Study of a Needleless Intermittent Intravenous-Access System for Peripheral Infusions: Analysis of Staff, Patient, and Institutional Outcomes

Abstract

To assess the effect on staff-and patientrelated complications of a needleless intermittent intravenous access system with a reflux valve for peripheral infusions. DESIGN: A 6-month cross-over clinical trial (phase I, 13 weeks; phase II, 12 weeks) of a needleless intermittent intravenous access system (NL; study device) compared to a conventional heparin-lock system (CHL, control device) was performed during 1991 on 16 medical and surgical units. A random selection of patients was assessed for local intravenous-site complications; all patients were assessed for the development of nosocomial bacteremia and device-related complications. Staff were assessed for percutaneous injuries and participated in completion of product evaluations. A cost analysis of the study compared to the control device was performed. SETTING: A 1,100-bed, teaching, referral medical center. PATIENTS AND STAFF PARTICIPANTS: 594 patients during 602 patient admissions, comprising a random sample of all patients with a study or control device inserted within a previous 24-hour period on study and control units, were assessed for local complications. The 16 units included adult inpatient general medicine, surgical, and subspecialty units. Pediatrics, obstetricsgynecology, and intensive-care units were excluded. All patients on study and control units were assessed for development of nosocomial bacteremia and device-related complications. All staff who utilized, manipulated, or may have been exposed to sharps on study and control units were assessed for percutaneous injuries. Nursing staff completed product evaluations. INTERVENTION: The study device, a needleless intermittent intravenous access system with a reflux valve, was compared to the control device, a conventional heparin lock, for peripheral infusions. RESULTS: During the study, 35 percutaneous injuries were reported. Eight injuries were CHL-related; no NL-related injuries were reported (P=.007). An evaluation of 602 patient admissions, 1,134 intermittent access devices, and 2,268 observed indwelling device days demonstrated more pain at the insertion site for CHL than NL; however, no differences in objective signs of phlebitis were noted. Of 773 episodes of positive blood cultures on study and control units, 6 (0.8%) were device-related (assessed by blinded investigator), with no difference between NL and CHL. Complications, including difficulty with infusion (P<.001) and disconnection of intravenous tubing from device (P<.001), were reported more frequently with CHL than with NL. Of nursing staff responding to a product evaluation survey, 95.2% preferred the study over control device. The projected annual incremental cost to our institution for hospitalwide implementation of NL for intermittent access for peripheral infusions was estimated at $82,845, or $230 per 1,000 patient days. CONCLUSIONS: A needleless intermittent intravenous access system with a reflux valve for peripheral infusions is effective in reducing percutaneous injuries to staff and is not associated with an increase ...

Use of safety-engineered devices by healthcare workers for intravenous and/or phlebotomy procedures in healthcare settings: a systematic review and meta-analysis

“…Out of the 22 included studies, twelve studies assessed the introduction of IV safety devices [53–64], five studies assessed the introduction of phlebotomy safety devices [5, 26, 65–67], and five studies assessed the simultaneous introduction of IV and phlebotomy safety devices [68–72]. Four of the studies of the “IV safety devices” category also reported data for subcutaneous, intramuscular, and/or intradermal injection devices separately [68, 70–72].…”

“…, MasterGuard Anti-Stick Needle Protector™ by Medisystems Corp [66]. , Safesite System™ by Braun Medical, Inc [64], Lifeshield™ by Abbott Laboratories [56], Saf-Site™ by Burron Medical [56], Punctur-Guard™ by Bio-Plexus, Inc [6], and Venipuncture Needle-Pro™ by Smiths Medical [6]. The remaining six studies mentioned neither the brand name of the device nor the manufacturer or supplier.…”

“…Nine out of the 22 studies reported their funding sources; these include:Becton Dickinson; [26]National Institute of Allergy and Infectious Diseases; the Centers for Disease Control and Prevention; and the Prevention Epicenters; [70]The Directorate General of Public Health of the Autonomous Community of Valencia, Spain; [71]The Educational Resource Centers, Inc, at the National Institute for Occupational Safety and Health; [57]New York State Department of Health and Braun Medical, Inc. [64]The Centers for Disease Control and Prevention/National Institute of Occupational Safety and Health; Mr. William E. Flanagan Jr; [55]The French Ministry of Health and la Mutuelle Nationale des Hospitaliers and the following companies: Becton-Dickinson, Bristol-Myers-Squibb, Glaxo Wellcome, Johnson & Johnson Medical, Kendall Sherwood David & Geck, MAPA Hutchinson, Merck Sharp & Dohme Chibret, Sanofi Winthrop, SIMS France, and Terumo; [69]Baxter Healthcare Corporation [53, 59]. …”

“…The remaining 21 studies were non-randomized employing a before-and-after study design. Of these 21 studies, four collected data retrospectively throughout the study period [53, 57, 62, 68], three collected data retrospectively for the “before” period and prospectively for the “after” period [54, 64, 66], eight collected data prospectively throughout the study period [26, 55, 59, 67, 69–72], and one collected data retrospectively for the “before period” but was unclear with regards to the “after” period [65]. The five remaining non-randomized studies did not specify their data collection approach [6, 58, 60, 61, 63].…”

“…The included studies involved hospital-based nursing staff ( n  = 20) [6, 26, 53–64, 67–72], clinical staff of hospital-affiliated hemodialysis units ( n  = 1) [66] laboratory personnel and non-nursing phlebotomists ( n  = 7) [6, 55, 57, 62, 65, 68, 70], ancillary/outpatient staff ( n  = 3) [26, 55, 70], housekeeping staff ( n  = 7) [53, 57, 58, 62, 70–72], hospital aide ( n  = 1) [58], surgical and operation room staff ( n  = 7) [26, 53, 58, 59, 62, 68, 70], ambulatory care HCWs ( n  = 1) [60], attending physicians ( n  = 9) [26, 53, 58, 59, 62, 68, 70–72], interns, residents, and fellows ( n  = 6) [6, 26, 57, 59, 70, 71], medical students ( n  = 3) [6, 59, 68], and nursing students ( n  = 2) [59, 71]. …”