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Evaluation of syringes for ionized calcium measurements.

UNLABELLED: Commercially available ready to use syringes (Radiometer, Sarstedt, Ciba-Corning and Portex), containing heparinate as an anticoagulant have been tested to evaluate the magnitude of induced preanalytical errors. Tonometered serum pools adjusted to four Ca2+ concentrations were sampled anaerobically. MEASUREMENTS: Ca2+ and pH (ICA2 with 3 digits, Radiometer Medical A/S, Denmark; Heparin: anti-Xa factor activity on a chromogenic substrate. Results were expressed as means of 10 measurements and as percentages of the reference values. Sarstedt syringes, (Li-heparinate), yielded a negative bias (-3%). However for 0.5 or 1 mL samples the bias reached -4% to -6%. Radiometer syringes (QS50 and QS90; calcium titrated heparinate) demonstrated biases below -2%. The bias in the Ciba-Corning (Gas-Lyte) syringe was below 2%. Portex (Pulsator) syringes showed biases above +4% even for nominal sampling volumes. All syringes (except Pulsator) released anticoagulant amounts corresponding to the expected values. Radiometer and Ciba-Corning were the only recommendable devices.

Anticoagulants↗

Oral syringe use survey.

Use of oral syringes at children's and ASHP-accredited residency hospitals in the United States was surveyed. Questionnaires were mailed to 131 hospitals; 117 (89.3%) were returned. Of the responding hospitals, 54.5% of children's hospitals and 67.1% of residency hospitals used oral syringes. There was no definite preference for a particular brand or type (glass vs. plastic) of syringe. Patients who often required liquid dosage forms, including pediatric and geriatric patients and patients with nasogastric tubes, were most frequently included in oral syringe distribution systems. Twenty-six of the 73 hospitals utilizing oral syringes used them for most unit dose liquids in all drug distribution systems. The remainder reported use for specific medications or circumstances. Expiration dating policies varied from 24 hours to one year to the manufacturer's expiration dating. The survey indicates widespread use of oral syringes and identifies a need for evaluation of medication stability in these devices.

Aged↗

Determination of conditions for the production scale sterilization of prefilled syringes.

External and internal differences in pressure of prefilled syringes can cause plunger movement during sterilization, which might cause drug product contamination. Consequently the pressure inside the autoclave during sterilization should be controlled carefully to prevent contamination of the drug product by microorganism and particulates. A previously determined theoretical relationship of temperature to pressure in sealed bottles was modified for prefilled syringes to take plunger movement into account. This modification yielded a correction factor that includes a coefficient of linear thermal expansion for the syringe, thermal expansion of the plunger, and friction between the plunger and the syringe wall. To confirm the accuracy of this modified relationship, 100 mL polypropylene prefilled syringes with butyl rubber plungers, some of which carried pressure and temperature sensors, were used to test various sterilization conditions at the experimental scale. The results showed that the major problem in establishing the pressure conditions for production scale sterilization is temperature distribution throughout the load. However, an over pressure sterilization cycle at 121 degrees C and 0.34 MPa showed the best results. Microbial challenge and light-obscuration particle count tests were performed on the syringes from the worst-case location predicted from modified relationship; the results show that these conditions preserved the sterility of the drug product and protected it from particulate contamination.

Disposable Equipment↗

Trends of ear syringing at Ibadan, Nigeria.

Ear syringing is a procedure by which the external auditory canal is irrigated with a normal saline at body temperature. It is a procedure which every doctor or nurse should be able to perform proficiently. A study of 622 patients that needed ear syringing was done between December 1999 and June 2001 to determine its trend. There were 341(55%) males and 281(45%) females with age ranged from 3.5months to 89 years: 44.4% were in the first decade of life. Cerumen auris 99% remained the commonest indication for syringing in this study with bilateral cerumen auris constituting 53.1% while right and left cerumen auris constituted 24.4% and 21.5% respectively. Cerumen auris constituted 66% of total 933 Otologic cases seen during the study period. Other indications were otitis externa 0.7% (otomycosis 0.5%; bacterial 0.2%) and foreign body 0.3%. The majority of patients (86%) required between 500mls and 1000mls of fluid for irrigation and 94.9% required not more than one attempt at syringing. The complications recorded were mainly vertigo 0.2% and tympanic membrane perforation 0.2% respectively. Thus ear syringing, though simple and sometimes taken for granted may be fraught with dangers; it is a very safe procedure in trained hands and that after at least three attempts of ear syringing for cerumen auris and if it persists despite effective applications of cerumenolytic agents prior to irrigation, the procedure should be discontinued and other methods of imparted cerumen auris removal should be employed.

