title: Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel.
abstract: BACKGROUND
  Needlestick 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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  We searched CENTRAL, MEDLINE, EMBASE, NHSEED, Science Citation Index Expanded, CINAHL, Nioshtic, CISdoc and PsycINFO (until January 2014) and LILACS (until January 2012).
  
  
  METHODS
  We included randomised controlled trials (RCT), controlled before and after studies (CBA) and interrupted time-series (ITS) designs on the effect of safety engineered medical devices on needlestick injuries in healthcare staff.
  
  
  METHODS
  Two 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.
  
  
  RESULTS
  We included four RCTs with 1136 participants, two cluster-RCTs with 795 participants and 73,454 patient days, four CBAs with approximately 22,000 participants and seven ITS with an average of seven data points. These studies evaluated safe modifications of blood collection systems, intravenous (IV) systems, injection systems, multiple devices and sharps containers. The needlestick injury (NSI) rate in the control groups was estimated at about one to five NSIs per 1000 person-years. There was only one study from a low- or middle-income country. The risk of bias was high in most studies.In one ITS study that evaluated safe blood collection systems, NSIs decreased immediately after the introduction (effect size (ES) -6.9, 95% confidence interval (CI) -9.5 to -4.2) and there was no clear evidence of an additional benefit over time (ES -1.2, 95% CI -2.5 to 0.1). Another ITS study used an outdated recapping shield.There was very low quality evidence that NSIs were reduced with the introduction of safe IV devices in two out of four studies but the other two studies showed no clear evidence of a trend towards a reduction. However, there was moderate quality evidence in four other studies that these devices increased the number of blood splashes where the safety system had to be engaged actively (relative risk (RR) 1.6, 95% CI 1.08 to 2.36).There was no clear evidence that the introduction of safe injection devices changed the NSI rate in two studies.The introduction of multiple safety devices showed a decrease in NSI in one study but not in another. The introduction of safety containers showed a decrease in NSI in one study but inconsistent results in two other studies.There was no evidence in the included studies about which type of device was better, for example shielding or retraction of the needle.
  
  
  CONCLUSIONS
  For safe blood collection systems, we found very low quality evidence in one study that these decrease needlestick injuries (NSIs). For intravenous systems, we found very low quality evidence that they result in a decrease of NSI compared with usual devices but moderate quality evidence that they increase contamination with blood. For other 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. All studies had a considerable risk of bias and the lack of evidence of a beneficial effect could be due both to confounding and bias. This does not mean that these devices are not effective.Cluster-randomised controlled studies are needed to compare the various types of safety engineered devices for their effectiveness and cost-effectiveness, especially in low- and middle-income countries.
authors.affiliation: University of Maryland Baltimore, 110 South Paca Street, Rm 4-S-100, Baltimore, Maryland, USA, 21201.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Lavoie
authors.forename: Jos H
authors.initials: JH
authors.lastname: Verbeek
authors.forename: Manisha
authors.initials: M
authors.lastname: Pahwa
mesh_terms: D001800:Blood Specimen Collection / Q000295:instrumentation* / Q000379:methods; D006282:Health Personnel; D006801:Humans; D007262:Infusions, Intravenous / Q000295:instrumentation; D007267:Injections / Q000295:instrumentation; D016602:Needlestick Injuries / Q000517:prevention & control*; D009784:Occupational Diseases / Q000517:prevention & control*; D011482:Protective Devices; D016032:Randomized Controlled Trials as Topic