Effect of adverse storage conditions on performance of glucometer test strips.

OBJECTIVE: A study was conducted to assess the impact of adverse storage environments, i.e., not manufacturer recommended, on the performance of reagent test strips used with a point of care testing (POCT) glucometer to measure whole blood glucose levels. DESIGN/SETTING: Glucose reagent test strips were placed in open, i.e., uncapped, and closed, i.e., capped vials. These vials were those used by the manufacturer to package and store the reagent test strips. One of each type of vial was placed in the manufacturer-recommended storage environment at room temperature and the adverse environments (incubator, direct light to mimic sunlight exposure, humidity, and refrigerated). The Accu-Chek Easy glucometer and reagent test strips as well as Accu-Chek Easy high and low glucose control solutions, manufactured by Roche, were used for this study. MAIN OUTCOME MEASURES: On day-3, day-7, and then once every 7 days, one strip from each vial in each environment was tested with the same glucometer using both a high and a low glucose control. The strip was considered failed for a type of vial and storage environment when either control was out of the reference range on a regular testing day and still out of range when tested the subsequent day. Testing continued up to 50 days. RESULTS: For the tested environments it was found that, overall, test strip stability lasted longer for closed vials than open vials. For open vials in adverse storage conditions, the refrigerator environment offered the longest stability at 35 to 50 days and direct light and humidity offered the shortest periods of stability at 3 to 14 days. CONCLUSIONS: The results of this study support the manufacturer's recommendations to store POCT glucose test strips in their original vial, capped, and at room temperature, though refrigeration may offer an alternative storage environment with acceptable stability. As compliance with testing, quality control, and storage instructions is often an issue with POCT, the manufacturers of these systems for blood glucose measurement should design storage systems that allow the patient to store the glucose meter and the reagent strips in the same location. Manufacturers may also need to consider designing storage systems that are more portable, knowing that patients must take the glucose meters and test strips with them when they travel. Roche's Accu-Chek Compact system is an example of such a design. The glucose test strips are incorporated into a drum that is stored in the Accu-Chek meter itself. When a patient performs a fingerstick blood glucose measurement, the drum advances to move a test strip outside the meter. When the test is complete, the test strip is ejected for disposal. Future studies to clarify the effect of adverse storage conditions, particularly refrigeration, on the integrity of POCT test systems and reagent strips is warranted with currently marketed brands.     

Evaluation of four mycobacterial blood culture media: BACTEC 13A, Isolator/BACTEC 12B, Isolator/Middlebrook agar, and a biphasic medium

Four commercially available mycobacterial blood culture systems were compared for sensitivity and time to detection of growth. A 5-ml volume of SPS-anticoagulated blood was cultured in a BACTEC 13A vial and a modified M7H11/BHI biphasic medium. In addition, two aliquots of Isolator concentrates, each derived from 5 ml of blood, were inoculated into a BACTEC 12B vial and onto a pair of Middlebrook 7H11 agar plates (M7H11). Mycobacteria were recovered from 32 of 180 cultured specimens (17.8%). Growth was detected in 30 (93.7%) of the 13A vials, 27 (84.4%) of the M7H11 agar plates, 26 (81.2%) of the 12B vials, and 14 (43.8%) of the biphasic bottles. The mean times to growth detection in the 13A vial (14.2 days) and the 12B vial (13.7 days) were shorter than in either the M7H11 plates (20.8 days) or the biphasic medium (24.1 days). When the Isolator/12B vial-and-M7H11 plates were evaluated as a single system, 29 cultures (90.6%) had a mean time to growth detection of 13.5 days. Colony-forming units per ml were inversely associated with time to growth detection. Delay in transport (greater than 24 h) appeared to reduce viability. The direct inoculation feature makes the 13A vial very suitable for mycobacterial blood cultures.     

