Interlaboratory Comparison of Analytical Methods for Residual Ethylene Oxide in Medical Device Materials

Marlowe, Donald E; Lao, Nelson T.; Eaton, A.R.; Page, B. F. J.; Lao, Chang S.

doi:10.1002/jps.2600760414

Cited by 13 publications

(6 citation statements)

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“…In most cases for the various EtO standard concentrations, the interlaboratory reproducibility was higher than the intralaboratory reproducibility (refer to Table 4), which is typical in most of these types of studies. Astonishingly, the reproducibility among several SPME fibers reported here is somewhat better than results from a previous interlaboratory comparison sanctioned by AAMI for quantifying residual EtO in medical devices materials (AAMI, 1995;Marlowe et al, 1987).…”

Section: Repeatability/reproducibilitycontrasting

confidence: 53%

Round‐robin evaluation of a solid‐phase microextraction–gas chromatographic method for reliable determination of trace level ethylene oxide in sterilized medical devices

Harper

Cushinotto

Blaszko³

et al. 2007

Biomedical Chromatography

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Medical devices that are sterilized with ethylene oxide (EtO) retain small quantities of EtO residuals, which may cause negative systemic and local irritating effects, and must be accurately quantified to ensure non-toxicity. The goal of this round-robin study is to investigate the capability of a novel solid-phase microextraction-gas chromatographic (SPME-GC) method for trace-level EtO residuals analysis: three independent laboratories conducted a guided experiment using this SPME-GC method, in assessing method performance, ruggedness and the feasibility of SPME fibers. These were satisfactory across the independent laboratories, at the 0.05-5.00 ppm EtO range. This method was then successfully applied to analyze EtO residuals in several sterilized/aerated medical devices of various polymeric composition, reliably detecting and quantifying the trace levels of EtO residuals present ( approximately 0.05 ppm EtO). SPME is a feasible alternative for quantifying trace-level EtO residuals in sterilized medical devices, thereby lowering the limit of quantification (LOQ) by as much as two to three orders of magnitude over the current GC methodology of direct liquid injection.

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Section: Repeatability/reproducibilitycontrasting

confidence: 53%

Round‐robin evaluation of a solid‐phase microextraction–gas chromatographic method for reliable determination of trace level ethylene oxide in sterilized medical devices

Harper

Cushinotto

Blaszko³

et al. 2007

Biomedical Chromatography

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show abstract

“…Some EtO-sterilized medical devices may retain trace quantities of EtO residuals even after controlled aeration at levels that cause local irritation in patients (Harper et al, 2008). Direct liquid injection gas chromatography (GC) analysis (Sandra et al, 2002) of acetonebased exhaustive extractions or conventional headspace (HS) analyzer-based sampling is still widely employed to analyze EtO residuals found in medical devices (AAMI, 1995;Marlowe et al, 1987;Gramiccioni et al, 1985). The sensitivity of the above approaches are adequate for quantifying EtO residuals when the medical device sample is large enough to contain detectable quantities of EtO residuals.…”

Section: Introductionmentioning

confidence: 99%

Optimization of a novel headspace–solid‐phase microextraction–gas chromatographic method by means of a Doehlert uniform shell design for the analysis of trace level ethylene oxide residuals in sterilized medical devices

