Department of Surgery, Washington University in St Louis School of Medicine, St Louis, MO.
Department of Surgery, Washington University in St Louis School of Medicine, St Louis, MO.
J Am Coll Surg. 2018 Feb;226(2):117-125. doi: 10.1016/j.jamcollsurg.2017.10.020. Epub 2017 Nov 11.
With an array of hernia meshes with varying properties, intraoperative decision making for the optimal mesh is critical. Although meshes are subjected to regulatory review through the Food and Drug Administration, it is unknown whether mesh properties are visually accessible. To facilitate greater knowledge for the surgeon on mesh choice, we aimed to comprehensively analyze hernia mesh packaging and regulations.
Labeling guidelines and 510(k) requirements across Food and Drug Administration-regulated products were analyzed and compared with mesh packaging. Packages and Instructions for Use were analyzed for commonly available hernia meshes. Literature review was conducted to understand recommended guidelines for mesh products. A novel hernia mesh packaging label was designed to rectify under-reporting.
We found that food labels undergo critical scrutiny and detailed specifications, yet medical devices are not subjected to similar guidelines. The highest reported property on packages was the presence of a barrier (80%), and the lowest reported property was barrier composition (33%). For Instructions for Use, the lowest reported properties were mechanics (31%) and thickness (11%), both of which were not reported on packaging. Descriptive terms for pore size and mechanics were reported inconsistently. To overcome this under-reporting of properties, we propose a novel packaging label with properties chosen from regulatory guidelines, packaging analysis, and literature review.
Although standardized terminology has been proposed in literature, property knowledge has not adequately permeated surgery, industry, or regulatory guidelines. There is extreme under-reporting and lack of consistency of clinically important mesh properties. Standardized packaging labels will provide accessibility of these properties and aim to bring standardized terminology into practice. With an increase in access to important properties, this can facilitate intraoperative decision making on a case-by-case basis.
由于具有各种特性的疝补片种类繁多，因此在手术中选择最合适的补片至关重要。尽管补片已通过食品和药物管理局的监管审查，但尚不清楚其特性是否易于肉眼观察。为了使外科医生对补片选择有更深入的了解，我们旨在全面分析疝补片的包装和法规。
分析了食品和药物管理局监管产品的标签指南和 510(k)要求，并将其与补片包装进行了比较。对常用疝补片的包装和使用说明进行了分析。进行了文献回顾，以了解有关补片产品的推荐指南。设计了一种新颖的疝补片包装标签，以纠正漏报问题。
我们发现食品标签经过严格审查和详细规定，而医疗器械并未遵循类似的准则。包装上报告最多的特性是存在屏障（80%），报告最少的特性是屏障组成（33%）。对于使用说明，报告最少的特性是力学性能（31%）和厚度（11%），这两个特性都没有在包装上报告。孔径和力学性能的描述性术语报告不一致。为了克服这些特性的漏报问题，我们提出了一种新颖的包装标签，其中特性选自监管指南、包装分析和文献综述。
尽管文献中提出了标准化术语，但这些属性知识尚未充分渗透到手术、行业或监管指南中。临床重要补片特性的报告严重不足且缺乏一致性。标准化包装标签将提供这些特性的可及性，并旨在将标准化术语付诸实践。随着对重要属性的了解增加，这可以有助于根据具体情况在手术中做出决策。
