Assessment of efficacy of postinfusion tubing flushing in reducing risk of cytotoxic contamination.

PURPOSE: Infusion of cytotoxic drugs carries the risk of occupational exposure of healthcare workers. Since disconnecting an infusion line is a source of contamination, flushing of tubing after infusion of cytotoxic agents is recommended, but the optimal volume of rinsing solution is unknown. The objective of this study was to assess whether postinfusion line flushing completely eliminates cytotoxics. METHODS: Infusions were simulated with 3 cytotoxics (gemcitabine, cytarabine, and paclitaxel) diluted in 5% dextrose injection or 0.9% sodium chloride injection in 250-mL infusion bags. Infusion lines were flushed using 5% dextrose injection or 0.9% sodium chloride solution at 2 different flow rates. The remaining concentration of cytotoxics in the infusion line was measured by a validated high-performance liquid chromatography (HPLC) method after passage of every 10 mL of flushing volume until a total of 100 mL had been flushed through. RESULTS: All cytotoxics remained detectable even after line flushing with 80 mL of flushing solution (a volume 3-fold greater than the dead space volume within the infusion set). Gemcitabine and cytarabine were still quantifiable via HPLC even after flushing with 100 mL of solution. Efficacy of flushing was influenced by the lipophilicity of drugs but not by either the flushing solvent used or the flushing flow rate. After 2-fold dead space volume flushing, the estimated amount of drug remaining in the infusion set was within 0.19% to 0.56% of the prescribed dose for all 3 cytotoxics evaluated. CONCLUSION: Complete elimination of cytotoxics from an infusion line is an unrealistic objective. Two-fold dead space volume flushing could be considered optimal in terms of administered dose but not from an environmental contamination point of view. Even when flushed, the infusion set should still be considered a source of cytotoxic contamination.

Treatment of invasive fungal infections: stability of voriconazole infusion solutions in PVC bags

Voriconazole is a novel broad-spectrum antifungal drug, employed in the treatment of invasive fungal infections, and represents an alternative to amphotericin B treatment. The manufacturer recommends that any unused reconstituted product should be stored at 2ºC to 8ºC, for no more than 24 h, but no recommendations about i.v. infusion solutions are given. Previous works have reported on the stability of voriconazole in polyolefin bags and just one in 5 percent dextrose polyvinyl chloride (PVC) bags, at a 4 mg.mL-1 concentration. In this work, the stability of voriconazole as an i.v. infusion solution in 0.9 percent sodium chloride and in 5 percent dextrose, in PVC bags, at 0.5 mg.mL-1, stored at 4 ºC and at room temperature, protected from light, was evaluated. These infusion solutions were analyzed for a 21-day period. Chemical stability was evaluated by HPLC assay. Visual inspection was performed and pH of the solutions was measured. No color change or precipitation in the solutions was observed. The drug content remained above 90 percent for 11 days in 0.9 percent sodium chloride and for 9 days in 5 percent dextrose solutions. The i.v. infusion solutions stored at room temperature were not stable. At room temperature, the voriconazole content dropped down to 88.3 and 86.6 percent, in 0.9 percent sodium chloride or 5 percent dextrose solutions, respectively, two days after admixture. Assays performed at the end of the study suggest the sorption of voriconazole by the PVC bags. The results of this study allow cost-effective batch production in the hospital pharmacy.

Treatment of invasive fungal infections: stability of voriconazole infusion solutions in PVC bags.

Voriconazole is a novel broad-spectrum antifungal drug, employed in the treatment of invasive fungal infections, and represents an alternative to amphotericin B treatment. The manufacturer recommends that any unused reconstituted product should be stored at 2 masculineC to 8 masculineC, for no more than 24 h, but no recommendations about i.v. infusion solutions are given. Previous works have reported on the stability of voriconazole in polyolefin bags and just one in 5% dextrose polyvinyl chloride (PVC) bags, at a 4 mg.mL-1 concentration. In this work, the stability of voriconazole as an i.v. infusion solution in 0.9% sodium chloride and in 5% dextrose, in PVC bags, at 0.5 mg.mL-1, stored at 4 masculineC and at room temperature, protected from light, was evaluated. These infusion solutions were analyzed for a 21-day period. Chemical stability was evaluated by HPLC assay. Visual inspection was performed and pH of the solutions was measured. No color change or precipitation in the solutions was observed. The drug content remained above 90% for 11 days in 0.9% sodium chloride and for 9 days in 5% dextrose solutions. The i.v. infusion solutions stored at room temperature were not stable. At room temperature, the voriconazole content dropped down to 88.3 and 86.6%, in 0.9% sodium chloride or 5% dextrose solutions, respectively, two days after admixture. Assays performed at the end of the study suggest the sorption of voriconazole by the PVC bags. The results of this study allow cost-effective batch production in the hospital pharmacy.

