This study aimed to describe adverse effects or reactions by medical devices. There may be unexpected effects caused by medical devices that can often be harmful to the patient. This is defined as a medical device adverse event or adverse effect (MDAE). We should prevent the recurrence of MDAEs by reporting them to regulatory authorities and device manufacturers. This reporting requires that manufacturers check the manufacturing process and update the medical device. However, it is difficult for both patients and medical persons to recognize and report MDAEs because adverse effects can be ambiguous to them in many cases. In addition, many medical persons lack an understanding of the role of this reporting. In Korea, the Ministry of Health and Welfare enacted laws and regulations for MDAE reporting in 2005. However, the number of MDAEs reported was still very small. The Ministry of Food and Drug Safety started the Medical Device Safety Monitoring Center project in 2011, with the purpose of promoting MDAE reporting. Since the Medical Device Safety Monitoring Center project began, the number of reported MDAEs rapidly increased from 137 in 2010 to 6,078 in 2017. Medical persons and device manufacturers should be encouraged to voluntarily report MDAEs and provide useful information. Korea is an important member of the International Medical Device Regulators Forum and leader of the Asia-Pacific Economic Cooperation Regulatory Committee. There should be medical device vigilance with global cooperation.
Equipment and Supplies ; Equipment Safety ; Humans ; Jurisprudence ; Korea ; Mandatory Reporting ; Recurrence ; Safety Management ; Social Control, Formal

INTRODUCTION: There is an increasing trend of physical child abuse cases reported in Singapore. Children presenting to the Emergency Department with injuries require a high index of suspicion for clinicians to distinguish those that are abusive in nature. MATERIALS AND METHODS: A retrospective study of children with diagnosis of NAI presenting to KK Women's and Children's Hospital (KKH) from June 2011 to May 2016 was conducted. RESULTS: There were 1917 cases reported from 1730 subjects, of  which: 8.8% of subjects had repeat visits; 55.2% of cases were male; and mean age was 7.69 years. Racial demographics were: Chinese 45.5%, Malay 33.4%, Indian 15.4% and Others 5.9%. The most frequent injuries sustained were head and neck (50.8%), limbs (32.2%), and chest (5.7%). Of the type of injuries, 55% had contusions, 21% had cane marks, 16% had lacerations, 4.4% had burn marks and 1% sustained fractures. Males were more likely to be caned ( <0.001); 54.9% of cases were admitted and 38.9% were discharged. Cases that presented without a parent ( <0.001), were known to Child Protective Service ( <0.001), or had a history of  parental substance abuse ( = 0.038), mental illness in caregiver ( = 0.021), or domestic violence ( <0.001) were more likely to require admission. CONCLUSION Analysing these factors provide a better understanding of  the presentation of  NAI cases, including 'red flags' and vulnerable groups who should have better protection.
Age Factors ; Child ; Child Abuse ; prevention & control ; statistics & numerical data ; Child, Preschool ; Cohort Studies ; Emergency Service, Hospital ; statistics & numerical data ; Ethnic Groups ; statistics & numerical data ; Female ; Hospitalization ; statistics & numerical data ; Humans ; Injury Severity Score ; Male ; Mandatory Reporting ; Needs Assessment ; Physical Abuse ; prevention & control ; statistics & numerical data ; Prevalence ; Retrospective Studies ; Risk Assessment ; Sex Factors ; Singapore ; Vulnerable Populations ; statistics & numerical data ; Wounds and Injuries ; diagnosis ; epidemiology

This paper reviewed structure and current status of laws related to patient safety using patient safety law matrix to promote systematic approach in legal system of patient safety. Laws related to patient safety can be divided into three areas: laws for preventing; laws for knowing about; and laws for responding. In the case of Korea, gaps are especially prominent in the areas of laws for knowing about and responding. Patient safety law which will be enacted in July 2016 will fill the gap in the area of laws for knowing about. This law will be comprehensive law, covering the full spectrum of laws related to patient safety. However, after reviewing current patient safety law in Korea, the following drawbacks were identified: absence of code for grasping the current patient safety level; absence of code for mandatory reporting in patient safety reporting system; and absence of code for privilege about patient safety work product. Furthermore we need wider discussions about covering issues of open disclosure, apology law, coroners system, and complaint management system in patient safety law.
Coroners and Medical Examiners ; Disclosure ; Hand Strength ; Humans ; Jurisprudence ; Korea* ; Mandatory Reporting ; Patient Safety* ; Risk Management

