Dataset Information

Effectiveness of a Closed-System Transfer Device in Reducing Surface Contamination in a New Antineoplastic Drug-Compounding Unit: A Prospective, Controlled, Parallel Study.

ABSTRACT:

Background

The objective of this randomized, prospective and controlled study was to investigate the ability of a closed-system transfer device (CSTD; BD-Phaseal) to reduce the occupational exposure of two isolators to 10 cytotoxic drugs and compare to standard compounding devices.

Methods and findings

The 6-month study started with the opening of a new compounding unit. Two isolators were set up with 2 workstations each, one to compound with standard devices (needles and spikes) and the other using the Phaseal system. Drugs were alternatively compounded in each isolator. Sampling involved wiping three surfaces (gloves, window, worktop), before and after a cleaning process. Exposure to ten antineoplastic drugs (cyclophosphamide, ifosfamide, dacarbazine, 5-FU, methotrexate, gemcitabine, cytarabine, irinotecan, doxorubicine and ganciclovir) was assessed on wipes by LC-MS/MS analysis. Contamination rates were compared using a Chi2 test and drug amounts by a Mann-Whitney test. Significance was defined for p<0.05. Overall contamination was lower in the "Phaseal" isolator than in the "Standard" isolator (12.24% vs. 26.39%; p < 0.0001) although it differed according to drug. Indeed, the contamination rates of gemcitabine were 49.3 and 43.4% (NS) for the Standard and Phaseal isolators, respectively, whereas for ganciclovir, they were 54.2 and 2.8% (p<0.0001). Gemcitabine amounts were 220.6 and 283.6 ng for the Standard and Phaseal isolators (NS), and ganciclovir amounts were 179.9 and 2.4 ng (p<0.0001).

Conclusion

This study confirms that using a CSTD may significantly decrease the chemical contamination of barrier isolators compared to standard devices for some drugs, although it does not eliminate contamination totally.

SUBMITTER: Simon N

PROVIDER: S-EPMC4938267 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of a Closed-System Transfer Device in Reducing Surface Contamination in a New Antineoplastic Drug-Compounding Unit: A Prospective, Controlled, Parallel Study.

Simon Nicolas N Vasseur Michèle M Pinturaud Marine M Soichot Marion M Richeval Camille C Humbert Luc L Lebecque Michèle M Sidikou Ousseini O Barthelemy Christine C Bonnabry Pascal P Allorge Delphine D Décaudin Bertrand B Odou Pascal P

PloS one 20160708 7

<h4>Background</h4>The objective of this randomized, prospective and controlled study was to investigate the ability of a closed-system transfer device (CSTD; BD-Phaseal) to reduce the occupational exposure of two isolators to 10 cytotoxic drugs and compare to standard compounding devices.<h4>Methods and findings</h4>The 6-month study started with the opening of a new compounding unit. Two isolators were set up with 2 workstations each, one to compound with standard devices (needles and spikes) ...[more]

PMID: 27391697

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Project description:ObjectivesThe United States National Institute for Occupational Safety and Health (NIOSH) is developing a protocol to assess the containment performance of closed system transfer devices (CSTDs) when used for drug preparation (task 1) and administration (task 2) and published a draft protocol in September 2016. Nine possible surrogates were proposed by NIOSH for use in the testing. The objectives of this study were to: (A) select the most appropriate surrogate; (B) validate the NIOSH protocol using this surrogate; and (C) determine the containment performance of four commercial CSTDs as compared with an open system of needle and syringe using the validated NIOSH protocol.Methods2-Phenoxyethanol (2-POE) was selected as a surrogate based on its water solubility, Henry's volatility constant, detectability by mass spectrometry, and non-toxicity. Standard analytical validation methods including system suitability, limit of detection (LOD), and limit of quantitation (LOQ) as well as system cleaning validation were performed. The amount of 2-POE released when the CSTDs were manipulated according to two tasks defined by NIOSH was determined using mass spectrometry coupled to thermal desorption and gas chromatography. This approach allows sensitivity of detection below 1 part per billion (ppb). Equashield, Tevadaptor (OnGuard), PhaSeal, and ChemoClave were assessed according to manufacturers' instructions for use.Results2-POE was tested and validated for suitability of use within the NIOSH protocol. A simple and efficient cleaning protocol achieved consistently low background values, with an average value, based on 85 measurements, of 0.12 ppb with a 95% confidence interval (CI) of ±0.16 ppb. This gives an LOD for the tests of 0.35 ppb and an LOQ of 0.88 ppb. The Equashield, Tevadaptor (OnGuard), and PhaSeal devices all showed average releases, based on 10 measurements from five tests, that were less than the LOQ (i.e. < 0.88 ppb), while the ChemoClave Vial Shield with Spinning Spiros showed average releases of 2.9±2.3 ppb and 7.5±17.9 ppb for NIOSH tasks 1 and 2 respectively at the 95% confidence level. The open system of needle and syringe showed releases, based on two measurements from a single test, of 4.2±2.2 ppb and 5.1±1.7 ppb for NIOSH tasks 1 and 2 respectively at the 95% confidence level.Conclusions2-POE proved to be an ideal surrogate for testing of CSTDs using the NIOSH protocol. We propose that a CSTD can be qualified using the NIOSH testing approach if the experimental LOQ is less than 1 ppb and the release values are below the LOQ. Equashield, Tevadaptor (OnGuard), and PhaSeal meet these acceptance criteria and can therefore all be qualified as CSTDs, but the ChemoClave system does not and so would not qualify as a CSTD.