Assessment of cerebrospinal fluid outflow conductance using constant-pressure infusion--a method with real time estimation of reliability.

The outflow conductance (C(out)) of the cerebrospinal fluid (CSF) system is a parameter considered to be predictive in selection for hydrocephalus surgery. C(out) can be determined through an infusion test. A new apparatus for performing infusion tests in a standardized and automated way was developed. The objective was to evaluate repetitiveness as well as to propose and evaluate a method for real time estimation of the reliability of individual C(out) investigations. Repeated investigations were performed on an experimental model simulating the CSF system, and on 14 patients with hydrocephalus. DeltaC(out), calculated as the 95% confidence interval of C(out), was introduced as an estimate of the reliability of individual C(out) investigations. On the model, no significant difference was found between DeltaC(out) and the actual C(out) variation in repeated investigations (p = 0.135). The correlation between the first and the second patient investigation was high (R = 0.99, p < 0.05), although there was a significant difference between the investigations (p < 0.05). The standard deviation of difference was 2.60 microl (s kPa)(-1). The repetitiveness of C(out) with the new apparatus was high, and DeltaC(out) reflected the reliability of each investigation. This feature has to be taken into account in every individual case, before making a decision or performing research based on measurements of C(out) in the future.

Changing practice in the subcutaneous infusion of fluids to improve safety.

Many nurses administer subcutaneous infusion therapy; it is seen as an alternative to intravenous therapy. But how sharp-safe is the equipment they use? An evaluation of a clinical trial on a catheter to replace metal butterfly needles is outlined, together with details of how this was introduced into clinical areas.

Comparison of subcutaneous infusion needles for transfusion-dependent thalassemia patients by the intrapersonal cross-over assessment model.

Needle-induced trauma is one of the major contributing factors for poor compliance in patients with thalassaemia major on iron chelation therapy. A new generation of needles is currently available on the market, but their theoretical advantages have not been tested clinically. We performed a study to compare the pros and cons of the representative prototypes from each of the new (Thalaset needle) and old (butterfly scalp vein needle) generations of needles. Patients with thalassemia major who had been receiving subcutaneous iron chelation therapy for at least 2 years were recruited. Patients using butterfly needles were instructed to switch to the newer form of needle (Thalaset) for 2.5 months and then to change back to butterfly needles for another 2.5 months. Comparison was done by the intrapersonal cross-over model using three identical sets of questionnaires collected at the beginning of the study and after the use of Thalaset and butterfly needles, respectively. Fifty-four (22 females; 32 males) patients were included in the statistical analysis. The median age was 24.1 years (range = 7.6-47.2 years). Local reactions such as pain, itchiness, tenderness, and swelling were significantly different among the three evaluation periods and were all in favor of the Thalaset needle (all with P < 0.001), even after adjusting for the intention-to-treat calculation. The Thalaset needle is significantly better than the butterfly needle in reducing needle-related trauma. It induced fewer local skin reactions such as pain, itchiness, tenderness, and swelling. However, recommendations for its routine clinical use require further cost-effectiveness analysis.

An introduction to the Micrel Micropump MP Daily portable syringe driver.

In this article the author describes the Micrel Micropump MP Daily (MP Daily) portable syringe driver. This follows the author's experience of a 4-month pilot of the device by an inpatient palliative care unit. Portable syringe drivers are commonly used to deliver continuous subcutaneous infusions in palliative care situations. Those in current use are not without problems and serious adverse events have occasionally been reported, mainly resulting from confusion between models. The MP Daily syringe driver addresses some of these issues while remaining small, lightweight and inexpensive, with a long battery life and fitting into the pocket of a shirt of pyjama jacket. Improvements over current models include an on/off button, the absence of facilities to set a zero rate or change the rate once the syringe driver is running, and the absence of a boost button. In addition, there are improved alarms, a message display system and a configuration menu. Although confusion remains a problem, and the ideal has not yet been reached, the MP Daily goes some considerable way towards reducing risks and opportunities for human error.

Using benchmarking data to determine vascular access device selection.

Benchmarking data has validated that patients with planned vascular access device (VAD) placement have fewer device placements, less difficulty with device insertions, fewer venipunctures, earlier assessment for placement of central VADs, and shorter hospital stays. This article will discuss VAD program planning, early assessment for VAD selection, and benchmarking of program data used to achieve positive infusion-related outcomes.

