OBJECTIVE: To further improve the regulation of medical device Introduction for Use (IFU) and improve the quality of medical device Introduction for Use (IFU). METHODS: Summarize domestic regulatory experience and deficiencies through literature research, and introduce the international experience gathered from the IMDRF coordination document Principles of Labelling for Medical Devices and IVD Medical Devices. RESULTS: The IMDRF international coordination document categorizes ten chapters to define and summarize the basic principles that medical device instructions and labels should contain. CONCLUSIONS According to the current status of medical device specification supervision and drawing on international supervision experience, improvement suggestions are proposed in terms of refining the IFU requires to improve the quality of the instructions, e.g. dynamic adjustment of IFU management requirements, strengthen the management of IFU for home used medical devices, and improving the standardization and rationality of medical device IFU content. We should continue to maintain effective management of medical device IFU.
Product Labeling

This study examined the awareness, understanding, attitudes, and purchase intention regarding food labeling on bakery products in the context of health consciousness. The purpose of the study was to provide basic data for bakery product labeling, which has been insufficient to date, and to develop measures to expand the labeling system. The results of the study showed that higher subjective understanding and better attitude towards bakery food labeling can positively increase the purchase intention. We believe that the bakery industry needs to promote food labeling proactively, while also developing products addressing health concerns. This study is also valuable to academia because it provides insights into the relationship between the consumer's understanding of and attitudes towards nutritional information and purchase intention. In addition, it is beneficial to the bakery industry because it establishes marketing strategies that increase the purchase intent among both consumers with high health consciousness and those who infrequently purchase baked goods.
Consciousness* ; Food Labeling* ; Intention* ; Marketing ; Product Labeling

Filler injection is an extremely popular cosmetic procedure in Korea, but surprisingly few dermatologists are aware of the package inserts in filler products. In the era of legal dispute, it is important that we fully understand the indications, contraindications, and side effects of the individual filler products. The purpose of this paper is to provide a general overview of the contents of package inserts of filler products that are commercially available in Korea, especially in terms of the contraindications of filler injection. The authors emphasize that greater improvement in the Korean package inserts of filler products can be expected. Currently, practicing physicians are usually blamed for filler complications. We also found many significant translational errors. We hope that dermatologists take more interest in filler package inserts by reading this overview.
Dissent and Disputes ; Hope ; Korea* ; Product Labeling*

Investigated and analyzed the graphical symbols commonly used in medical equipment, their benefits and drawbacks. From the perspective of human factors engineering, some root causes of poor pictogram as well as their relations with medical equipment adverse events were addressed. Furthermore, how to deal with the problems with current pictogram aiming at reducing use error was also discussed.
Equipment Design ; Equipment and Supplies ; Product Labeling

Unique Device Identification (UDI) is a hot spot research area in the medical device administration. It comes a breakthrough from International Medical Device Regulators Forum (IMDRF) and government implementation recently. The article reviewed the advancement of IMDRF UDI program, discussed the framework for UDI system, analyzed the implementation of UDI in other countries, put forward some suggestions on the development of medical device coding system in our country.
Equipment and Supplies ; standards ; Product Labeling ; standards

PURPOSE: We evaluated a rapid preparation procedures for the labeling and quality control of 99mTc-ECD, MAG3, and MIBI using microwave heating and Sep-Pak cartridges. MATERIALS AND METHODS: 99mTc labeling of ECD, MAG3, and MIBI kit preparation was performed according to the package inserts with microwave heating modification. Heating time was 10-15 sec, and heating was performed with 3 mm plastic bottle with screw cap to prevent radiation contamination. Labeling efficiency was obtained with C18 or Alumina N Sep-Pak cartridges. RESULTS: The radiochemical purity of 93~96% for 99mTc-ECD and 95~99% for 99mTc-MIBI was obtained using Alumina N Sep-Pak cartridge. The optimum irradiation time of microwave method for 3 ml 99mTc-labeled radiopharmaceutical solution was 10 sec for 99mTc-ECD and 99mTc-MIBI, and 15 sec for 99mTc-MAG3. The RESULTS of quality control data with Sep-Pak cartridges were well correlated with TLC method. The total preparation time of these radiopharmcaeuticals was 5~6 min including quality control procedure. CONCLUSION: This study demonstrates that radiopharmaceuticals preparation by microwave heating and quality control by Sep-Pak cartridges can be efficiently utilized as an alternative to the recommended method by manufacturer's manual.
Aluminum Oxide ; Heating* ; Hot Temperature* ; Microwaves* ; Plastics ; Product Labeling ; Quality Control* ; Radiopharmaceuticals ; Technetium Tc 99m Mertiatide