Adolescent↗

Hidden reality on the introduction of auto-disable syringes in developing countries.

With the growing concerns about the risk of unsafe injections (e.g. unsterilized injection practices), WHO, UNICEF and UNFPA decided to introduce the auto-disable (AD) syringe for immunization in the world. The AD syringe is designed to be automatically locked after a single use, hence no chance of reuse. Consequently, the risk of infection can be reduced for the recipient. On the other hand, the management of increased medical waste is becoming difficult, as the waste volume of AD syringes would be 200 times as much as those of sterilizable syringes. The used and improperly disposed AD syringes could be a huge source of blood-borne infections and environmental pollution at the community level. This study attempted to explore the present situation with regard to the introduction of AD syringes for immunization in Lao PDR. We conclude that reviewing the present 'safe injection' policy is urgently required in Lao PDR, as well as in other developing countries where the disposal system for medical wastes is not yet well established.

Child, Preschool↗

Estimation of cost savings from reprocessing of plastic syringes. A case analysis.

Analysis of the cost of reprocessing plastic syringes in a hospital sterilization unit is considered. A simple model to estimate the cost of reprocessed syringes, showed that a syringe that had been reprocessed once was 29.8% cheaper than a new one. Reprocessing each of the 21,000 plastic syringes that are reprocessed in this unit per month once, realises savings in the order of KSh37,590 (US$ 1600). Although this unit reprocesses syringes about 10 times before disposal, the largest savings per reprocessing cycle occurred during the first 5 cycles. The cost of a reprocessed syringe does not reach its asymptotic value until after about 1,000 cycles.

Central Supply, Hospital↗

Changes in oxygen measurements when whole blood is stored in iced plastic or glass syringes.

Tonometered whole-blood and plasma specimens were tested in plastic and glass syringes to determine whether clinically significant changes in gas tensions occur during sample storage. When whole blood was tonometered with 60 and 100 mL/L (6% and 10%) oxygen and then stored for 30 min in iced plastic syringes, the pO2 of the samples remained stable (mean change = +0.4 and +0.8 mmHg, respectively). However, for 140 mL/L (14%) oxygen tonometry, the pO2 increased significantly (mean change = +8.4 mmHg; P less than 0.0001). When tonometered plasma was stored in iced plastic syringes, the pO2 increased progressively at all three concentrations, with the smallest change occurring at 140 mL/L (mean change = +12.6 mmHg) and the greatest at 60 mL/L oxygen (mean change = +20.9 mmHg). In contrast, when iced glass syringes were used for storing plasma or whole blood, no clinically significant changes in pO2 were found at any of the tonometered oxygen values for 60 min. When whole blood was stored in plastic syringes at ambient temperature for 30 min, again no clinically significant changes in pO2 were found at these tonometry conditions. Apparently, some blood gas samples stored in iced plastic syringes may yield clinically significant errors in oxygen tension.

Blood Gas Analysis↗

Dry electrolyte-balanced heparinized syringes evaluated for determining ionized calcium and other electrolytes in whole blood.

By analyzing whole blood containing no anticoagulants (uncoagulated whole blood) immediately after collection, we evaluated the relative changes in the concentrations of ionized calcium and other electrolytes in whole blood collected in dry heparinized syringes and in serum prepared from blood collected in evacuated blood-collection tubes. Using these dry heparinized syringes, we collected and analyzed whole blood that contained either 33 or 13 int. units of lithium heparin or 40 int. units of electrolyte-balanced heparin per milliliter of blood. We evaluated the effects both of these heparins at different concentrations of ionized calcium and of the incomplete filling of the syringes. We conclude that: (a) when analyzed within 2-3 min after collection, uncoagulated whole blood provides ionized calcium results unaffected by anticoagulants or cellular metabolism; (b) the preparation of serum unpredictably changes ionized calcium; (c) the use of dry electrolyte-balanced heparin virtually eliminates the interference in ionized calcium concentrations between 0.9 and 1.6 mmol/L; and (d) incomplete filling of electrolyte-balanced heparinized syringes produces no effect in syringes two-thirds full (60 int. units/mL heparin concentration) and a small effect in syringes one-third full (120 int. units/mL heparin).

Adult↗

Multiple reuse of disposable insulin syringes in hospital.

In a prospective study disposable insulin syringes were repeatedly used for injecting insulin to 92 insulin-taking diabetic patients admitted in hospital with various illnesses. One separate syringe was used for each patient; the syringes were not washed or boiled and were not kept in spirit or in refrigerator during reuse. Syringes were flushed with air, needle recapped and replaced into their plastic cover. Number of injections made using one syringe was 2 to 120 (mean 31.3, SEM 2.3). For the patients' total insulin - taking period in hospital one disposable syringe per patient was enough in all but six cases. There were 2792 reinjections and incidence of infection of the injection site was zero.

