与在内牙科中使用低化溶液相关的监管问题
Ove A Peters1, Nidambur V Ballal2, Shu Abe3,4
1School of Dentistry, The University of Queensland, Herston, Queensland, Australia.
International endodontic journal
|November 27, 2024
概括
在全球范围内,对甲 (NaOCl) 根管灌剂的规定各不相同. 欧盟现在将它们归类为高风险医疗器械,影响牙科市场,而其他地区有不同的分类.
科学领域:
- 牙周内科医院 牙周内科医院 牙周内科医院
- 牙科材料科学 牙科材料科学
- 监管事务 监管事务
背景情况:
- 低酸 (NaOCl) 是内牙治疗中的关键灌剂.
- 欧盟最近的监管变化将内牙灌剂归类为高风险医疗器械.
- 这种分类影响了用于根管治疗的NaOCl溶液的可用性和监管.
研究的目的:
- 评估全球主要牙科市场内用于牙周内的低化 (NaOCl) 溶液的监管状况.
- 了解欧盟的医疗器械法规 (MDR) 对内牙灌剂的影响.
- 识别传统牙科供应道之外的NaOCl溶液的替代来源.
主要方法:
- 在线查询与医疗器械法规有关的法律文本.
- 在关键的国际市场与当地卫生当局进行直接沟通.
- 调查采购NaOCl溶液的非牙科市场来源.
主要成果:
- 截至2024年中期,用于牙周内科的NaOCl溶液在美国和加拿大仍然未经分类.
- 欧盟已经将这些解决方案重新归类为MDR的高风险医疗器械,这是英国,瑞士和土耳其采用的分类.
- 日本仍然面临着很高的监管障碍,而中国在2017年将NaOCl降级为中等风险. 其他调查的国家 (澳大利亚,印度,巴西) 采用中低风险类别.
- 在一些地区,从药房购买药品和使用家庭漂白剂被确定为替代途径.
结论:
- 牙周内化 (NaOCl) 溶液的全球监管环境非常多样化.
- 需要一种平衡的监管方法,以确保安全而不过度监管.
- 协调或明确的指导方针是必要的,以导航在内牙科中NaOCl的不同法律要求.
关键词:
欧盟2017年7月45日 欧盟2017年7月45日 欧盟2017年7月45日 欧盟2017年7月45日 欧盟2017年7月45日 欧盟2017年7月45日 欧盟2017年7月45日 欧盟2017年7月45日 欧盟2017年7月45日 欧盟2017年7月45日 欧盟2017年7月漂白剂 漂白剂 漂白剂 漂白剂医疗器械监管法规 医疗器械监管法规药房 药房 药房 药房一个根管道的根管道.更多相关视频
07:07Controlled-release of Chlorine Dioxide in a Perforated Packaging System to Extend the Storage Life and Improve the Safety of Grape Tomatoes
Published on: April 7, 2017
11.0K
14:20High Throughput SiRNA Screening for Chloropicrin and Hydrogen Fluoride-Induced Cornea Epithelial Cell Injury
Published on: June 16, 2018
5.8K
相关概念视频
03:00Electrolysis
26.0K
In a galvanic cell, the electrical work is done by a redox system on its surroundings as electrons produced by the spontaneous redox reactions are transferred through an external circuit. Alternatively, an external circuit does work on a redox system by imposing a voltage sufficient to drive an otherwise nonspontaneous reaction in a process known as electrolysis. For instance, recharging a battery involves the use of an external power source to drive the spontaneous (discharge) cell reaction in...
26.0K
01:27Chemical Agents for Microbial Control
2
Chemicals play important roles in controlling microbial growth by targeting microbial structures and functions as sanitizers, antiseptics, disinfectants, and sterilants.Alcohols are commonly used sanitizers, effectively disrupting lipid membranes, which compromises cell integrity. They are also used as antiseptics and disinfectants due to their rapid action and versatility.Phenols and their derivatives phenolics , known for denaturing proteins and disrupting cell membranes, are particularly...
2
01:12Local Anesthetics: Adverse Effects
389
While local anesthetics are generally safe and well-tolerated, they can occasionally cause adverse effects that vary in severity. Local anesthetics can induce toxicity at two distinct levels. They can either produce local effects through direct contact with the neural elements or be absorbed into the bloodstream from the injection site, leading to systemic effects.
Once absorbed into the systemic circulation, local anesthetics can affect the organs that depend on the functioning of sodium...
Once absorbed into the systemic circulation, local anesthetics can affect the organs that depend on the functioning of sodium...
389
01:26Regulation of Sodium and Potassium
413
The regulation of sodium and potassium ion concentrations in the human body is a complex process governed primarily by hormones such as aldosterone, antidiuretic hormone (ADH), and atrial natriuretic peptide (ANP).
Sodium Regulation
Sodium ions make up approximately 90% of extracellular cations, with a normal blood plasma concentration of 136–148 mEq/L. A decrease in blood volume and pressure triggers the release of renin from granular cells in the juxtaglomerular complex (JGC), primarily...
Sodium Regulation
Sodium ions make up approximately 90% of extracellular cations, with a normal blood plasma concentration of 136–148 mEq/L. A decrease in blood volume and pressure triggers the release of renin from granular cells in the juxtaglomerular complex (JGC), primarily...
413
01:30Cleaning, Sterilization, and Disinfection
6.6K
Cleaning, disinfection, and sterilization are the methods that help to break the infection chain and prevent disease.
Cleaning
The cleaning process usually involves using water with detergents or enzymatic cleaner and removing foreign material from objects and surfaces, including organic material such as body fluids or inorganic material like soil. Cleaning is performed before high-level disinfection and sterilization because foreign materials on the cover of the devices interfere with process...
Cleaning
The cleaning process usually involves using water with detergents or enzymatic cleaner and removing foreign material from objects and surfaces, including organic material such as body fluids or inorganic material like soil. Cleaning is performed before high-level disinfection and sterilization because foreign materials on the cover of the devices interfere with process...
6.6K
04:01Factors Affecting Solubility
33.1K
Compared with pure water, the solubility of an ionic compound is less in aqueous solutions containing a common ion (one also produced by dissolution of the ionic compound). This is an example of a phenomenon known as the common ion effect, which is a consequence of the law of mass action that may be explained using Le Chȃtelier’s principle. Consider the dissolution of silver iodide:
33.1K