Project description:ObjectivesThe goal of this research was to evaluate how material curl, package structure and handling of pouches containing medical devices affect rates of contact between non-sterile surfaces and sterile devices during aseptic transfer.MethodsOne hundred and thirty-six individuals with practical experience in aseptic technique were recruited. Participants were asked to present the contents of four different pouch designs (a standard, one designed to curl in, another to curl out and one that incorporated a tab) using two transfer techniques. During the first block of trials "standard technique" was used; participants presented using their typical methods to the sterile field. Trials in the second block employed "modified technique"; participants were instructed to grab the package at the top center and present package contents using a single, fluid motion. The outside of the pouch and the backs of the participants' hands were coated using a simulated contaminant before each trial. The simulant was undetectable in the visible spectrum, but fluoresced under a black light. The dependent variable was recorded in a binary fashion and analyzed using a generalized linear mixed model.ResultsParticipants were between 20-57 and the averaged year 5.1 years of experience in aseptic technique. The data analysis was based on generalized linear mixed effects (GLMM) model, which accommodates the repeated measurements within the same participant. The effect of the pouch design was significant (P‹0.001), but the effect of aseptic technique did not suggest significance (P = 0.088). Specifically, pouches designed with the material curled outward resulted in significantly fewer contacts with non-sterile surfaces than the other styles, including the inward, tab, and standard styles; this was true regardless of the used aseptic technique, standard (P = 0.0171, P = 0.0466, P = 0.0061, respectively) or modified (P‹0.0001 for all comparisons)).ConclusionResults presented here contribute to a growing body of knowledge that investigates packaging as a potential route of contamination for sterile devices during aseptic presentation. Specifically, we provide insights regarding how both package design and opening technique can be informed in ways that build safety into the healthcare system.

Project description:Background: Aerosol-producing dental procedures are of concern in the spread of infections, especially during the COVID-19 pandemic. Periodontal prophylaxis is the most common aerosol-producing procedure conducted in dental practice globally. During COVID-19, many national and international organizations advocated the use of pre-procedural mouth rinsing to prevent the spread of infections from aerosol-generating procedures in the dental setting; however, many questioned the scientific basis for such recommendations. Objective: This systematic review aimed to evaluate the effectiveness of pre-procedural rinsing when preforming periodontal prophylaxis in reducing aerosol contamination in the dental setting. Methods: A comprehensive standardized search strategy was employed, informed by a defined PICO question across four electronic databases. The review of the literature was conducted using the PRISMA framework. Agreement between assessors was determined throughout. Synthesis of study characteristics and key outcomes were conducted. Cochrane's risk-of-bias tool for randomized trials (RoB 2) was employed to assess the quality/bias among studies. Results: The initial search yielded 731 citations across the four databases; 95 potentially effective studies were identified, with 56 effective studies found. Thirty randomized control trial studies were identified, 21 with a focus on effectiveness of pre-procedural mouth rinsing, involving 984 participants (aged 18-70). Agreement between assessors was high (Kappa >0.80). Various pre-procedural mouth rinses were tested, most frequently chlorhexidine (CHX) in 18 studies. The concentrations, volume, and prescribed duration of rinsing varied among studies, hampering meta-analyses. Nonetheless, all studies identified significant reductions in bacterial contamination, as measured by colony forming units (cfu). The effectiveness of CHX over other agents was evident with more than half of the studies (7/15) reporting over a 70% reduction in bacterial contamination (cfu). There were concerns over the risk of bias in most studies (76.2%); 19.0% had a high risk of bias and 4.8% were of low risk of bias. Conclusion: There is substantial evidence to support pre-procedural mouth rinsing, such as with chlorohexidine, to effectively reduce aerosol contamination when performing periodontal prophylaxis compared to mouth rinsing with water or not rinsing.

