Study of a needleless intermittent intravenous-access system for peripheral infusions: analysis of staff, patient, and institutional outcomes.

OBJECTIVE: To assess the effect on staff- and patient-related 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, obstetrics-gynecology, 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 in either insertion-site complications or nosocomial bacteremia. Institutions should consider these data, available institutional resources, and institution-specific data regarding the frequency and risk of intermittent access-device-related injuries and other types of sharps injuries in their staff when selecting the above or other safety devices.

Epidemiology of injuries by needles and other sharp instruments. Minimizing sharp injuries in gynecologic and obstetric operations.

Surgical and obstetric HCWs and epidemiologists will benefit from working together to describe the frequency and circumstances of percutaneous injuries in operating and delivery rooms. Rates of percutaneous injury vary among institutions, and attending and resident surgeons are among those at greatest risk for injury. Gynecologic surgery appears to have one of the highest rates of injury of the surgical specialties, and rates of injury vary by procedure within a given specialty. Suture needles cause the majority of injuries. Certain actions such as holding tissue while suturing or cutting are associated with a higher risk of injury. Many percutaneous injuries appear to be preventable. Epidemiologic data can be used to develop strategies based on the industrial hygiene model to reduce the incidence of percutaneous injury and to collect and disseminate data on the efficacy of new preventive measures. Potentially safer instruments and suture needles, technique modification strategies, and personal protective equipment such as cut-resistant gloves and finger protective strips are now available. Scientific assessment is needed of these and other new measures to determine whether they will decrease the risk of percutaneous injury, be acceptable to users, be cost effective, and avoid adverse consequences to patients or HCWs.

How to select and evaluate new products on the market.

New devices and products often promise to protect health-care workers and patients from transmission of viral infections. These need to be evaluated carefully for efficacy, applicability, and cost in an objective, structured manner.

Bloodstream infections associated with a needleless intravenous infusion system in patients receiving home infusion therapy.

OBJECTIVE: To determine risk factors for bloodstream infections (BSIs) in an outbreak among patients receiving home intravenous infusion therapy. DESIGN: Case-control and retrospective cohort studies. SETTING: Home health agency. PATIENTS: Patients receiving home intravenous infusion therapy from Rhode Island Home Therapeutics (RIHT) from January through December 1993. MAIN OUTCOME MEASURE: Development of primary BSI. METHODS: We compared patients with BSI (ie, case patients) with randomly selected noninfected RIHT patients receiving intravenous therapy, conducted a cohort study of all RIHT patients receiving intravenous therapy via a central venous catheter (CVC), and conducted a culture survey of injection cap luminal fluid. RESULTS: Case patients were more likely than controls to have had therapy via a CVC (11/11 vs 14/32; odds ratio [OR] undefined; P < .001) or total parenteral nutrition and intralipid therapy (TPN/IL) (9/11 vs 3/32; OR, 43.5; 95% confidence interval [CI], 4.9 to 510.0). Among RIHT patients with CVCs, risk factors for BSI were receipt of TPN/IL (9/35 vs 2/67; rate ratio [RR], 8.6; 95% CI, 2.0 to 37.7) or use of a needleless infusion system (10/41 vs 1/61; RR, 14.9; 95% CI, 2.0 to 111.8). Only the combination of both exposures was significantly associated with development of a BSI (P < .001). Luminal fluid from injection caps of needleless devices was significantly more likely to be culture positive than fluid from protected-needle devices (5/23 vs 0/18; RR undefined; P = .04). CONCLUSIONS: Our data suggest that a needleless device used for TPN/IL was associated with increased risk of BSI when injection caps were changed every 7 days.

Disposal-related sharps injuries at a New York City Teaching Hospital.

OBJECTIVE: To characterize disposal-related sharps injuries. DESIGN: A three-part study including (a) descriptive analysis of disposal-related injuries in a 1-year period, (b) 4:1 matched case-control study of nurses injured while using sharps disposal containers, and (c) survey to solicit opinions of users of containers. SETTING: An 1,181-bed teaching hospital in New York City. PARTICIPANTS: For epidemiologic analyses, persons with self-reported injuries identified via New York State and Occupational Safety and Health Administration forms and control nurses without self-reported injuries. For survey, convenience sample of hospital nurses, laboratory workers, and maintenance workers. MAIN OUTCOME MEASURES: Circumstances of injuries determined by study questionnaires. Employee opinions obtained by questionnaires and discussions during small group sessions. RESULTS: Three hundred sixty-one persons reported sharps injuries, of whom 72 (20%) had disposal-related injuries. Persons with disposal-related injuries included four hospital visitors and one patient. Of 67 disposal-related injuries among employees, 25 (37%) directly involved use of a sharps disposal container. Significant risk factors for injury included container height greater than 4 ft above the floor, distance less than 5 ft from site of sharp object use to nearest container, and lack of attendance at universal precautions inservice classes. Survey groups involved 69 employees who identified a variety of preferred features for sharps disposal containers. CONCLUSIONS: Disposal of sharp objects is an important cause of sharps injuries. Ergonomic factors, worker education, and appropriate container design should be considered in injury prevention strategies. Relevant guidelines and regulations are lacking and are needed.

Risk of occupational infection with blood-borne pathogens in operating and delivery room settings.

Surveillance data and case reports substantiate that health care workers are at risk for occupationally acquired infection with blood-borne pathogens. The risk of transmission of blood-borne pathogens to a health care worker depends on the prevalence of blood-borne pathogen infection among patients, the likelihood of transmission of infection per blood contact, and the nature and frequency of occupational blood contacts. In surgical and obstetrical settings, blood contact varies with occupation, specialty, procedures performed, and precautions used. Many contacts appear to be preventable by changes in technique or instrument design and by use of protective barriers. Studies are needed to assess the impact of such interventions.

Cefaclor: summary of clinical experience.

Cefaclor, a new semisynthetic cephalosporin antibiotic for oral use, was studied by 62 clinical investigators in six countries in 1493 adult and paediatric patients. The pooled data reveal that satisfactory clinical responses were obtained in 80% of urinary tract infections, 87% of upper respiratory tract infections, 90% of cases of otitis media, 99% of lower respiratory tract infections, and 96% of skin and skin structure infections. Administration of this antibiotic was associated with a low incidence of adverse reactions including gastrointestinal (2.6%) and hypersensitivity (1.5%). Of particular clinical interest were the outstanding results obtained in the treatment of otitis media and lower respiratory tract infections.

Cefaclor--summary of clinical experience.

Cefaclor, a new semisynthetic cephalosporin antibiotic for oral use, was studied by 62 clinical investigators in 6 countries in 1493 adult and paediatric patients. The pooled data reveal that satisfactory clinical responses were obtained in 80% of urinary tract infections, 87% of upper respiratory infections, 90% of cases of otitis media, 99% of lower respiratory tract infections, and 96% of skin and skin structure infections. Administration of this antibiotic was associated with a low incidence of adverse reactions including gastrointestinal (2.6%) and hypersensitivity reactions (1.5%). Of particular clinical interest were the outstanding results obtained in the treatment of otitis media and lower respiratory tract infections.