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.

Multistate Outbreak of Burkholderia cepacia Complex Bloodstream Infections After Exposure to Contaminated Saline Flush Syringes: United States, 2016-2017.

BACKGROUND: Burkholderia cepacia complex (Bcc) has caused healthcare-associated outbreaks, often in association with contaminated products. The identification of 4 Bcc bloodstream infections in patients residing at a single skilled nursing facility (SNF) within 1 week led to an epidemiological investigation to identify additional cases and the outbreak source. METHODS: A case was initially defined via a blood culture yielding Bcc in a SNF resident receiving intravenous therapy after 1 August 2016. Multistate notifications were issued to identify additional cases. Public health authorities performed site visits at facilities with cases to conduct chart reviews and identify possible sources. Pulsed-field gel electrophoresis (PFGE) was performed on isolates from cases and suspect products. Facilities involved in manufacturing suspect products were inspected to assess possible root causes. RESULTS: An outbreak of 162 Bcc bloodstream infections across 59 nursing facilities in 5 states occurred during September 2016-January 2017. Isolates from patients and pre-filled saline flush syringes were closely related by PFGE, identifying contaminated flushes as the outbreak source and prompting a nationwide recall. Inspections of facilities at the saline flush manufacturer identified deficiencies that might have led to the failure to sterilize a specific case containing a partial lot of the product. CONCLUSIONS: Communication and coordination among key stakeholders, including healthcare facilities, public health authorities, and state and federal agencies, led to the rapid identification of an outbreak source and likely prevented many additional infections. Effective processes to ensure the sterilization of injectable products are essential to prevent similar outbreaks in the future.

Hepatitis C Contamination of Medication Vials Accessed with Sterile Needles and Syringes.

BACKGROUND: Health care-associated hepatitis C virus outbreaks from contaminated medication vials continue to be reported even though most practitioners deny reusing needles or syringes. The hypothesis was that when caring for hepatitis C virus-infected patients, healthcare providers may inadvertently contaminate the medication vial diaphragm and that subsequent access with sterile needles and syringes can transfer hepatitis C virus into the medication, where it remains stable in sufficient quantities to infect subsequent patients. METHODS: A parallel-arm lab study (n = 9) was performed in which contamination of medication vials in healthcare settings was simulated using cell culture-derived hepatitis C virus. First, surface-contaminated vials were accessed with sterile needles and syringes, and then hepatitis C virus contamination was assessed in cell culture. Second, after contaminating several medications with hepatitis C virus, viral infectivity over time was assessed. Last, surface-contaminated vial diaphragms were disinfected with 70% isopropyl alcohol to determine whether disinfection of the vial surface was sufficient to eliminate hepatitis C virus infectivity. RESULTS: Contamination of medication vials with hepatitis C virus and subsequent access with sterile needles and syringes resulted in contamination of the vial contents in sufficient quantities to initiate an infection in cell culture. Hepatitis C virus remained viable for several days in several commonly used medications. Finally, a single or 2- to 3-s wipe of the vial diaphragm with 70% isopropyl alcohol was not sufficient to eliminate hepatitis C virus infectivity. CONCLUSIONS: Hepatitis C virus can be transferred into commonly used medications when using sterile single-use needles and syringes where it remains viable for several days. Furthermore, cleaning the vial diaphragm with 70% isopropyl alcohol is not sufficient to eliminate the risk of hepatitis C virus infectivity. This highlights the potential risks associated with sharing medications between patients.

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.

Predrawn prehospital medications are microbiologically safe for up to 48 hours.

BACKGROUND: Prehospital medical teams are commonly required to administer a range of medications for urgent stabilisation and treatment. The safe preparation of medications during resuscitation requires attention, time and resources, and can be a source of medication error. In our two road and HEMS (Helicopter Emergency Medical Service) prehospital services, medication errors are mitigated by predrawing commonly used medications to set concentrations daily (Hunter Retrieval Service, HRS) or second-daily (CareFlight Sydney, CFS). However, there are no published data confirming that such practice is microbiologically safe. METHODS: A convenience sample of 299 predrawn medication syringes with syringe dwell times up to 48 hours were collected at the end of their operational deployment. Predrawn medication syringes collected for culture were ketamine, midazolam, fentanyl, thiopentone, rocuronium, suxamethonium, metaraminol and normal saline. The samples were incubated and cultured at a tertiary hospital pathology laboratory using best-practice methodology for non-tissue samples. The samples were collected from June 2017 to February 2018. RESULTS: The mean dwell times ranged from 30.7 hours (fentanyl at HRS) to 48.5 hours (rocuronium at CFS). None of the 299 cultured samples yielded significant micro-organisms. One sample of suxamethonium with a syringe dwell time of 34 hours grew Bacillus cereus but was likely a contaminant introduced during sample collection. CONCLUSION: Predrawing of the eight studied medications for urgent prehospital procedures appears to be a microbiologically safe practice with syringe dwell times up to 48 hours.

