An evaluation of a Stenotrophomonas maltophilia outbreak due to commercial arterial blood gas collection kit.

BACKGROUND: Stenotrophomonas maltophilia is a gram-negative bacterium that can cause hospital infections and outbreaks within hospitals. This study aimed to evaluate an outbreak of Stenotrophomonas maltophilia, caused by ready-to-use commercial syringes containing liquid lithium and heparin for arterial blood gas collection in a university hospital. METHODS: Upon detecting an increase in Stenotrophomonas maltophilia growth in blood cultures between 15.09.2021 and 19.11.2021, an outbreak analysis and a case-control study (52 patients for the case group, 56 patients for the control group) were performed considering risk factors for bacteremia. Samples from possible foci for bacteremia were also cultured. Growing bacteria were identified by matrix-assisted laser desorption ionization time-of-flight mass spectrometry. The genetic linkage and clonal relationship isolates were investigated with pulsed-field gel electrophoresis (PFGE) in the reference laboratory. RESULTS: In the case-control study, the odds ratio for the central venous catheter [3.38 (95% confidence interval [CI]: 1.444, 8.705 ; p = 0.006)], for surgery [3.387 (95% confidence interval [CI]: 1.370, 8.373 ; p = 0.008)] and for arterial blood gas collection history [18.584 (95% confidence interval [CI]:4.086, 84.197; p < 0.001)] were identified as significant risk factors. Stenotrophomonas maltophilia growth was found in ready-to-use commercial syringes used for arterial blood gas collection. Molecular analysis showed that the growths in the samples taken from commercial syringes and the growths from blood cultures were the same. It was decided that the epidemic occurred because the method for sterilization of heparinized liquid preparations were not suitable. After discontinuing the use of the kits with this lot number, the outbreak was brought under control. CONCLUSIONS: According to our results, disposable or sterile medical equipment should be included as a risk factor in outbreak analyses. The method by which injectors containing liquids, such as heparin, are sterilized should be reviewed. Our study also revealed the importance of the cooperation of the infection control team with the microbiology laboratory.

Compatibility of [99mTc]Tc-EDDA/HYNIC-TOC and [68Ga] Ga-DOTA-TOC in a syringe for intravenous administration.

OBJECTIVE: Drug quality in medical devices is not evaluated during the marketing authorization of radiopharmaceuticals. Therefore, the extemporaneous change of packaging made for preparation of patient unit doses in a syringe is the responsibility of radiopharmacists. The present study aimed to determine the impact of packaging and storage in a polypropylene syringe on the quality of hydrophilic drugs [Tc]Tc-EDDA/HYNIC-TOC (Tektrotyd) and [Ga]Ga-DOTA-TOC (Somakit-TOC). METHODS: Appearance, pH, radiochemical purity, sterility, and endotoxin tests were performed according the current European Pharmacopoeia. Subvisible and visible particles tests of the European Pharmacopoeia were adapted due to limited preparation volume (<25 ml). Sorption tests were performed according to the literature. RESULTS: After 2 h storage in a syringe, drug sorption of Tektrotyd and Somakit-TOC was of less than 2.5% and similar to other Tc-radiopharmaceuticals (range: from 1.1 ± 0.5% to 4.2 ± 0.6%). For Tektrotyd, this sorption phenomenon was positively influenced by the drug concentration and a short contact with the medical device (4.8 ± 0.2% up to 5 s vs. 2.3 ± 0.2%, n = 4; P < 0.001). For Somakit-TOC, the duration of contact with syringe had no impact (1.6 ± 0.2% up to 5 s vs. 1.7 ± 0.6%; P = 1.000). No drug radiolysis or alteration of microbiological aspects were observed. No impurity from a 3-piece-syringe was observed according to drug aspect, pH, and subvisible and visible particles, which remained within specification of the current European Pharmacopoeia. CONCLUSION: This study found that drug sorption to packaging was compatible with clinical use and absence of drug alteration of Tektrotyd and Somakit-TOC after repackaging in a syringe in polypropylene and prolonged storage during 2 h.

Qualification of a chemotherapy-compounding robot.

