Cuny E, Fredekind R E, Budenz A W
University of the Pacific School of Dentistry, San Francisco, Calif. 94115, USA.
J Am Dent Assoc. 2000 Oct;131(10):1443-8. doi: 10.14219/jada.archive.2000.0055.
Some government agencies and state legislatures recently have passed regulations mandating the use of safety-enhanced devices, including dental anesthetic safety needles. Little information exists, however, on the efficacy and utility of these types of needles currently on the market.
The authors evaluated four types of dental safety needles and syringes for clinical acceptability. Two of these devices were deemed unacceptable owing to inherent features identified during the bench test. The remaining two devices were clinically evaluated using an 11-statement survey. Senior dental students completed the survey at one, two, four, five, six and eight weeks from introduction of the devices to a dental school clinic. Junior dental students joined the senior students using one of the devices for the last six months of the evaluation and joined the senior students in completion of a final survey at 52 weeks.
The survey results indicated increasing user dissatisfaction with nine of the safety device features evaluated over the 52 weeks. At eight weeks, use of one of the two devices was discontinued owing to poor clinical performance. A review of the blood exposure incident reports that routinely are collected following an exposure incident revealed a small increase in exposures involving anesthetic needles. The sample size was too small to determine statistical significance of the change in injury rate, but it did show that needlesticks continue to occur in spite of the use of safety devices.
None of the safety devices tested successfully passed the clinical evaluation. Continued evaluation is necessary to ensure that effective safety devices are available to dental practitioners.
Evaluators had significant concerns about the usability of dental safety needles and their ability to adapt to using them effectively. Results of a review and bench tests indicate that the devices tested are no safer than traditional anesthetic needles.
一些政府机构和州立法机构最近通过了法规,强制要求使用增强安全性的器械,包括牙科麻醉安全针。然而,目前市场上这类针的有效性和实用性方面的信息很少。
作者评估了四种类型的牙科安全针和注射器的临床可接受性。其中两种器械因在台架试验中发现的固有特性而被认为不可接受。其余两种器械通过一项包含11项陈述的调查进行临床评估。高年级牙科学生在器械引入牙科学校诊所后的1周、2周、4周、5周、6周和8周完成该调查。低年级牙科学生在评估的最后6个月加入高年级学生,使用其中一种器械,并在52周时与高年级学生一起完成最终调查。
调查结果表明,在52周的时间里,用户对所评估的9项安全器械特性的不满情绪不断增加。在8周时,由于临床性能不佳,停止使用了两种器械中的一种。对暴露事件后常规收集的血液暴露事件报告的审查显示,涉及麻醉针的暴露略有增加。样本量太小,无法确定伤害率变化的统计学显著性,但确实表明,尽管使用了安全器械,针刺伤仍在继续发生。
所测试的安全器械均未成功通过临床评估。有必要继续进行评估,以确保牙科从业者能够使用有效的安全器械。
评估人员对牙科安全针的可用性及其有效使用的适应能力深感担忧。审查和台架试验结果表明,所测试的器械并不比传统麻醉针更安全。