DiCicco

Láng

Harper

2009

Biomedical Chromatography

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Medical devices sterilized by ethylene oxide (EtO) retain trace quantities of EtO residuals, which may irritate patients' tissue. Reliably quantifying trace level EtO residuals in small medical devices requires an extremely sensitive analytical method. In this research, a Doehlert uniform shell design was utilized in obtaining a response surface to optimize a novel headspace-solid-phase microextraction-gas chromatographic (HS-SPME-GC) method developed for analyzing trace levels of EtO residuals in sterilized medical devices, by evaluating sterilized, polymer-coated, drug-eluting cardiovascular stents. The effects of four independent experimental variables (HS-SPME desorption time, extraction temperature, GC inlet temperature and extraction time) on GC peak area response of EtO were investigated simultaneously and the most influential experimental variables determined were extraction temperature and GC inlet temperature, with the fitted model showing no evidence of lack-of-fit. The optimized HS-SPME-GC method demonstrated overall good linearity/linear range, accuracy, repeatability, reproducibility, absolute recovery and high sensitivity. This novel method was successfully applied to analysis of trace levels of EtO residuals in sterilized/aerated cardiovascular stents of various lengths and internal diameter, where, upon heating, trace EtO residuals fully volatilized into HS for extraction, thereby nullifying matrix effects. As an alternative, this novel HS-SPME-GC method can offer higher sensitivity compared with conventional headspace analyzer-based sampling.

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“…DMF, on the other hand, extracted many additional components from the plastic samples and quickly contaminated the inlet and column of the analytical instrument.” Water, however, worked well as an extraction solvent for this particular plastic. A separate study by Marlowe et al examined water, acetone, DMF, and thermal extraction using headspace for one acrylic sample. This study concluded that each method was suitable for residual EO analysis and that “neither water nor triple thermal extraction removed all the residual EO.” No attempt to exhaustively extract samples with DMF or acetone was made.…”

Section: Introductionmentioning

confidence: 99%

“…Previous investigations of EO extraction, and its dependence on specific methods and solvents, have provided some critical proofs of concept in the overall understanding of this important sterilant. [8][9][10][11][12][13][14][15] Danielson et al 10 compared water, acetone, and dimethyl formamide (DMF) as extraction solvents for a sterilized unspecified plastic solution administration set and alcohol pads. This study showed that "acetone was not a good choice of solvent, as it had a peak with the same chromatographic retention time as EO.…”

Section: Introductionmentioning

confidence: 99%

“…Water, however, worked well as an extraction solvent for this particular plastic. A separate study by Marlowe et al 11 examined water, acetone, DMF, and thermal extraction using headspace for one acrylic sample. This study concluded that each method was suitable for residual EO analysis and that "neither water nor triple thermal extraction removed all the residual EO."…”

Section: Introductionmentioning

confidence: 99%

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Solvent or thermal extraction of ethylene oxide from polymeric materials: Medical device considerations

et al. 2017

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Ethylene oxide (EO) gas is commonly used to sterilize medical devices. Bioavailable residual EO, however, presents a significant toxicity risk to patients. Residual EO is assessed using international standards describing extraction conditions for different medical device applications. We examine a series of polymers and explore different extraction conditions to determine residual EO. Materials were sterilized with EO and exhaustively extracted in water, in one of three organic solvents, or in air using thermal desorption. The EO exhaustively extracted varies significantly and is dictated by two factors: the EO that permeates the material during sterilization; and the effectiveness of the extraction protocol in flushing residual EO from the material. Extracted EO is maximized by a close matches between Hildebrand solubility parameters δ , δ , and δ . There remain complexities to resolve, however, because maximized EO uptake and detection are accompanied by great variability. These observations may inform protocols for material selection, sterilization, and EO extraction. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 2455-2463, 2018.

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Interlaboratory Comparison of Analytical Methods for Residual Ethylene Oxide in Medical Device Materials

Cited by 13 publications

References 1 publication

Round‐robin evaluation of a solid‐phase microextraction–gas chromatographic method for reliable determination of trace level ethylene oxide in sterilized medical devices

Round‐robin evaluation of a solid‐phase microextraction–gas chromatographic method for reliable determination of trace level ethylene oxide in sterilized medical devices

Optimization of a novel headspace–solid‐phase microextraction–gas chromatographic method by means of a Doehlert uniform shell design for the analysis of trace level ethylene oxide residuals in sterilized medical devices

Solvent or thermal extraction of ethylene oxide from polymeric materials: Medical device considerations

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