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The Life-Saving Importance of Medical Labels

Last Updated:2月8日,2022年

medical labels save lives every day

当只有几秒钟从死亡中分开生命时,清晰的医疗设备指示标签至关重要。寿命外部除颤器(AED)等救生设备不仅由医疗专业人员使用,而且常见的公民突然和意外地发现自己的困难情况。虽然疯狂地与AED一起拯救生命的措施,但是任何人都需要的是褪色或难以辨认的指导标签。这就是为什么医疗设备标签意味着能够承受严苛的医疗保健环境,并且保持完全清晰可清晰地具有挽救生命的重要性。

What is an AED?

心脏有自己的电气系统。电信号从顶部开始,向下脉冲导致心脏泵。每个节拍都依赖于电信号。然而,信号可能变得异常,强迫心脏跳动太快,慢,或不规则。

An AED checks the rhythm of a person’s heart1, and if irregular, sends a shock to restore normalcy. Portability and ease of use make AEDs very effective at saving lives, and because of this they are commonly found in healthcare facilities, golf courses, malls, airports, hotels, and other public places. Every AED has a procedure identification plate with specific instructions to ensure that anyone can use the device.

AED

The Science of Defibrillation

除颤是用于描述外部震惊心脏的过程的术语。心室纤维化(VF),表示心律异常。AED分析了患者心脏的节奏,如果不规则,则放置在胸部上的电极施用电击。

The machine will not elicit a shock unless it detects an irregularity. The shock interrupts the immediate beat cycle to restore a healthy rhythm. CPR (cardiopulmonary resuscitation) has a low success rate (less than 5%)1when a victim faces sudden cardiac arrest (SCA). However, the chance of survival increases drastically when CPR is combined with the use of an AED!

除颤器

突然心脏骤停(SCA)的统计数据

During the day, most people are not at home—they are in public areas. While AEDs are available for the home, based on statistics, it’s much more useful to have them handy in public spaces. A study by a team of cardiologists in India found that 64% of SCA victims were stricken during the day, especially in the morning2。在123名受害者中,101名是40岁以上的男性,其中五个贡献的健康问题之一:糖尿病,高血压,心脏病的家族史,烟草成瘾或不活跃的生活方式。完成这项研究的医生鼓励公众学习CPR以及如何找到和使用AED。

Sudden cardiac arrest also affects children. In 2005, a 14-year-old freshman died during basketball tryouts after she collapsed on the gym floor3.。The young girl did not respond to CPR as emergency personnel arrived 12 minutes later. In 2014, the Puget Sound Heart Project donated AEDs to every Tacoma high school.4.

CA Survival

快点,快

AEDs are commonplace in public areas, but they are only as effective as bystanders are active! 90% of victims survive when treated with an AED in one minute or less, but chances of survival significantly decrease with each passing minute. While many people wait for trained personnel to address the situation, a Johns Hopkins study found that speed is more important than training.5.Non-medical volunteers were more successful at saving lives than trained EMTs because the volunteers had time on their side. Early defibrillation can double a victim’s odds of survival. A University of Washington study found that sixth graders successfully revived a mannequin only 23 seconds slower than professionally trained workers.6.

缺乏对AED的知识以及进一步损害受害者的担忧是无所作为的最常见原因之一。但是,意识蔓延。例如,Pulspoint应用程序7.这有助于智能手机用户找到可用AED的75%的加利福尼亚州使用了26个州和1,600个社区,拥有750,000个活跃的用户。

What are the FDA’s Specifications (or Requirements) for Medical Device Labels?

What Are the FDA's Specifications for Medical Device Labels?

The FDA defines medical device labels as any printed matter that accompanies the item and includes product labels, packaging, and any other written, printed, or graphic material on the item’s immediate container.Requirements related to medical device labelingare found within Title 21 of the Code of Federal Regulations (CFR). The regulations are broad and cover a large variety of medical device types and use cases. The FDA has specifications for general device labeling (21CFR Part 801)that includes definitions related to the information that must be clearly visible on a device. This section defines not only the required information but also important exemptions for additional requirements for specific types of devices. There are also guidelines related to symbols that may be used and the change control and documentation process for properly managing medical device product labeling.

Another important section is21CFR Part 830that definesUDI label requirements。UDI包括识别可在任何时间用于跟踪和更改控制目的的序列号,到期日和批号等信息。这些标签可以保护消费者,并在医疗保健行业的医疗设备公司之间标准化这一核心信息。医疗设备根据其直接影响其对其持续维持支持,健康程度以及潜在的健康风险水平的直接影响。随着时间的推移,UDI要求已经向这些类别推出,以III类和2020年与I类分类完成。FDA也维持可搜索Global Unique Device Identification Database (GUDID)that contains all submitted UDI information.

What Information Should a Medical Device Label Contain?

每个医疗设备可能具有独特的产品,区域或特定于市场的规则,该规定管理产品和相关包装必须存在的具体信息。几乎所有医疗设备必须存在的标记是符合UDI的标签,其中包含称为UDI标记的条形码标签。根据21CFR部分830,UDI标签必须包含以下信息。
  • 设备标识符。Information related to the specific device must bepermanently affixed到产品并识别制造商名称,地址,品牌名称和型号。医疗设备制造商还必须包括正在制造的特定设备类别的国际公认的全球医疗设备命名法(GMDN)标识符。本文被认为是该生产模型的所有单位的标准,每个设备都是相同的。
  • 生产标识符。This data is related to the production for this exact unit and could include the date of manufacture, lot or batch number, serial number, and expiration date. The exact information displayed could vary based on the tracking system of each manufacturer but must meet the minimum reporting requirements from the regulations.
  • HCT/P Identifier.Medical devices that are considered human cell, tissue, or cellular and tissue-based products (HCT/P) must contain a special identification code that is defined in 21CFR第1271.290部分
  • Additional Information.Based on unique requirements for the type of device, you may also find information related to safety warnings, product quantity and packaging size, and storage and handling requirements.

The Importance of Medical Labels

上面讨论的所有SCA的生存数据rely directly on the AED user’s ability to operate the device quickly and effectively—training or no training. If the AED instruction label is unmarred and easily followed, the victim has a far better chance of survival. Anodized aluminum has long been a standard for medical device labels, but many of these fade or become damaged over time. There is now a better option. Metalphoto photosensitive anodized aluminum—long known to be one of the most durable materials for military and industrial labels and data plates—was recently proven to withstand thousands of sterilization cycles without fading, corroding, or harboring bacteria.Metalphoto medical labels MeterPhoto非常适合无菌环境,符合AAMI / CDV-1ST79:2010 / A2.06以及2007年FDA修订法案,以建立独特的设备识别(UDI)系统。Metalphoto在阳极氧化铝内嵌入无机,卤化银照相图像,这使其能够抵抗高达1,200°F,磨损和化学照射的温度。由于图像是摄影,因此它不仅令人难以置信的清晰,而且还具有所有条码符号系统和UDI系统所需的细节和对比。Metalphoto是医疗应用中的理想解决方案,其中塑料标签会破裂,屏幕印刷阳极氧化铝将在多次灭菌循环暴露患者,公民和医生以低效率,挫折,甚至危险之后淡化。

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