Multidose vial contamination in anesthesia

The intent of this research was to address the following question: Will an alteration in the drug aspiration technique cause a significant difference in the incidence of multidose vial contamination? The control group consisted of multidose vials collected at the end of each day from staff anesthetists. The use of these vials reflected the practice technique of a single needle and syringe for each vial. The vial, as well as needle and syringe, were used on all cases managed for the day. The experimental group consisted of multidose vials collected at the end of each day from the four investigators. The vials and syringes were utilized in the same manner as the control group with the exception that a new needle was used each time a vial was reentered. Upon completion of the collection period, guaiac testing, using Hemoccult slides and developer, was performed on a 0.1 cc sample from each vial. A multidose vial was considered positive for blood contamination if traces of blue appeared on the Hemoccult slide in a 15-minute period. A chi-square statistic was applied to the cumulative data. The control group consisted of 492 multidose vials. Of the 492 multidose vials tested, 11 were guaiac positive, 2.24%. The experimental group consisted of 369 multidose vials. Of the 369 multidose vials, one tested guaiac positive, 0.27%. A chi-square test on the cumulative data demonstrated a significant (p less than .05) difference between the two groups. The research demonstrated that occult blood may be contained within the used multidose vials suggesting that contaminated drug may then be injected into another patient.(ABSTRACT TRUNCATED AT 250 WORDS)     

Risk of latex allergy from medication vial closures

A latex allergy, like all allergies, is a serious matter that requires special precautions on behalf of patients and healthcare workers. The FDA final rule on the labeling of natural rubber-containing medical devices will assist in the creation of a latex-safe environment for latex-sensitive individuals. Currently, this ruling does not apply to medication vial closures that contain latex. Until further action by the FDA, the only way to determine whether a medication vial closure contains latex is by directly contacting the pharmaceutical manufacturer. Moreover, in order to rule whether special labeling should be mandatory for latex-containing medication vials, additional evidence is needed to clarify whether exposure to trace amounts of latex from a medication vial stopper can cause allergic reactions in individuals who are sensitive to latex.     

Calfactant sterility in multiple doses from single-use vials

BACKGROUND: Calfactant is an exogenous surfactant used to treat and prevent respiratory distress syndrome in the newborn infant. It is available in single-use preservative-free vials, but contains enough volume to provide multiple doses to small infants. OBJECTIVE: To measure the preservation of calfactant sterility at 12- and 24-hour intervals following initial violation of vial contents and to extrapolate cost savings associated with product conservation. METHODS: A prospective sterility study was performed using calfactant suspension obtained from vials prescribed for infants who had received their dose in the delivery room or the neonatal intensive care unit (NICU). After initial vial entry, test vials were stored in the NICU pharmacy satellite under refrigeration (temperature range 2.2-7.2 degrees C). Re-entry of test vials and sample removal was performed 12 and 24 hours after initial entry with an 18- or 20-gauge needle. All samples were removed by a neonatal respiratory therapist and placed into 3-mL latex-free, Leur-lok plastic syringes and examined by 3 culture media: MacConkey agar, blood agar, and thioglycollate broth. RESULTS: A total of 89 surfactant samples from 45 vials were cultured; 45 at a mean time of 13.36 hours (range 11-41) and 44 at a mean time of 25.8 hours (range 22-60) after initial vial entry. These samples represented the technique of multiple respiratory therapists. All samples were negative for bacterial growth at 24 and 48 hours (beta = 0.9). CONCLUSIONS: Results from this short-term sterility study represent an initial step in the evaluation of multiple doses of surfactant from a single-use vial. The data suggest that 1-2 re-entries into a vial of calfactant, within 24 hours after the initial breach, can be a safe and economical method of providing more than a single dose of surfactant to infants weighing <1 kg. We encourage each institution to reproduce these findings before applying this concept to their patients.     