KIRO® Oncology (Kiro Grifols, Spain) is a robotic system for automated compounding of sterile injectable drugs including intravenous cytotoxic treatments. The present article describes the qualification procedure applied prior to production phases. Peristaltic pumps which ensure the reconstitution of drugs were tested with water and NaCl 0.9%. The performance of the robot (accuracy and precision) to prepare bags, syringes and elastomeric pumps was evaluated with three placebo solutions (aqueous, foaming and viscous) using gravimetric controls. Microbiological controls were also performed. The pumps met the requirements set for volumes ranging from 5 to 100 mL. A total of 274 preparations was compounded. For the bags, the filling accuracy was within the limit of ±10% from 1 to 48 mL with aqueous solution, from 0.6 to 48 mL with foaming solution and from 5 to 48 mL with viscous solution. For all syringes and elastomeric pumps, it was within the limit of ±10%. The precision was validated for all preparations, except for bags and syringes prepared with 0.6 and 0.25 mL, respectively. The samples of surfaces and air complied with ISO 5 class environment. Among the 24 gloves tests performed, two presented microbiological growth. All Media fill tests were validated. The qualification procedure led us to exclude injections of any active principle volume strictly lower than 1 mL. The microbiological contamination of operators' gloves remains a critical point. Our operators will be made aware of the issue during the training period.

Stability of sodium bicarbonate injection 8.4% in syringes over a six-week period in refrigerated temperature.

Background Dysfunctional central venous catheter prohibits the administration of potential life-saving chemotherapy and the delivery of essential supportive care needs to patients. Sodium bicarbonate injection has been shown to impede against fibrin clot formation and prolong prothrombin time and thrombin clotting time. Sodium bicarbonate injection has been tried as a second-line agent with good results in a small number of patients (internal data not published) when alteplase failed. We assessed whether the pre-filled sodium bicarbonate injection in 5 mL syringes would not only preserve sterility and retain its pH and concentration but also amount to the potential cost savings for future use when stored in a refrigerated environment. Methodology Twelve pre-filled 5 mL syringes were prepared aseptically, of which four each were tested for pH, sodium bicarbonate injection concentration and sterility when stored in refrigerated temperature over a six-week period. A standard pH meter, enzymatic carbon dioxide analyzer, and a 14-day incubation for microbial detection were employed for this study. Results Sodium bicarbonate concentration measured in the form of carbon dioxide ranged from 923 mmol/L or (1846 mosol/L) to 1006 mmol/L or (2012 mosmol/L), and pH ranged from (7.88 to 8.05) were reported over the duration of the study period. The 14-day incubation period resulted in no microbial growth. Conclusion Our study results have indicated that the pH and sodium bicarbonate injection concentration values were stable and within range, comparable to those reported by the manufacturer within the study period. The contents of the subdivided sodium bicarbonate injection 5 mL syringes retained sterility over a 14-day incubation period.

Storage and transport of reconstituted omacetaxine mepesuccinate: Considerations for home administration.

Purpose Omacetaxine mepesuccinate ("omacetaxine") is approved by the US Food and Drug Administration for the treatment of adult patients with chronic- or accelerated-phase chronic myeloid leukemia with resistance and/or intolerance to two or more tyrosine kinase inhibitors. In May 2014, the US Food and Drug Administration approved revisions to the packaging information that included directions for home administration of reconstituted omacetaxine by patients or caregivers using syringes filled at a healthcare facility. We developed recommendations for the transport, storage, and spill-clean procedure of reconstituted omacetaxine for home and clinic administration. Methods We conducted chemical stability and microbial growth studies of reconstituted omacetaxine solution stored in vials and syringes at room temperature or refrigerated for various durations. Several shipping configurations were tested in simulated transport conditions to evaluate their ability to contain solution leakage and maintain product quality during distribution. In addition, we evaluated cleaning products and procedures for their effectiveness in removing residual omacetaxine from household surfaces after mock spills. Results Reconstituted omacetaxine showed limited degradation when refrigerated for 14 days in vials and syringes, and no microbial growth was observed for 12 days after intentional inoculation. In shipping studies, the configurations maintained prepared syringes within the recommended storage temperature range throughout transport and could contain leaks if spills occurred. In the event of an accidental spill in a home environment, effective cleaning can be achieved using household cleaning products and defined procedures. Conclusion These data provide important information regarding the safe transportation and administration of reconstituted omacetaxine in the home and clinic.