Project description:BackgroundDental unit waterlines (DUWLs) provide water for handpieces, air/water syringes, and mouth-rinse water outlets. DUWL contamination can negatively affect the operating environment and public health. Therefore, it is important to elucidate the bacterial concentrations and microbial composition in the DUWLs from different dental specialties.MethodsWe collected 350 5-mL dental water samples (from high-speed handpieces, air/water syringes, and mouth-rinse water outlets) from 60 dental chair units (DCUs) at a dental hospital to determine the bacterial concentrations by culture methods. Meanwhile, to investigate the diversity and community structure of microbe in the DUWLs, 17 high-quality DNA from 60 250-mL air/water syringe water samples, which were collected from the same 60 DCUs, were analyzed using 16S rDNA high-throughput sequencing.ResultsThe median bacterial concentration was 166 (31.5, 672.5) CFU/mL and the range was 0-3,816,000 CFU/mL. Only 42.6% of the water samples had bacterial concentrations below 100 CFU/mL. The Kruskal-Wallis H-test revealed that the water samples from three dental specialties had significantly different bacterial concentrations (H = 27.441, P < 0.01). High-throughput sequencing results showed significant differences in bacterial community structure between periodontics and the other two dental specialties. In the samples from three dental specialties, 508 OTUs were detected, with 160, 182 and 176 OTUs unique to the periodontics, endodontics and prosthodontics specialties, respectively. Linear discriminant analysis (LDA) effect size (LEfSe) suggested that Hydrocarboniphaga, Zoogloea, Aquabacterium, and Hydrogenophaga were enriched in the periodontics specialty; Acinetobacter, Geothrix, and Desulfovibrio were enriched in the prosthodontics specialty; and Alistipes, Clostridium XIVa, and Serratia were enriched in the endodontics specialty. Seven potentially human-pathogenic genera (Pseudomonas, Acinetobacter, Sphingomonas, Ochrobactrum, Rhizobium, Brevundimonas, and Methylobacterium) with relative abundance exceeding 1% were also detected in the DUWLs.ConclusionsThe bacterial concentrations and microbial composition were influenced by different dental specialties, so a validated disinfection protocol should be used to control DUWL contamination in different dental specialties.

Project description:BackgroundGene transfer is an important tool for cellular therapies. Lentiviral vectors are most effectively transferred into lymphocytes or hematopoietic progenitor cells using spinoculation. To enable cGMP (current Good Manufacturing Practice)-compliant cell therapy production, we developed and compared a closed-system spinoculation method that uses cell culture bags, and an automated closed system spinoculation method to decrease technician hands on time and reduce the likelihood for microbial contamination.MethodsSepax spinoculation, bag spinoculation, and static bag transduction without spinoculation were compared for lentiviral gene transfer in lymphocytes collected by apheresis. The lymphocytes were transduced once and cultured for 9 days. The lentiviral vectors tested encoded a CD19/CD22 Bispecific Chimeric Antigen Receptor (CAR), a FGFR4-CAR, or a CD22-CAR. Sepax spinoculation times were evaluated by testing against bag spinoculation and static transduction to optimize the Sepax spin time. The Sepax spinoculation was then used to test the transduction of different CAR vectors. The performance of the process using healthy donor and a patient sample was evaluated. Functional assessment was performed of the CD19/22 and CD22 CAR T-cells using killing assays against the NALM6 tumor cell line and cytokine secretion analysis. Finally, gene expression of the transduced T-cells was examined to determine if there were any major changes that may have occurred as a result of the spinoculation process.ResultsThe process of spinoculation lead to significant enhancement in gene transfer. Sepax spinoculation using a 1-h spin time showed comparable transduction efficiency to the bag spinoculation, and much greater than the static bag transduction method (83.4%, 72.8%, 35.7% n = 3). The performance of three different methods were consistent for all lentiviral vectors tested and no significant difference was observed when using starting cells from healthy donor versus a patient sample. Sepax spinoculation does not affect the function of the CAR T-cells against tumor cells, as these cells appeared to kill target cells equally well. Spinoculation also does not appear to affect gene expression patterns that are necessary for imparting function on the cell.ConclusionsClosed system-bag spinoculation resulted in more efficient lymphocyte gene transfer than standard bag transductions without spinoculation. This method is effective for both retroviral and lentiviral vector gene transfer in lymphocytes and may be a feasible approach for gene transfer into other cell types including hematopoietic and myeloid progenitors. Sepax spinoculation further improved upon the process by offering an automated, closed system approach that significantly decreased hands-on time while also decreasing the risk of culture bag tears and microbial contamination.

Dataset Information

Effectiveness of a Closed-System Transfer Device in Reducing Surface Contamination in a New Antineoplastic Drug-Compounding Unit: A Prospective, Controlled, Parallel Study.

Background

Methods and findings

Conclusion

Publications

Effectiveness of a Closed-System Transfer Device in Reducing Surface Contamination in a New Antineoplastic Drug-Compounding Unit: A Prospective, Controlled, Parallel Study.

Similar Datasets

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