Antimicrobial residual drug error in the intensive care unit; a single blinded prospective observational study

ObjectiveTo determine the percentage of drug remaining in discarded antibiotic vials after use.DesignBlinded prospective observational trial.Setting26-bed Australian metropolitan tertiary referral intensive care unit.Main outcome measuresPercentage of labelled dose remaining in the vial after discard.MethodDiscarded antibiotic vials collected over a 7-day period in an adult intensive care unit were analysed. Each collected vial had any drug remnant washed out and made up to a known volume. A 1 ml aliquot of each vials washings was analysed using high performance liquid chromatography. From this concentration, the percentage of the drug remaining in the vial after discard was calculated. Additionally, each vial was weighed before and after washing to determine the weight of the remnant in each vial.ResultsA total of 311 vials comprising of 11 different drugs and 14 individual vial types were collected. The median residual drug error across all vials was 3.7 %. The drug with the highest median was piperacillin at 6.1 % (IQR 4.3) and the lowest was amoxicillin 0.2 % (IQR 0.1). The single highest value for a given vial was vancomycin (500 mg) with 33.2 % and the lowest for a given vial was 0.1 % amoxicillin (1 g). These two drugs also exhibited the greatest range between the maximum and minimum value for any drug being 32 % and 0.9 % respectively.ConclusionsOur study shows that up to a third of the intended dose may fail to reach the patient, highlighting a significant factor in the administration of antibiotics to the critically ill population.Implications for clinical practiceResidual drug often remains in antibiotic vials meaning that drug is not reaching the patient. There is considerable variation in the method by which medications are reconstituted in clinical settings. Two person checks should be completed after reconstitution in order to ensure that the medication is fully reconstituted and extracted from the vial.     

The effect of preactivation vial temperature on the acoustic properties of Definity™

Definity^TM is a widely available clinically approved ultrasound contrast agent. The manufacturer’s instructions indicate that the refrigerated vial should be allowed to reach room temperature prior to its 45 s mechanical agitation activation process. Activation results in vial heating and it has been previously observed that “smaller” bubbles are formed later in this process (>10 s) when the vial temperature is elevated. The objective of this work was to examine the effects of preactivation vial temperature on the size distribution, frequency dependent attenuation (1.5–27 MHz) and nonlinear imaging performance of Definity^TM. Experiments were conducted with vials at refrigerator temperature (2°C), room temperature (22°C) or 37°C at the outset of the activation procedure. The size distributions were found to be strongly dependent on preactivation vial temperature and the attenuation results indicated considerable differences in the frequency response of the agent, most notably the appearance of a peak at 4 MHz for the 2°C case. Nonlinear imaging results performed using a 1–5 MHz transducer probe with a wall-less vessel phantom indicated that 2°C vials produced a signal enhancement 5.1 dB greater than for 22°C Definity^TM (p < 0.05). These results, therefore, indicate that not permitting the vial to reach room temperature has a considerable impact on the imaging performance of Definity^TM. Conversely, activating a cooled vial can provide a means by which to improve contrast enhancement when using low frequency clinical transducers.     

EVALUATION OF DRUG CONTAMINATION LEVELS IN AN ADMIXTURE PREPARATION AREA

The risks of drug contamination after transfer manipulations between vials used in admixture preparations were estimated. The transfers were performed inside a safety cabinet using sodium pertechnetate ⁹⁹Tc^min saline as a 'model' admixture.
An air contamination monitor was attached to the safety cabinet above the transfer manipulation area. The monitor filter and all utensils used were collected for measurement of contamination levels in each sample trial.
Three types of transfer were performed; one 'open' procedure and two 'closed' procedures, one including an air vent needle in the receiving vial and the other without air vent needle in the receiving vial. The closed procedure including an air vent needle appears to combine good personnel- and product protection.     

Evaluation of Bactec high blood volume resin media.

BACTEC PLUS high-blood-volume resin media (aerobic BP 26 vial and anaerobic BP 27 vial) were compared with standard BACTEC media (aerobic NR 6A and anaerobic NR 7A vial). A total of 2253 blood culture sets, each consisting of the four vials, were collected. Positive cultures were obtained from 403 sets and grew 428 organisms; 271 organisms were considered as significant. The BACTEC PLUS high blood volume resin (BP-HBV) media grew significantly more Staphylococcus aureus, coagulase-negative staphylococci, Candida albicans, Enterococcus faecalis, and Pseudomonas aeruginosa. After taking into account the difference of blood volume between the two systems, only S. aureus was significantly more detected by the aerobic BP 26 vial. An enhanced recovery rate with the anaerobic BP 27 vial could not be established. BP-HBV media had an enhanced recovery rate over the standard BACTEC media for S. aureus and C. albicans in patients receiving antibiotics.     

