Reddy Viraj K, Lavoie Marie-Claude, Verbeek Jos H, Pahwa Manisha
Cochrane Work Review Group, Finnish Institute of Occupational Health, Neulaniementie 4, Kuopio, Finland, 70101.
Cochrane Database Syst Rev. 2017 Nov 14;11(11):CD009740. doi: 10.1002/14651858.CD009740.pub3.
Percutaneous exposure injuries from devices used for blood collection or for injections expose healthcare workers to the risk of blood borne infections such as hepatitis B and C, and human immunodeficiency virus (HIV). Safety features such as shields or retractable needles can possibly contribute to the prevention of these injuries and it is important to evaluate their effectiveness.
To determine the benefits and harms of safety medical devices aiming to prevent percutaneous exposure injuries caused by needles in healthcare personnel versus no intervention or alternative interventions.
We searched CENTRAL, MEDLINE, EMBASE, NHSEED, Science Citation Index Expanded, CINAHL, Nioshtic, CISdoc and PsycINFO (until 11 November 2016).
We included randomised controlled trials (RCT), controlled before and after studies (CBA) and interrupted time-series (ITS) designs of the effect of safety engineered medical devices on percutaneous exposure injuries in healthcare staff.
Two of the authors independently assessed study eligibility and risk of bias and extracted data. We synthesized study results with a fixed-effect or random-effects model meta-analysis where appropriate.
We included six RCTs with 1838 participants, two cluster-RCTs with 795 participants and 73,454 patient days, five CBAs with approximately 22,000 participants and eleven ITS with an average of 13.8 data points. These studies evaluated safe modifications of blood collection systems, intravenous (IV) systems, injection systems, multiple devices, sharps containers and legislation on the implementation of safe devices. We estimated the needlestick injury (NSI) rate in the control groups to be about one to five NSIs per 1000 person-years. There were only two studies from low- or middle-income countries. The risk of bias was high in 20 of 24 studies. Safe blood collection systems:We found one RCT that found a safety engineered blood gas syringe having no considerable effect on NSIs (Relative Risk (RR) 0.2, 95% Confidence Interval (95% CI) 0.01 to 4.14, 550 patients, very low quality evidence). In one ITS study, safe blood collection systems decreased NSIs immediately after the introduction (effect size (ES) -6.9, 95% CI -9.5 to -4.2) but there was no further decrease over time (ES -1.2, 95% CI -2.5 to 0.1, very low quality evidence). Another ITS study evaluated an outdated recapping shield, which we did not consider further. Safe Intravenous systemsThere was very low quality evidence in two ITS studies that NSIs were reduced with the introduction of safe IV devices, whereas one RCT and one CBA study provided very low quality evidence of no effect. However, there was moderate quality evidence produced by four other RCT studies that these devices increased the number of blood splashes when the safety system had to be engaged actively (relative risk (RR) 1.6, 95% CI 1.08 to 2.36). In contrast there was low quality evidence produced by two RCTs of passive systems that showed no effect on blood splashes. Yet another RCT produced low quality evidence that a different safe active IV system also decreased the incidence of blood leakages. Safe injection devicesThere was very low quality evidence provided by one RCT and one CBA study showing that introduction of safe injection devices did not considerably change the NSI rate. One ITS study produced low quality evidence showing that the introduction of safe passive injection systems had no effect on NSI rate when compared to safe active injection systems. Multiple safe devicesThere was very low quality evidence from one CBA study and two ITS studies. According to the CBA study, the introduction of multiple safe devices resulted in a decrease in NSI,whereas the two ITS studies found no change. Safety containersOne CBA study produced very low quality evidence showing that the introduction of safety containers decreased NSI. However, two ITS studies evaluating the same intervention found inconsistent results. LegislationThere was low to moderate quality evidence in two ITS studies that introduction of legislation on the use of safety-engineered devices reduced the rate of NSIs among healthcare workers. There was also low quality evidence which showed a decrease in the trend over time for NSI rates.Twenty out of 24 studies had a high risk of bias and the lack of evidence of a beneficial effect could be due to both confounding and bias. This does not mean that these devices are not effective.
AUTHORS' CONCLUSIONS: For safe blood collection systems, we found very low quality evidence of inconsistent effects on NSIs. For safe passive intravenous systems, we found very low quality evidence of a decrease in NSI and a reduction in the incidence of blood leakage events but moderate quality evidence that active systems may increase exposure to blood. For safe injection needles, the introduction of multiple safety devices or the introduction of sharps containers the evidence was inconsistent or there was no clear evidence of a benefit. There was low to moderate quality evidence that introduction of legislation probably reduces NSI rates.More high-quality cluster-randomised controlled studies that include cost-effectiveness measures are needed, especially in countries where both NSIs and blood-borne infections are highly prevalent.