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.

Bacterial Contamination of Syringes and Fluids in Diagnostic and Interventional Neuroangiography.

(1) Background: Bacterial contamination has been shown to occur during angiographies, although data on its frequency and relevance are sparse. Our aim was to evaluate the incidence of bacterial contamination of syringes used under sterile conditions during neuroangiographies. We sought to differentiate between contamination of the outside of the syringes and the inside and to detect the frequency, extent and germ spectrum of bacterial contamination. (2) Methods: We prospectively collected 600 samples from 100 neuroangiographies. Per angiography, fluid samples from the three routinely used syringes as well as the syringes themselves were analyzed. We analyzed the frequency and extent of contamination and determined the germ spectrum. (3) Results: The majority of samples (56.9%) were contaminated. There was no angiography that showed no contamination (0%). The outer surfaces of the syringes were contaminated significantly more frequently and to a higher extent than the inner surfaces. Both the frequency and extent of contamination of the samples increased with longer duration of angiographic procedures. Most of the bacterial species were environmental or skin germs (87.7%). (4) Conclusions: Bacterial contamination is a frequent finding during neuroangiographies, although its clinical significance is believed to be small. Bacterial contamination increases with longer duration of angiographic procedures.

Genotypic and morphological identification of opportunistic microorganisms in triple-syringe tubing from dental units.

BACKGROUND: In Mexico and around the world, water in dental units, including triple syringes, comes from municipal chlorinated water mains. The microbial contamination of dental unit water systems constitutes a risk factor for opportunistic infections. OBJECTIVES: The present work aimed to identify the bacteria present in the triple-syringe water lines of dental units at a dental school of a public university in Mexico, with a hypothesis that opportunistic bacteria of importance to human health would be found. MATERIAL AND METHODS: A cross-sectional study was carried-out. A total of 100 samples of triple-syringe tubing from dental units operated by a dental school of a public university in Mexico were analyzed before and after their use in dental practice. Bacterial biofilm was cultured and isolated from the tubing, using standard microbiological methods, and then the species present were identified through 16S rRNA gene sequencing. The characterization of the biofilm was performed by means of scanning electron microscopy (SEM). RESULTS: Bacterial growth was observed in 20% of the non-disinfected and 10% of the disinfected samples, with 11 strains isolated. Six genera and 11 bacterial species were genetically identified. Coagulasenegative staphylococci (CoNS), considered opportunistic human pathogens, were among the most critical microorganisms. Scanning electron microscopy revealed a thick polymeric matrix with multiple bacterial aggregates. CONCLUSIONS: Opportunistic bacteria from human skin and mucous membranes were detected. Under normal conditions, these bacteria are incapable of causing disease, but are potentially harmful to immunosuppressed patients.

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.

Drug waste of ready-to-administer syringes in the intensive care unit: Aseptically prepared syringes versus prefilled sterilized syringes.