BD BACTEC™ Mycosis IC/F culture vials for fungemia diagnosis and follow-up: a retrospective study from 2013 to 2020

This retrospective study compared the BD BACTEC? Mycosis IC/F with the BD BACTEC? Plus Aerobic/F and BD BACTEC? Lytic Anaerobic/F culture vials (i.e., standard vials) for fungemia diagnosis at Nîmes University Hospital, France. From 2013 to 2020, 57 blood samples were concomitantly collected in the 3 culture vial types. For 43.8% of these samples, all vials were positive for yeast. The mean time to positivity was shorter (32.0 hours vs 44.2 hours; ?12.2 hours) and longer (89.4 hours vs 33.7 hours; +55.7 hours) with the BD BACTEC? Mycosis IC/F culture vials than with the other culture vials in patients without and with antifungal treatment, respectively. Moreover 31.6% and 24.6% of samples were positive only with the standard vials and with the BD BACTEC? Mycosis IC/F culture vials, respectively. The BD BACTEC? Mycosis IC/F culture vials are useful for the initial fungemia diagnosis (before any treatment) because they provide faster results.     

Residual amount of vancomycin hydrochloride in vials after use

We macroscopically observed vials of vancomycin hydrochloride (VCM) for injection (0.5 g/vial) dissolved in various solvents, and determined the presence or absence of residual VCM crystals. In addition, the residual VCM in vials after use was measured using a bioassay. In vials evaluated after use, the percentage of vials in which VCM crystals were macroscopically confirmed, the mean residual amount of VCM in the vials (residual %), and the percentage of vials with ≥50 mg (10 %) of residual VCM were 28.1 %, 15.0 ± 7.5 mg (3.0 %), and 0 %, respectively, after the dissolution of a single VCM vial in 10 ml of distilled water for injection (n = 57); 63.8 %, 30.2 ± 19.1 mg (6.0 %), and 16.1 %, respectively, after the dissolution of a single VCM vial in 100 ml of physiological saline (n = 224); and 72.2 %, 38.5 ± 28.0 mg (7.7 %), and 33.3 %, respectively, after the dissolution of two VCM vials in 100 ml of physiological saline (n = 18). The mean residual VCM amount was greater when using physiological saline than when using distilled water for injection as a solvent. These results show the need to follow the dissolution method described in the package insert, which calls for the addition of 10 ml of distilled water for injection to each 0.5 g VCM vial.     

Optimizing recovery of cytomegalovirus in the shell vial culture procedure.

We have investigated three factors that may be related to the recovery of cytomegalovirus (CMV) using the shell vial culture procedure. First, we compared fluorescent-antibody staining of shell vial cultures using a monoclonal antibody to a CMV immediate early antigen at 16 vs 40 hr after inoculation. Of 332 routinely submitted specimens cultured in duplicate and stained at the different times, 25 (7.5%) were positive at 16 hr and 32 (9.6%) were positive at 40 hr. The increased yield was 28%. Second, we analyzed the effect of using duplicate shell vials (both stained at 40 hr) for all routinely submitted CMV cultures. During a 6-month period, 272 (12.5%) of the 2157 cultures processed with duplicate shell vials were positive, including 222 positive in both vials and 50 positive in only one. Assuming that a single-vial setup would have detected 50% of those positive in only one of the two vials, the increased yield attributable to the duplicate vial was estimated at 10% (25/(222 + 25)). Third, we investigated the effects of seeding density and culture age on the shell vial assay. Cell age of greater than 1 day was associated with a decrease in sensitivity both in cultures that were confluent and in those that were subconfluent at the time of inoculation. Incorporating these findings in the routine shell vial culture procedure used in our Clinical Virology Laboratory has resulted in a greater overall detection of CMV in shell vial cultures than in conventional 6-week tube cultures.     