The Sterility of Partially Used Hyaluronic Acid Fillers After Long Storage.

BACKGROUND: Hyaluronic acid (HA) gel fillers represent most soft tissue augmentation procedures currently used, because they have lower rates of complications compared with other materials. Many patients do not consume an entire syringe of filler but may require a retouch or intermittent augmentation after some time. The remaining material is commonly stored in a specific environment for reuse by the same patient. OBJECTIVE: There are an insufficient number of recommendations concerning the safety of storing and reusing dermal fillers in the literature because of the paucity of studies. The aim of this study was to investigate the potential infectious contamination associated with the storage of HA fillers after patient treatment. METHODS: Hyaluronic acid from previously used syringes was stored at room temperature under sterile conditions for varying durations beginning from 2009. Later, the material was submitted for panculture, including gram-positive and gram-negative bacteria, mycobacteria, and fungi. RESULTS: No fungal or mycobacterial agents were cultured from any of the samples. There were a few positive bacterial cultures, but they were predominantly contaminated with normal skin surface flora. CONCLUSION: Although it is commonly practiced, the storage of HA fillers after initial patient injection carries a real but small risk of contamination.

Safety of Prefilled Buffered Lidocaine Syringes With and Without Epinephrine.

BACKGROUND: Lidocaine is often used in conjunction with epinephrine and sodium bicarbonate for local anesthesia. Compounding lidocaine as needed can be highly disruptive to clinic flow, which has led many dermatology clinics to prefill syringes with these solutions, but current regulations recommend the disposal of these preparations within 12 hours, creating medical waste. OBJECTIVE: To evaluate the safety of buffered lidocaine with and without epinephrine drawn from multiuse vials and stored for up to 4 weeks. METHODS: Syringes were filled with lidocaine 1%, lidocaine 1% with 1:100,000 epinephrine, lidocaine 1% with bicarbonate (10:1 ratio), or lidocaine 1% with 1:100,000 epinephrine with bicarbonate (10:1 ratio). The samples were stored for 4 weeks either at controlled room or controlled cold temperature. They were then centrifuged and cultured for anaerobic bacteria, aerobic bacteria, and fungus. RESULTS: Prefilled lidocaine syringes are not subject to bacterial or fungal growth after being stored for 4 weeks. CONCLUSION: Prefilled syringes of lidocaine remain safe to use for up to 4 weeks, and the current regulations placed on the disposal of these solutions should be revisited.

Media-fill simulation tests in manual and robotic aseptic preparation of injection solutions in syringes.

OBJECTIVE: The purpose of this study was to evaluate the contamination rate of media-fill products either prepared automated with a robotic system (APOTECAchemo™) or prepared manually at cytotoxic workbenches in the same cleanroom environment and by experienced operators. Media fills were completed by microbiological environmental control in the critical zones and used to validate the cleaning and disinfection procedures of the robotic system. METHODS: The aseptic preparation of patient individual ready-to-use injection solutions was simulated by using double concentrated tryptic soy broth as growth medium, water for injection and plastic syringes as primary packaging materials. Media fills were either prepared automated (500 units) in the robot or manually (500 units) in cytotoxic workbenches in the same cleanroom over a period of 18 working days. The test solutions were incubated at room temperature (22℃) over 4 weeks. Products were visually inspected for turbidity after a 2-week and 4-week period. Following incubation, growth promotion tests were performed with Staphylococcus epidermidis. During the media-fill procedures, passive air monitoring was performed with settle plates and surface monitoring with contact plates on predefined locations as well as fingerprints. The plates got incubated for 5-7 days at room temperature, followed by 2-3 days at 30-35℃ and the colony forming units (cfu) counted after both periods. The robot was cleaned and disinfected according to the established standard operating procedure on two working days prior to the media-fill session, while on six other working days only six critical components were sanitized at the end of the media-fill sessions. Every day UV irradiation was operated for 4 h after finishing work. RESULTS: None of the 1000 media-fill products prepared in the two different settings showed turbidity after the incubation period thereby indicating no contamination with microorganisms. All products remained uniform, clear, and light-amber solutions. In addition, the reliability of the nutrient medium and the process was demonstrated by positive growth promotion tests with S. epidermidis. During automated preparation the recommended limits < 1 cfu per settle/contact plate set for cleanroom Grade A zones were not succeeded in the carousel and working area, but in the loading area of the robot. During manual preparation, the number of cfus detected on settle/contact plates inside the workbenches lay far below the limits. The number of cfus detected on fingertips succeeded several times the limit during manual preparation but not during automated preparation. There was no difference in the microbial contamination rate depending on the extent of cleaning and disinfection of the robot. CONCLUSION: Extensive media-fill tests simulating manual and automated preparation of ready-to-use cytotoxic injection solutions revealed the same level of sterility for both procedures. The results of supplemental environmental controls confirmed that the aseptic procedures are well controlled. As there was no difference in the microbial contamination rates of the media preparations depending on the extent of cleaning and disinfection of the robot, the results were used to adapt the respective standard operating procedures.