Bangladesh↗

Evaluation of force requirements during use of recycled plastic syringes.

Forces required to withdraw the piston in recycled syringes were investigated. New disposable syringes were used as a reference. The force required in withdrawal of the piston for recycled syringes was between 3 and 8 times that required for the reference syringes. Lubrication reduced the force for the recycled syringes substantially. A modification of syringe recycling protocol is suggested.

Developing Countries↗

[The syringe dispenser project in Larvik. Experiences after one year].

Limiting the use of contaminated syringes is an important step in the battle against hepatitis B and HIV epidemics. In 1987 a project, the first of its kind, was started in Larvik and the county of Vestfold in Norway. Syringe dispensers were put up in order to ensure that drug addicts had access to sterile syringes throughout the day and night. Looking back on one year's operation, the results and reactions are positive. The programme led to increased availability of syringes, reduced use of contaminated syringes, no pollution problems of significance and a decrease in the incidence of hepatitis B. We have also been able to channel increased information to a group hitherto difficult to reach. The involvement of the local public-health authorities has increased their contact with intravenous drug users. This has in turn laid the foundation for better future cooperation with this group. Setting up syringe dispensers has been shown to be an important factor in the battle against hepatitis B and HIV epidemics. This project has also provided a starting point for further work on drug abuse.

Evaluation Studies as Topic↗

The effects of the liberalization of syringe sales on the behaviour of intravenous drug users in France.

A study to evaluate the effects of the liberalization of syringe sales in France, which was carried out in 1987 and 1988 in Paris and at Créteil, Maisons-Alfort, Metz, Bordeaux and Marseille by a research team of the Institute for Epidemiological Research on Drug Dependence (IREP) in Paris, included two samples of intravenous users of drugs, primarily heroin: a street sample of 157 persons and a sample of 123 persons undergoing treatment for drug addiction at in-patient facilities. The study, based on interviews, showed that the emergence of acquired immunodeficiency syndrome (AIDS) had brought about a radical change in the environment of intravenous drug users, of whom approximately 40 per cent were infected with the human immunodeficiency virus (HIV). Liberalized syringe sales had an obvious effect on the behaviour of intravenous drug users: approximately half of them did not share syringes and purchased them at pharmacies, while the rest continued sharing syringes in a variety of ways. The authors concluded that the decision to make syringes freely available for sale was not, by itself, sufficient to cope with the syringe-sharing problem and that, in addition, appropriate educational programmes, personalized and geared to each subject's special circumstances, needed to be provided.

Acquired Immunodeficiency Syndrome↗

Analysis of hydroxyzine hydrochloride, meperidine hydrochloride and atropine sulfate in glass and plastic syringes.

The apparent stability of combinations of hydroxyzine hydrochloride and meperidine hydrochloride (50 mg/2 ml each) and of these two drugs (50 mg/2.5 ml each) and atropine sulfate (0.4 mg/2.5 ml) in prefilled glass and plastic syringes was studied. Syringes (3 ml) containing the combinations were stored at 25 C and 3 C for 10 days and analyzed at specific time intervals. Absorption spectra, chromatographic characteristics and pH were determined in addition to visual inspection. Results of these qualitative tests indicated that the mixtures apparently were stable for 10 days at room temperature or when refrigerated. No differences were found between solutions stored in glass and those stored in plastic syringes. Degradation of the syringe contents or appearance of additional constituents was not detected in any of the admixtures, and they were considered to be chemically compatible within the limitations of the study. The study suggests that storage of these combinations in syringes is feasible but the results cannot be extrapolated to drug solutions or syringes other than those studied.

Atropine↗

Viral contamination of intradermal skin test syringes.

Intradermal skin tests are often performed using a common syringe with multiple needles. Bacterial contamination of intradermal skin test syringes can occur as a result of apparent siphoning caused by needle changing. The bacterial contamination of the syringe can be prevented by flushing the contaminated needle prior to changing. In this study, two different needle changing techniques were examined using a polio virus contaminant. Viral contamination of the syringe was not prevented by flushing the infected needle prior to removal. All syringes were contaminated with virus regardless of needle changing technique. We, therefore, cannot recommend the continued use of a common syringe for intradermal skin tests between patients regardless of needle changing technique.

Equipment Contamination↗

Outcome of multiple usage of disposable syringes in the insulin-requiring diabetic.