Effect of macroscopic air bubbles on cell lysis by shock wave lithotripsy in vitro.

In studies of cells or stones in vitro, the material to be exposed to shock waves (SWs) is commonly contained in plastic vials. It is difficult to remove all air bubbles from such vials. Because SWs reflect at an air-fluid interface, and because existing gas bubbles can serve as nuclei for cavitation events, we sought to determine in our system whether the inclusion of small, visible bubbles in the specimen vial has an effect on SW-induced cell lysis. We found that even small bubbles led to increased lysis of red blood cells (1- to 3-mm diameter bubbles, 9.8+/-0.5% lysis, n = 7; no bubbles, 4.4+/-0.8%, n = 4), and that the degree of lysis increased with bubble size. Damage could not be reduced by centrifuging the cells to the opposite end of the vial, away from the bubble. B-scan ultrasound imaging of blood in polypropylene pipette bulbs showed that, with each SW, bubbles were recruited from the air interface, mixing throughout the fluid volume, and these appeared to serve as nuclei for increased echogenicity during impact by subsequent SWs; thus, bubble effects in vials could involve the proliferation of cavitation nuclei from existing bubbles. Whereas injury to red blood cells was greatly increased by the presence of bubbles in vials, lytic injury to cultured epithelial cells (LLC-PK1, which have a more complex cytoarchitecture than red blood cells) was not increased by the presence of small air bubbles. This suggests different susceptibility to SW damage for different types of cells. Thus, the presence of even a small air bubble can increase SW-induced cell damage, perhaps by increasing the number of cavitation nuclei throughout the vial, but this effect is variable with cell type.     

Emerging Role for Use of Liposomes in the Biopreservation of Red Blood Cells

SUMMARY: Biopreservation is the process of maintaining the integrity and functionality of cells held outside the native environment for extended storage times. The development of red blood cell (RBC) biopreservation techniques that maintain in vitro RBC viability and function represents the foundation of modern blood banking. The biopreservation of RBCs for clinical use can be categorized based on the techniques used to achieve biologic stability, including hypothermic storage and cryopreservation. This review will examine the emerging role of liposomes in the RBC biopreservation, including the incorporation of liposomes into RBC membranes as an effective approach for minimizing RBC hypothermic storage membrane lesion and use of liposomes as a permeabilization strategy for the intracellular accumulation of novel intracellular cryoprotectants. Integration of current biopreservation research with blood banking practices offers enormous potential for future improvements of safety and efficacy of RBC transfusion.     

Serum growth factor stability in different eye drop packaging systems during storage

Serum eye drops (SED) have shown beneficial effects in patients suffering from dry eye syndrome and are manufactured for an increasing number of patients in Australia every year. Previous studies have examined the stability of serum growth factors during storage in either experimental vessels not used as the final packaging system or in eye drop bottles. To ensure the quality and safety of SED product manufactured in Australia, the stability of growth factors in serum packaged into two different systems during storage at different temperatures was examined. Healthy blood donors provided a whole blood donation, from which serum was prepared, diluted to 20% and dispensed into either a tube or a vial packaging system. The stability of growth factors, fibronectin and total protein in tube segments was comparable to matched vials samples during storage at −30 °C, 4 °C, 22 °C and 37 °C, with the exception of EGF and fibronectin in 20% SED stored in tube segments, which were more sensitive to storage conditions at 4 °C and 22 °C when compared to vials. Additionally, the growth factor, fibronectin and total protein concentration in both tube segments and vials was stable during storage at −30 °C for at least 9 months. This study highlights the impact of different manufacturing procedures on serum growth factor stability during storage.     