用于采血或注射的设备导致的经皮暴露损伤使医护人员面临感染血源性疾病的风险,如乙型和丙型肝炎以及人类免疫缺陷病毒(HIV)。诸如护罩或回缩式针头之类的安全装置可能有助于预防这些损伤,评估其有效性很重要。
确定安全医疗设备相对于无干预措施或替代干预措施而言,预防医护人员因针头导致的经皮暴露损伤的利弊。
我们检索了Cochrane系统评价数据库、医学期刊数据库、荷兰医学文摘数据库、英国国家卫生服务电子图书馆数据库、科学引文索引扩展版、护理学与健康领域数据库、美国国家职业安全与健康研究所数据库、印度医学中央索引数据库和心理学文摘数据库(截至2016年11月11日)。
我们纳入了关于安全工程医疗设备对医护人员经皮暴露损伤影响的随机对照试验(RCT)、前后对照研究(CBA)和中断时间序列(ITS)设计。
两位作者独立评估研究的纳入资格和偏倚风险并提取数据。我们在适当的情况下采用固定效应或随机效应模型荟萃分析来综合研究结果。
我们纳入了6项RCT(共1838名参与者)、2项整群RCT(共795名参与者和73454个患者日)、5项CBA(约22000名参与者)和11项ITS(平均13.8个数据点)。这些研究评估了采血系统、静脉输液(IV)系统、注射系统、多种设备、锐器容器的安全改进措施以及安全设备实施方面的立法。我们估计对照组的针刺伤(NSI)发生率约为每1000人年1至5次针刺伤。仅有两项研究来自低收入或中等收入国家。24项研究中有20项偏倚风险较高。安全采血系统:我们发现一项RCT,该研究发现一种安全工程血气注射器对针刺伤没有显著影响(相对危险度(RR)0.2,95%置信区间(95%CI)0.01至4.14,550名患者,极低质量证据)。在一项ITS研究中,安全采血系统在引入后立即降低了针刺伤发生率(效应量(ES)-6.9,95%CI -9.5至-4.2),但随着时间推移没有进一步下降(ES -1.2,95%CI -2.5至0.1,极低质量证据)。另一项ITS研究评估了一个过时的盖帽护罩,我们未进一步考虑。安全静脉输液系统:两项ITS研究中有极低质量证据表明,引入安全静脉输液设备可降低针刺伤发生率,而一项RCT和一项CBA研究提供了极低质量证据表明无效果。然而,另外四项RCT研究提供了中等质量证据表明,当安全系统必须主动启用时,这些设备会增加血液飞溅的次数(相对危险度(RR)1.6,95%CI 1.08至2.36)。相比之下,两项关于被动系统的RCT提供了低质量证据表明对血液飞溅无影响。另一项RCT提供了低质量证据表明,另一种不同的安全主动静脉输液系统也降低了血液渗漏的发生率。安全注射设备:一项RCT和一项CBA研究提供了极低质量证据表明,引入安全注射设备并未显著改变针刺伤发生率。一项ITS研究提供了低质量证据表明,与安全主动注射系统相比,引入安全被动注射系统对针刺伤发生率无影响。多种安全设备:一项CBA研究和两项ITS研究提供了极低质量证据。根据CBA研究,引入多种安全设备可降低针刺伤发生率,而两项ITS研究未发现变化。安全容器:一项CBA研究提供了极低质量证据表明,引入安全容器可降低针刺伤发生率。然而,两项评估相同干预措施的ITS研究结果不一致。立法:两项ITS研究中有低至中等质量证据表明,引入安全工程设备使用方面的立法可降低医护人员针刺伤发生率。也有低质量证据表明针刺伤发生率随时间呈下降趋势。24项研究中有20项偏倚风险较高,缺乏有益效果的证据可能是由于混杂因素和偏倚。这并不意味着这些设备无效。
对于安全采血系统,我们发现对针刺伤影响不一致的极低质量证据。对于安全被动静脉输液系统,我们发现针刺伤发生率降低和血液渗漏事件发生率降低的极低质量证据,但中等质量证据表明主动系统可能增加血液暴露。对于安全注射针头、引入多种安全设备或引入锐器容器,证据不一致或没有明显的有益证据。有低至中等质量证据表明引入立法可能降低针刺伤发生率。需要更多高质量的整群随机对照研究,包括成本效益措施,尤其是在针刺伤和血源性感染高发的国家。