Investigating the impact of clinical anaesthetic practice on bacterial contamination of intravenous fluids and drugs.

Syringes (N = 426), ventilator machine swabs (N = 202) and intravenous (IV) fluid administration sets (N = 47) from 101 surgical cases were evaluated for bacterial contamination. Cultures from the external surface of syringe tips and syringe contents were positive in 46% and 15% of cases, respectively. The same bacterial species was cultured from both ventilator and syringe in 13% of cases, and was also detected in the IV fluid administration set in two cases. A significant association was found between emergency cases and contaminated syringes (odds ratio 4.5, 95% confidence interval 1.37-14.8; P = 0.01). Other risk factors included not using gloves and failure to cap syringes.

Microbial contamination of single-and multiple-dose vials after opening in a pulmonary teaching hospital

OBJECTIVES: Intravenous therapy is a complex procedure usually requiring the preparation of the medication in the clinical area before administration to the patient. Breaches in aseptic technique may result in microbial contaminations of vials which is a potential cause of different avoidable infections. We aimed to investigate the prevalence and pattern of microbial contamination of single- and multiple-dose vials in the largest pulmonary teaching hospital in Iran. METHODS: In a period of 2 months, opened single- and multiple-dose vials from different wards were sampled by a pharmacist. The name of the medication, ward, labeling of the vials, the date of opening, and storing temperature were recorded for each vial. Remained contents of each vial were cultured using appropriate bacterial and fungal growth media. RESULTS: Microbial contamination was identified in 11 of 205 (5.36%) of vials. The highest contamination rate was 14.28% for vials used in interventional bronchoscopy unit. The most frequent contaminated medication was insulin. Gram-positive bacteria (81.82%) were more significantly involved than gram-negative ones (9.09%) and fungi (9.09%), with the highest frequency for Staphylococcus epidermidis . CONCLUSIONS: Our data demonstrate that repeated use of vials especially if basic sterility measures are disobeyed can cause microbial contamination of administered products to the patients. Infection preventionists are responsible to train health care workers regarding aseptic techniques and apply guidelines for aseptic handling of intravenous solutions.

Risk factors for developing a cutaneous injection-related infection among injection drug users: a cohort study.

BACKGROUND: Cutaneous injection-related infections (CIRI), such as abscesses and cellulitis, are common and preventable among injection drug users (IDU). However, risk factors for CIRI have not been well described in the literature. We sought to characterize the risk factors for current CIRI among individuals who use North America's first supervised injection facility (SIF). METHODS: A longitudinal analysis of factors associated with developing a CIRI among participants enrolled in the Scientific Evaluation of Supervised Injecting (SEOSI) cohort between January 1, 2004 and December 31, 2005 was conducted using generalized linear mixed-effects modelling. RESULTS: In total, 1065 participants were eligible for this study. The proportion of participants with a CIRI remained under 10% during the study period. In a multivariate generalized linear mixed-effects model, female sex (Adjusted Odds Ratio (AOR) = 1.68 [95% Confidence Interval (CI): 1.16-2.43]), unstable housing (AOR = 1.49 [95% CI: 1.10-2.03]), borrowing a used syringe (AOR = 1.60 [95% CI: 1.03-2.48]), requiring help injecting (AOR = 1.42 [95% CI: 1.03-1.94]), and injecting cocaine daily (AOR = 1.41 [95% CI: 1.02-1.95]) were associated with an increased risk of having a CIRI. CONCLUSION: CIRI were common among a subset of IDU in this study, including females, those injecting cocaine daily, living in unstable housing, requiring help injecting or borrowing syringes. In order to reduce the burden of morbidity associated with CIRI, targeted interventions that address a range of factors, including social and environmental conditions, are needed.

