Edlich Richard F, Wind Tyler C, Heather Cynthia L, Thacker John G
Plastic Surgical Research Program, University of Virginia Health System, Charlottesville, Virginia, USA.
J Long Term Eff Med Implants. 2003;13(2):69-83. doi: 10.1615/jlongtermeffmedimplants.v13.i2.10.
During operative procedures, operating room personnel wear sterile surgical gloves designed to protect them and their patients against transmissible infections. The Food and Drug Administration (FDA) has set compliance policy guides for manufacturers of gloves. The FDA allows surgeons' gloves whose leakage defect rates do not exceed 1.5 acceptable quality level (AQL) to be used in operating rooms. The implications of this policy are potentially enormous to operating room personnel and patients. This unacceptable risk to the personnel and patient could be significantly reduced by the use of sterile double surgical gloves. Because double-gloves are also susceptible to needle puncture, a double-glove hole indication system is urgently needed to immediately detect surgical needle glove punctures. This warning would allow surgeons to remove the double-gloves, wash their hands, and then don a sterile set of double-gloves with an indication system. During the last decade, Regent Medical has devised non-latex and latex double-glove hole puncture indication systems. The purpose of this comprehensive study is to detect the accuracy of the non-latex and latex double-glove hole puncture indication systems using five commonly used sterile surgical needles: the taper point surgical needle, tapercut surgical needle, reverse cutting edge surgical needle, taper cardiopoint surgical needle, and spatula surgical needle. After subjecting both the non-latex and latex double-glove hole puncture indication systems to surgical needle puncture in each glove fingertip, these double-glove systems were immersed in a sterile basin of saline, after which the double-gloved hands manipulated surgical instruments. Within two minutes, both the non-latex and latex hole puncture indication systems accurately detected needle punctures in all of the surgical gloves, regardless of the dimensions of the surgical needles. In addition, the size of the color change visualized through the translucent outer glove did not correlate with needle diameter. On the basis of this extensive experimental evaluation, both the non-latex and latex double-glove hole puncture indication systems should be used in all operative procedures by all operating room personnel.
在手术过程中，手术室工作人员佩戴无菌手术手套，旨在保护他们自己和患者免受传染性感染。美国食品药品监督管理局（FDA）已为手套制造商制定了合规政策指南。FDA允许泄漏缺陷率不超过1.5可接受质量水平（AQL）的外科医生手套在手术室中使用。该政策对手术室工作人员和患者的影响可能是巨大的。使用无菌双层手术手套可显著降低对工作人员和患者的这种不可接受的风险。由于双层手套也容易被针刺破，因此迫切需要一种双层手套破洞指示系统，以便立即检测手术针造成的手套刺破。这种警示将使外科医生能够脱掉双层手套、洗手，然后戴上一套带有指示系统的无菌双层手套。在过去十年中，Regent Medical公司设计了非乳胶和乳胶双层手套破洞穿刺指示系统。这项全面研究的目的是使用五种常用的无菌手术针：锥形尖端手术针、锥形切割手术针、反向切割边缘手术针、锥形心脏尖端手术针和刮铲手术针，检测非乳胶和乳胶双层手套破洞穿刺指示系统的准确性。在非乳胶和乳胶双层手套破洞穿刺指示系统的每个手套指尖都被手术针刺破后，将这些双层手套系统浸入一个无菌盐水中盆中，之后戴双层手套的手操作手术器械。在两分钟内，无论手术针的尺寸如何，非乳胶和乳胶破洞穿刺指示系统都能准确检测出所有手术手套上的针刺。此外，透过半透明外层手套看到的颜色变化大小与针的直径无关。基于这一广泛的实验评估，所有手术室工作人员在所有手术过程中都应使用非乳胶和乳胶双层手套破洞穿刺指示系统。