A computerized data acquisition system for infusion devices--a clinical support tool, or a risk management tool?

A prototype computerized system for automatic data collection from multi-vendor infusion devices was constructed. The system was specifically designed around the needs of the critical care environment, and a survey of clinical staff was conducted to determine the functional requirements. Hardware, software and system configuration was based on the Medical Information Bus IEEE 1073 standard for medical device data communications. The infusion devices were configured into device communication controllers (DCC), which were polled at 0.25 Hz by a PC configured as a bedside communication controller (BCC). The system stores data samples after intervals of 1 ml of drug delivery and following any changes in the infusion rate. The system demonstrated significant opportunities for supporting clinical care and for the management of health care technology.

[Perfusion instruments: analysis of product surveillance in 1998 and its on-the-job training. Subcommittee 4b for Product Surveillance]. / Matériels de perfusion: le bilan de la matériovigilance en 1998 et ses enseignements pour la pratique. Sous-commission 4b de matériovigilance.

OBJECTIVES: To analyze retrospectively the data base of the French national vigilance reporting system concerning infusion devices during the year 1998. METHODS: Each report has been reviewed and classified, except implantable catheter ports. RESULTS: The study included 309 reports. Among them, 28% concerned infusion pumps and 72% single use devices, i.e. catheters, infusion lines, taps, connectors, etc. We observed six deaths and 23 severe incidents. Only 25% of devices could be formally investigated by manufacturers. The origins of incidents were very different between infusion pumps and single use devices. The first showed simple failures, software errors, maintenance omissions or errors, and problems related to obsolescence of the device. The second revealed manufacturer quality insurance failures, design and utilization errors, and problems related to the technique itself rather than device. DISCUSSION: Our findings are similar to the few data available in international literature. They address the need to obtain an adequacy between the performances of devices which vary with generations of devices and the clinical risks: newest and safest devices should be preferred for the infusion of the most critical drugs.

Infusion perfusion: i.v. pumps for every need.

Infusion pumps offer many options to improve patient care. Learn the latest technology and use this guide to choose the right pumps for your units.

The potential for use of steam at atmospheric pressure to decontaminate or sterilize parenteral filling lines incorporating barrier isolation technology.

Barrier isolators that enclose aseptic filling equipment are being proposed as a means of: (1) assisting in achieving a 10(-6) sterility assurance level (SAL) in the filling area and (2) minimizing the clean environment required in the manufacturing area. The need for operator and maintenance access to the interior of the barrier isolators presents difficulties in achieving the above goals. Several methods are available for reducing the microbial level inside the isolation barrier. If the objective is the decontamination of all surfaces inside the enclosure, saturated steam at atmospheric pressure can be used. If the objective is to sterilize the inside of the enclosure, saturated steam at atmospheric pressure with added H2O2 can be used. Test data and practical interface considerations relative to various methodologies will be reviewed.

Peripheral access options.

With the dramatic downsizing of acute care facilities and shifting to alternate care settings, infusion therapy is a major aspect of outpatient and home health services. Health care reform has forced health care practitioners to make cost-driven clinical decisions, while at the same time demanding quality outcomes. Technology has advanced our capabilities to provide infusion therapies in all settings. Controversial questions are asked regarding the selection of the appropriate device, catheter tip position, tip position verification, and care and management techniques, which only well-designed research protocols can answer. In the meantime, clinical decisions must be based on current science and physiologic principles, rather than tradition, anecdotal observation, or competitive financial agendas. Peripheral access catheters, if widely used, afford a tremendous opportunity for positive outcomes and cost savings.

Marketing home i.v. antibiotic therapy to physicians.

Home intravenous antibiotic therapy (HIVAT) is a safe, efficient, and cost-saving alternative to hospitalization--and the program of choice among patients and their families. Before the full spectrum of benefits can be realized, home infusion companies face the challenge of educating primary care physicians in HIVAT patient selection, antibiotic considerations, and the home care provider team approach.

Hypodermoclysis (HDC) for symptom control vs. the Edmonton Injector (EI).

Hypodermoclysis (HDC) is a well-known method of providing symptom control in terminally ill patients. In this article we make reference to two previous reports describing our use of HDC and a new method of subcutaneous narcotic delivery called the Edmonton Injector (EI). The rationale for using HDC mainly for rehydration and the EI when subcutaneous narcotics are needed is explored. The controversy surrounding the treatment of dehydration in the terminally ill is examined. Finally, the advantages on our palliative care unit of the convenience, increased flexibility, and cost and time saving of these two treatment methods are discussed.