Stability of bortezomib 1-mg/mL solution in plastic syringe and glass vial

BACKGROUND: The proteasome inhibitor bortezomib (BTZ), used in antineoplastic chemotherapy, must be diluted in NaCl 0.9% for injection and stored for no more than 3 hours in a syringe or 8 hours in a vial. Better information on its stability could improve storage. OBJECTIVE: To assess the stability of BTZ solution (1 mg/mL) in syringes and vials. METHODS: BTZ 1-mg/mL solutions were prepared by adding sterile NaCl 0.9% to Velcade vials containing 3.5 mg of lyophilized BTZ. Syringes were filled with 1 mL of solution and stored in the dark at 5 degrees C or 60 degrees C; others were not protected from light and stored at 22 degrees C. Velcade vials containing 1 mL of solution were stored at 5 degrees C in the dark. Samples were taken at various times over 23 days and assayed in duplicate. An HPLC method for assaying the stability of BTZ was validated. Appearance and pH were recorded. RESULTS: There was no color change or precipitation in the samples, and the pH was stable. Oxidation, light, and storage temperature all affected the chemical stability of BTZ. The mean concentrations of BTZ in syringes stored for 2, 3, and 5 days at 60, 22, and 5 degrees C were >95% of the initial concentration. The mean concentration of BTZ in vials stored for 5 days at 5 degrees C was >95% of the initial concentration. CONCLUSIONS: BTZ stored refrigerated in vials or syringes and protected from light is chemically stable for 5 days after reconstitution.     

Correlation of urine pH with the detection of cytomegalovirus by the shell vial technique

The influence of the pH of urine on the detection of cytomegalovirus (CMV) by the shell vial assay was evaluated. The pH values of 295 urine specimens ranged from 4.7 to 8.5 (mean 6.3) and were not significantly different in culture-positive versus culture-negative samples. None of the urine specimens appeared to be toxic for the cells used in the shell vial assay. We recommend inoculation of urine specimens into shell vials without adjustment of pH.     

A sampling device for septum-sealed blood containers

The device described replaces the sampling probe of any automatic diluter. It enables septum-sealed blood vials to be sampled without exposing the blood to the atmosphere, and dispenses the blood into sealed reaction vials. The advantages are that loss of volatiles in the sample and exposure of operators to open blood containers are eliminated.     

Maximizing extraction of botulinum toxin type A from vials

OBJECTIVES: To determine the residual botulinum toxin remaining in vials after using 3 different extraction methods and to analyze the different techniques for measuring extraction efficacy. DESIGN: Multicentered comparative study. SETTING: Three academic movement disorder clinics. PARTICIPANTS: Thirty physicians were randomly surveyed for their botulinum toxin extraction methods. Three physicians evaluated the most common methods. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Amount of toxin left in vials after each extraction method. RESULTS: Toxin was least successfully extracted by using the vial inversion method. More toxin was extracted by using the 2-in needle method. The top removal method produced the least waste of toxin but is considered unsafe. CONCLUSIONS: The best and safest method for consistently extracting the most botulinum toxin from its vial was to use a long 21-gauge 2-in needle attached to a 3-mL syringe.     

Comparison of iodine- and fluorescein-labeled monoclonal antibodies for detection of Chlamydia trachomatis inclusions in cells grown in glass vials

A fluorescein-labeled monoclonal antibody was compared with the iodine stain for the detection of chlamydial inclusions in McCoy cells grown on cover slips in glass vials. The remainder of the original specimen extracts in 2-sucrose phosphate transport medium from 100 specimens (50 male, urethra; 50 female, cervix), stored at ?70°C and previously determined to be culture positive for $\text{Chlamydia trachomatis}$ by the iodine stain, were inoculated into vials containing monolayers of McCoy cells. Cover slips were coded and examined microscopically after 40 hr at 35°C. The mean numbers of inclusions detected by iodine and by immunofluorescence were the same. One-half of the specimens had eight or fewer inclusions present. There was a trend indicating that less time was required for microscopic examination of cover slips for chlamydial inclusions with immunofluorescence than with the iodine-staining method. The tagged monoclonal antibody is a high-quality immunodiagnostic reagent for use in the immunofluorescence test; however, our data derived from stored specimen extracts indicate equivalence of detection of inclusions in the glass vial system compared to iodine.