BACKGROUND: The availability of ready-to-administer (RTA) syringes for intravenous (IV) drugs facilitates rapid and safe administration in emergency and intensive care situations. Hospital pharmacies can prepare RTA syringes through aseptic batchwise filling. Due to excess production of these RTA syringes for sufficient availability for patient care and their limited (microbiological) shelf-life, waste is unavoidable, which contributes to environmental pollution. RTA prefilled sterilized syringes (PFSSs) have much longer shelf-lives than aseptically prepared RTA syringes and might contribute to reducing drug waste. AIM: This study aimed to evaluate the difference in drug waste between RTA syringes that were prepared through aseptic batchwise filling and RTA PFSSs in the Intensive Care Unit (ICU). METHODS: We measured drug waste of RTA syringes over an 8-year time period from August 2015 to May 2023 in the 32-bed ICU of the University Medical Center Utrecht. We distinguished between RTA syringes prepared through aseptic batchwise filling by our hospital pharmacy ("RTA aseptic syringes", shelf-life of 31 days) and RTA PFSSs (shelf-life of 18 months). An intervention group of three drug products that were replaced by PFSSs was compared to a control group of five drug products that were not replaced by PFSSs during the study period. We then defined four different periods within the total study period, based on quarantine time of the RTA aseptic syringes and time of PFSS introduction: 1) no quarantine, 2) 3-day quarantine, 3) 7-day quarantine and 4) PFSS introduction. Our primary endpoint was the number of RTA syringes that was wasted, expressed as the percentage of the total number of syringes dispensed to the ICU in each of these four periods. We used a Kruskall-Wallis test to test if waste percentages differed between time periods in the control and intervention groups, with a post-hoc Dunn's test for pairwise comparisons. Furthermore, we applied two interrupted time series (ITS) analyses to visualize and test the effect of introducing different quarantine times and the PFSSs on waste percentage. RESULTS: Introduction of PFSSs significantly decreased drug waste of RTA syringes irrespective of drug type in the intervention group, from 31% during the 7-day quarantine period to 5% after introduction of the PFSS (p<0.001). The control group showed no significant decrease in drug waste over the same time periods (from 20% to 16%; p=0.726). We observed a significant difference in the total drug waste of RTA aseptic syringes between time periods, which may be attributed to the implementation of different quality control quarantine procedures. The ITS model of the intervention group showed a direct decrease of 17.7% in waste percentage after the introduction of PFSSs (p=0.083). CONCLUSION: Drug waste of RTA syringes for the ICU can be significantly decreased by introducing PFSSs, supporting hospitals to enhance environmental sustainability. Furthermore, the waste percentage of RTA syringes prepared through aseptic batchwise filling is significantly impacted by duration of quarantine time.

Automatic MDCT injectors: hygiene and efficiency of disposable, prefilled, and multidosing roller pump systems in clinical routine.

OBJECTIVE: This study evaluated three different injection systems with regard to microbiological contamination, time efficiency, and user handling during a clinical routine. SUBJECTS AND METHODS: A total of 825 patients were included. A double-syringe contrast injector with disposable syringes (system A; n = 150) and one that used prefilled syringes (system B; n = 150) were microbiologically analyzed during single use of the syringes in one patient. Moreover, the contamination of a roller pump injector capable of multidosing several patients from a contrast agent container, without the need for prior filling, was determined after being used for an entire day (system C; n = 35 injections/day for 15 days). The hygienic background was guaranteed by taking imprints of the surfaces of devices and the palms of the hands of members of CT staff before the clinical investigation. The time required for assembly of the injection systems and for filling or refilling of each injector system was measured. The handling of the three systems also was subjectively ranked by the technicians. RESULTS: Injection systems A, B, and C remained microbiologically sterile and free of contamination throughout their use in clinical routine. The mean (± SD) time for injection system assembly and installation of syringes and filling did not differ significantly between injection systems A and B (system A, 2.5 ± 1.1 minutes; system B, 1.9 ± 1.3 minutes; p = 0.12), whereas the time for assembly of system C was significantly shorter (0.9 ± 0.6 minutes; p < 0.05 vs system A; p < 0.05 vs system B). In the subjective ranking of injector handling, systems B and C were preferred. CONCLUSION: Double-syringe injectors used with disposable or prefilled contrast agent syringes, as well as roller pump injectors, ensure hygienic conditions in clinical routine. However, time efficiency and handling are aspects that favor prefilled and roller pump systems.

Wounds and Skin and Soft Tissue Infections in People Who Inject Drugs and the Utility of Syringe Service Programs in Their Management.

Significance: Opioid use disorder and transition to injection drug use (IDU) are an urgent, nationwide public health crisis. Wounds and skin and soft tissue infections (SSTIs) are common complications of IDU that disproportionately affect people who inject drugs (PWID) and are a major source of morbidity and mortality for this population. Critical Issues: Injections in a nonsterile environment and reusing or sharing needles facilitates bacterial inoculation, with subsequent risk of serious complications such as sepsis, gangrene, amputation, and death. PWID are susceptible to infections with a wide spectrum of organisms beyond common culprits of SSTI, including Clostridium and Bacillus spp., as well as Candida. Recent Advances: Syringe services programs (SSPs) are cost-effective and successful in reducing harms associated with IDU. SSPs provide new equipment to PWID and aid in discarding used equipment. SSPs aim to reduce the risks of unhygienic injecting practices, which are associated with transmission of infections and blood-borne pathogens. Future Directions: Concurrently run SSPs and wound care clinics are uniquely positioned to facilitate care to PWID. Providing new, sterile equipment as well as early wound care intervention can reduce morbidity and mortality as well as health care expenditures by reducing the number of SSTI and injection-related wounds that require hospital admission. Establishment of wound care clinics as part of an SSP represents an untapped potential to reduce harm.