Passive surveillance (PS) is a traditional approach to communicable disease surveillance. To complement the approach, several countries have adopted active surveillance (AS) systems that involve the voluntary participation of physicians. This study compares AS versus PS systems in Korea based on the systems' reporting propensity of chickenpox. A mail questionnaire survey was conducted with a random sample of physicians involved in the PS system (N=1,955) and all sentinel physicians of the AS system (N=193). Multiple regression analysis was conducted to identify factors associated with reporting propensity. The reporting propensity of physicians in the AS system was significantly higher than that in the PS surveillance system, 2.7 versus 1.9 on a 5-point Likert scale (p<0.05). Multiple regression analysis showed that, in addition to the type of the surveillance system, physician knowledge of chickenpox as a notifiable disease and the type of institution with which a physician was affiliated were significant factors for a physician's reporting propensity. For both systems, the common barriers for reporting were 'lack of confidence in diagnosis,' 'burden from interference by the public health department following reporting,' and 'complexity of the reporting system.' In conclusion, AS of communicable diseases appeared to have a significantly better performance compared to PS in Korea in the case of chickenpox reporting. These findings would be useful for countries concerned with developing more effective strategies for improving the reporting rate of notifiable diseases.
Chickenpox ; Communicable Diseases ; Complement System Proteins ; Korea ; Mandatory Reporting ; Postal Service ; Public Health ; Surveys and Questionnaires ; Republic of Korea* ; Sentinel Surveillance

Attitude to Health ; Civil Defense ; ethics ; Communicable Disease Control ; Communication ; Ethics, Medical ; Freedom ; Health Personnel ; ethics ; Health Planning ; ethics ; Health Priorities ; ethics ; Humans ; Influenza A Virus, H1N1 Subtype ; isolation & purification ; Influenza, Human ; epidemiology ; Mandatory Programs ; ethics ; Moral Obligations ; Pandemics ; ethics ; Patient Rights ; ethics ; Primary Health Care ; ethics ; Public Health ; ethics ; Public Health Administration ; ethics ; Resource Allocation ; ethics ; Singapore ; Trust

BACKGROUND: Tissues for transplantation can save lives or restore essential functions. According to national policies and regulations, access to suitable transplantation, as well as the level of safety, quality, efficacy of donation, and transplantation of tissues, differ significantly between countries. We reviewed a few guidelines on tissue banking from the aspect of screening tests. In addition, four-year experience with screening panels for donated bones and donors at a tertiary hospital is introduced. METHODS: Seven national and international guidelines for screening tests for donors and donated tissues were reviewed. At our institution, screening tests for donation involve two steps. At retrieval, the first screening panel, including ABO/Rh typing, unexpected antibody screening, VDRL, HBsAg, anti-HBs, anti-HBc IgM, anti-HCV, anti-HIV, and microbiological cultures was performed. The second screening panel, including the same tests, except culture studies, was performed after 90 days. From 2008 to 2011, a total of 245 retrievals of bone tissue were performed and the screening panel results were analyzed. RESULTS: Mandatory screening serologic tests for living donors can differ according to local law or regulation and/or screening for endemic diseases. At our institution, among 245 donated bones for a period of four years, 61 bone tissues were discarded due to noncompliance for the second screening (n=32), contamination or no culture study results (n=9), abnormal serologic test results (n=8), and so on. CONCLUSION: Donor screening policies for tissue banking are various according to national laws or endemic disease status. Second screening tests with consideration of the window period should be adopted.
Adoption ; Bone and Bones ; Donor Selection ; Endemic Diseases ; Hepatitis B Surface Antigens ; Humans ; Immunoglobulin M ; Jurisprudence ; Living Donors ; Mandatory Testing ; Mass Screening ; Serologic Tests ; Social Control, Formal ; Tertiary Care Centers ; Tissue Banks ; Tissue Donors ; Transplants

