncture stimulation were statistically analyzed using SPM$^{(R)}$ for Windows$^{(R)}$. Results: Acupuncture applied at acupoint GV. 20 increased rCBF in both the anterior frontal lobes, the right frontotemporal lobes, and the left anterior temporal lobe and the left cerebellar hemisphere. Acupuncture at GV 26 increased rCBF in the left prefrontal cortex. Acupuncture at LI. 4 increased rCBF in the left prefrontal and both the inferior frontal lobes, and the left anterior temporal lobe and the left cerebellar hemisphere. Acupuncture at ST. 36 increased rCBF in the left anterior temporal lobe, the right inferior frontal lobes, and the left cerebellum. Acupuncture at SP. 6 increased rCBF in the left inferior frontal and anterior temporal lobes. In the control stimulation, no significant rCBF increase was observed. Conclusion: The results demonstrated a correlation between stimulation at each acupoint with increase in rCBF to the corresponding brain areas.

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Tc-99m ECD Brain SPECT in Patients with Traumatic Brain Injury: Evaluating Distribution of Hypoperfusion and Assesment of Cognitive and Behavioral Impairment in Relation to Thalamic Hypoperfusion (뇌외상 환자의 Tc-99m ECD 뇌 SPECT에서 뇌 혈류감소의 분포 및 시상의 혈류감소에 대한 인지 및 행동장애 평가)

  • Park, Soon-Ah;Lim, Seok-Tae;Sohn, Myung-Hee
    • The Korean Journal of Nuclear Medicine
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    • v.34 no.6
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    • pp.445-455
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    • 2000
  • Purpose: We evaluated the distribution of hypoperfusion in patients with traumatic brain injury (TBI) and the relationship of thalamic hypoperfusion to severity of cognitive and behavioral sequelae. Materials and Methods: Tc-99m ECD SPECT and MRI were performed in 103 patients (M/F=81/22, mean age $34.7{\pm}15.4$ yrs) from 0.5 to 55 months (mean 10.3 months) after TBI. The patients were divided into three groups showing no abnormalities (G1), focal (G2) and diffuse injury (G3) on MRI. Psychometric tests assessed 11 cognitive or behavioral items. In all patients, we evaluated the distribution of hypoperfused areas in SPECT, and in 57/103 patients, neuropsychological (NP) abnormalities in patients with thalamic hypoperfusion were compared with those of patients without thalamic hypoperfusion. Results: The perfusion deficits were most frequently located in the frontal lobe (G1, 42.3%: G2 34.5%: G3 33.3%), temporal lobe ($24{\sim}26%$) thalami ($21{\sim}22.4%$), parietal and occipital lobe (${\leq}10%$). Numbers of NP abnormalities in the cases of cortical hypoperfusion with or without concomitant thalamic hypoperfusion were following: the former $4.7{\pm}1.5$ and the latter $3.2{\pm}1.4\;in\;G1,\;5.0{\pm}1.1\;and\;4.8{\pm}1.2\;in\;G2,\;6.8{\pm}1.8\;and\;6.3{\pm}1.1\;in\;G3$, respectively. This difference according to thalamic hypoperfusion was significant in G1 (p=0.002), but was not significant in G2 or G3. Conclusion: SPECT in patients with TBI had demonstrated hypoperfusion mostly involving the frontal, temporal and thalami. In normal group on MRI, frontal hypoperfusion was more prominent than that of any other group, Furthermore in this group, SPECT could predict severity of NP outcome by concomitant thalamic hypoperfusion with cerebral cortical abnormalities.