Pseudomonas bloodstream infections associated with a heparin/saline flush--Missouri, New York, Texas, and Michigan, 2004-2005.

On January 26, 2005, CDC was notified of four cases of Pseudomonas fluorescens bloodstream infection among patients at an oncology clinic in Missouri. All patients had received a heparin/saline flush to prevent clotting of indwelling, central venous catheters. The flushes were preloaded in syringes by IV Flush and distributed by Pinnacle Medical Supply (Rowlett, Texas). On January 31, a nationwide alert against use of all heparin or saline flushes preloaded in syringes by IV Flush was issued by the Food and Drug Administration; the company recalled these products. As of February 15, state and local health departments and CDC had identified a total of 36 Pseudomonas species infections in patients in four states who were administered the heparin/saline flushes from multiple lots. This report describes the ongoing investigation and provides recommendations for investigation and management of potential cases.

Sterility validity period of vials after multiple sampling under vertical laminar airflow hood.

STUDY OBJECTIVES: The aim of this study is to validate the sterility period of vials after multiple sampling under Grade A vertical laminar airflow hood. METHODS: Vials filled aseptically with a sterile culture medium have been sampled with syringes three times a week over one month under Grade A vertical laminar airflow hood and in the mean-while, keeping the vials out of the laminar airflow hoods. RESULTS: No microbial growth has been observed. On the basis of these results, it has been decided to modify our standard operating procedures, to allow keeping the vials for two weeks in a box out of the laminar airflow hoods (ambient temperature Grade B) or any controlled environment (under refrigeration). CONCLUSIONS: This study validates the multiple use of vials of small to large volumes (5-100 mL), to simplify handling and to reduce the costs in centralized cytostatic reconstitution units in hospital pharmacies, with no microbial risk.

Microbial contamination in dental unit waterlines

The quality of water in a dental unit is of considerable importance because patients and dental staff are regularly exposed to water and aerosol generated from the dental unit. The aim of this study was to evaluate the occurrence of microbial contamination in dental unit waterlines. Water samples were collected aseptically from the waterlines (reservoir, triple-syringe, high-speed) of 15 dental units. After serial dilution to 1:10(6) in APHA, the samples were seeded by the pour-plate technique and cultured in plate count agar (Difco) for 48 h at 32ºC. Analysis was based on the number of colony forming units (CFU). The Wilcoxon non-parametric test indicated that the levels of water contamination were highest in the triple-syringe (13 of 15) and in the high-speed (11 of 15); both levels were higher than those of the water reservoir. There was no significant statistical difference between the level of contamination in the triple-syringe and the high-speed as determined by the Mann-Whitney test [p(H0) = 40.98 percent; Z = - 0.2281]. Because biofilm forms on solid surfaces constantly bathed by liquid where microorganisms are present, these results indicate that the water in the dental unit may be contaminated by biofilm that forms in these tubules

Prefilled syringes: safe and effective.

BACKGROUND: Preloaded syringes are time savers, but questions have arisen anecdotally about the risk of infection from this procedure and the possible loss of potency, especially when performed with buffered syringes. OBJECTIVE: To show that preloaded syringes do not develop colonies of bacterial organisms and to confirm that anesthetic potency is maintained for at least 2 weeks. METHODS: Thirty-six syringes were stored for a period of 2 weeks on a shelf in our clinical procedure area with no protection from heat or light. The majority of these were then cultured for bacteria and fungi and one of them was used on one of the authors to determine the potency of the anesthetic. RESULTS: Preloaded syringes do not appear to be prone to the development of bacterial contamination for at least a 2-week period and potency of the anesthetic is maintained. CONCLUSION: Preloaded syringes are time savers and are a safe modality for use in the practicing dermatology office.