The majority of diabetics in this country use disposable syringes and needle units for their insulin injections. Health care providers have traditionally recommended that these disposable syringes be discarded after each use to reduce the possibility of infection; manufacturer's instructions also state that the disposable syringes are to be used once and then discarded. Despite the limited research in this area, many American diabetic teaching programs have recently adopted a policy of encouraging ambulatory diabetics to reuse their syringes. However, the subject remains controversial. Of 166 subjects surveyed at a diabetic clinic, 74 (44.6%) reused their insulin syringes. Four syringes were found to be contaminated with normal skin flora. No pathogenic organisms were isolated. In addition, 15.1% of the subjects did not clean their hands or the site prior to the injection.

Adult↗

Stability of cephalexin monohydrate suspension in polypropylene oral syringes.

The stability of cephalexin monohydrate suspension in plastic oral syringes was studied. Commercially available cephalexin monohydrate powder for oral administration was reconstituted according to the manufacturer's instructions and stored in the original containers or drawn into 5-mL clear polypropylene oral syringes. The original containers and syringes were divided into groups and stored at -20, 4, 25, 40, 60, or 80 degrees C. Powder from two additional lots was similarly reconstituted and packaged; these original containers and syringes were stored at 80 degrees C only to assess interlot variability. Immediately after reconstitution and at specified times during storage, three syringes and the corresponding three original containers stored at each temperature were removed, and their contents were analyzed for cephalexin concentration using the standard USP iodometric assay for antibiotics. The stability-indicating nature of the assay was documented. Cephalexin monohydrate followed a first-order rate of degradation at temperatures of 40, 60, and 80 degrees C. At temperatures of -20, 4, and 25 degrees C, cephalexin monohydrate exhibited no appreciable degradation during the 90-day study period. Cephalexin monohydrate suspension reconstituted from powder as a suspension and repackaged in clear polypropylene oral syringes was stable for 90 days when stored under ambient, refrigerated, and frozen conditions.

Administration, Oral↗

Stability of ampicillin trihydrate suspension in amber plastic oral syringes.

The stability of ampicillin trihydrate oral suspension stored in amber plastic oral syringes was studied. Commercially available ampicillin trihydrate powder for oral suspension was reconstituted according to manufacturer's instructions and drawn into 5-mL amber polypropylene plastic oral syringes. The syringes were divided into groups and stored at -20, 4, 25, 60, or 80 degrees C. Powder from two additional lots was similarly reconstituted and packaged and stored at 80 degrees C only to assess interlot variability. Immediately after reconstitution and at specified times during storage, three syringes at each storage temperature were removed and their contents analyzed for ampicillin trihydrate concentration by a spectrophotometric assay. Samples stored at frozen (-20 degrees C) or refrigerated (4 degrees C) temperature retained at least 90% of the initial ampicillin concentration throughout the 47-day study period. Samples stored at room temperature retained at least 90% of the initial ampicillin concentration for 30 days and exhibited an apparent zero-order degradation rate. Samples stored at heated temperatures (60 and 80 degrees C) exhibited an apparent first-order degradation process, with the concentration of ampicillin decreasing to less than 90% of initial concentration within two hours. Reconstituted ampicillin trihydrate powder for oral suspension is stable for at least 30 days when stored at room, refrigerated, or frozen temperature in the amber plastic oral syringes studied. The expiration dates recommended by the manufacturer for ampicillin trihydrate suspension stored in its original container can also be used for reconstituted suspension stored in these amber plastic syringes.

Ampicillin↗

New gas-liquid equilibration method: syringe tonometer.

This new apparatus for gas-liquid equilibration (tonometry) in a transportable vessel is designed for tonometry of blood or buffer solution in a specially designed syringe. Gas enters the syringe chamber through small holes in the tip of the syringe plunger and bubbles upward through the sample. The syringe plunger is a second chamber, which is used for warming and humidifying the gas before it enters the tonometer chamber. The entire syringe is housed in a transparent, temperature-controlled environment during equilibration. After equilibration, the sample is easily entered into a blood-gas analyzer. At most, gas-liquid O2/CO2 equilibration for 2.5 mL of buffer or blood requires less than 13 min. Comparisons with a standard thin-film tonometer show good agreement for pO2 and pCO2 over the range 0-93 kPa (0-700 mmHg) and 2-20 kPa (14-150 mmHg), respectively. The syringe tonometer eliminates contamination of the sample during transfer and transport to the analyzer, thus making tonometry more technique-independent. The apparatus is simple and easy to use, with definite advantages over existing methods of tonometry.

Blood Gas Analysis↗