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Dopamine Transporter Density Assessed with $[^{123}I]IPT$ SPECT Before and After Risperidone Treatment in Children with Tourette's Disorder (뚜렛 장애 아동에서 Risperidone 치료 전후 $[^{123}I]IPT$ SPECT로 측정한 기저 신경절 도파민 운반체 밀도)

  • Kim, Tae-Hoon;Ryu, Won-Gee;Park, Se-Young;Chi, Dae-Yoon;Choi, Tae-Hyun;Lee, Kyung-Yul;Cheon, Keun-Ah;Yun, Mi-Jin;Kim, Jai-Keun;Lee, Jong-Doo;Ryu, Young-Hoon
    • The Korean Journal of Nuclear Medicine
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    • v.38 no.1
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    • pp.41-51
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    • 2004
  • PURPOSE: Tourette's disorder (TD), which is characterized by multiple waxing and waning motor tics and one or more vocal tics, is known to be associated with abnormalities in the dopaminergic system. To testify our hypothesis that risperidone would improve tic symptoms of TD patients through the change of the dopaminergic system, we measured the dopamine transporter (DAT) densities between drug-naive children with TD and normal children, and investigated the DAT density before and after treatment with risperidone in drug-naive children with TD, using iodine-123 labelled $N-(3-iodopropen-2-yl)-2{\beta}-carbomethoxy-3beta-(4-chlorophenyl)tropane$ ($[^{123}I]IPT$) single photon omission computed tomography (SPECT). MATERIALS and METHODS: $[^{123}I]IPT$ SPECT Imaging and Yale Global Tic Severity Scale-Korean version (YGTSS-K) for assessing the tic symptom severity were carried out before and after treatment with risperidone for 8 weeks in nine drug-naive children with TD. Eleven normal children also underwent SPECT imaging 2 hours after an intravenous administration of $[^{123}I]IPT$. RESULTS: Drug-naive children with TD had a significantly greater increase in the specific/nonspecific DAT binding ratio of both basal ganglia compared with the normal children. However, no significant difference in the specific/nonspecific DAT binding ratio of the basal ganglia before and after treatment with risperidone in children with TD was found, although tic symptoms were significantly improved with risperidone. CONCLUSION: These findings suggest that DAT densities are directly associated with the pathophysiology of TD, however, that the effect of risperidone on tic symptoms in children with TD is not attributed to the change of dopaminergic system.

Usefulness of $^{99m}Tc$-labeled RBC Scan and SPECT in the Diagnosis of Head and Neck Hemangiomas (두경부 혈관종 진단시 $^{99m}Tc$-RBC Scan and SPECT 검사의 유용성)

  • Oh, Shin-Hyun;Roh, Dong-Wook;Ahn, Sha-Ron;Park, Hoon-Hee;Lee, Seung-Jae;Kang, Chun-Goo;Kim, Jae-Sam;Lee, Chang-Ho
    • The Korean Journal of Nuclear Medicine Technology
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    • v.12 no.1
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    • pp.39-43
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    • 2008
  • Purpose: There are various methods to diagnose hemangioma, such as ultrasonography (US), computed tomography (CT), magnetic resonance imaging (MRI) and nuclear medicine. However, by development of SPECT imaging, the blood-pool scan using $^{99m}Tc$-labeled red blood cell has been used, because it was non-invasive and the most economical method. Therefore, in this study, we proposed that the usefulness of $^{99m}Tc$-RBC scan and SPECT of the head and neck to diagnose unlocated hemangiomas. Materials and Methods: $^{99m}Tc$-RBC scan and SPECT was performed on 6 patients with doubtful hemangioma (4 person, head; 1 person, neck; 1 person, another). We labeled radiopharmaceutical using modified in vivo method and then, centrifuged it to remove plasma. After a bolus injection of tracer, dynamic perfusion flow images were acquired. Then, anterior, posterior, both lateral static blood-pool images were obtained as early and 4 hours delayed. SPECT was progressed 64 projections per 30 seconds. Each image was interpreted by physicians, Nuclear medicine specialist, and technologist blinded to patient's data. Results: In 5 patients of all the radioactivity of doubtful site didn't change in flow images, but, in blood-pool, delayed and SPECT images, it was increased. So, it was a typical hemangioma finding. The size of lesion was over 2 cm, and it could discriminate as comparing to the delayed and SPECT imaging. On the other hand, in 1 patient, the radioactivity was increased in blood-pool images, but, not in delayed and SPECT images, so, it was proved no hemangioma. Conclusion: Using $^{99m}Tc$-RBC Scan and SPECT, we could diagnose the hemangiomas in head and neck, as well as, liver, more non-invasive, economical, and easy. Therefore, it considered that $^{99m}Tc$-RBC scan and SPECT would offer more useful information for diagnosis of hemangioma, rather than otherimaging such as US, CT, MRI.

