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.

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.

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.

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.

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.

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.

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.

Microbial stability of syringes of anesthetic drugs prepared in the operating room.

STUDY OBJECTIVE: To determine whether microbial contamination of anesthesia syringes prepared in the operating room (OR) become contaminated in a time-dependent fashion. DESIGN: Observational. SETTING: Operating suite in a major university hospital. PATIENTS: None (in vitro study). 400 syringes were studied for microbial contamination. INTERVENTIONS: Syringes prepared in the OR by anesthesia personnel were sampled at 1, 2, 3, or 4 h in a sterile fashion and sent to the microbiology laboratory for quantitative culture of any bacteria. MEASUREMENTS: Colony forming units (CFU) per mL of drug were calculated and any identified positive cultures were identified by Matrix-Assisted Laser Desorption/Ionization Time of Flight Mass Spectrometry. Logistic regression was used to test the effect of time since preparation on prevalence of positive culture, as was the effect of number of accesses of the syringe and identity of the drug. MAIN RESULTS: Overall, 9/400 (2.25%) syringes were positive for bacteria. The median (interquartile range [IQR]) concentration of bacteria among positive cultures was 100 (100,100) CFU. All cultured species were generally nonpathogenic common contaminants. There was no effect of time since preparation, number of accesses of the syringe at the time of sampling, or drug identity (propofol vs. other). CONCLUSIONS: Contamination of anesthesia syringes is uncommon and occurs at a low overall concentration of bacteria. Contamination does not appear to be time related, and thus calls into question the reasonableness of USP Chapter 797's one-hour requirement.

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.

Cross-sectional study of the microbiological safety profile of reusing hyaluronic acid fillers.

INTRODUCTION: Facial filling with hyaluronic acid (HA) is a dermatological procedure that has been emerging today. There are not many references regarding safety of reusing the remaining product for later touch-up in the same patient. OBJECTIVE: To determine the microbiological safety of reusing hyaluronic acid that is remnant from syringes used for facial filling, stored at room temperature or cooled in a refrigerator at 4°C. MATERIALS AND METHODS: In culture medium, small aliquots of leftovers from 31 hyaluronic acid fillers, previously used for facial filling, were inoculated. The fillers were stored in their original syringes at room temperature or cooled in a standard refrigerator at 4°C for a period ranging from 1 week to 12 months after initial use. LIMITATIONS: The small number of samples limits extrapolation of the results obtained. RESULTS: After 42 days of inoculation in culture medium, none of the samples showed any aerobic or anaerobic bacterial or fungal growth. CONCLUSION: Hyaluronic acid fillers did not show any fungal or bacterial contamination after being opened and stored at room temperature in nonaseptic conditions. The possibility of reusing the remaining portion of the material in the syringe can be safe and economically viable.

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.

Serratia marcescens Bacteremia: Nosocomial Cluster Following Narcotic Diversion.

OBJECTIVE To describe the investigation and control of a cluster of Serratia marcescens bacteremia in a 505-bed tertiary-care center. METHODS Cluster cases were defined as all patients with S. marcescens bacteremia between March 2 and April 7, 2014, who were found to have identical or related blood isolates determined by molecular typing with pulsed-field gel electrophoresis. Cases were compared using bivariate analysis with controls admitted at the same time and to the same service as the cases, in a 4:1 ratio. RESULTS In total, 6 patients developed S. marcescens bacteremia within 48 hours after admission within the above period. Of these, 5 patients had identical Serratia isolates determined by molecular typing, and were included in a case-control study. Exposure to the post-anesthesia care unit was a risk factor identified in bivariate analysis. Evidence of tampered opioid-containing syringes on several hospital units was discovered soon after the initial cluster case presented, and a full narcotic diversion investigation was conducted. A nurse working in the post-anesthesia care unit was identified as the employee responsible for the drug diversion and was epidemiologically linked to all 5 patients in the cluster. No further cases were identified once the implicated employee's job was terminated. CONCLUSION Illicit drug use by healthcare workers remains an important mechanism for the development of bloodstream infections in hospitalized patients. Active mechanisms and systems should remain in place to prevent, detect, and control narcotic drug diversions and associated patient harm in the healthcare setting. Infect Control Hosp Epidemiol 2017;38:1027-1031.

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.

Impact of Sterilization Method on Protein Aggregation and Particle Formation in Polymer-Based Syringes.

The effects of sterilization methods on the storage stability of erythropoietin (EPO) in polymer-based syringes were assessed by quantifying protein oxidation, aggregation, and particle formation. Micro-particle counting and size exclusion chromatography coupled with a multi-angle light scattering detector demonstrated much lower levels of protein particles and aggregates for EPO stored for 12 weeks in steam-sterilized than in radiation (Rad)-sterilized syringes. Intermediate levels of damage were observed for EPO stored in ethylene oxide-sterilized syringes. HPLC analysis documented that the Rad-sterilized syringes caused increased oxidation of the protein during storage. In contrast, in the steam- and ethylene oxide-sterilized syringes EPO oxidation did not change. Analysis with electron spin resonance revealed that only Rad-sterilized syringes formed radicals in the syringe body, which persisted over the 12-week storage period. These results demonstrated that Rad-sterilization generated radicals in the syringes which in turn caused increased EPO oxidation, particle formation, and protein aggregation. Therefore, steam sterilization was shown to be a preferable sterilization method for the polymer-based syringe system when using biopharmaceutical drugs highly sensitive to oxidation, and particle formation and aggregation.