BACKGROUND: Since November 2012, some of over-the-counter (OTC) medications have been sold in convenience store without pharmacist' s supervision. We purposed to examine if the product labels of OTCs provide sufficient information that is appropriate for consumers who may have low health literacy. METHODS: We compared the difficulty of words that are utilized in pharmaceutical product labels of interest (intervention) with those in the 6th grade textbook (control). Pharmaceutical products of interest were comprised of 13 OTCs which have been sold currently in convenience stores. We grouped words into the 4 levels of difficulty based on the Korean Vocabulary Classification for Education, and statistically tested words frequency in each level between OTCs and control. RESULTS: The 13 OTC labels included lay language (easier or equal to language used in primary school) about 10% less; professional language about 10% more (p < 0.001 in all). Labels for analgesics had the longest and most difficult information, followed by common cold preparations, muscle pain relievers as plaster or cataplasma and digestives. CONCLUSION: The 13 OTC labels might fail to provide appropriate information for safety use by consumers in terms of the difficulty level of words. The improvement of labels of OTC medications and consumer education strategies are called for safety use of OTC medications sold in convenience stores.
Analgesics ; Classification ; Common Cold ; Comprehension* ; Education ; Health Literacy ; Myalgia ; Organization and Administration ; Pharmaceutical Preparations ; Product Labeling* ; Vocabulary

OBJECTIVETo provide references for the evolvement of medical devices labeling and manual administration in China,

METHODSBy content analysis, 10 juristic documents relevant to device labeling and manual were collected from FDA website, compared to which, the federal regulation was mainly analyzed.

RESULTSThere are five main differences of device labeling regulation between U.S.A. and China: juristic system, administrative scope, administrative target, characteristics and practice,

CONCLUSIONSA set of comprehensive juristic system for device labeling has been established by FDA. from which China should draw experience, to administrate the prescription devices and the over-the-counter devices in classification, and set up device labeling guidance, thus guarantee the safety and efficacy of device.

The use of psychotropic medications in lactating women is controversial. Despite widely accepted advantages of human milk, patients and professionals hesitate to use medications during breastfeeding. Package inserts written by manufacturers routinely discourage breastfeeding to prevent law suits. Here we conducted a review to help professionals to decide medication for lactating women on an evidence-based risk-benefit analysis. First, we reviewed lactational pharmacology. The relative infant dose (RID) was defined to give an objective measure for infant exposure to medication, and drugs with RID lesser than 10% were considered quite safe. Subsequently, we reviewed each category of psychotropic medications which were commonly used in mental illness. We provided information for each drug such as Dr. Hale's lactation risk category, RID, half-life, and time to peak plasma level as references for the risk analysis. There was no contraindicated psychotropic medication during breastfeeding, but for lithium, close monitoring of infant serum levels is warranted. In conclusion, most of medications used to treat mental illness in lactating women were usually safe. Nevertheless, medication use in lactating women should always be considered on an individualized risk-benefit analysis, and untoward adverse effects on the infant should be monitored.
Breast Feeding ; Drug Combinations ; Female ; Half-Life ; Humans ; Infant ; Jurisprudence ; Lactation ; Lithium ; Milk, Human ; Piperonyl Butoxide ; Plasma ; Product Labeling ; Pyrethrins

BACKGROUND: The appropriate usage of antibiotics needs informations such as its effectiveness for a given infection, administration route, the amount of effective dose, and the dose intervals. In this study, in order to find any significant discrepancy regarding to the details of explanation of the necessary information for appropriate antibiotic usages, we compares informations about 51 antibiotics, one from package inserts in Korea and the other from physician's desk reference (PDR) certified by FDA in the United States of America. MATERIALS AND METHODS: Package inserts about antibiotics, only oral or parenteral agent, were perused to collect three categories of data: the recommended dosage, dose interval, and adjustment of dose to indications or the severity of infection. These data available in Korea were compared with 61 antibiotics (32 oral and 29 parenteral agents) cited in PDR. RESULTS: Package inserts for 51 antibiotics were gathered, because the remaining 10 antibiotics in PDR are not domestically commercialized. Among data on antibiotics comparable with those in PDR, 59% (30 cases:15 oral and 15 parenteral agents) suggested the dose similar to that of PDR, 37% (19 cases:8 oral and 11 parenteral agents) recommend less dose, and 4% in only 2 oral agents showed more dose. About half of the drugs recommending lower dosage were imported from Japanese pharmaceutical company, and the recommended doses of these antimicrobial agents were similar to those in Japan. About 59% (30 cases: 15 oral and 15 parenteral agents) directed dose interval or duration similar to those of PDR and 17% (9 parenteral agents) suggested less administration or longer duration. Surprisingly, in contrast to only 6% (3 cases) of PDR, 24% (12 cases:10 oral and 2 parenteral agents) recommended more administration or shorter duration. About 39% (24 cases:13 oral and 7 parenteral agents) revealed no information for dose adjustment commens to indications or the severity of infection. CONCLUSION: This study revealed that many guidelines in Korea recommend lower doses and/or unreasonable dose intervals. In future studies, improved antibiotic usage guidelines should be established based on pharmacokinetic and pharmacodynamic researches, on the aspect of optimal dosage, dose interval, and dose adjustment commensurate to the indications and the severity of the infection.
Americas ; Anti-Bacterial Agents ; Anti-Infective Agents ; Asian Continental Ancestry Group ; Humans ; Japan ; Korea* ; Product Labeling* ; United States