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The Assessment of Scattered Ray According to the Beam Thickness of Z-axis in MDCT(Multi Detector Computed Tomography) (MDCT(다배열검출기 전산화단층촬영장치)에서 Z-축의 빔 두께에 따른 산란선의 평가)

  • Ryu, Gwi-Bok;Kim, Hyun-Soo;Lyu, Kwang-Yeul;Dong, Kyung-Rae;Kweon, Dae-Cheol
    • Journal of radiological science and technology
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    • v.33 no.2
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    • pp.127-132
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    • 2010
  • The purpose of this study is to measure scattered ray which is occurred except for Z-axis range of the detector in MDCT's iso-center and present the basic data about the standard for reduction of scattered ray. The development of MDCT brings out the enlargement of beam thickness to the patient's Z-axis, which distributes to the increase in exposure dose according to the rise of scattered ray. Also MDCT brings out the increase of scattered ray about 4times more than SDCT. To evaluate scattered ray according to the change of beam thickness on MDCT, we measured scattered ray of MDCT's Z-axis beam thickness by using one 16-slice CTs and two 64-slice CTs. We used the ionization chamber 60ml 2026C as the equipment of measurement. In our results, we found out that the change of scattered ray according to the beam thickness in the same kVp has increase of scattered ray. Secondly we found out the increase of scattered ray according to the increase of kVp. Lastly we found out the decrease of scattered ray according to the increase of the distance from the ionization chamber.

Analysis of Bacterial Contamination on Surface of General Radiography Equipment and CT Equipment in Emergency Room of Radiology (영상의학과 응급실내의 일반촬영장비와 전산화단층촬영장비 표면에서의 세균 오염에 관한 분석)

  • Hong, Dong-Hee;Kim, Hyeong-Gyun
    • Journal of radiological science and technology
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    • v.39 no.3
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    • pp.421-427
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    • 2016
  • We aim to offer basic materials about infection management through conducting bacterial contamination test about general radiography equipment and CT equipment installed in ER of three general hospitals with 100 sickbeds or more located in Gyeongsangbuk-do Province, and suggest management plan. It had been conducted from 1st December 2015 to 31st December, and objects were general radiography equipment and CT equipment of emergency room located in Gyeongsangbuk-do Province. For general radiography equipment, sources were collected from 4 places such as upper side of control box which employees use most, upper side of exposure button, whole upper side of table which is touching part of patient's skin, upper side of stand bucky's grid, and where patients put their jaws on. For CT equipment, sources were collected from 3 places such as upper side of control box which radiography room employees use most, X-ray exposure button, whole upper side of table which is touching part of patient's skin, and gantry inner. Surface contamination strain found at general radiography equipment in emergency room of radiology are Providencia stuartii(25%), Stenotrophomonas maltophilia(18%), Enterobacter cloacae(8%), Pseudomonas species(8%), Staphylococcus epidermidis(8%), Gram negative bacilli(8%), and ungrown bacteria at incubator after 48 hours of incubation (67%) which is the biggest. Most bacteria were found at upper side of stand bucky-grid and stand bucky of radiology's general radiography equipment, and most sources of CT equipment were focused at patient table, which means it is contaminated by patients who have various diseases, and patients who have strains with decreased immunity may get severe diseases. Thus infection prevention should be made through 70% alcohol disinfection at both before test and after test.