PURPOSE: This study aimed to describe Korean nurses' willingness to report suspected elder abuse and examine its related factors. METHODS: A descriptive correlational design was used. A convenience sample of 365 nurses from a hospital completed our questionnaires. Stepwise logistic regression analysis was performed to examine predictors of willingness to report. RESULTS: Sixty-eight nurses (18.6%) were not willing to report suspected elder abuse. In the stepwise logistic regression analysis, fewer years in clinical work, a higher level of knowledge on elder abuse law, and the perception of more severe abuse were found to be significant predictors of willingness to report elder abuse. CONCLUSION: As the Welfare of the Aged Act included a clause on mandated reporters, nurses' role in intervening in elder abuse cases has become more critical. In order to increase nurses' reporting, education on elder abuse should be provided to all nurses, and support programs should be designed for nurses to effectively involve them in reporting elder abuse.
Aged ; Elder Abuse ; Humans ; Jurisprudence ; Logistic Models ; Mandatory Reporting ; Surveys and Questionnaires

OBJECTIVES: Quarantine measure for prevention of epidemic disease and further evaluations of their efficiency are possible only by elaborating analyses of imported cases. The purpose of this study was to analyze descriptive epidemiological characteristics of pandemic influenza A (H1N1) cases imported to Korea. METHODS: We collected two sets of data. The first set, comprised daily reported cases of H1N1 obtained from local cities in accordance with government policy about mandatory reporting of all H1N1 cases during May 1 to August 19, 2009. The second set, including 372 confirmed imported H1N1 cases, identified from 13 National Quarantine Stations in the Korea Centers for Disease Control and Prevention from May 24 to December 31, 2009. However, given the lack of information on the nature of the imported H1N1 cases from the two data sets during the over lapping period from May 24 to August 19, we express the number of imported cases as a range for this period. RESULTS: We estimated that the number of imported H1N1 cases from May 1 to August 19, 2009, was between 1,098 and 1,291 and the total number of cases was 2,409 to 2,580. We found the number of imported cases was beginning to diminish as of August. A analysis of the second data set showed that the distribution of sex was similar (males 50.7%, females 49.3%) and the age distribution from 20 to 59 was 61.5% and that of 60 and over was 0.8% of the 372 cases. We identified 25 countries where people infected with H1N1 traveled and 67.5% were in Asia. But the proportion of cases (/1,000) by region shows Oceania (0.199), South America (0.118), Southeast Asia (0.071), North America (0.049), Europe (0.035), and Northeast Asia (0.016) in that order. The order of H1N1 peaking was the Southern Hemisphere, Tropics, and the Nothern Hemisphere. CONCLUSIONS: This study provided information that could make possible the evaluation of the government quarantine measure for stopping imported disease from causing community-acquired spread in the future.
Age Distribution ; Asia ; Asia, Southeastern ; Centers for Disease Control and Prevention (U.S.) ; Europe ; Female ; Hospitals, Isolation ; Humans ; Influenza, Human ; Korea ; Mandatory Reporting ; North America ; Oceania ; Pandemics ; Quarantine ; South America

Adolescent ; Communicable Disease Control ; legislation & jurisprudence ; Female ; Humans ; Immunization Programs ; Male ; Mandatory Programs ; Papillomaviridae ; immunology ; Papillomavirus Vaccines ; therapeutic use ; Patient Compliance ; Risk ; United States ; Vaccination ; legislation & jurisprudence ; trends

The Guthrie bacterial inhibition assay (BIA) tests for elevated phenylalanine (PHE) by measuring B. subtilis growth zone density in an agar medium. Dried blood spots with elevated PHE on initial BIA screening undergo repeat BIA testing and thin-layer chromatography (TLC). Specimens with elevated PHE by TLC or BIA on second-tier testing require recall. To streamline PKU screening and reduce the recall rate, we tested a modified BIA protocol incorporating autoclaving of dried blood spots. Autoclaving improves growth zone appearance and has been previously reported to reduce the number of specimen requiring repeat testing. From June to October 2006, dried blood spot samples with initially elevated PHE were autoclaved at 110°C for 5 min, then retested by BIA. Samples with still-elevated PHE were analyzed by TLC. 1078 of 37,268 samples (2.89%) had initially elevated PHE. After autoclaving, 1036 no longer exhibited elevated PHE decreasing to 42 (0.11%) the number requiring TLC. By comparison, the unmodified algorithm resulted in 3.14% of samples received from July - December 2006 requiring both repeat BIA and TLC testing. We have since modified our PKU screening algorithm to require repeat BIA testing from autoclaved samples prior to TLC analysis. This translates to a significant reduction in time and resources for second-tier testing and follow-up, and prevents stress for the parents of a newborn who would have been recalled unnecessarily.