Pumping infusions with a syringe may cause contamination of the fluid in the syringe.

Clinicians often perform pumping of infusions with a syringe (PIS) to quickly deliver fluid or blood transfusion to patients, especially during an emergency. Despite the efforts of the clinicians, critically ill patients are prone to acquire catheter-related bloodstream infections. Although clinicians have reported the possibility of PIS contamination, no group of researchers has studied nor confirmed this possibility. Here, we examined whether PIS can cause bacterial contamination of the fluid inside the syringes, using microbiological tests, including the analysis Escherichia coli DH-5 alpha growth by measuring the absorbance at OD600. We confirmed that contamination of fluid in the barrel was almost proportional to the applied volume of bacterial fluid. Aliquots of DH-5 alpha artificially applied on the surface of the gloved hand of an examiner, the plunger or the inner side of the barrel of a syringe could permeate inside the syringe. Furthermore, disinfection with ethanol before PIS almost successfully prevented bacterial multiplication. Our findings suggest that PIS can cause intraluminal contamination when performed with unsterilized hands, and that previous disinfection with ethanol can effectively prevent PIS-induced contamination. These results highlight the risk of PIS-induced contamination and the importance of disinfection in the daily clinical practice.

Microbiologic contamination and time efficiency of use of automatic MDCT injectors with prefilled syringes: Results of a clinical investigation.

OBJECTIVE: Multiple use of syringes in automatic injectors is considered to place patients at risk of septic complications. The purpose of this study was to evaluate the microbiologic contamination and time efficiency associated with routine clinical use of single-use prefilled disposable syringes for contrast administration. SUBJECTS AND METHODS: To ensure a hygienic background, imprints of devices and the palms of the hands of staff members were microbiologically analyzed before the clinical investigation. The microbiologic contamination of prefilled contrast and saline syringes was analyzed according to two protocols: single use of prefilled contrast syringes and saline syringes (n = 60) and single use of prefilled contrast syringes but multiple use of saline syringes for four injections or patients (n = 60). The time required for assembly of the injection system and filling and refilling for each protocol was measured. RESULTS: Contamination of the surfaces of devices and palms in the CT department was within the acceptable range for hygienic conditions. Prefilled disposable syringes for the contrast agent and saline solution used once had no microbiologic contamination. Microbial contamination with coagulase-negative staphylococci was found in two saline syringes used repeatedly. The time for assembly of the injection system and installation of prefilled syringes did not differ significantly (p = 0.45) between the single-use protocol (2.3 +/- 1.1 minutes) and the multiple-use protocol (2.0 +/- 1.4 minutes). CONCLUSION: Use of prefilled contrast syringes with single-use saline syringes is associated with time-efficient assembly of injection systems and prevents microbiologic contamination in clinical routine, especially in the care of immunocompromised patients.

Two serial check valves can prevent cross-contamination through intravenous tubing during total intravenous anesthesia.

BACKGROUND: Nonsterile handling of propofol for anesthesia has been linked with severe sepsis and death. Placing a single check valve in the IV tubing does not prevent retrograde ascension of pathogens into propofol-filled syringes, so we designed an IV tubing set with multiple check valves. To estimate the efficacy of this design, we measured the concentration of pathogens detected upstream in the IV tubing in relation to the pathogen concentration in a model of a contaminated patient. METHODS: A glass container with a rubber sealed port was filled with a suspension of either bacteria or phagocytes and kept at 37°C ("contaminated patient" model). A bag of normal saline was connected to an IV cannula, punctured through the rubber sealed port of the patient model. Two additional sidestream infusion lines were connected to syringes in 2 standard infusion pumps. One of the syringes contained propofol and the other contained normal saline as a substitute for an opioid preparation. After 5 hours of infusion, we obtained samples from different parts of the infusion lines and syringes. The samples were streaked out on blood agar plates and incubated at 37°C for 24 hours. We repeated this experiment with 6 different pathogens. RESULTS: We incubated 825 agar plates. Whereas the concentration of bacteria and phagocytes in the "patient" had significantly increased during the 5-hour experiments (positive control), no bacterial growth could be detected in any of the incubated plates. CONCLUSION: The data from this experimental setting suggest that the design with multiple check valves in paired configuration prevents retrograde contamination. Of note, this does not permit the reuse of propofol syringes because reusing is against the manufacturer's recommendations.